AVAGAST: A randomized, double-blind, placebo-controlled, phase III study of first-line capecitabine and cisplatin plus bevacizumab or placebo in patients with advanced gastric cancer (AGC).

作者：Yubin Kang, Atsushi Ohtsu, Eric Van Cutsem, Sun Young Rha, Akira Sawaki, Sunmin Park, Ho Yeong Lim, Jun Wu, Bernd Langer, Manish A. Shah · 发表于：Journal of Clinical Oncology · 年份：2010 · DOI：10.1200/jco.2010.28.18_suppl.lba4007 · 被引用次数：111 · 研究领域：Gastric Cancer Management and Outcomes、Cholangiocarcinoma and Gallbladder Cancer Studies、Colorectal Cancer Treatments and Studies

LBA4007 Background: The median survival for patients (pts) with AGC in most phase III studies is less than 1 year. The addition of bevacizumab (bev) to chemotherapy (chemo) is supported by a strong preclinical rationale and by phase II evaluation. AVAGAST is the first randomized study to compare the efficacy and safety of bev + chemo vs placebo + chemo. Methods: Pts with inoperable, locally advanced or metastatic stomach/gastroesophageal junction adenocarcinoma with no prior therapy were randomized 1:1 to capecitabine (cape, or 5-FU) + cisplatin (cis) and either bev (7.5 mg/kg iv) or placebo q3w. Stratification variables: geographical region, fluoropyrimidine treatment, disease status. Cis was given for 6 cycles; bev/placebo + cape/5-FU were given until disease progression or unmanageable toxicity. Primary objective: compare overall survival (OS); secondary objectives: compare progression-free survival (PFS), overall response rate (ORR), and safety (as overseen by an independent DSMB). Results: From Sep 2007 to Dec 2008, 774 pts were enrolled. Treatment arms were balanced. Approx 95% of pts were metastatic. Two-thirds of pts were male, 49% of pts were from Asia/Pacific, 32% from Europe and 19% from the Americas. Median OS was 10.1 months with chemo + placebo and 12.1 months with chemo + bev in the intent-to-treat population (HR 0.87; p=0.1002). Median OS according to geographical region was 6.8 vs. 11.5 months (HR 0.63) in the Americas, 8.6 vs. 11.1 months (HR 0.85) in Europe...