Multicenter phase II study of S-1 and docetaxel combination chemotherapy for advanced or recurrent gastric cancer patients with peritoneal dissemination.
Multicenter phase II study of S-1 and docetaxel combination chemotherapy for advanced or recurrent gastric cancer patients with peritoneal dissemination.
复制标题
S-1和多西他赛联合化疗治疗腹膜播散的晚期或复发性胃癌患者的多中心II期研究。
DOI：
10.1007/s00280-013-2086-0
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发表时间：
2013
影响因子：
3
通讯作者：
K.
中科院分区：
文献类型：
--
作者：
Shigeyasu;K.
腹膜播散是胃癌最常见、最致命的转移和复发方式。为评价替吉奥联合多西他赛化疗方案治疗晚期或复发性胃癌伴腹膜播散的疗效和耐受性，设计了一项多中心、Ⅱ期临床研究。口服S-1 80 mg/m2/天，每日两次，持续2周，随后停药1周。在第1天进行多西他赛40 mg/m2输注，同时进行S-1给药。主要终点为总生存期（OS）和疾病进展时间（TTP）。次要终点是反应率和safety status.ResultsPatients接受了中位数为4个周期的S-1和多西他赛方案（范围1-43）。疾病控制率为73.7%（14/19）。中位总生存期为459天（15.3个月），而中位进展时间为212天（7.1个月）。中性粒细胞毒性最常见（n= 7，36.8%）。结论替吉奥联合多西他赛治疗晚期或复发胃癌腹膜转移是一种安全有效的治疗方案。
PurposePeritoneal dissemination is the most frequent and life-threatening mode of metastasis and recurrence in patients with gastric cancer. A multicenter phase II study was designed to evaluate the efficacy and tolerability of S-1 and docetaxel combination chemotherapy regimen for the treatment of advanced or recurrent gastric cancer patients with peritoneal dissemination.MethodsNineteen patients with histologically confirmed unresectable or recurrent gastric cancer with peritoneal dissemination were enrolled. Oral S-1 at 80 mg/m2/day was administered twice daily for 2 weeks, followed by 1 drug-free week. Docetaxel infusion at 40 mg/m2was performed on day 1, simultaneous with S-1 administration. The primary endpoints were overall survival (OS) and time to progression (TTP). The secondary endpoints were the response rates and safety status.ResultsPatients received a median of 4 cycles of the S-1 and docetaxel regimen (range 1–43). The disease control rate was 73.7 % (14/19). Median overall survival was 459 days (15.3 months), while median time to progression was 212 days (7.1 months). Neutropenia was the most common type of toxicity (n= 7, 36.8 %).ConclusionsCombination chemotherapy with S-1 and docetaxel is a tolerable and effective treatment for advanced or recurrent gastric cancer patients with peritoneal dissemination.