Study design and patients
bleeding, embolic events, hematologic, hepatic, and renal function, thrombotic
BRAIN METASTASIS, BLEEDING, RECURRENCE, GASTROINTESTINAL BLEEDING, MAY, SOLID TUMOR, ADENOCARCINOMA, ONCOLOGY
This was an open‐label, multicenter, randomized phase II study comparing XP with or without sorafenib in chemotherapy‐naive patients with metastatic GC. Patients were enrolled from 12 centers in Korea, China, and Taiwan.Patients with histologically proven metastatic gastric or gastroesophageal junction adenocarcinoma were eligible if they had at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Other eligibility criteria included age 18–74 years, Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0–1, and adequate hematologic, hepatic, and renal function. Patients who had received prior systemic chemotherapy were not included, except those who had completed adjuvant chemotherapy >6 months (12 months for platinum‐based therapy) before a recurrence of GC. Although a trastuzumab‐containing regimen has become the standard first‐line regimen for HER2‐positive advanced GC after the publication of ToGA trial in 2010, trastuzumab was not clinically available in South Korea until June 2011. Thus, HER2‐positive patients were not excluded during the early stage of patient accrual (January 2011 to May 2011), and some HER2‐positive patients (Patients with local‐regional gastric or gastroesophageal adenocarcinoma who could potentially become candidates for surgery with curative intent following systemic therapy were excluded. Other exclusion criteria were a history of gastrointestinal bleeding > grade 1, any other bleeding > grade 2, evidence of brain metastasis, and any thrombotic or embolic events within the past 6 months.