A phase II trial of weekly paclitaxel and carboplatin for elderly patients with advanced non-small cell lung cancer (NSCLC)

Abstract

7248 Background: Paclitaxel combined with carboplatin (PC) is a commonly used regimen in advanced NSCLC. Although some studies suggested that PC is also effective for elderly patients, weekly paclitaxel combined with carboplatin for those patients has not been reported. We conducted this phase II trial to evaluate the safety and the efficacy of weekly paclitaxel and carboplatin for elderly patients with advanced NSCLC. Methods: Patients with stage IIIB, IV or postoperative recurrent NSCLC, PS ≤ 1, ≥ 70 years old received weekly paclitaxel (70mg/m2/wk) on d1, 8, 15, and carboplatin (AUC 6) on d1. Treatment was repeated every 4 weeks. Results: From May 2002 to Aug 2004, 42 patients were enrolled: median age (range), 75 (70–81); male/female, 32/10; stage IIIB/IV/postoperative recurrence, 13/25/4. Two patients never received study drug and 40 patients were evaluable for the safety and the efficacy. ≥Grade 3 toxicities included neutropenia (70%); thrombocytopenia (15%); anemia (13%); infection (10%); fatigue and febrile neutropenia (5%). No ≥grade 3 neurotoxicity was observed. One treatment related death (infection) was observed. Overall response rate was 45%; CR=0, PR=18, SD=11, PD=7, NE=4. To date, median survival time was 13 months and the 1-year survival rate was 58%. Conclusion: These results suggest that weekly paclitaxel and carboplatin is comparable to standard PC in efficacy and seems to be safer than standard PC. We are now conducting a randomized trial that compare weekly paclitaxel and carboplatin to standard PC. No significant financial relationships to disclose.