Dear Jamie, I know a patient who was intolerant to Gleevec and went on to Sprycel at Adelaide, if you wish, your sister can speak to her? She is feeling well on Sprycel. Sprycel is already FDA approved in the US so its safety has been tested and also its efficacy. Below, find an abstract presented from Dr. Hochhaus of Germany in the European Hematologic Association 2006 meeting that took place in June which give a 73% of major cytogenetic remission rate for Gleevec-intolerant patients.
Is your sister hesitating about side-effects? Sprycel can lower blood counts in some folks, does your sister have low blood counts in general? And what side-effects of Gleevec made her intolerant of Gleevec? Anyway, here is the Phase II study of Sprycel for chronic phase patients. There are patients taking Sprycel on this list, as well. You may want to take a look at the group archives. Best Regards, Anjana View abstract data AuthorHochhaus, Hochhaus , Mannheim, Universitaet Heidelberg Germany Co-author(s) Kantarjian, H , Houston, MD Anderson Cancer Center Shah, N , Los Angeles, UCLA Rosti, G , Bologna, Universita Di Bologna Cervantes, F , Barcelona, University of Barcelona Facon, T , Lille, Service Des Maladies du Sang Countouriotis, A , Los Angeles, Mattel Children's Hospital Ezzeddine, R , Wallingford, Bristol-Myers Squibb Branford, S , Adelaide, IMVS Druker, B , Portland, Oregon Health and Science University Topic26. Chronic myeloid leukemia KeywordsCML,Dasatinib,imatinib-resistance,kinase-inhibitors Background: Dasatinib (BMS-354825) is a novel, oral, multi-targeted kinase inhibitor of BCR-ABL and SRC kinases with preclinical and clinical activity against imatinib resistant BCR-ABL mutations. Aims: To demonstrate the activity of dasatinib in patients (pts) with CP-CML who are resistant to (primary or acquired resistance, or detection of BCR-ABL mutations highly associated with imatinib resistance) or intolerant (grade 3-4 non hematologic or persistant hematologic toxicity) of imatinib. Methods: START-C is an open-label Phase II study of dasatinib in imatinib-resistant (IM-R) or -intolerant (IM-I) pts with CP-CML. Between February-August 2005, 387 pts were recruited at 75 centers worldwide. Dasatinib was given at 70 mg twice daily (BID) with dose escalation to 90 mg BID in pts lacking response, and dose reductions to 50 and 40 mg BID for intolerance. Evaluations were weekly blood counts for the first 12 weeks; bone marrow cytology and cytogenetics every 3 months; and molecular monitoring of BCR-ABL transcript levels by real-time quantitative polymerase chain reaction (RT-PCR) every 4 weeks for the first 12 weeks, and then every 12 weeks while on study. The primary endpoint was major cytogenetic response (MCyR) rate. Results: Of the 387 pts, 271 were IM-R and 116 were IM-I pts. Median age was 58 yrs (range 21-85); 49% were male. Median time from diagnosis of CML was 61 months. Prior treatment included interferon in 252 (65%) and stem cell transplant in 38 (9.8%). All patients received prior IM: doses >600 mg/day in 214 (55%), >3 years in 207 cases (53%); 141 pts (36%) achieved MCyR on prior IM. Efficacy and safety data are currently available from 186 pts (127 IM-R, 59 IM-I) accrued prior to May 12, 2005. With =6 months of follow up, 168 (90%) pts had a complete hematologic response (CHR), and 83 (45%) pts had a MCyR: 40 (31%) of IM-R pts, and 43 (73%) of IM-I pts. Rate of MCyR was 37% among the 65 pts with BCR-ABL mutations. Grade 3/4 neutropenia or thrombocytopenia was reported in 83 (45%) pts and 85 (46%) pts with onset after 4-8 weeks of therapy in most pts. Dose interruptions occurred in 146 (78%), and dose reductions in 96 (52%) pts with an average daily dose of 108 (range 19-169) mg. Non-hematologic toxicity consisted mainly of Grade 1/2 diarrhea, headache, superficial edema, and pleural effusion, with =2% Grade 3/4. There was no cross-intolerance between dasatinib and IM. Conclusions: Dasatinib demonstrated substantial hematologic and cytogenetic activity in IM-R and IM-I pts with CP-CML. An updated analysis of 387 pts with 6 months of follow up, in addition to the molecular response analysis, will be presented. --~--~---------~--~----~------------~-------~--~----~ [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 -~----------~----~----~----~------~----~------~--~---
