I am totally dismayed by the complete lack of a scientific approach by Dr. Atalluh and BMS in trying to prove their hypothesis that dasatinib produces an earlier response than Gleevec.
Nothing short of a randomized head to head clinical trial against Gleevec would confirm this. This looks more like a marketing effort than a clinical trial. Zavie On 6/3/07, Cheryl-Anne <[EMAIL PROTECTED]> wrote: > > > Hello All, > > Here's the latest news on Sprycel from ASCO - it all sounds rather > good. It is nice to know that we have two options for this disease and > that evidence continues to grow in the overall efficacy of both > Gleevec and Sprycel. I heard a rumor that Tasigna (AMN 107) might be > approved this summer in the US. This will give us three options - > cheers for us! > > As for the comments on the five year data with Gleevec, this being > cancer, I do not think we can wait another two years to play catch up. > The data for Gleevec will always be growing and it was the first drug > on the market - so that is a no brainer. Besides if we made that the > criteria for all drugs, then Gleevec would never have been so > successful. At the time Gleevec was launched there was 10 year data on > Interferon....The point being is that we have to be pioneers and take > certain calculated risks. This new evidence on Sprycel makes it a bit > eaiser for those struggling with having to make decisions on switching > treatment. > > On the other comment raised at the end, I feel strongly that Dasatinib > will produce the same results as Imatinib - meaning that these > treatments cannot be stopped as neither Gleevec or Sprycel inhibit the > stem cells. But I feel confident that there has been much work in the > area of stem cells - so we'll just have to stay tuned. > > Cheers to all! > Cheryl-Anne > > > > ASCO: Dasatinib (Sprycel) Works as First-Line Therapy for Chronic > Myelogenous Leukemia > > > By Peggy Peck, Managing Editor, MedPage Today > Reviewed by Robert Jasmer, MD; Associate Clinical Professor of > Medicine, University of California, San Francisco > June 02, 2007 > add your knowledge Add Your Knowledge(tm) Additional ASCO Coverage > > Ehab Atallah, M.D. > Anderson Cancer Center > > CHICAGO, June 2 -- Almost all patients treated off-label with > dasatinib (Sprycel) for chronic myelogenous leukemia (CML) had a > complete cytogenetic response within a year of beginning therapy, > researchers reported here. > > "Patients taking dasatinib achieve complete cytogenetic response - > absence of the mutated protein that drives this disease - more rapidly > than we've observed historically using the current front-line therapy. > Side effects are very manageable," said Ehab L. Atallah, M.D., a > fellow in oncology at the University of Texas M. D. Anderson Cancer > Center, in Houston. > > He noted that dasatinib, which is approved for treatment of patients > who are unresponsive or resistant to treatment with imatinib > (Gleevec), was able to achieve a response in 40% of those difficult to > treat patients. > > "Our hypothesis was that treating with dasatinib first would produce > an earlier response, which might translate to a better overall > survival," Dr. Atallah said at the American Society of Clinical > Oncology meeting. "We haven't proved that here, but these early > results are encouraging." > > In the study, Dr. Atallah and colleagues treated 35 patients with CML > with dasatinib as a first-line therapy. Patients, who were enrolled > from November 2005 through December 2006, received either 100 mg of > dasatinib once a day or 50 mg twice daily. > > Dose escalation to 140 mg/day or 180 mg/day or dose reduction to 80 to > 40 mg a day, based on response and toxicity, was permitted. > > In 77% of those patients a complete response was achieved as early as > three months; 92% of patients had a complete response at 6 months, and > 95% had achieved a complete response at 12 months. > > Those rates are slightly better than the six-month 54% complete > response for low-dose imatinib treatment (400 mg) observed at M. D. > Anderson, Dr. Atallah said. At 800 mg daily, imatinib had an 85% > response at six months and a 92% complete cytogenetic response at 12 > months. The 12-month response for the 400 mg imatinib dose was 72%. > > Dasatinib was approved by the FDA a year ago for use in patients whose > disease is unresponsive to or becomes resistant to imatinib. > > Both drugs bind to and block a genetically flawed protein known as BCR- > ABL, which causes the disease. Dr. Atallah noted that dasatinib binds > to both open and closed forms of BCR-ABL, while imatinib binds only to > the closed form. > > Dasatinib's side effects were manageable and mainly low-grade, with 15 > patients having to temporarily stop treatment. > > "This study is certainly good news for patients with chronic > myelogenous leukemia," commented Mitchell Smith, M.D., Ph.D., director > of the lymphoma service at Fox Chase Cancer Center in Philadelphia. > > "It's always great for patients to have choices and now we have at > least two drugs that appear to work very well in this disease," he > said, "and there are even other drugs behind dasatinib that are going > to be available in case the front-line drugs don't work or are not > tolerated." > > But Dr. Smith said it was unlikely that doctors would jump on > dasatinib as a first-line drug. "We have a lot of experience with > imatinib and we will want to see if dasatinib is effective for as long > as imatinib. We have evidence that imatinib is effective at least for > five years." > > Moreover, even with evidence of dasatinib's efficacy, the durability > of the treatment effect is unknown. "We still don't know when-or if-it > will be possible to stop treatment," said Dr. Smith. "With imatinib, > we know that even after a year of treatment, the disease will return > if therapy is ended." > > The trial was sponsored by Bristol-Myers Squib Co. Dr. Smith reported > no financial conflicts of interest. > Complete ASCO Coverage > Primary source: Journal of Clinical Oncology > Source reference: > Ehab Atallah, "Abstract 7005: Use of dasatinib in patients with > previously chronic myelogenous leukemia in chronic phase." Journal of > Clinical Oncology, 25:18S, p 358s. > > > > > -- Zavie Miller (age 68) 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 (suspect) 2.8 log reduction Sep/05 3.0 log reduction Jan/06 PCRU 11/06 at The Ottawa Hospital e-mail: [EMAIL PROTECTED] Tel: 613-726-1117 Fax: 309-296-0807 Cell: 613-202-0204 Yahoo ID: zaviem --~--~---------~--~----~------------~-------~--~----~ [CMLHope] A support group of http://cmlhope.com ------------------------------------------------- You received this message because you are subscribed to the Google Groups "CMLHope" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [EMAIL PROTECTED] For more options, visit this group at http://groups.google.com/group/CMLHope -~----------~----~----~----~------~----~------~--~---
