Prospective randomized phase II study of FOLFIRI versus FOLFOX7 in advanced gastric adenocarcinoma: A Chinese Western Cooperative Gastrointestinal Oncology Group study.

1 Background: The purpose was to compare mFOLFIRI (arm A) with mFOLFOX7 (arm B) as first-line treatments in patients (pts) with locally advanced gastric adenocarcinoma in an open, randomized, phase II study. Methods: Previously untreated metastatic or recurrent gastric adenocarcinoma pts with measurable disease received mFOLFIRI (arm A) or mFOLFOX7 (arm B) every 2 weeks. The second-line treatment was mFOLFOX7 for arm A and mFOLFIRI for arm B. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), disease control rate (DCR) and toxicity. Results: In total, 200 pts were included. The evaluable population consisted of 128 pts (54 in arm A; 74 in arm B). The median PFS of arm A was 2.9 months (m) (1.9 to 4.1 m) versus 4.1 m (3.2 to 4.8 m) for arm B(p0.109). The median OS was 9.9 months (6.0 to 13.5 m) for arm A versus 12.0 m for arm B (10.3 to 13.7m; p= 0.431). The DCRs for arm A and arm B were 59.3% and 66.3%, respectively (p = 0.850). In subgroup an...