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卡培他滨节拍化疗在转移性结直肠癌维持治疗中的探索性Ⅱ期研究 被引量:16

Metronomic chemotherapy with capecitabine as maintenance following first-line induction chemotherapy in metastatic colorectal cancer
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摘要 背景与目的:转移性结直肠癌患者一线诱导化疗后的维持治疗方案如何选择,尚存在争议。本研究将卡培他滨节拍化疗应用于转移性结直肠癌维持治疗,评估其疗效与安全性。方法:本研究是单臂、单中心探索性研究。接受一线诱导化疗(XELOX、mFOLFOX6、FOLFIRI)18~24周的转移性结直肠癌患者,评估为临床获益后接受卡培他滨500 mg,每天2次口服维持治疗,直至疾病进展。研究首要终点是无进展生存期(progression-free survival,PFS),包括卡培他滨维持治疗的PFS和诱导化疗续贯维持治疗的PFS。次要终点为总生存期(overall survival,OS)和不良反应。结果:2014年10月16日—2017年12月31日于上海交通大学医学院附属瑞金医院接受治疗的转移性结直肠癌患者37例接受节拍化疗维持治疗。中位随访时间15.0个月(4.0~41.4个月)。节拍化疗维持治疗的中位PFS为5.6个月(1.7~38.5个月),诱导化疗续贯维持治疗的中位PFS为11.4个月(6.8~44.3个月)。主要的不良反应为白细胞减少(8/37,21.6%)、恶心呕吐(5/37,13.5%)和手足综合征(3/37,8.1%)。没有1例患者出现3~4级严重不良反应。结论:卡培他滨节拍化疗应用于转移性结直肠癌诱导化疗后维持治疗安全、有效。 Background and purpose: The optimal strategy of maintenance therapy following first-line chemotherapy for metastatic colorectal cancer(mCRC) patients is controversial. This pilot study was to evaluate the efficacy and safety of metronomic chemotherapy with capecitabine as maintenance therapy in metastatic colorectal cancer. Methods: This was a single-arm, singlecenter trial, and patients received maintenance therapy of capecitabine 500 mg, twice per day as metronomic chemotherapy following 18-24 weeks of induction chemotherapy with XELOX, mFOLFOX6 or FOLFIRI and achieved clinical benefit. The primary end point was progression-free survival(PFS). The secondary end points included overall survival(OS) and toxicity. Results: Between 16 th Oct., 2014 and 31 st Dec., 2017, 37 patients were enrolled in the study from Shanghai Jiao Tong University School of Medicine in China. The median follow-up time was 15 months(4.0-41.4 months). The primary end point PFS(metronomic maintenance therapy) was 5.6 months(1.7-38.5 months). The PFS(from the induction chemotherapy following maintenance therapy to the first progression) was 11.4 months(6.8-44.3 months). The most common toxicities were neutropenia, nausea, vomiting and hand-foot syndrome. None of the patients had 3-4 grade toxicity. Conclusion: Metronomic chemotherapy with capecitabine as maintenance therapy can be considered an appropriate option following the induction chemotherapy in mCRC patients with acceptable toxicities.
作者 蒋劲松 任若冰 耿梅 黎皓 JIANG Jinsong;REN Ruobing;GENG Mei;LI Hao(Department of Oncology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China)
出处 《中国癌症杂志》 CAS CSCD 北大核心 2019年第3期218-222,共5页 China Oncology
关键词 结直肠癌 卡培他滨 节拍化疗 维持治疗 Colorectal cancer Capecitabine Metronomic chemotherapy Maintenance therapy
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