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S-1、多西他赛和顺铂联合化疗治疗不可切除转移性胃癌患者的 II 期研究。

Phase II study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer.

机构信息

Fourth Department of Internal Medicine, School of Medicine, Sapporo Medical University, South 1 West 16, Chuo-ku, Sapporo, Japan.

出版信息

Cancer Chemother Pharmacol. 2010 Sep;66(4):721-8. doi: 10.1007/s00280-009-1215-2. Epub 2009 Dec 30.

DOI:10.1007/s00280-009-1215-2
PMID:20041328
Abstract

PURPOSE

We evaluated the activity and toxicity of docetaxel, cisplatin, and S-1 (DCS) combination chemotherapy in patients with unresectable metastatic gastric cancer.

METHODS

Patients with histologically proven, unresectable metastatic gastric adenocarcinoma, performance status (PS) 0-2, and no prior chemotherapy were eligible. Patients received oral S-1 (40 mg/m(2) b.i.d.) on days 1-14 and intravenous cisplatin (60 mg/m(2)) and docetaxel (60 mg/m(2)) on day 8 every 3 weeks.

RESULTS

Thirty-four patients were enrolled between March 2005 and April 2007. Three patients were considered ineligible and did not receive the DSC therapy. Clinical characteristics were as follows: median age, 63 years (range, 44-77); PS, 0/1/2: 23/8/0; women/men, 8/23; and well-differentiated/undifferentiated adenocarcinoma, 10/21. The objective response rate was 87.1% with 1 complete response (3.2%) and 26 partial responses (83.9%) in 31 assessable patients. Four had stable disease (12.9%) but none had progressive disease. Of these 27 responders, 8 (25.8%) achieved downstaging and 7 (22.6%) underwent curative surgery. The median survival time and progression-free survival were 687 days [confidence interval (95% CI), 600.0-1,138.1] and 226 days (95% CI, 182.5-379.3), respectively. Most common grade 3/4 hematologic toxicity was neutropenia (77.4%). Most common grade 3 nonhematologic toxicities included anorexia (35.5%) and nausea (32.3%). All treatment-related toxicities resolved, and no toxic deaths were observed.

CONCLUSIONS

DCS combination chemotherapy is highly active against unresectable metastatic gastric cancer and can be given safely with proper management of adverse events. Further studies of this combination are warranted.

摘要

目的

我们评估了多西紫杉醇、顺铂和 S-1(DCS)联合化疗在不可切除转移性胃腺癌患者中的疗效和毒性。

方法

符合条件的患者为组织学证实的不可切除转移性胃腺癌,表现状态(PS)0-2,且无既往化疗史。患者接受口服 S-1(40mg/m2,bid),第 1-14 天;静脉注射顺铂(60mg/m2)和多西紫杉醇(60mg/m2),第 8 天,每 3 周一次。

结果

2005 年 3 月至 2007 年 4 月期间共入组 34 例患者。3 例患者因不符合条件而未接受 DCS 治疗。临床特征如下:中位年龄 63 岁(范围,44-77 岁);PS:0/1/2:23/8/0;女性/男性:8/23;高分化/低分化腺癌:10/21。31 例可评价患者中,1 例(3.2%)完全缓解,26 例(83.9%)部分缓解,客观缓解率为 87.1%。4 例疾病稳定(12.9%),无进展病例。在这 27 例缓解者中,8 例(25.8%)降期,7 例(22.6%)接受根治性手术。中位总生存时间和无进展生存时间分别为 687 天[95%置信区间(CI):600.0-1,138.1]和 226 天(95%CI:182.5-379.3)。最常见的 3/4 级血液学毒性是中性粒细胞减少(77.4%)。最常见的 3 级非血液学毒性包括厌食(35.5%)和恶心(32.3%)。所有治疗相关毒性均可缓解,无毒性死亡。

结论

DCS 联合化疗对不可切除转移性胃腺癌具有高度活性,在适当处理不良反应的情况下可以安全使用。有必要对此联合方案进行进一步研究。

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