CML

Hi Amy,
I am not sure if anyone has replied to you yet but potassium levels
could also be affected by diuretics, especially Lasix. Lasix has been
known to seriously deplete potassium levels and it might sometimes be
necessary to take potassium supplements and or at least eat a banana or
so a day. This should definetly be followed by a doctor as this can be
quite serious.
Best,
Cheryl-Anne

My potassium has been low for the entire 5+ years I have been on
Gleevec. Luckily it has never gotten to a critical point, but it
has gotten low enough to be of concern.
Holly

Hey everyone!
I have met a person that was diagnosed w/ CML in September, started
Gleevec and had done ok, I think. Had a Gastric Bypass in January, and
started having problems with Potassium levels. No matter what they
tried her Potassium fell below normal levels and became critical. She
has been in and out of the hospital numerous times. I'm wondering if
anyone has had any problems with thier Potassium while/since being on
Gleevec. I myself have never heard of this problem......so just
checking with you all!
Thanks,
Amy B

Hi guys...just a quick update to say day five and i havent had a
headache for two days. looking good..but i wont count my chickens
before they hatch. A few leg aches but nothing a pill dosn't help. Off
to sydney tomorrow so looking forward to a great holiday with my friend.
Have a good week and ill try and find a interent cafe.
Susie Leech
Dx Nov 2002
Started BMS trial 8th March
# 675 Zero Club

Zavie - that's phenomenal! I hope it's due to the vaccine, because that
will be great news for all of us - but whatever the cause, congratulations.
You'll have to create a new category for your club: reaching zero without
drugs!!
Richard R

Dear Zavie,
This is a huge news!!! This really could be
breakthrough. Keeping fingers crossed! Toes too.
:-)Can you tell us more about the vaccine.
Cheers
Madhulika

Hi All,
In trying to catch up with the posts I missed while in Niger (Africa), I
came upon this one and the interchange leading up to it. The only thing I'd
add is that although Anjana is not an MD and isn't always 100% correct,
neither am I, even though I am an MD; moreover at this point I'm betting
that Anjana is quite a bit more current on the latest CML science than I am
since she spends so much more time on it that I do nowadays.
Recommendation to newbies, and everyone on the list: take the time to
educate yourself by reading this and other CML lists, ask questions whenever
you spot a contradiction or don't understand something that's said (if you
don't understand it, there's a great chance that others don't either, and
you'll be doing them a favor by asking), and take what everyone - including
your doctor - says with a grain of salt. Online support groups like this
aren't perfect, but they fill an important gap in health care. And the
amazing thing is that, while it's not unusual to find minor errors in any
given post (including some that I've flung out there), collectively over
time we almost always seem to get the story right. While I don't read or
post to the CML lists as often as I used to (I'm healthy so I'm busy with
the rest of my life again!), I still look upon them as lifesavers. They
sure were in the first couple of years (I was dx'd in '00), and I'm sure
they would/will be again if I suffer any sort of a setback. So thank you
Nancy, Anjana and ALL of you who keep these lists full of good stuff, and on
the straight-and-narrow.
All the best,
Richard R

March 12, 2006
A Cancer Drug's Big Price Rise Disturbs Doctors and Patients
By ALEX BERENSON
On Feb. 3, Joyce Elkins filled a prescription for a two-week supply of
nitrogen mustard, a decades-old cancer drug used to treat a rare form
of lymphoma. The cost was $77.50.
On Feb. 17, Ms. Elkins, a 64-year-old retiree who lives in Georgetown,
Tex., returned to her pharmacy for a refill. This time, following a
huge increase in the wholesale price of the drug, the cost was $548.01.
Ms. Elkins's insurance does not cover nitrogen mustard, which she must
take for at least the next six months at a cost that will now total
nearly $7,000. She and her husband, who works for the Texas Department
of Transportation, are paying for the medicine by spending less on
utilities and food, she said.
The medicine, also known as Mustargen, was developed more than 60
years ago and is among the oldest chemotherapy drugs. For decades, it
has been blended into an ointment by pharmacists and used as a topical
treatment for a cancer called cutaneous T-cell lymphoma, a form of
cancer that mainly affects the skin.
Last August, Merck, which makes Mustargen, sold the rights to
manufacture and market it and Cosmegen, another cancer drug, to
Ovation Pharmaceuticals, a six-year-old company in Deerfield, Ill.,
that buys slow-selling medicines from big pharmaceutical companies.
The two drugs are used by fewer than 5,000 patients a year and had
combined sales of about $1 million in 2004.
Now Ovation has raised the wholesale price of Mustargen roughly
tenfold and that of Cosmegen even more, according to several
pharmacists and patients.
Sean Nolan, vice president of commercial development for Ovation, said
that the price increases were needed to invest in manufacturing
facilities for the drugs. He said the company was petitioning insurers
to obtain coverage for patients.
The increase has stunned doctors, who say it starkly illustrates two
trends in the pharmaceutical industry: The soaring price of cancer
medicines and the tendency for those prices to have little relation to
the cost of developing or making the drugs.
Genentech, for example, has indicated it will effectively double the
price of its colon cancer drug Avastin, to about $100,000, when
Avastin's use is expanded to breast and lung cancer patients. As with
Avastin, nothing about nitrogen mustard is changing but the price.
The increases have caused doctors to question Ovation's motive and
left lymphoma patients wondering how they will afford Mustargen, which
is sometimes not covered by insurance, because the drug's label does
not indicate that it can be used as an ointment. When given
intravenously to treat Hodgkin's disease, its other primary use, the
drug is generally covered by insurance.
"Nitrogen mustard has been around forever," said Dr. Len Lichtenfeld,
the deputy chief medical officer of the American Cancer Society.
"There's nothing that I am aware of in the treatment environment that
would explain an increase in the cost of the drug."
Dr. David H. Johnson, a Vanderbilt University oncologist who is a
former president of the American Society of Clinical Oncology, said he
had contacted Ovation to ask its reasons for raising Mustargen's price.
"I'd like to have some evidence from them that it actually costs them
X amount, so that the pricing makes sense," Dr. Johnson said.
"It's unfortunate that a price adjustment had to occur," Mr. Nolan
said. "Investment had not been made in these products for years."
Ovation, a privately held company, also needs the money to conduct
research on several new drugs for rare diseases, Mr. Nolan said.
He acknowledged that Merck still made Mustargen and Cosmegen, an
antibiotic that is used to treat a rare childhood kidney cancer, for
Ovation. He said he was not sure when Ovation would begin producing
the drugs, and a Merck spokesman said that Merck would continue to
provide the drugs to Ovation as long as necessary.
But people who analyze drug pricing say they see the Mustargen
situation as emblematic of an industry trend of basing drug prices on
something other than the underlying costs. After years of defending
high prices as necessary to cover the cost of research or production,
industry executives increasingly point to the intrinsic value of their
medicines as justification for prices.
Last year, in his book "A Call to Action," Henry A. McKinnell, the
chairman of Pfizer, the world's largest drug company, wrote that drug
prices were not driven by research spending or production costs.
"A number of factors go into the mix" of pricing, he wrote. "Those
factors consider cost of business, competition, patent status,
anticipated volume, and, most important, our estimation of the income
generated by sales of the product."
In some drug categories, such as cholesterol-lowering treatments, many
drugs compete, keeping prices relatively low. But when a medicine does
not have a good substitute, its maker can charge almost any price. In
2003, Abbott Laboratories raised the price of Norvir, an AIDS drug
introduced in 1996, from $54 to $265 a month. AIDS groups protested,
but Abbott refused to rescind the increase.
And once a company sets a price, government agencies, private
insurers, and patients have little choice but to pay it. The Food &
Drug Administration does not regulate prices, and Medicare is banned
from considering price in deciding whether to cover treatments.
While private insurers can negotiate prices, they have limited leeway
to exclude drugs from coverage based on price, said C. Lee Blansett, a
partner at DaVinci Healthcare Partners, which works with drug makers
on pricing and marketing.
"Price is simply not included in whether or not to cover a drug," Mr.
Blansett said.
The result has been soaring prices for some drug classes, notably
cancer treatments. In 1992, Bristol-Myers Squibb faced protests for
its plans to charge $4,000 a year for Taxol, a breast cancer
treatment. Now, most new cancer treatments are priced at $25,000 to
$50,000 annually. In some cases, companies are pushing through
substantial price increases on already-expensive drugs.
Last year, Genentech raised the price of Tarceva, a lung-cancer drug,
by about 30 percent, to $32,000 for a year's treatment. In an
interview last month, Dr. Susan Desmond-Hellmann, the president of
product development for Genentech, said that the company had raised
Tarceva's price because the drug works better than Genentech had
anticipated.
"Tarceva was a more powerful and more active agent than what we
understood at the time of launch, and so more valuable," she said. In
an environment of soaring cancer drug costs, Mustargen's previous
price was a comparative bargain, giving Ovation the opportunity to
raise it substantially, said Dr. Richard Hoppe, a professor of
radiation oncology at Stanford University and an expert in treating
cutaneous lymphoma.
Mustargen's patent protection expired many years ago, so any company
can make it. But because its sales are tiny, no drug maker has
invested in a generic version.
"There's only one company that makes the drug, and they can decide
what it's worth," Dr. Hoppe said.
Nitrogen mustard was initially tested as a chemical weapon. Its
properties as an anti-cancer agent were discovered more than 60 years
ago; today, it has been superseded by newer, less toxic medicines, and
it is a niche product, with sales of only $546,000 in 2004, according
to IMS Health, a market research firm.
Still, Dr. Hoppe and other oncologists call nitrogen mustard an
effective treatment for cutaneous lymphoma, which initially appears as
a rash but can turn deadly if it spreads inside the body. Some
patients need only tiny amounts of the ointment, but others must apply
it every day across large areas of their bodies.
Mr. Nolan of Ovation said that his company intended to work to improve
access to insurance coverage for Mustargen. But Ovation has just begun
to petition insurers to cover the drug. Meanwhile, patients are paying
Mustargen's new, higher price out of pocket.
This is not the first time that Ovation has sharply raised the price
of a drug it owns. In 2003,the company bought Panhematin, a treatment
for a rare enzymatic disease called porphyria, from Abbott
Laboratories. While Abbott still produces Panhematin, Ovation raised
Panhematin's price, which had been $230 a dose, to $1,900, according
to Desiree Lyon, executive director of the American Porphyria Foundation.
"It was a major increase," Ms. Lyon said. But she said that Ovation
had worked to improve insurance coverage for Panhematin and find ways
for patients to get the drug even if they could not afford it.
Ovation also financially supports the porphyria foundation in its
efforts to increase awareness of the disease and of Panhematin as a
treatment, she said.
But many patients who rely on expensive drugs are stuck in a bind. Don
Schare of Saratoga, Calif., said he paid $1,260 last month for 200
grams of nitrogen mustard cream, about 10 times what he paid for his
prior prescription. Mr. Schare, 69, said he was covered by the new
Medicare Part D drug program as well as supplemental insurance from
AARP, but that neither of his plans covered Mustargen.
Jeffrey Malavasic, 58, a retired railroad worker in Florence, Ore.,
said he had decided to fill only half of his Mustargen prescription
when he learned of the price increase. He used the drug sparingly in
the past and will be even more frugal, he said.
But Ms. Elkins has a severe case of lymphoma and must cover much of
her body with Mustargen each day. She said that the ointment was
working, so she and her husband would find a way to pay for it.

Congratulations Perry!
With best wishes from your friends in Montreal and the CML Society.
Cheers and best wishes for continued success.
Cheryl-Anne

Hi all, got home today after a 7 to 8 hour drive. I had my biopsy
yesterday and started my new BMS drug in the afternoon. Im on 100mg
daily and so far..ive had just a slight headache. fingers cross it wont
be anymore than that..I know its only early days...but so far looking
good. Having blood test in adelaide on 22nd so will know more whats
happending...then.
Have a great weekend and will keep you posted.
Susie Leech
Dx Nov 2002
started BMS 8th March 2006
# 675 Zero Club

I've been on Gleevec for almost 4 years and I have not lost any
weight. My weight seems to have stabilized & is not going up. It
seems like the people who have lost weight have done it by going to
Weight Watchers and exercising and really working hard to get the
weight off.
Mary K
haven't some of you experienced some loss of weigh after 2 or 3 years
of treatment??

Hi all,
I'm posting below a discussion in the wake of the ASH meeting. This is
from a series about CML from ASH that I am privvy to. I'm not posting
them all because there are too many (62 pages in a pdf) but will post
some of them. I have also removed links and references for my
convenience.
Below is the fifth and last one I am posting.
~Jennifer G.
www.cmlsupport.com <http://www.cmlsupport.com/
===================
Activity and Safety of Dasatinib in CML and Ph+ ALL
Allen Yang, MD, PhD:
The next set of abstracts specifically deals with dasatinib therapy.
Stephen O'Brien, MD:
A total of 529 patients have been evaluated in the dasatinib phase I and
II studies. The results of the 84-patient phase I study, originally
launched in 2003 for patients with CML and Ph+ ALL, were updated. The
dasatinib phase II dasatinib studies initiated in February 2005 were
designed for CML patients by stage of disease, as well as for patients
with Ph+ ALL, and included more than 1000 patients. Results from the
first 445 phase II patients were presented.
Because follow-up is quite short at only 5 to 6 months, we have to be
cautious about interpreting these data. However, the rates of
cytogenetic response are fairly encouraging, especially considering that
these patients failed prior imatinib therapy.
Dr. Apperley, you helped lead the START-A study, a phase II
investigation of dasatinib in imatinib-resistant or intolerant patients
with CML in the accelerated phase (Capsule Summary).[31] The results, as
presented here at ASH by Dr. Guilhot, suggest that dasatinib has
significant efficacy in this population, and most patients with BCR-ABL
point mutations had a response. A total of 107 patients were reported;
complete hematologic response was seen in 35 patients (33%) and no
evidence of leukemia in 28 (26%), for a major hematologic response rate
of 59%. Major cytogenetic responses were seen in 31% of patients
including complete cytogenetic response in 21%. Again, hematologic
toxicity was substantial, but manageable; the most common grade 3/4
hematologic toxicity was thrombocytopenia, occurring in 85 patients
(79%), and nonhematologic toxicities were usually mild or moderate.
Dr. Talpaz and colleagues[33] reported on START-B, a phase II study of
dasatinib in imatinib-resistant/intolerant patients with CML in myeloid
blast crisis (Capsule Summary). In this report on the first 74 patients,
hematologic response was seen in 51% of patients, and complete
cytogenetic responses were seen in 27% of patients. Responses were seen
both in patients who had BCR-ABL domain mutations and in
imatinib-resistant patients without mutations. Treatment was associated
with grade 3/4 myelosuppression, which occurred in the majority of
patients but was manageable with treatment interruptions. Nonhematologic
toxicities were not common and were typically grade 1 or 2. Given the
short follow-up, these results are quite encouraging.
We also saw a presentation of the START-C phase II study of dasatinib in
patients with imatinib-resistant or intolerant chronic phase Ph+ CML
(Capsule Summary).[8] These patients seemed to respond extremely well.
In this analysis that included 186 patients, hematologic response was
seen in 90%, and there were high rates of major cytogenetic response:
45% overall and 73% among imatinib-intolerant patients. Responses were
durable, according to investigators, with 86% of patients remaining on
therapy at 6 months. There was no progression among patients who had
achieved major cytogenetic response.
Finally, Dr. Ottmann reported results of START-L, a phase II study of
dasatinib in patients resistant or intolerant to imatinib with CML in
lymphoid blast crisis or Ph+ ALL (Capsule Summary).[34] Major
hematologic response was reported in 13 (31%) of 42 patients in lymphoid
blast crisis and in 15 (42%) of 36 of the Ph+ ALL patients. Rates of
complete cytogenetic response were 43% and 58% in those groups,
respectively. Again, myelosuppression was common, and grade 3/4
nonhematologic toxicities were uncommon.
Allen Yang, MD, PhD:
With regard to these data, when should community oncologists consider
referring imatinib-resistant patients to trials with these new tyrosine
kinase agents, and which trial should they consider first?
Jane Apperley, MD:
That is difficult to answer. I think these new agents are extremely
valuable additions to the armamentarium for patients with CML.
Determining the moment that a patient fails imatinib has been a
controversial issue for the last couple of years for hematologists
around the world. But there are some very clear indications as to when
failing patients should be referred to clinical trials, such as loss of
a previous hematologic, cytogenetic, or molecular response. The failure
to achieve a cytogenetic response by 6 months or 12 months may also
indicate a need for referral to clinical trial, because the IRIS study
has informed us that those patients are not going to do as well as
others.[1]
Stephen O'Brien, MB ChB:
It may be a while before either of these agents receives US Food and
Drug Administration (FDA) approval. So, there may need to be some sort
of early access or expanded access program that makes the drugs more
fully available. However, the nature of such programs has not been
clearly defined yet.
Allen Yang, MD, PhD:
What about these agents in the context of transplants? Traditionally,
after imatinib failure, patients would opt for transplant if a donor was
available. Now, with these drugs on the horizon, has your thinking about
transplantation changed?
Stephen O'Brien, MD:
It depends. For a young patient who is failing imatinib and has a good
donor, I would be very hesitant to recommend one of these new and as yet
unproven drugs when there is a potentially curative therapy available.
There would have to be very good reasons not to transplant that patient.
But as we discussed earlier, it is completely different for the
68-year-old who does not have a viable transplant option. In that case,
I would consider using one of these new agents.
Jane Apperley, MD:
In my opinion, it depends on why the patient has failed imatinib. A
patient who has progressed to an advanced phase of disease may derive
some temporary benefit from one of the new agents but is unlikely to be
cured or to have long-term survival. For these individuals, transplant
should be considered much earlier. For the individual in chronic-phase
CML without a 3 log10 reduction in molecular expression, it is an
entirely different matter.
Hagop Kantarjian, MD:
In that context, mutational analysis would be important, particularly if
specific mutations are detected that we know do not respond to the new
kinase inhibitors. In this circumstance, there is no point in enrolling
patients with those types of mutations in studies with these new agents.
Transplantation or alternative strategies that do not depend on mutation
status may make more sense.
Stephen O'Brien, MB ChB:
To summarize, the efficacy data for both these agents are exciting and
promising. We are awaiting further follow-up with great interest.
Hematological toxicity seems to be common with both agents and requires
frequent dose reductions.
Allen Yang, MD, PhD:
One of the differences between the new agents and imatinib is that,
although they all cause edema, there appears to be a higher incidence of
grade 1 and 2 pleural and pericardial effusions with the new tyrosine
kinase inhibitors. Most of this occurs in patients with advanced-phase
disease. Although few patients have discontinued treatment because of
these problems, they are new problems to be aware of.
Hagop Kantarjian, MD:
The incidence of peripheral edema and severe peripheral edema appears to
be less common with the new kinase inhibitors than with imatinib. The
pleural effusions with imatinib are severe in about 1%-2% of patients,
and there are anecdotal reports of pleural-pericardial events. Severe
effusions did occur in the phase I and in the phase II dasatinib
studies, with more events observed in blast crisis than in the chronic
phase, and in the twice-daily higher-dose schedules than with the
once-daily lower-dose schedules. But if identified early, treatment can
be interrupted, or doses can be adjusted. Additionally, with the use of
diuretics like furosemide or steroid therapy, these effusions may not
become clinically significant.
Jane Apperley, MD:
Many patients were enrolled in these trials because they were intolerant
to imatinib because of skin rashes or abnormal liver function studies.
There does not seem to be cross-toxicity; people who develop abnormal
liver function studies on imatinib do not seem to have abnormal liver
function results with the new agents. I find that fascinating, because
the incidence of grade 1/2 liver abnormalities is common with both
agents.
Stephen O'Brien, MB ChB:
On the other hand, we found patients who had skin rashes on imatinib who
also got skin rashes on AMN107.
Jane Apperley, MD:
Our phase II dasatinib trial had only 22 patients who enrolled because
of abnormal liver function studies, and none of them developed serious
abnormal liver function test results (Capsule Summary).[31]
Hagop Kantarjian, MD:
Some of the patients in our phase II dasatinib study enrolled because of
severe intolerance to imatinib-mostly extramedullary toxicity, such as
liver dysfunction, rashes, severe muscle aches, bone aches, and cramps
(Capsule Summary).[33] As 40t does not appear that there is
cross-toxicity across these 2 agents.
Allen Yang, MD, PhD:
What do you predict for the future with these agents? Should they be
used in combination? Are they to be used for imatinib-resistant patients
only? Are they ever going to be used as upfront treatment?
Stephen O'Brien, MD:
For the time being, I think the most obvious role is going to be in the
context of imatinib failure. I anticipate that studies will explore
their use in first-line therapy. We have very few, if any clinical data
to suggest that combination treatment is safe, viable, or desirable.
However, I think that is inevitably going to be explored over the next
year or so.
Jane Apperley, MD:
I think there will undoubtedly be studies exploring combination
therapies. Whether the toxicity of combining 2 or more agents will be
acceptable is another matter, in view of the extent of hematologic
toxicity observed with single-agent dasatinib and AMN107.

Thanks for the postings from ASH, I found them all to be very informative
and interesting. Glad to read so much positive information.
Jennifer

Hi all,
I'm posting below a discussion in the wake of the ASH meeting. This is
from a series about CML from ASH that I am privvy to. I'm not posting
them all because there are too many (62 pages in a pdf) but will post
some of them. I have also removed links and references for my
convenience.
Below is the first one.
~Jennifer G.
www.cmlsupport.com
=======================================
Long-term Treatment With Imatinib: 5-Year Update (IRIS)
Allen Yang, MD, PhD:
Let us begin our discussion of the recent American Society of Hematology
(ASH) meeting with Dr. Simonsson's presentation, which provided
long-term follow-up evaluation of cytogenetic and molecular responses in
newly diagnosed chronic myeloid leukemia (CML) patients treated with
imatinib in the IRIS (International Randomized IFN vs STI571) study
(Capsule Summary).[1]
Jane Apperley, MD:
This was a highly anticipated follow-up of the IRIS study, which
included 1106 patients with newly diagnosed chronic-phase CML randomized
to receive imatinib or interferon/cytarabine. As reported 2 years ago in
the New England Journal of Medicine, the estimated rate of complete
cytogenetic response was 76.2% for patients in the imatinib arm vs 14.5%
in the interferon/cytarabine arm (P < .001) at a median follow-up of 19
months.[2] Progression to accelerated-phase or blast-crisis CML was
significantly less common in the imatinib group. In a subsequent report
later that year, Dr. Hughes and colleagues[3] indicated that many more
patients in the imatinib arm had a 3 log10 or greater reduction in
BCR-ABL transcript levels after 12 months of therapy. Furthermore,
patients achieving that level of response had an essentially negligible
risk of disease progression.
At this meeting, Dr. Simonsson and colleagues focused their attention on
the imatinib arm of the IRIS study. They found that there was an 86%
rate of complete cytogenetic remission by 54 months on imatinib, as well
as very good progression-free and overall survival, even among patients
with high-risk Sokal scores. Patients were analyzed according to the
depth of molecular response that they had previously achieved at 12
months, with a reduction in BCR-ABL transcripts of 3 log10 or greater
defined as a major molecular response. Survival without progression to
accelerated phase or blast crisis at 54 months was 100% in patients who
at 12 months had achieved a major molecular response. By comparison,
survival without progression was 95% for patients who had a cytogenetic
response that did not surpass that 3 log10 level and 89% for patients
who at 12 months had not achieved a cytogenetic response (P < .001).
These results suggest that complete cytogenetic remission is a good
prognostic indicator.
Hagop Kantarjian, MD:
The previous publication by Dr. Hughes and colleagues emphasized
progression-free survival, which was defined as maintenance of best
cytogenetic response. By contrast, the current analysis utilizes major
molecular response. Nevertheless, all patients who have a complete
cytogenetic response appear to be doing well at 5 years' follow-up.
Stephen O'Brien, MB ChB:
This presentation of longer-term data is important because it tells us
not only who is doing well but who might not do well in the long term.
We have to remember that many of these patients do not achieve the gold
standard therapeutic target of major molecular response. Although these
results are encouraging, there is still work to be done to improve the
major molecular response rate.
Jane Apperley, MD:
One additional consideration is that these data do not reveal what
proportion of patients loses these major molecular responses. If it is a
relatively small proportion, we do not have to worry. What is really
important is the fact that we have changed how we define progression.
Formerly, progression meant loss of best response. Now, progression is
defined as real progression to advanced-phase disease. We do have other
therapies that can be employed when best response is lost. For these
patients and their physicians, the critical factor is whether they
develop accelerated-phase or blast-crisis CML.
Hagop Kantarjian, MD:
You have highlighted an important point. Last year, Dr. Silver and
colleagues[4] calculated that the rate of loss of best response was
about 4% per year in the first 4 years after initiation of imatinib
therapy.However, the transformation to accelerated phase and blast
crisis is about 2% per year. Therefore, one half of the patients who
lose their best response continue to do well, whereas the other half
progress to more advanced disease. For those who lose their best
response but do not progress clinically, there is need for alternative
therapies, such as the new kinase inhibitors. For those eligible
patients, this might also mean referral to an allogeneic transplant
program.
Jane Apperley, MD:
Another important point about these results is that the rate of
development to blast phase appears to decrease with time, which
contrasts markedly with historical data.[5]

Hi all,
I'm posting below a discussion in the wake of the ASH meeting. This is
from a series about CML from ASH that I am privvy to. I'm not posting
them all because there are too many (62 pages in a pdf) but will post
some of them. I have also removed links and references for my
convenience.
Below is the third one.
~Jennifer G.
www.cmlsupport.com <http://www.cmlsupport.com/
===================
High-Dose Imatinib in Patients With Early Chronic-Phase CML
Allen Yang, MD, PhD:
In another interesting abstract presentation by Dr. Cortes and
colleagues,[12] 115 patients with early chronic-phase CML were given 800
mg of imatinib per day, compared with the standard dose of 400 mg per
day in a phase II study (Capsule Summary). This study was initiated
after single-center data from last year at ASH that showed higher
12-month complete molecular responses to imatinib at 800 mg per day
(Capsule Summary).[13]
Hagop Kantarjian, MD:
Both preclinical and early clinical data suggest that doubling the dose
of imatinib may result in an earlier and higher rate of complete
cytogenetic response, without increased toxicity,[14] thereby increasing
the likelihood of achieving a major molecular response. The potential
scientific implication is that attacking the disease earlier and more
intensely may prevent development of resistance and mutations, which may
ultimately improve the long-term prognosis.
As reported by Dr. Cortes, this strategy produced early and high rates
of molecular response, including a disease reduction of 4 logs or
greater. Major molecular response and complete molecular response at 1
year were 64% and 54%, respectively, which are better than response
rates reported with imatinib 400 mg daily by that time point.
Although the results do appear to be promising, the study also raises
several concerns. The first is that doubling the dose of imatinib would
double the costs of the treatment. Secondly, none of these studies has
shown a significant improvement in progression-free survival or overall
survival. A third criticism is that doubling the dose of imatinib may
not make sense, given the fact that the new kinase inhibitors are 50 to
300 times more potent. Although the concept of dose-dense imatinib was
and still is interesting, high-dose imatinib is probably going to be
relegated to second-tier treatment status as we continue to study the
new kinase inhibitors. In addition, although this study does demonstrate
that imatinib dose intensification can result in earlier and higher
rates of complete cytogenetic and major molecular responses, the rate of
major molecular response appears to plateau over time at around 70% for
both the 400-mg and 800-mg regimens. Therefore, why give 800-mg
treatment when the same results could be obtained with longer duration
of 400-mg treatment?
The rates of 4 log10 reduction or more, or PCR negativity, continue to
be promising at approximately 3 years in the MD Anderson study, although
follow-up is currently very short. However, the bottom line is that
treatment with high-dose kinase inhibitors is an interesting concept in
terms of reducing early the levels of minimal residual disease, and it
may prevent the development of mutations (eg, the BCR-ABL mutation
T315I) that lead to resistance.

Hi all,
I'm posting below a discussion in the wake of the ASH meeting. This is
from a series about CML from ASH that I am privvy to. I'm not posting
them all because there are too many (62 pages in a pdf) but will post
some of them. I have also removed links and references for my
convenience.
Below is the fourth one.
~Jennifer G.
www.cmlsupport.com <http://www.cmlsupport.com/
===================
Matching Patient Response to Optimal Imatinib Dosing
Allen Yang, MD, PhD:
This discussion raises important clinical questions for the community
physician. What is the optimal dose of imatinib? When should a dose
higher than 400 mg be used? Should higher doses be reserved only for
accelerated-phase or blast-crisis CML? Should the dose be increased only
when patients do not achieve molecular milestones, or should dose
increases be based on how patients feel?
Hagop Kantarjian, MD:
I think the general feeling among most of the investigators in this
field is that for most newly diagnosed patients with CML, the standard
dose of 400 mg is enough, whereas higher doses should be used only in
selected instances such as accelerated-phase or blast-crisis CML or for
patients who either failed to achieve an optimal response or have lost
their optimal response. More specifically, high-dose imatinib is
probably warranted when standard therapy has failed to produce a
complete hematologic response at 3 months or a major cytogenetic
response at 12 months, or when either cytogenetic or hematologic
response has been lost. Other than these instances, I think high-dose
imatinib remains investigational and should not be used in community
practice.
Stephen O'Brien, MB ChB:
I think that is a fair assessment of when to increase the dose. In
practice, however, it is actually quite difficult to deliver the higher
doses in most of those patients because of both hematologic and
nonhematologic toxicity.
Jane Apperley, MD:
That is a good point. It has been noted that the development of
cytopenias in those first few months is definitively associated with a
poorer outcome.[16] However, we need to ask ourselves whether the poor
outcome is biologically destined in that individual patient or whether
the cytopenias prevent delivery of optimal drug doses.
There is a lack of consensus as to what to do when a patient is clearly
losing response. Although the natural inclination is to increase the
dose, I think it is important to consider why the patient is losing the
response and to consider sending samples to a major center to look for
mutations. Such an analysis could reveal reasons for the loss of
response that could alter the subsequent treatment strategy.
Allen Yang, MD, PhD:
Would you send samples for analysis if the patient has had a molecular
relapse, or would you wait?
Jane Apperley, MD:
I think any major change in a patient's condition, such as a change from
a molecular response to nonmolecular response, the loss of a cytogenetic
response, or the loss of hematological response would be a reason to
send samples for molecular analysis. We are looking quite carefully at
why loss of response occurs, and it is clear from the available data
that some of these mutations are not responsive to the new agents or to
higher doses of existing therapy.
Hagop Kantarjian, MD:
Unfortunately, mutation analysis is not available to the vast majority
of physicians and patients. Furhthermore, the significance of those
mutations remains uncertain, not to mention what is to be done once
those mutations are detected. Several studies have shown that if a
patient has cytogenetic or hematologic relapse, or shows a significant
rise in molecular disease on PCR, then those mutations, if detected,
have clinical relevance.[17-21] They may predict lack of response not
only to imatinib but also to the new kinase inhibitors, necessitating a
major change of therapy.
On the other hand, we may detect mutations that are worrisome but not
necessarily relevant in patients who are responding. We have to monitor
those patients and perhaps stop sending samples from patients who are
responsive. However, we should continue sending samples to detect
mutations in patients who are not responsive by accepted criteria, such
as hematologic relapse, cytogenetic relapse, or a significant rise in
molecular disease. In those instances, if particularly relevant
mutations such as T315I are detected, it may not make sense to give
high-dose imatinib or one of the new kinase inhibitors. Rather, it may
make more sense to take these patients to immediate transplant.
Allen Yang, MD, PhD:
Dr. O'Brien, what do you do if you find a T315I mutation in a sequencing
analysis of BCR-ABL?
Stephen O'Brien, MB ChB:
This is an excellent question. Contradictory data were presented at this
meeting about the relevance of that particular mutation. For example,
Dr. Sherbenou and colleagues[20] showed that T315I could be detected,
yet seemed to have no clinically significant effects, in patients with
complete cytogenetic responses. So it does not appear that having T315I
will inevitably lead to clinical problems. I think that monitoring by
PCR and then perhaps performing mutation analysis is an absolutely
cost-effective, reasonably evidence-based approach. Regular PCR
monitoring should trigger a mutation analysis if there is a significant
increase in molecular disease. What is deemed significant can be
debated, but it is usually fairly apparent.
Hagop Kantarjian, MD:
There are many studies on the significance of mutations in the context
of imatinib therapy in CML. The bottom line is that the significance of
any given mutation depends on several factors: the context (eg,
responsive disease vs resistant disease), the kind of mutation (eg,
T315I vs less important mutations), and what to do once the mutation is
detected. Depending on these factors, imatinib therapy may or may not
help. Another important question is when is it necessary to act on those
mutations? The study from Dr. Sherbenou evaluated patients who were in
cytogenetic response. There were 8 patients who had T315I mutations.
Although several of those patients progressed, some patients who had the
mutation did quite well. Importantly, one could not detect any
difference in outcome solely on the basis of whether a patient had
mutations, regardless of if they were P-loop or non-P-loop mutations, or
if there was a T315I mutation. This just proves that studies in
cytogenetically responsive disease may generate misleading data and that
the discovery of mutations in otherwise asymptomatic patients should not
necessarily be interpreted in the same way as mutations found in
resistant disease.
Jane Apperley, MD:
This point about mutations is quite important but needs to be confirmed
by other groups, because mutation analysis is highly dependent on the
detection methods and standards of sensitivity that are employed.

Hi all,
I'm posting below a discussion in the wake of the ASH meeting. This is
from a series about CML from ASH that I am privvy to. I'm not posting
them all because there are too many (62 pages in a pdf) but will post
some of them. I have also removed links and references for my
convenience.
Below is the second one.
~Jennifer G.
www.cmlsupport.com
===================
Residual Disease Reduction With Longer-Term Imatinib Treatment (IRIS)
Allen Yang, MD, PhD:
In another follow-up presentation of IRIS data, Dr. Goldman and
colleagues[6] evaluated levels of cytogenetic response, including major
molecular response, at 4 years (Capsule Summary). As part of a subset
analysis of 124 patients who had achieved complete cytogenetic remission
at 1 year and had tissue samples available for polymerase chain reaction
(PCR) analysis at 4 years, the investigators reported a significant
increase in the reduction of molecular disease over time. The results
show that as patients continue imatinib therapy, the amount of minimal
residual molecular disease continues to decrease, rather than plateau or
increase (paired t test: P < .0001), with a mean log reduction of 3.14
and 3.54 at 1 and 4 years, respectively, and a median log reduction of
3.08 and 3.78 at 1 and 4 years. Furthermore, the proportion of these 124
patients with more than a 4 log10 reduction in BCR-ABL transcripts
increased from 22%-41% over that same time period. These data suggest
that continuous therapy is important and may be one of the reasons for
the reduction in the annual rate of transformation to accelerated-phase
or blast-crisis CML.
Jane Apperley, MD:
I think we should be careful about the interpretation of these data,
which encompass only a subset of the 397 patients in IRIS who remain on
first-line imatinib. I would like to know what is happening to the
patients who were not included in this analysis.
Allen Yang, MD, PhD:
I think that the important point about this abstract is that after 4
years, patients were still converting from being PCR positive to being
PCR negative. Based on these findings, how should a community physician
treat patients who after 2 or 3 years still have not achieved a
complete, major molecular response by PCR? Should they continue
treatment? Should they consider additional therapies?
Hagop Kantarjian, MD:
Actually, most experts are cautious about the interpretation of PCR
results from commercial laboratories. Rather than discussing PCR
negativity, I think it is better to talk about a reduction in molecular
disease of 4 logs or more, which goes beyond the minimum requirement for
major molecular response. However, detecting this level of disease can
result in significant amounts of false-positive and false-negative
results. Notwithstanding, investigators are reporting increasing rates
of disease reduction by 4 logs or more. For example, in the article
published by Hughes, the Australians showed that more than 50% of
patients achieved a cumulative log reduction rate of 4 or more at 5
years, which is an incredible percentage.[3] How should we interpret
this? If, after many years, a patient does not have at least a 3 log10
reduction in the amount of disease, should we intervene? From a clinical
point of view, the vast majority of these patients are asymptomatic.
From the scientific and research point of view, these patients might be
ideal candidates for interventions, such as vaccines or nonspecific
immune therapy, like interferon, that stimulate the immune system. It is
also possible that some of the new kinase inhibitors may be useful in
this setting.
Stephen O'Brien, MB ChB:
I concur. PCR is not yet so robust or standardized that we can depend on
it as a completely reliable tool for disease monitoring. We are
confident that achieving a 3 log10 reduction or a major molecular
response is an important endpoint, but failure to achieve that endpoint
does not necessarily indicate failure of therapy. I think it is
premature to say that anyone who does not achieve a 3 log10 reduction
after 2 years should change treatment or increase their dose of
imatinib, especially since we are now seeing improved responses after
several years in some of these patients.
Jane Apperley, MD:
It is true that the Europeans have been very enthusiastic about
monitoring response by PCR, whereas clinicians in the United States have
typically monitored their patients with fluorescence in situ
hybridization (FISH). Previously, I supported the European view
regarding PCR monitoring, but now, after reading Dr. Simonsson's results
from his long-term IRIS study follow-up, I wonder whether the
achievement of complete cytogenetic response is actually good enough. It
is obviously important to know when a patient is "failing" therapy,
however failure may be defined, as long as there is some alternative
therapy to offer. In the case of young patients with potential donors
for transplant, monitoring should be performed very carefully in order
to identify failure as early as possible. For older patients who are not
candidates for transplant, failure to respond might justify switching
them to one of the new tyrosine kinase inhibitors. Although long-term
durability has not yet been proven in this situation, studies we will
discuss today suggest that the next generation of tyrosine kinase
inhibitors is quite effective in the short term.[7-9]
Allen Yang, MD, PhD:
Do you still perform PCR for your patients who are not transplant
candidates?
Jane Apperley, MD:
Yes. We monitor PCR to identify the patient who is doing poorly.

Hello Tracey,
From what I have heard, the brand name will not be unveiled until FDA
approval. Of course, in this new age of the internet, it will be
interesting to see if we do not fid out sooner.
Cheers,
Cheryl-Anne

Hello Susie,
nice talking with you today.
I hope all goes well with your trial.
When did you have your BMB?
Forgot to ask you that.
Talk to you hopefully tomorrow if all goes well at the hospital.
Take care....
Ursula
Susie <leechys@...
Hi everyone just wanted to let you all know that ive started the new
drug BMS today...im on 100mg in one hit everyday. Really looking
forward to it and hoping all goes well...
going home tomorrow, keep you posted..
Susie Leech
Dx Nov 2002
Started BMS 8th March 2006
# 675 Zero Club
SPONSORED LINKS
Individual medical Cml Leukemia Health professional Cancer
center

Hi Ursula,
Sorry to hear that you ran into these problems so early in the game.
Were you randomized to the 140 mg dose in one shot? This could be the
cause. Many patients have had their doses reduced because of side
effects and have done much better.
Zavie
Zavie Miller (age 67)
67 Shoreham Avenue
Ottawa, Canada, dxd AUG/99
INF OCT/99 to FEB/00, CHF
No meds FEB/00 to JAN/01
Gleevec since MAR/27/01 (400 mg)
CCR SEP/01. #102 in Zero Club
PCRU 5/02 at RVH
2.8 log reduction Sep/05
3.0 log reduction Jan 06
e-mail: zmiller@...
Tel: 613-726-1117
Fax: 309-296-0807
Cell: 613-202-0204

Hi everyone just wanted to let you all know that ive started the new
drug BMS today...im on 100mg in one hit everyday. Really looking
forward to it and hoping all goes well...
going home tomorrow, keep you posted..
Susie Leech
Dx Nov 2002
Started BMS 8th March 2006
# 675 Zero Club

Hi all,
I had the second BMB earlier. They did the first important part only today,
said the more painful biopsy was not necessary this time. That was last done
for diagnosis 3 months ago.
I took an Ativan before hand and it hurt heaps, I reckon I nearly squeezed
Yianis' hand off! I am sore but it is bearable.
My platelets are down and so is my haemoglibin due to heavy, irregular periods.
I was offered a transfusion yesterday but said no for the moment. I have been
put on the pill to stop the bleeding and Iron and Folate tablets and they will
monitor the counts twice a week. Phillip said the Glivec is causing this,
marrow suppression. The Registrar at the hospital asked him if he was prepared
to lower my dose of Glivec but he said no and that he was 'happy' with things
for the moment, but to have it monitored closely.
I feel as if I need heaps of rest and sleep, but psychologically my work keeps
me going.
Jackie

Hello to all of you,
As some of you are probably aware I am participating in the BMS Trial
and are now in my second week.
I just like to give you some insight into the side effects I am
experiencing since the last week.
Besides the obvious Nausea, Headaches and swelling of facial parts and
the feeling of having a Brick on top of my eyes I also have severe
pain underneath my right ribcase which extented allover my pelvic and
my lower Back including my legs, in particular the right leg.
I went to the Emergency Dept of a known cancer hospital and had a
bloodtest done which did not confirm my fear of acute appendicitis.
An ultrasound of my ovaries did not show any abnormal signs either.
I am still having this pain in my right side underneath the ribcage
and am not fully convinced that it is a side effect of the Drug, but
perhaps an inflammation of the appendix.
Besides all that I am not my usual self but feel weak and lustless.
I do hope that in a few days I do overcome all those "side effects"
and have my life back as it used to be.
If it were not for this "fake" appendix symptoms I could deal with all
the other signs.
I'll be seeing my Doc at the Peter MacCallum Cancer Hospital in
Melbourne by next Tuesday for a big check up.
Folks that's it for today.
I wish you all well and happy!
Ursula

Hi Everyone,
I'm assuming that Dasatinib is the generic name that will be used for
the BMS drug, (like Gleevec's generic name is Imatinib) but I'm
wondering if anyone knows what brand name they will give it?
Just curious,
Tracey

BMS cancer drug gets FDA priority review
PRINCETON, N.J., March 7 (UPI) -- Bristol-Myers Squibb said Tuesday
the Food and Drug Administration gave priority review to cancer drug
dasatinib.
The company said the FDA will also review the new drug application
for possible accelerated approval, meaning the treatment may be
approved within six months, or by June 28, BMS said.
BMS is seeking an indication for the compound for the treatment of
chronic myelogenous leukemia and Philadelphia chromosome-positive
acute lymphoblastic leukemia in adult patients with resistance or
intolerance to prior therapy.
Dasatinib is a second-generation protein tyrosine kinase inhibitor
that some analysts predict could be as clinically and commercially
successful as Novartis' Gleevec.
However, Novartis has its own second-generation protein tyrosine
kinase inhibitor in development.
That treatment, AMN-107 -- which is in phase 2 studies -- may be
able to treat CML cases that are resistant to Gleevec.

Susan,
Glad to hear that you got into the trial. I sur hope that BMS is the thing
for you.
Susan Loewenkamp <loewen1@...
Hi Gang,
First of all, after 5 BMBs plus 2 dry draws I finally got into a BMS trial at
Greenebaum Cancer Center at the University of Maryland. I didn't get into the
Georgetown trial because, in my opinion, they didn't know what they were doing
and judged within only the strictest parameters and believed unbelievable
results. Thankfully, Dr. Rapoport at the UM saw the trend in my BMB results and
said they could be read as disease progression and that the lab work may also
have been bad.
Yesterday I had two dry draws from my left hip when Dr. R suggested a sternum
draw. For those who haven't had this done, I recommend it. A much shorter
needle, easy draw and not nearly as painful as the hip. Plus, those of us who
have had a lot of draws by now have built up scar tissue and getting through
that can be painful. And, as yesterday proved, sometimes there's just no liquid
to draw.
Now I have to replace the job I have which I'm grateful for but which is mostly
mindless minutia but the people are nice. I'm writing a children's book which
is fun and the 10-year-old girl next door is serving as my advisor which is a
lot of fun.
Susan L

SPONSORED LINKS
Individual medical Cml Leukemia Health professional Cancer
center

I know most of you complain about gain weigh with gleevec, but haven't some of
you experienced some loss of weigh after 2 or 3 years of treatment??

Hi Gang,
First of all, after 5 BMBs plus 2 dry draws I finally got into a BMS trial at
Greenebaum Cancer Center at the University of Maryland. I didn't get into the
Georgetown trial because, in my opinion, they didn't know what they were doing
and judged within only the strictest parameters and believed unbelievable
results. Thankfully, Dr. Rapoport at the UM saw the trend in my BMB results and
said they could be read as disease progression and that the lab work may also
have been bad.
Yesterday I had two dry draws from my left hip when Dr. R suggested a sternum
draw. For those who haven't had this done, I recommend it. A much shorter
needle, easy draw and not nearly as painful as the hip. Plus, those of us who
have had a lot of draws by now have built up scar tissue and getting through
that can be painful. And, as yesterday proved, sometimes there's just no liquid
to draw.
Now I have to replace the job I have which I'm grateful for but which is mostly
mindless minutia but the people are nice. I'm writing a children's book which
is fun and the 10-year-old girl next door is serving as my advisor which is a
lot of fun.
Susan L

Chat Reminder - Tuesday 9:00 PM EDT
Photo - Capucin Monestary - Montreal - Feb 2006

On the subject of transplants my perspective is that while there has been
lots of progress made in improving the chances of survival with a
transplant, there is still some way to go. However, I would not be so quick
to say they should not be considered at all. There are thousands upon
thousands of people in this world who have gone through transplants and have
done very well. I have many friends who have had NHL and are doing very
well post autologus transplant. There are many children who have had AML or
ALL and do very well through transplants.
Unfortunately some do relapse which indicates that not all the mysteries of
cancer has revealed itself to us yet. That being said I have known several
co-workers who are post transplant and doing quite well. Some days I almost
envy them. They are completely drug free and happily re-building their
lives and not looking back too much. They go through the usual anxiety that
we go through from time to time as check up time approaches, but being
completely un-tethered by drugs and no real residual side effects to speak
of, they have an opportunity to be free from the constant reminder of cancer
by taking pills and noticing the side effects.
Yes, I have known of many people to who have not made it quite to the other
side of transplant, one was a close friend who I had known for 25 years and
was dxed with CML just 5 months after me. He developed menningeal leukemia
and needed to undergo a transplant. It was a poorly matched MUD, but he had
not other options.
Making the decision to go through a SCT isn't easy, but it is something that
I have spent some time thinking about as an exercise to know what I would if
it were me. In these days of Gleevec, if you are responding well then the
decision is probably quite easy to stay with it. The other options are
higher dose IM, or BMS and now AMN trials. That being said I know of some
patients who just decided that they didn't want a life of drugs and side
effects and went for the transplant anyway, and a few years out, are doing
just fine. If it were me, if I were much younger (I am 48) and had a
perfect sibling match, and not doing well with IM, I'd probably investigate
a transplant.
In Danes case in particular, it is good to see that he is doing pretty well
considering, and I am hoping that this bout of GVHD brings on GVL and gets
him beyond CML.
In all cases it is up to the patient to gather as much information as they
feel comfortable with, keeping in mind that there are some people out there
who do not want to know it all. We cannot "force-feed" information to
people, but we do have a responsibility to keep our minds open and realize
that we are not all the same and approach our decision making differently.
We need to remember that we need to celebrate our differences.
Sometimes we forget that CML is a very complex disease and for all the
progress that has been made, we do not have all the answers..
Peace, Love, and all good things to everyone.
Cheryl-Anne

I am having heavy and irregular periods. It seems that I will finish a heavy
period, clear up for a few days then start another heavy period then clear up
for the rest of the month. Its very strange.
My platelets are a bit low, 26? (not sure of that figure) but my GP said
yeterday that if it drops to 20 or below then I might have to get some red
packed cells and that this could be causing the bleeding.
He has written a note to my haemotologist whether I should be given Tronexanic
acid or hormonial manipulation.
Any clues here?
Jackie

dane714@... wrote:
Update 3/4/06
I know that this is something of and Anti-BMT list these days, but here is
an update for those who may be interested.
Best wishes, Dane Tessler
Hi Dane, I am so glad to see your post. I kinda thought you forgot about
us:)
Actually I check your caringbridge site often to make sure your doing well.
I am sorry to hear about the GVHD but also glad to know that it can help.
I think everyone is probably shaking their heads wondering why you would say
this is an anti BMT group?
As you know from previous experince we are using the Gleevec, AMN, BMS
rather than the BMT first line option. Personally speaking, I would like to
keep the BMT option for last. And even as a last resort option, there will
be those who may still have to resort back to Gleevec, AMN or BMS.
I have been particpating on these list for almost 5 1/2 years now and I am
sure you too rememeber that what we've learned is that most members not only
opt for the drugs before BMT just because their scared, there are also many
other important factors for each individual.
One in particular reason I am sure you may remember is that most of us don't
have the sibling match option. Some have no match at all.
Most who do, usually take the BMT route as we all know the success rate is
much higher versus an unrelated BMT.
Then there are other things to consider like insurance, finances or better
yet who will take care of me? Yes it's true some people don't have a family
member or a loved on that can be there to provide that strong support system
required for BMT patients. Maybe its who will care for my children even if I
do have someone to be there for me? Or what if I don't make it and I have
children is there any one other than the State to care for them. These
reasons may not be real for many but sadly they are for some. And of cours
the list of reasons go on and on which is why so many people don't take the
BMT opton as front line therapy. How about the fact that the best specialist
in the world when possible recommend the drugs first?
And then we have the best excuse that I can think of...
The one that motivates me daily and will motivate me to move to the next
phase of drugs if and when that's ever neccesary: I hope that the drugs I
take today can save a life tomorrow...
We miss your post Dan, you were always a very strong supporter on all the
list and I for one hope the reason you haven't posted isn't because you
think this is a anti- BMT list? If that's the case I will pray for the one
who started that rumor.
And my prayers are always with you as you continue on your journey.
Lisa Martinez

Hey Dane:
I will be sending XTRA prayers for you regarding DLI. . .
"K"
"I AIN'T FINISHED YET"!!!

Update 3/4/06
I know that this is something of and Anti-BMT list these days, but here is an
update for those who may be interested.
Best wishes, Dane Tessler
www.caringbridge.org/tx/dane

DAne, Glad to see that you have GVHD. It may be uncomfortable, but hopfully it
will give you the results that we all liong for. Diesease FREE!!!!
Don't know why your would say that people are anti BMT, I just think that with
other options, they are afraid of it. Rememger, you went the drug route first,
too.
Your old friend,
Shelley
dane714@... wrote:
Update 3/4/06
I know that this is something of and Anti-BMT list these days, but here is an
update for those who may be interested.
Best wishes, Dane Tessler
www.caringbridge.org/tx/dane

Hi all..
got my date to start BMS trial, 8th March. Going to Adelaide (7hour
drive) on Monday ready to have x-rays and blood work as well as lung
function on Tuesday. Wednesday 9am i have my biopsy then in the
afternoon I see the Doctor again to start my new drug...
Fingers Crossed...
Susie Leech
Dx Nov 2002
Currently off Gleevec
Starting BMS Trial 8th March
#675 Zero Club

Hi Susie
I just wanted to wish you good luck with starting BMS this week. I have
read of your problems with glivec, you poor t hing.
I also appear to be intolerant to glivec and I am going on Thursday for
my BMS assessment and if all goes according to plan I will start on
March 20th.
I can't imagine having to drive for 7 hours to get to see your
specialist - it is mind boggling. I live in the London Suburbs and for
this trial I have to go to the Hammersmith Hospital which is probably
only 15 miles from here but may take an hour to get there in the rush
hour. The distances seem so great to us. Do you live in a small town or
what?
I hope that you don't mind all the questions.
Let me know how it goes for you.
All good wishes from cold sunny London
Susan
Dx Mar 05
CCR May 05
Glivec 400mg with a couple of breaks!

Chat Reminder Saturday 9:00 AM

Hey everybody
Have to admit to having felt a bit low in the last couple of days
because of hearing about people dying from this disease. Somehow I
had managed to forget how serious this all is. Bothered me much more
than I thought it would but now I am safely back in denial...and
happy to be there!
Just wanted to thank you all for the support and the strength to
finally demand copies of my test results from my oncologist who has
now agreed to make copies for me. Would never have had the strength
to demand this if I had not had the knowledge and encouragement from
this site.....THANKS!
Um..when I get them I am going to post agin and perhaps somebody
kind will help e to understand them if that's OK?
In the meantime - strength to you all
Jane
Diagnosed Nov 05
South Africa
Gleevec 400mg

Hi Jane,
I just wanted to say that you have every right to have a copy of your
own medical record and of all tests that are run on you. You don't
have to be shy about it. Just tell the front office people.. "Can
you make a copy of that for me?" and they should not have any problem
with it. If they do, then you need to talk to the office manager.
Also, I also use my pet names for my USER NAME!
"Snickers" is an 18 year old black and tan tabby cat and still going
strong!
"Sunny" is a 15 year old medium-hair orange tabby.
Sincerely,
Snickersunny (Lynn)
Dx'd 12/03
400 mg

Tracey-
Thanks for the outline and information, that explained it well.
I have had no blasts in any bone marrow or peripheral blood ever, in any lab
tests so I guess that does make it chronic phase. I hope that I never see
the word blast ever! The word itself gives me the heebie jeebies (sp?).....
Thanks again for the information!
Jen

Sue,
your daughter is having close to what is declared Gleevec "intolerance".
Gleevec failure is when the disease progresses rather than digresses, likely
because of mutations. Intolerance is one fo the criteria that would allow
your daughter to get into one the other two drug trials, BMS and/or AMN. By
the way, Gleevec failure is also a criteria to get in those studies.
Best wishes,
Mario
_____
From: S. Folle [mailto:loggin23@...]
Sent: Thursday, March 02, 2006 1:05 PM

Hello Sue, it's been a while since we chatted.
I am sorry to hear that your daughter is having such a rough time with
Gleevec.
My first question is how many mgs is she taking and when was her last PCR
test and or BMB? Also what were the results of these test?
Lisa Martinez
Message: 10
Date: Thu, 2 Mar 2006 10:04:38 -0800 (PST)
From: "S. Folle" <loggin23@...
Subject: GLEEVEC FAILURE
Could someone please explain to me how you determine "Gleevec failure?: Is
it when the side effects become so obtrusive that you can't continue taking
it or when the Gleevec isn't working to fight the cancer?
My daughter is having such adverse side effects with fatigue, pigmentation
changes, diarrhea that I think it is time to look at other options but
because it continues to fight the leukemia, she doesn't think she should
stop it.
Of course, it is her decision and I respect that but it sure is hard to
hear her say she is "existing" instead of "living."
Sue

Could someone please explain to me how you determine "Gleevec failure?: Is it
when the side effects become so obtrusive that you can't continue taking it or
when the Gleevec isn't working to fight the cancer?
My daughter is having such adverse side effects with fatigue, pigmentation
changes, diarrhea that I think it is time to look at other options but because
it continues to fight the leukemia, she doesn't think she should stop it.
Of course, it is her decision and I respect that but it sure is hard to hear
her say she is "existing" instead of "living."
Sue

Hey again,
Thanks for writing me back. I appreciate all the support in my concerns on
here. I was started on the 600mg as Dr. Mauro felt that was were the average
dose was looking to start. He did state that he felt I would do okay on 400mg
and at that time we were discussing the trial of 400 vs 800mg. I felt 800 would
be too much. And 400 would be too little so I went along with the 600mg.
What would be the signs of being in accerated phase at diagnoses? This is what
my tests showed: WBC were around 21,000 and platelets were low normal. Spleen
was alittle enlarged (not too bad) and I was having sweats.
I am hoping that I was in early chronic phase as my CBC didnt seem to be as bad
as I have heard others being at diagnoses. And my counts responded quickly with
the first couple dose of hydroxyuria and Gleevec.
I am hoping to be at a 3 log reduction by May 29th as that is my 1 year on
Gleevec. I am repeating a CBC today and Dr. Mauro is sending me the PCR kit
today to do and send back up to him for a March 27th appointment.
Jennifer
Jennifer S. Smith RN

Hi Jennifer!
I just wanted to let you know that I also have CML and am a Mom of
two young daughters, age 6 and 9. I am 43 (I got a later start on
the kid front ;-).
I just wanted to say that I completely know how you feel about side
effects. It's hard enough having CML and the side effects and then
on top of everything else, trying to raise young children, all the
while. You can only do your best. Some days are better than others.
I'm sure you will agree. I just do more on the good days, and lay
low on the not so great ones. My girls have really stepped up to the
plate to help me out around the house etc, and have really matured
through my CML experience. They are turning out great!
I am on 400 mg and I still get side effects! I'm on lasix for the
water retention. I get the occasional bout with GI problems, but
mine have diminished, as time on Gleevec has gone on. Hopefully,
that will happen with you as well.
I would certainly discuss your dose with Dr. Mauro. Like Nancy
stated, I'm sure he just wants to get you to the best cyto repsonse
possible, and many times, that's with a higher dose.
You want to stick around as long as possible to see these kids grow
up. So, although it is difficult, just hang in there. Be good to
yourself and do good things for yourself. You have a big job getting
well and being a Mother and Spouse. I completely understand.
Best wishes and friendship from a fellow Mom with CML!
Lynn (Snickersunny)
Dx'd 12/03
400 mg Gleevec

Tucson Region
Ernesto Portillo Jr. : 2-nation resident who is claimed by neither
needs lifesaving care
Ernesto Portillo Jr.
Tucson, Arizona | Published: 03.02.2006
Eduardo Lopez was born in Sonora and educated in Arizona. So he
flows easily across the border, fluid in both languages and
cultures.
Yet now faced with life-sucking leukemia, he is stuck between both
worlds.
Lopez, 28, has chronic myelogenous leukemia. He's taking medicine to
hold it off, but it's just a matter of time before the potent
disease spreads through his body.
He will need a bone-marrow transplant, likely in a few months, if he
is to live.
But neither country can provide him with the medical services he
needs.
He doesn't qualify for U.S. public help because he is not a citizen.
And he can't receive public medical care in Mexico because he didn't
work in the country.
Lopez is in the netherworld of strict regulations and requirements
that determine who can and cannot receive medical care.
"I'm fighting for my life," Lopez said.
We talked Tuesday at the Arizona Cancer Center. He drove from
Nogales, Sonora, where he lives, to have his blood drawn and
checked. It's part of his routine.
Another part of his routine is trying to raise more than $100,000
for the transplant. That's not counting the $20,000 he owes for
medication, blood testing and biopsies.
So far he's collected $3,000 and a promise that a portion of the
transplant will be paid for by his former Tucson employer. He can't
find a good-paying job in Nogales.
Still, he has a long way to go to get well and a lot of money to
raise.
When Lopez was 4 years old, his parents moved to Nogales, Ariz.,
where he attended public schools. After graduating from Nogales High
School, he enrolled at the University of Arizona.
It was legal. Lopez had a student visa.
While at the university, Lopez worked for two years at the Arizona
Cancer Center. He never imagined that he would return as a patient.
In 2004, Lopez graduated with an economics degree. His visa allowed
him to work temporarily for a year. He sold cars at Jim Click Ford.
He loved it and did well, he said. But he could not renew his work
visa.
Lopez returned to Nogales, Sonora, to live in his parents' house.
They had become legal residents and moved to Rio Rico, a few miles
north of Nogales. He couldn't become a legal resident along with
them because he was too old.
Several months later, Lopez began to feel the pain in his body and
the bumps on his head. By November, doctors diagnosed him.
His form of leukemia, referred to as CML, affects one to two people
among 100,000, according to the National Institutes of Health.
For now, the medicine is holding off the leukemia. But when Lopez
reaches the next stage, the "blast" phase, the leukemia will be
difficult to treat.
It's been explained to him, and he's read the literature.
But he can beat his leukemia with a transplant. He just needs the
money.
Click and some of his employees have donated money and have promised
more, said Ardie Delforge, a patient assistance representative at
the Arizona Cancer Center.
She works with patients to get them medical care, financial help and
services.
She called Lopez a fighter.
Lopez and his friends have organized a raffle. He even has sold
raffle tickets to the debt collectors who have called him about his
unpaid medical bills.
He is humbled by the help he's received. He said he intends to pay
it back.
If you can help Lopez, call Delforge of the Arizona Cancer Center at
626-7378. Some donations can be tax-deductible.
Ernesto Portillo Jr.'s column appears Tuesdays, Thursdays and
Saturdays. Reach him at 573-4242 or at eportillo@.... He
appears on "Arizona Illustrated," KUAT-TV, Channel 6, at 6:30 p.m.
and midnight Fridays.

Hi Jennifer,
The goal of treatment is to have a 3 log reduction for the best chance of
not relapsing. So, that is the information that you want. When people do
get to a good level of response, doctors do decrease their dosage to lower
side effects. I think that Dr. Mauro wants to treat you aggressively
because of your 'young' age and I think I might remember that you had some
features of acceleration???? 600mg is that standard initial dose for
someone who is not early chronic phase.
Cytogenetic remission/response or CCR is actually zero from the cyto test.
It is MCR (major cyto response) that is 35% or less ph+. 1 out of 200 cells
would be your FISH.....which could actually be considered zero because
there are some false positives with FISH.
Mostly you would be concerned with PCR testing now.....and the 3 log
reduction.
You would not qualify for a BMS trial at this point (because I think you
are probably CCR).......but BMS drug should be approved soon.....and that
would be an option to see if you have fewer side effects on that drug than
with Gleevec. This is a much more potent drug, and should get you to a
lower PCR value sooner.
Nancy C.

Hi gang-
I have a concern that I wanted to run by the group and get some opinions.
Little background on me.
Dx: CML 5/13/05. Gleevec 600 mg daily.
33 years old, married with 3 kids (10, 7, 5).
My concern: I want to know what the consensus of opinion is on reducing my
dose to 400mg. Now, I would never do this without consulting my Dr, Dr.
Mauro, but wanted to get opinions of others in this group, whom I respect. I
suffer from many side effects from fatigue, nausea, hair turning white, losing
the pigmentation in my face, neuropathy at night in my hands, fluid
retention around my eyes, diarrhea, gastritis, etc.... Moreover, I am greatly
concerned with the amount of toxicity in my body that the drug is doing to my
organs. I feel like I am young and have a long time to take this drug, I am
just
wondering what kind of damage this is doing to my insides. I do however,
realize that without this drug, I wouldn't be here for long and I feel blessed
to have it as an option. I don't not have a sibling match and I have a rare
HLA typing.
From what I understand from the doctor is that if you skip or reduce the
dose you have a risk of developing a resistance to the drug. I certainly don't
want to risk that nor have I missed any doses thus far. I am just wondering
if I would feel better on a lesser dose or if its too late to think about
that since I am already on the 600mg? I I am responding well to the Gleevec
and
believe I am in cytogenic remission. (under 35%). Last testing showed 1
out of 200 cells.
I am just curious as to what others think and your opinions are just that
and would be appreciated greatly. I realize we are all individuals and our
treatments and responses are different but I would like to just get your
impressions of my personal situation. I know I am asking a real self center
question here but I am really struggling and need a little input.
Well wishes to all of you!
Hugs-
Jennifer

Sisie,
Congratulations on getting into the BMS trial. I have not been keping upo
with the posts lately, so I did not know of your struggle.
Susie <leechys@...
Thankyou to all for your words of encouragement and prayers for me
to get another drug other than Gleevec. A big thankyou to Zavie, he
has been a tower of strength and support through my jouney of no
Gleevec.
Tim tried to get me on the AMN trial without success. I don't know
much about the BMS trial only what ive seen and heard from post and

Hi all. Hope this finds everyone doing well.
Just read about Di Lindberg and am truly overwhelmed for the family.
She seemed like an angel - and is now at peace.
I don't think I shared this with the group - but I have been asked to
sit on the Eastern NC Chapter of the LLS as a patient advocate.
It's a humbling opportunity to represent the patients here in eastern
North Carolina. Please pray that I can add value to this incredible
organization.
Anyway, Dr. Tom Shea (a peach of a wonderful dr and well known here
in NC) from UNC Chapel Hill gave an ASH update on Leukemia last
evening at one of the LLS's info sessions. I apologize if Anjana or
anyone else has already posted this information already! : - )
He mentioned some interesting data on the IRIS 54 month study "Annual
Progression Events on First Line Imatinib (Gleevec) with minimum four
years of follow up". Interesting, the opportunity for disease
progression seems to be highest in year two and then goes back down
significanty in year four.
Year Progression AccelPhase/BlastCris.
1st 3.4% 1.5%
2nd 7.5% 2.8%
3rd 4.8% 1.6%
4TH 1.5% 0.9%
These are really terrific findings - although I found it interesting
that progression during the 2nd year - spiked abit (not much though
in the grand scheme of things)
Other good news:
- At 54 months - more than 90% of patients randomized on Gleevec are
still alive
- Gleevec patients with CCR have good long-term outcomes - even those
with high risk Sokal score.
While we are CML patients - he noted that CLL (Chronic Lymph. Leuk)
is starting to be treated with thalidomide and they have seen good
results with that. I recall thalidomide being the culprit in birth
defects back in the 50's and 60's. He said it causes drowsiness and
it was sometimes given to pregnant women to help them sleep hence the
birth defects.
Anyway - again, I apologize if anyone posted this information prior.
I thought it was worth sharing since it's really another piece of
good news coming out of ASH.
Thanks all!
Barb Heathcote

Thankyou to all for your words of encouragement and prayers for me
to get another drug other than Gleevec. A big thankyou to Zavie, he
has been a tower of strength and support through my jouney of no
Gleevec.
Tim tried to get me on the AMN trial without success. I don't know
much about the BMS trial only what ive seen and heard from post and

Christine,
Thank you for sharing the news about Diana. I didn't know her but spent
quite a while reading her journals (teary-eyed). She handled her
worsening condition with grace, conviction and even humor. Would that we
could all do that.
Jennifer G.

Lisa Martinez
Avatel Technologies
National Account Manager
1-866-835-2062 x 1015
Message: 3
Date: Mon, 27 Feb 2006 17:31:58 -0800 (PST)
From: Shelley Orenstein <ornurse954@...
Subject: Re: sensitive scalp pain
Shelley,
It has hit Florida very hard in the last month or so.
I had my Flue shot as I always do ands till came down with the flue this
year which felt terrible but I feel it could have been worse had I not had
my shot. 3 days after I was done with that I had a terrible sinus pressure
and draining that made me miserable! I had sinusitis and had to take an
antibiotic.
During this time my son, his wife and all 3 of my baby granddaughters had
bronchitis, my 9 year old had sinusitis and my 14 year old had the flue...
Our local news channels are saying the hospitals and clinics are swamped
with patients that with all of the above.
My office has had at least 3 people a week out for one of the above.
Of course we now have all the pollen falling everywhere and one day its 30
degrees, the next its 80. So yes people ... please do not ignore any of
these nasty little bugs.
Just to let others know, please do not "ignore" a cold with coughing,
especially if you run a temp. I had taken 2 rounds of antibiotics, and then
ran a fever. When I finally got to the doctor 24 hours later, he was upset
that I had waited so long. He stuck me in the hospital for IV antibiotics
and breathing treatments.

Hi,
Sad news. Diana Lindberg passed away today. She was an incredible
inspiration for many of us. She was courageous beyond words, Grace and
Grit.
Please visit her caring bridge site for details and for those who
didn't know her, look over her story, she was amazing.
http://www.caringbridge.org/europe/dilindberg/index.htm
Peace, love and everything good,
Christine
dx 11/98

Chris,
PCR'S do jump a little. I have been in the same situation for a couple of
years now. Dr. Mauro tells me not to worry. You can always e mail him your
results and he wil give you his opinion. As for the sensitivity, I notice it on
many parts of my skin. It is only uncomfortable when I put some pressure on my
skin, so I just ignore it. I just contribute most of my aches and pains to age
or posssible Gleevec. I can't help getting older, and Gleevec gets me there.
Just to let others know, please do not "ignore" a cold with coughing,
especially if you run a temp. I had taken 2 rounds of antibiotics, and then ran
a fever. When I finally got to the doctor 24 hours later, he was upset that I
had waited so long. He stuck me in the hospital for IV antibiotics and
breathing treatments.
Christine Finsand <chrisfinsand2@...
Hello everyone! it's been a while but I have been reading and learning from
all of you. Thanks for all your insights and sharing. I was wondering if
anyone else is having scalp pain. It seems that the longer my hair gets, the
more scalp pain and sensitivity I have. Some days it hurts to have even the
slightest touch to my head.
Also, I have been ccr neg since last June (2005) and was pcr neg as of last nov
(2005). I started gleevec (400) dec 3rd 2003 immediately upon diagnosis of
cml. this past month I had another pcr and it is now no longer neg. How
serious is that. the numbers weren't high, but it wasn't zero. My doc will do
another pcr on Wed and then we'll see where to go from there.
any thoughts on any/all of this??
chris in minn

SPONSORED LINKS
Individual medical Cml Leukemia Health professional Cancer
center

Hi Christine,
The majority of us are PCR positive so that's not something to worry
about. What you want to know, is what kind of log reduction you've
achived and what is the trend over time.
Ideally, you want to achive a three log reduction from your baseline
value which is a 1000 fold decrease (or three decimal spots to the
left of your original PCR). If you didn't have a PCR on diagnosis
then your lab should have a general number that they attribute to
average newly diagnosed patients.
Some people waffle back and forth between positive and negative on
their PCR's, as long as the change is less than 1 log, then it's
usually not significant.
The bottom line is that you want to track your PCR trend to see if
it's going up, going down or remaining stable. This will take a few
tests at the same lab to do.
Take care,
Tracey

Cancer Care Connects is hosting a teleconference regarding the recent
ASH meeting.
Guest Speaker-Dr. Michael Mauro, OHSU and
Richard Dickens-Blood Cancers Mind/Body Program.
Tues, February 28, 2006
1:30-2:30 p.m. Eastern Time
-Overview of CML
-Treatment Choices
-Finding Presented at ASH
-New Treatment Approaches
-Clinical Trials
-Managing Side Effects, Discomfort, and Pain
-Communicating with Your Healthcare Team
-Quality of Life Considerations
-The Importance of a Support Network
1-800-813-HOPE
(212) 712-8080
www.cancercare.org

Hello everyone! it's been a while but I have been reading and learning from all
of you. Thanks for all your insights and sharing. I was wondering if anyone
else is having scalp pain. It seems that the longer my hair gets, the more
scalp pain and sensitivity I have. Some days it hurts to have even the
slightest touch to my head.
Also, I have been ccr neg since last June (2005) and was pcr neg as of last nov
(2005). I started gleevec (400) dec 3rd 2003 immediately upon diagnosis of
cml. this past month I had another pcr and it is now no longer neg. How
serious is that. the numbers weren't high, but it wasn't zero. My doc will do
another pcr on Wed and then we'll see where to go from there.
any thoughts on any/all of this??
chris in minn

So sad. so so sad. I just read through his site. I can't imagine his family's
pain.
:{
Alicia
View our family's photos at webshots
Our pet's pages:
www.catster.com/?219163 www.dogster.com/?215653 www.dogster.com/?225974

Stephen ended his battle with CML yesterday, and has taken his place
next to the lord, strong and able to be a kid again. Stephen was a
young warrior and fought bravely. If you get a chance stop by and
leave a few words for Stephens family.
Amy B.
http://www.caringbridge.org/tx/stephenthompson/

Dear Ana,
Please accept our deepest condolences on the loss of your grandmother
and your uncle.
I checked the drug interaction lists and there is no problem taking
Valerian and Gleevec together.
Send your mom my best regards.
Zavie

my mum is pcru since 3 months ago. this last week she has suffer the lost of her
mother and a brother, she is very depressed, and i'm worry if this can affect
CML. I gave her some VALERIAN pills and they made her good, but I don't know if
it could affect gleevec. any suggestion?? we are going to her doc on monday.

Hi Tammy,
The site that Mario mentioned is excellent for information on BMS.
I can also tell you that I am aware of at least 2 patients here in
Montreal who were in blast phase when they started on the BMS
trial. One was actually brought in to the hopsital in an ambulance -
she was so sick. Both patients have responded very well. In fact
one of the patients recently achieved PCRU!
Just a few words meant to give you and your husband hope that this
drug will work out well for him.
Love, Light, Peace and all good things,
Cheryl-Anne

Platelet Donor Pool Feared to Shrink
By ANDREW BRIDGES, Associated Press Writer 29 minutes ago
That sticky, colorless stuff in blood that makes it clot could become
scarcer for chemotherapy, radiation and transplant patients who need
regular transfusions.
The federal government wants to overhaul the guidelines for platelet
donations to ensure donors are protected. Donation center officials
say the changes could have an unintended consequence: as much as a 50
percent reduction in the supply.
They have flooded the Food and Drug Administration with letters of
opposition, some running dozens of pages.
The government wants to limit annual platelet donations to 24 pints
per donor. Now, the limit is on how often someone can donate 24
times a year. That could equal 72 pints a year since donors can give
up to three pints at a time.
Platelets, with just a five-day shelf life, are transfused almost
immediately. They are chronically scarce.
The blood officials fear the changes to the 18-year-old guidelines
would mean a 10 percent to 50 percent drop in the volume of donated
platelets, which are vital for patients who can't make them on their
own. During chemotherapy, cancer patients can require six pints to
eight pints of transfused platelets a day for weeks.
"It's something they need a continuous, reliable supply of," said Doug
Delhay, who has donated more than six gallons of platelets since 1998.
"To me, life is a gift we receive and it's a gift we can give," said
Delhay, 52, a maintenance supervisor for an electric utility in the
Lincoln., Neb., area.
The FDA's rationale and timing are coming under question.
"At a time when the supply is tight and for what reason? The FDA did
not provide us with the information that tells us why," said Dr. Louis
Katz, executive vice president for medical affairs at the Mississippi
Valley Regional Blood Center in Davenport, Iowa.
Dr. Jay Epstein, director of the FDA's Office of Blood Research and
Review, said the proposal is intended as a recommendation. But
donation officials said they would view it as a requirement.
"There were audible gasps all across the country at blood centers,"
said Katz, a member of the FDA advisory committee.
In addition to volume restrictions, FDA is proposing that a doctor be
present or within 15 minutes of a donation center while platelets are
being drawn and that people who take aspirin and medications such as
Ibuprofen wait several days longer before giving platelets.
Epstein said 1988 was the last time the FDA's guidelines for platelet
donations were overhauled.
He said there have been no reports from donors about significant
problems stemming from giving platelets. He added, however, that there
isn't enough information to assess whether current practices are safe.
"It's not really surprising that (the blood donation) industry has
expressed concerns because we are suggesting there are things that
have come into current practice that may not be for the best," Epstein
said.
An FDA advisory committee plans to consider the proposal March 9.
Most platelet donation is done through a process called apheresis,
which involves drawing whole blood from a donor's arm and running it
through a centrifuge to separate out the platelets. Red blood cells,
white bloods cells and plasma are returned through the other arm. This
reduces the impact on donors and allows them to give as many as three
pints in a one- to two-hour session.
Platelets also can be culled from donated whole blood, but it can take
six pints to produce the one that a single apheresis donor can give.
In letters sent to the agency since September, nervous blood donation
officials said people have safely have made double and triple
donations for years.
Dr. Joy L. Fridey and Mark Kaniewski of the City of Hope National
Medical Center in Duarte, Calif., said the changes could cause
shortfalls in the availability of platelets.
"We are not at all confident that nearly enough donors could be
recruited to make up for the platelet losses that would occur should
this proposal be formalized. Thus, we are fearful that the platelet
supply will be severely inadequate to meet transfusion needs," the two
cancer hospital officials wrote.
City of Hope said it would face a 15 percent deficit if the guidelines
went into effect. Others predict more serious shortages.
"We would lose 50 percent of the platelets we collect and that is a
conservative estimate. We would probably lose more than that," said
Dr. Patricia Kopko, medical director of BloodSource, a blood bank in
Sacramento, Calif.
The American Red Cross estimated it would lose 65,000 pints of
platelets a year, slightly more than 10 percent of the 638,971 pints
the charity collected in 2004.
Phyllis Ericson, chief executive officer of the Community Blood Bank
in Lincoln, Neb., where Delhay donates, said the requirement to have a
doctor nearby would be restrictive and costly. Calling paramedics for
an emergency is a better solution, Ericson said.
"Physicians just don't run around town for things; 911 runs around
town," she said.
___
On the Net:
Food and Drug Administration: http://www.fda.gov
America's Blood Centers: http://www.americasblood.org/
American Red Cross: http://www.redcross.org/

Tammy,
Go to the link below and you'll find a ton of infor