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Biotech / Medical : Cell Therapeutics (CTIC) -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (479)	2/28/2005 3:47:50 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 946

Thanks, Ian. Hard to maintain focus today. :-( Glad someone remembered. Rick

To: Ian@SI who wrote (479)	2/28/2005 3:52:58 PM
From: Icebrg	Read Replies (1) \| Respond to of 946

Ian There is more than that. The "standard investigation" normally referred to, as far as doublet therapy in first-line NSCLC is concerned, indicates that treatment beyond 4 cycles will not bring any survival benefit. Journal of Clinical Oncology, Vol 20, Issue 5 (March), 2002: 1335-1343 © 2002 American Society for Clinical Oncology Phase III Trial Comparing a Defined Duration of Therapy Versus Continuous Therapy Followed by Second-Line Therapy in Advanced-Stage IIIB/IV Non–Small-Cell Lung Cancer By Mark A. Socinski, Michael J. Schell, Amy Peterman, Kamal Bakri, Steven Yates, Robert Gitten, Paul Unger, Joanna Lee, Ji-Hyun Lee, Maureen Tynan, Martha Moore, Merrill S. Kies From the Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and Department of Medicine and Center on Outcomes Research and Education, Northwestern University, Chicago, IL. Address reprint requests to Mark A. Socinski, MD, Director, Multidisciplinary, Thoracic Oncology Program, CB #7305, University of North Carolina, Chapel Hill, NC 27599; email: socinski@med.unc.edu. PURPOSE: To compare four cycles of therapy versus continuous therapy to determine the optimal duration of chemotherapy in advanced non–small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Stage IIIB/IV NSCLC patients were randomized to arm A (four cycles of carboplatin at an area under the curve of 6 and paclitaxel 200 mg/m2 every 21 days) or arm B (continuous treatment with carboplatin/paclitaxel until progression). At progression, all patients on both arms were to receive second-line weekly paclitaxel at 80 mg/m2/wk. The primary end points were survival and quality of life (QOL). RESULTS: Two hundred thirty patients were randomized. Fifty-seven percent of arm A patients completed four courses of therapy. In the 116 arm B patients, the median number of cycles delivered was four (range, zero to 19 cycles). Forty-two percent received five or more cycles; 18% received eight or more cycles. Overall response rates were 22% and 24% for arms A and B, respectively (P = .80). Median survival time and 1-year survival rates were 6.6 months and 28% for arm A and 8.5 months and 34% for arm B, respectively (log-rank P = .63). Rates of hematologic and nonhematologic toxicity were similar between the two arms, except for neuropathy. The rate of grade 2 to 4 neuropathy increased from 19.9% (95% confidence interval [CI], 13.6% to 26.2%) at cycle 4 to 43% (95% CI, 28.6% to 57.4%) at cycle 8. There were no differences in QOL. Only 45% of patients received second-line therapy (42% in arm A v 47% in arm B, P = .42). CONCLUSION: This study shows no overall benefit in survival, response rates, or QOL to continuing treatment with carboplatin/paclitaxel beyond four cycles in advanced NSCLC. Although not mentioned in the abstract, Socinski actually mentions that poor performance status patients had a statistically significant advantage going beyond 4 cycles. In the Stellar 3 trial, 63 % of the patients (in the blended population) received 4 or more cycles of therapy vs. 21 % which is "normal" (as per the Tandem database). For Stellar 4 the figures were 50 % vs. 16 %. According to data safety and monitoring committee, there were more cases of neuropathy in the treatment arm compared to the control arm. This was however according to the committee due to the fact that the treatment arm received more cycles of drug. Comparing the incidence of neuropathy on a per cycle basis did not show any indication that the treatment arm did worse. All in all, pretty positive. Erik