Randomized phase II study of carboplatin plus either docetaxel (CbD) or paclitaxel (CbP) in Japanese patients with advanced non-small cell lung cancer (NSCLC): JMTO LC07-01.

Abstract

e18069 Background: Platinum-based taxane chemotherapy has become a standard in the treatment of advanced NSCLC. However, no randomized data of CbD versus CbP have been available to date in Asian patients (pts). We report the analysis of a randomized phase II study comparing these two regimens. Methods: Chemotherapy-naive, ECOG PS 0-1, advanced NSCLC pts were enrolled. Carboplatin was administered at a fixed dose of AUC 6 on day1. Pts were randomized to either CbD (docetaxel 60 mg/m2 on day1, q3 wks) or CbP (paclitaxel 200 mg/m2 3h on day1, q3 wks) × 6 cycles in a ratio of 2 to 1, where the planned accrual was 90 pts (60/30 for CbD/CbP). Primary endpoint was PFS rate at 6 months (mo). Results: Ninety-one pts were enrolled and 90 pts were evaluable: median age 67 (range 37-82); M/F, 77/23%; cStage IIIB/IV/Relapse, 34/54/12%; Ad/Sq/Others, 59/26/16%; 6% had received prior RT. Demographics were well balanced between the two arms. Of the planned 360/180 cycles, 64/77% of those were administered in CbD/CbP. Median follow-up time was 15.8 mo. Data for survival, response rate, and toxicity in both arms are presented in the Table. PFS rate at 6 mo and median PFS were 41% and 4.8 mo in CbD and 37% and 5.1 mo in CbP. Although summary statistics for efficacy were similar in both arms, survival (OS and PFS) curves crossed each other. There was one treatment-related death due to pneumonitis in CbD. Conclusions: Two taxane drugs were tolerated and showed a similar activity in combination with carboplatin. Besides CbP, one of the current standard, CbD can be an alternative platform regimen in the first-line treatment of advanced NSCLC. Regimen CbD CbP N 60 30 Response rate, 90% CI 22% (13-32%) 33% (19-50%) PFS, % at 6 mo (90% CI) median (90% CI) 41% (30-52%) 4.8 mo (4.1-6.9 mo) 37% (22-51%) 5.1 mo (4.4-6.1 mo) OS, % at 12 mo (90% CI) median (90% CI) 60% (48-69%) 18 mo (12-23 mo) 60% (44- 73%) 15 mo (10-18 mo) Gr ≥3 neutropenia 75% 87% Gr ≥3 anemia 10% 10% Gr ≥3 thrombocytopenia 5% 3% Gr ≥3 febrile neutropenia 15% 17% Gr ≥3 nausea 5% 3% Gr ≥3 vomiting 5% 0% Gr ≥2 sensory neuropathy 17% 13% Gr ≥2 myalgias 7% 0% Treatment-related death 1 case 0 case No significant financial relationships to disclose.