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- Title
The Multicenter, Phase II Prospective Study of Paclitaxel Plus Capecitabine as First-Line Chemotherapy in Advanced Gastric Carcinoma.
- Authors
Gong, Jifang; Hu, Bing; Zhang, Xiaotian; Zhang, Fengchun; Zhang, Jun; Xu, Nong; Fan, Qingxia; Bai, Yuxian; Jiao, Shunchang; Wang, Jinwan; Bai, Chunmei; Zheng, Leizhen; Shi, Yingqiang; Liu, Yunpeng; Liang, Jun; Hu, Guoqing; Cheng, Ying; Xu, Ruihua; Bai, Yu; Shen, Lin
- Abstract
Background.: The efficacy and toxicity of paclitaxel plus capecitabine (PX) as first‐line treatment in advanced gastric cancer (AGC) was evaluated. Methods.: Patients with previously untreated AGC were included. PX was given every 3 weeks until a maximum of six cycles or progression. Capecitabine monotherapy was continued for patients without disease progression. The primary endpoint was progression‐free survival, and secondary endpoints were objective response rate, overall survival (OS), and safety. Results.: Overall, 194 patients were treated per protocol and one patient was excluded because of allergy to paclitaxel. Response was evaluated in 175 patients, with an objective response rate of 34.8%. After a median follow‐up of 33.2 months, disease progression was observed in 141 patients, 137 died, and 16 were lost to follow‐up, with progression‐free survival of 188 days and OS of 354 days. In multivariate Cox regression analysis, no factor remained an independent predictor of OS. Forty‐five patients who received capecitabine monotherapy after PX had longer OS (531 days). Adverse events were mild (Fig. 1), and the most common grade 3–4 toxicities were leucopenia and neutropenia. Conclusion.: PX as a first‐line treatment has promising efficacy in AGC. Based on these data, a phase III study has been launched for further investigation. 摘要 背景. 评估紫杉醇联合卡培他滨(PX)作为晚期胃癌(AGC)一线治疗的疗效与毒性反应。 方法. 入组未曾治疗的AGC患者。PX每3周给予1次,直至满6个周期或疾病进展。无疾病进展的患者继续卡培他滨单药治疗。主要研究终点为无进展生存期,次要研究终点为客观缓解率、总生存期(OS)以及安全性。 结果. 共194例患者接受研究方案治疗,1例因对紫杉醇过敏而被排除。175例患者可评估疗效,客观缓解率为34.8%。中位随访33.2个月时,141例患者出现疾病进展,137例死亡,16例失访,无进展生存期为188天,OS为354天。在多变量Cox回归分析中,尚未发现一项因素能够作为OS独立预测因子。PX后接受卡培他滨单药治疗的45例患者OS更长(531天)。不良事件为轻度,最常见的3∼4级毒性反应为白细胞减少和中性粒细胞减少。 结论. 作为AGC一线治疗,PX显示出很有前景的疗效。基于这些数据,一项更深入的III期研究已经启动。The Oncologist 2014;19:173‐174
- Subjects
CANCER chemotherapy; LONGITUDINAL method; RESEARCH funding; STOMACH tumors; PROPORTIONAL hazards models; HAND-foot syndrome
- Publication
Oncologist, 2014, Vol 19, Issue 2, p173
- ISSN
1083-7159
- Publication type
Abstract
- DOI
10.1634/theoncologist.2013-0137