Docetaxel plus cisplatin versus vinorelbine plus cisplatin as adjuvant chemotherapy in stage IB-IIIA non-small cell lung cancer: Preliminary result of phase II pilot trial CHL001/TAX622.

Abstract

7063 Background: Adjuvant chemotherapy has become a standard of care for patients with completely resected stage IB, II and IIIA non-small cell lung cancer (NSCLC). However, few data exist comparing the efficacy of vinorelbine/cisplatin and docetaxel/cisplatin regimens for adjuvant treatment of NSCLC. Methods: Patients with stage IB, II and IIIA NSCLC who underwent curative resection were randomly assigned to arm A: docetaxel (75 mg/m2, day1) and cisplatin(75 mg/m2, day1) (DP) or arm B: vinorelbine (25 mg/m2, day 1, 8) and cisplatin(75 mg/m2, day1) (VP) for 4 cycles each. Both regimens were repeated every 3 weeks. Primary end point is disease free survival (DFS); secondary end points are safety, and quality of life (QOL). Results: 158 patients were enrolled between Dec 2005 and Nov 2008, 15 patients withdrew after randomization. As of this report, data of 143 patients was analyzed (82 from DP arm and 61 from VP arm). Patient demographics(DP/VP): median age 56.2/55.9 years; 70.7%/70.5% male; 54.1%/43.3% ad...