Phase I study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer.
Phase I study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer.
复制标题
不可切除的转移性胃癌患者的S-1，多西他赛和顺铂联合化疗的I期研究。
DOI：
10.1038/sj.bjc.6603957
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发表时间：
2007-10-08
影响因子：
8.8
通讯作者：
Niitsu, Y
中科院分区：
文献类型：
--
作者：
Takayama, T;Sato, Y;Sagawa, T;Okamoto, T;Nagashima, H;Takahashi, Y;Ohnuma, H;Kuroiwa, G;Miyanishi, K;Takimoto, R;Matsunaga, T;Kato, J;Yamaguchi, K;Hirata, K;Niitsu, Y
这项剂量递增研究的目的是确定多西紫杉醇、S-1和顺铂联合化疗对不可切除的转移性胃癌患者的最大耐受剂量（MTD）、剂量限制毒性（DLT）和初步疗效。 17 名患者在第 1-14 天接受口服 S-1（40mgm−2 bid），每 3 周在第 8 天静脉注射顺铂（60mgm−2）和多西紫杉醇（60、70 或 80mgm−2，取决于 DLT）。该组合的 MTD 推测为多西紫杉醇 70mgm−2。在此剂量水平下，40% 的患者（五分之二）在第一个疗程期间出现 4 级中性粒细胞减少症，20%（五分之一）出现 3 级恶心。因此，多西紫杉醇的推荐剂量被定义为60mgm−2。 DLT 为中性粒细胞减少症。缓解率 (RR) 为 88.2%（17 例中的 15 例），其中 1 例完全缓解，14 例部分缓解。有两种疾病稳定，但没有进展性疾病。在这 15 名应答者中，4 名 (23.5%) VEGF 高表达的患者表现出肿瘤快速消退并实现降期，从而导致随后进行治愈性胃切除术。其中三例已经无病生存约 3 年，表明已完全治愈。总之，该方案是可耐受的，并且显示出相当高的 RR，在转移性胃癌中具有明显的降期率。
The aim of this dose escalation study was to determine the maximum-tolerated dose (MTD), dose-limiting toxicities (DLTs) and preliminary efficacy of docetaxel, S-1 and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer. Seventeen patients received oral S-1 (40 mg m−2 bid) on days 1–14, intravenous cisplatin (60 mg m−2) and docetaxel (60, 70 or 80 mg m−2 depending on DLT) on day 8 every 3 weeks. The MTD of this combination was presumed to be docetaxel 70 mg m−2. At this dose level, 40% of the patients (two of five) developed grade 4 neutropenia and 20% (one of five) exhibited grade 3 nausea during the first course. Therefore, the recommended dose of docetaxel was defined as 60 mg m−2. The DLT was neutropenia. The response rate (RR) was 88.2% (15 of 17), consisting of one complete response and 14 partial responses. There were two stable diseases but no progressive disease. Of these 15 responders, four (23.5%) with high VEGF expression showed rapid tumour regression and achieved downstaging, leading to subsequent curative gastrectomy. Three of these have been disease free for about 3 years, suggesting a complete cure. In conclusion, this regimen was tolerable and showed a quite high RR, with an appreciable downstaging rate in metastatic gastric cancer.