Good point Zavie. Head to Head trials are the thing to do. The trial information that came out at ASCO is very good preliminary information (using a small co hort of patients which is always the case before larger studies are undertaken - it is the cautious ethical approach). Additionally, internal ethic review (IRB) boards at all participating hospitals must review the clincial trial criteria and aims as they are ultimately responsible to ensure patient safety. I think MD Anderson is one of the top leading cancer centres and has a very good track record in this respect. So, I wouldn't be inclined to brush this off as "marketing". Marketing is what happens to the data after the clinical tiral - usually ;-)
The head to head trial is listed below and is currently accruing. The P.I. is Dr. Brian Druker. There is also another trial at MD Anderson, led by Dr. Cortes. Both of these trials are in response to the recommendations of the FDA pannel that met last June at ASCO led By Professor Goldman that suggested that the data for Dasatinib was sufficient enough to warrant further investigations for the drug to be used as frontline therapy. Therefore, BMS is funding these studies based on this request. Just like most companies foot the bill for these studies by providing free drugs to patients who participate. This is no different from Novartis or Wyeth or Merck. So, all fo this is very good news for all fo us! I'll be posting news on Nilotinib too! Cheers, Cheryl-Anne Here's the link: http://www.cancer.gov/search/ResultsClinicalTrialsAdvanced.aspx?protocolsearchid=3363257 This is a randomized, multicenter study. Patients are stratified according to Hasford risk category (low vs intermediate vs high). Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive oral imatinib mesylate once daily. Arm II: Patients receive oral imatinib mesylate twice daily. Arm III: Patients receive oral dasatinib twice daily. In all arms, treatment continues for 12 months in the absence of disease progression or unacceptable toxicity. Patients are followed for up to 1 year. Trial Contact Information Trial Lead Organizations Southwest Oncology Group Brian Druker, MD, Study coordinator Ph: 503-494-5596 Marilyn Slovak, PhD, Study coordinator Ph: 626-256-4673 ext. 62438; 800-826-4673 Eastern Cooperative Oncology Group Peter Emanuel, MD, Study coordinator Ph: 205-934-6195 Email: [EMAIL PROTECTED] On Jun 4, 12:06 am, "Zavie Miller" <[EMAIL PROTECTED]> wrote: > 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 -~----------~----~----~----~------~----~------~--~---
