辅助 S-1 加多西他赛治疗根治性 D2 胃切除术后 III 期胃癌患者的 II 期可行性研究。
Phase II feasibility study of adjuvant S-1 plus docetaxel for stage III gastric cancer patients after curative D2 gastrectomy.
机构信息
Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan.
出版信息
Oncology. 2011;80(5-6):296-300. doi: 10.1159/000329090. Epub 2011 Jul 18.
OBJECTIVE
The aim of this prospective study was to evaluate the feasibility and safety of adjuvant S-1 plus docetaxel in patients with stage III gastric cancer.
METHODS
We enrolled 53 patients with pathological stage III gastric cancer who underwent D2 gastrectomy. They received oral S-1 (80 mg/m(2)/day) administration for 2 consecutive weeks and intravenous docetaxel (40 mg/m(2)) on day 1, repeated every 3 weeks (1 cycle). The treatment was started within 45 days after surgery and repeated for 4 cycles, followed by S-1 monotherapy (4 weeks on, 2 weeks off) until 1 year after surgery. The feasibility of the 4 cycles of chemotherapy, followed by S-1 administration, was evaluated.
RESULTS
A total of 42 patients (79.2%, 95% CI 65.9-82.9) tolerated the planned 4 cycles of treatment with S-1 and docetaxel, and 34 patients (64.2%, 95% CI 49.8-76.9) completed subsequent S-1 monotherapy for 1 year. Grade 4 neutropenia was observed in 28% and grade 3 febrile neutropenia in 9% of the patients, while grade 3 nonhematological toxicities were relatively low.
CONCLUSIONS
Adjuvant S-1 plus docetaxel therapy is feasible and has only moderate toxicity in stage III gastric cancer patients. We believe that this regimen will be a candidate for future phase III trials seeking the optimal adjuvant chemotherapy for stage III gastric cancer patients.
目的
本前瞻性研究旨在评估辅助 S-1 联合多西他赛治疗 III 期胃癌的可行性和安全性。
方法
我们纳入了 53 例接受 D2 胃切除术的病理 III 期胃癌患者。他们接受口服 S-1（80 mg/m²/天）治疗，连续 2 周，第 1 天静脉注射多西他赛（40 mg/m²），每 3 周重复（1 个周期）。手术后 45 天内开始治疗，重复 4 个周期，随后接受 S-1 单药治疗（4 周给药，2 周停药），直至手术后 1 年。评估 4 个周期化疗后再接受 S-1 治疗的可行性。
结果
共有 42 例患者（79.2%，95%CI 65.9-82.9）能够耐受计划的 4 个周期 S-1 和多西他赛治疗，34 例患者（64.2%，95%CI 49.8-76.9）完成了随后的 S-1 单药治疗 1 年。患者中有 28%发生 4 级中性粒细胞减少症，9%发生 3 级发热性中性粒细胞减少症，而 3 级非血液学毒性相对较低。
结论
辅助 S-1 联合多西他赛治疗 III 期胃癌是可行的，且毒性适中。我们认为，该方案将成为未来 III 期临床试验的候选方案，以寻找 III 期胃癌患者的最佳辅助化疗方案。
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