Phase III study of immediate versus delayed docetaxel after induction therapy with gemcitabine plus carboplatin in advanced non-small cell lung cancer: Updated report with survival

Abstract

LBA7516 Background: Gemcitabine (G) plus carboplatin (C) therapy is active in patients with advanced non-small-cell lung cancer (NSCLC). For nonprogressing patients, optimal timing of second-line therapy with a non-cross-resistant agent is unclear. This Phase III, randomized trial assessed the efficacy and safety of docetaxel (D) administered either immediately after GC induction therapy or upon disease progression (PD). Methods: Patients having either Stage IIIB with pleural effusion or Stage IV NSCLC were enrolled. Prior chemotherapy for NSCLC was not permitted. For GC induction, G 1000 mg/m2 was administered on Days 1, 8 followed by C AUC 5 on Day 1. After four 21-day cycles, nonprogressors were randomized to either the immediate D group (D 75 mg/m2 administered on Day 1 every 21 days, for a maximum of 6 cycles) or the delayed D group (patients given best supportive care after randomization and the same D regimen after first evidence of PD) treatment arms. Primary endpoint was overall survival (OS). Additional analyses included response rates, toxicity and progression-free survival (PFS). Results: Results are summarized in the table below. OS was not statistically different (p=0.071) between the two D arms. However, 31 patients (20.1%) in the delayed D arm and 38 patients (24.8%) in the immediate D arm were censored for OS analysis. PFS analysis (from randomization to first evidence of PD or death) showed a statistically significant (p=<0.0001) improvement in the immediate D arm. D given to NSCLS patients immediately after GC induction did not increase toxicity. Conclusions: Comparison of PFS for each D arm suggests a possible clinical benefit for immediate D therapy. However, even though OS trended in favor of immediate D therapy, the OS result did not reach statistical significance. The implications of these results will be discussed. [Table: see text] [Table: see text]