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Biotech / Medical : ARIAD Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: PuddleGlum who wrote (1504)	5/16/2005 1:30:07 PM
From: tuck	Read Replies (1) \| Respond to of 4474

>>A randomized, phase II ECOG trial of two dose levels of temsirolimus (CCI-779) in patients with extensive stage small cell lung cancer in remission after induction chemotherapy. A preliminary report Abstract No: 7005 Author(s): K. J. Pandya, D. E. Levy, M. Hidalgo, R. B. Cohen, M. W. Lee, J. H. Schiller, D. H. Johnson Abstract: Background: Temsirolimus (CCI-779), an ester of sirolimus, is an inhibitor of mTOR, shown to inhibit tumor cell proliferation in non-clinical models. Standard chemotherapy typically results in a 9 month median survival in extensive stage small cell lung cancer (SCLC-ES). A Phase II study was initiated in patients (pts) with SCLC-ES in remission (CR, PR, SD) following 4-6 cycles of carboplatin or cisplatin+etoposide or irinotecan, to determine the effects of temsirolimus on progression-free and overall survival. Methods: Between January 2002 and December 2003, 87 pts were randomized to 2 dose levels of temsirolimus (86 pts are eligible for this analysis): 44 pts to 25 mg (Arm A); 42 pts to 250 mg (Arm B), both given IV over 30 minutes weekly until progression. Pts were entered 4-8 weeks after completing induction therapy.Their characteristics are: male 42 (49%), female 44(51%); PS0: 38(44%), 1: 41(48%), 2: 4(5%); brain metastases 5(6%). Median follow up time is 33.8 months. Results: Toxicity: There were no treatment related grade (G) 5 toxicities on either arm. Worst G3/4 degree reported: 21 pts on Arm A and 26 pts in Arm B. G3/4 neutropenia: 4 in each arm; thrombocytopenia: 3 in Arm A, 9 in Arm B; hypercholesterolemia/triglyceridemia: 1/1 in Arm A, 3/3 in Arm B; hypophosphatemia: 2 in Arm A, 6 in Arm B. G3 allergic reaction: 1 in each arm; urticaria: 2 in Arm B. Survival: 8/44 pts (18%) are alive on Arm A, and 16/42 (38%) are alive on Arm B at the time of analysis. The median survival for all pts is 19.8 months (95% CI: 16.3 -22.9 months): Arms A 16.5 months and Arm B, 22.9 months. The median progression free survival for all pts is 5.5 months (95% CI: 4.4 - 7.7 months): Arm A 4.7 months and Arm B, 6.3 months. By comparison, the post randomization median survival was 8.9 months in 242 pts with CR, PR, SD following cisplatin+etoposide induction in ECOG phase III study E7593 (JCO 19:2114,2001). Conclusion: Temsirolimus appears to have significant activity in extensive stage small cell lung cancer and should be studied further in this setting. << From this year's ASCO meeting. Certainly curious to see what Rick will say, but maybe it's the competition . . . Cheeers, Tuck