A phase II, open-label, multicenter, prospective study of paclitaxel plus capecitabine with subsequent capecitabine maintenance therapy as first-line treatment for metastatic or recurrent gastric cancer.

作者：Lin Shen, J. Gong, X. Zhang, Bing Hu, F. Zhang, J. Zhang, Nong Xu, Qing Fan, Yuxian Bai, Shuyue Jiao · 发表于：Journal of Clinical Oncology · 年份：2011 · DOI：10.1200/jco.2011.29.4_suppl.98 · 研究领域：Gastric Cancer Management and Outcomes、Colorectal Cancer Treatments and Studies、Cholangiocarcinoma and Gallbladder Cancer Studies

98 Background: Paclitaxel has been shown to be effective in AGC. We assess the efficacy and safety of PX-X therapy as first-line treatment for metastatic or recurrent GC in a phase II, multicenter, prospective study. Methods: Patients with previously untreated gastric adenocarcinoma, signed informed consent, target lesion(s), KPS ≥ 70 and adequate organ functions are eligible. Paclitaxel was given as 80 mg/m 2 by 3-hour infusion day 1,8, capecitabine 1,000 mg/m 2 , BID, D1-14, Q3W. Cycles were repeated until progression or maximum 6 or AEs. Then the patients without progression began the second stage treatment as X with same dose/schedule until progression or AEs. PFS, RR, DCR, OS and AEs are the end points evaluated in this study. Results: From 12/2006 to 4/2010, 195 patients (ITT) were enrolled in 21 centers, 1 patient was withdraw due to allergy to paclitaxel, 194 cases were PP. After median follow up of 16.2 months, 16 cases lost. In ITT, 119 pts progressed, 104 pts died. Mean cycles the patients completed was 5. CR and PR were achieved in 1.0% (2 pts) and 32.3% (63 pts) of pts (RR 33.3%), 75 pts had SD (38.5%), 25 pts (12.8%) progressed. PFS of ITT is 208 d (95% CI: 169.1-246.8) and estimated OS is 456 d (95%CI: 286.9-624.2). 45 pts continued to X after PX with good tolerance, median cycles accepted was 4, and OS was longer than 590 d. 23 patients accepted surgery after chemotherapy; the survival data have not been reached. After disease progression, 61 cases accepted se...