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

作者：Panos M. Fidias, Shaker R. Dakhil, Alan P. Lyss, Danuta Z. Loesch, David Michael Waterhouse, J. L. Cunneen, R. Chen, Joseph Treat, Coleman K. Obasaju, Joan H. Schiller · 发表于：Journal of Clinical Oncology · 年份：2007 · DOI：10.1200/jco.2007.25.18_suppl.lba7516 · 被引用次数：44 · 研究领域：Lung Cancer Treatments and Mutations、Lung Cancer Diagnosis and Treatment、Hepatocellular Carcinoma Treatment and Prognosis

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...