FAST-ACT: A phase II randomized double-blind trial of sequential erlotinib and chemotherapy as first-line treatment in patients (pts) with stage IIIB/IV non-small cell lung cancer (NSCLC)

作者：J. S. Lee, Jorge Ignacio, Chuan-Xin Yu, C. Zhou, Yi‐Long Wu, Y. Chen, L. Zhang, Kaiqi Jin, Michael Johnston, Tony Mok · 发表于：Journal of Clinical Oncology · 年份：2008 · DOI：10.1200/jco.2008.26.15_suppl.8031 · 被引用次数：24 · 研究领域：Lung Cancer Treatments and Mutations、Lung Cancer Research Studies、Colorectal Cancer Treatments and Studies

8031 Background: Concurrent administration of EGFR TKIs and chemotherapy in 1st line failed to improve survival. Preclinical data suggested potential antagonism due to TKI-induced G1 arrest reducing cell cycle phase-dependent activity of chemotherapy, whereas sequential administration of EGFR-TKI following chemotherapy may improve efficacy [Gumerlock et al, ASCO 2003; Solit et al, Clin Can Res 2005]. Methods: All eligible pts with chemonaïve stage IIIB/IV NSCLC, performance status of 0/1 and adequate organ function were randomized to receive either erlotinib (E) 150mg/d or placebo (P) p.o. on d15–28 of 4-weekly chemotherapy cycles. Chemotherapy consisted of gemcitabine (G) 1250mg/m2 i.v. (d1, 8) plus either cisplatin (C) 75mg/m2 or carboplatin (C) 5xAUC (d1) for a maximum of 6 cycles. Responding pts continued to receive E or P until progression or unacceptable toxicity. The primary endpoint was non-progression rate (NPR: CR+PR+SD) at 8 wks using RECIST. Results: Between Aug 2006 and Apr 2007, 154 pts were enrolled from 7 countries. Median age was 57 years and 94% were Asian. Other baseline characteristics and efficacy results are shown in the table below. The median number of treatment cycles received was 6 vs 5 (GC-E vs GC-P). Rash-like events were noted in 66% of GC-E vs 35% of GC-P arm, and diarrhea was observed in 24% and 18% of pts, respectively. The most common grade 3–5 adverse events (GC-E vs GC-P) were neutropenia (20% vs 15%); anemia (8% vs 6%); thrombocytopenia (5%...