A feasibility study of postoperative chemotherapy with S-1 and cisplatin (CDDP) for gastric carcinoma (CCOG0703)
A feasibility study of postoperative chemotherapy with S-1 and cisplatin (CDDP) for gastric carcinoma (CCOG0703)
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DOI：
10.1007/s10120-010-0559-y
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发表时间：
2010-08-01
期刊：
影响因子：
7.4
通讯作者：
Nakao, Akimasa
中科院分区：
文献类型：
--
作者：
Kodera, Yasuhiro;Ishiyama, Akiharu;Nakao, Akimasa
背景。III期胃癌患者行D2剥离后S-1辅助化疗的疗效仍不理想。此外，一些术前诊断为II/III期的患者在手术探查后发现为IV期，这类人群的标准术后治疗尚未建立。一项对IV期胃癌患者行胃切除术后使用S-1/顺铂（CDDP）的可行性研究。试验的主要终点是5个疗程S-1/CDDP的相对剂量强度。已经预先确定了跳过、推迟或减少剂量的几个标准。2007年至2009年间，共收集31例患者，其中19例腹膜洗涤细胞学阳性，6例腹膜播散，5例转移至主动脉旁淋巴结，4例其他远处转移。只有7例患者按计划完成了5个周期（中位数为2个周期）。S-1和CDDP的中位相对剂量强度分别为37%和40%。治疗失败的原因是：7例患者在最后一次给药后5周内未能达到开始新疗程的标准，6例患者拒绝，4例患者疾病复发/进展，4例患者需要将剂量减少两个级别，3例患者连续两次跳过CDDP。所有患者的中位无进展生存期为363天。尽管S-1/CDDP在新辅助治疗和晚期/转移治疗中很有前景，但作为日本患者胃切除术后治疗，S-1/CDDP毒性太大。
Background. The outcome of stage III gastric cancer patients treated by D2 dissection followed by adjuvant chemotherapy with S-1 remains unsatisfactory. Moreover, some patients with a preoperative diagnosis of stage II/III turn out to be stage IV after surgical exploration, and a standard postoperative treatment for this population has not been established.Methods. A feasibility study of postoperative S-1/cisplatin (CDDP) was performed with patients who underwent gastrectomy for what turned out to be a stage IV gastric cancer. The primary endpoint of the trial was the relative dose intensity during five courses of S-1/CDDP. Several criteria to skip, postpone, or reduce the dose had been predetermined.Results. Between 2007 and 2009, 31 patients were accrued, including 19 patients who were positive for peritoneal washing cytology, 6 with peritoneal seeding, 5 with metastasis to the paraaortic nodes, and 4 with other distant metastases. Only 7 patients completed five cycles as planned (median, two cycles). The median relative dose intensities of S-1 and CDDP were 37% and 40%, respectively. Causes of treatment failure were failure to fulfill criteria for starting a new course within 5 weeks of the last administration of S-1 in 7, patient refusal in 6, disease recurrence/progression in 4, need to reduce dose by two levels in 4, and two successive skips of CDDP in 3 patients. The median progression-free survival time of all patients was 363 days.Conclusions. Although promising in the neoadjuvant and advanced/metastatic setting, S-1/CDDP is too toxic as a post-gastrectomy treatment for Japanese patients.