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Sub-category:
Adjuvant Therapy
Category:
Lung Cancer--Local-Regional and Adjuvant Therapy
Meeting:
2008 ASCO Annual Meeting
Abstract No:
NSA
Citation:
Author(s):
M.A. Socinski, E.F. Smit, P. Lorigan, K. Konduri, M. Reck, A. Szczesna, S. Hong, C. Visseren-Grul, S.C. Guba, N. Thatcher
Abstract:
Background: EC is a standard of care for first-line treatment of ED-SCLC. A randomized phase II trial comparing PC with P-cisplatin in ED-SCLC reported comparable response rates (39.5% PC, 35% P-Cis) and median survival for PC 10.4 mo (95% CI 7.4, 12.0) and for P-Cis 7.6 (95% CI 4.9, 10.3) (Socinski JCO 2006). Efficacy results were comparable to historic controls for EC. Methods: In this open label phase III trial, chemonaive pts with ED-SCLC and ECOG performance status (PS) 0-2 were randomized to PC (P 500 mg/m2 d1; C AUC 5 d1) or EC (E 100 mg/m2 d1,2,3; C AUC5 d1), every 3 weeks for =6 cycles. Randomization was stratified for PS, lactate dehydrogenase, gender, age, number of metastatic sites, and history of brain metastases. The study’s primary objective was non-inferiority of PC overall survival (OS) with a 15% margin, requiring enrollment of 1822 pts. An interim analysis was planned to test futility in terms of progression-free survival (PFS). The trial would be considered futile if the lower-limit of two-sided 90% CI for PFS hazard ratio (HR) (PC over EC) was >1.0. Results: This interim analysis included 733 pts (PC=364, EC=369) enrolled from 174 sites in 25 countries between Aug 2006 and Oct 2007. Stratification was balanced between arms, with 59% <65 years, 72% male, 87% PS 0/1, and 85% Caucasian. Both arms had median cycle number of 4. The SAE rate was 28% on PC and 24% on EC. No pts on EC, but 5 pts on PC, died of possible drug toxicity during study or within 30 days of discontinuation. PFS for pts on PC (3.68 mo) was inferior to EC (5.32 mo) (HR 1.79, [90% CI 1.49, 2.15]) and met the pre-specified futility rule. OS was 7.29 mo for PC (73% censored) and 9.56 mo for EC (82% censored), HR 1.78 (95% CI 1.29, 2.45). Overall response rate was 24.9% for PC and 40.5% for EC, p<0.001. Based on the Independent Data Monitoring Committee’s recommendation, study enrollment was closed for lack of efficacy. Conclusions: PC is inferior to EC for the treatment of chemonaive ED-SCLC pts. Translational research and pharmacogenomic analysis of tumor samples collected on study will hopefully aid development of new treatment strategies by better understanding SCLC biology.
Abstract Disclosures
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy
and are designated with a caret symbol (^) here and in the print version.
 Associated Presentation(s):
Other Abstracts in this Sub-Category:
Abstracts by M.A. Socinski:
Presentations by M.A. Socinski:
Educational Book Manuscripts by M.A. Socinski:
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