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S-1 联合顺铂 3 周方案辅助化疗治疗Ⅱ~Ⅳ期(M0)胃癌的初步研究。

Pilot study of adjuvant chemotherapy with 3-week combination of S-1 and cisplatin for patients with stage II-IV (M0) gastric cancer.

机构信息

Department of Hematology/Oncology, Kyungpook National University Hospital, Kyungpook National University School of Medicine, 200 Dongduk-Ro, Jung-Gu, Daegu, Korea.

出版信息

Invest New Drugs. 2012 Aug;30(4):1671-5. doi: 10.1007/s10637-011-9729-y. Epub 2011 Aug 17.

DOI:10.1007/s10637-011-9729-y
PMID:21845514
Abstract

PURPOSE

The feasibility of a 3-week combination of S-1 and cisplatin as an adjuvant chemotherapy for patients with curatively resected gastric cancer was investigated.

EXPERIMENTAL DESIGN

Korean patients with stage II-IV (M0) gastric adenocarcinoma who underwent a gastrectomy with D2 lymph node resection were enrolled. The S-1 was administered orally at 80 mg/m(2) divided into two daily doses for 14 days, while the cisplatin was administered at 60 mg/m(2) intravenously over 2 h every 21 days. The patients received a maximum of six cycles.

RESULTS

From January 2006 to July 2010, 74 patients were included in this study. The median patient age was 56 years (range, 22-71), and 51.4% (38/74) of the patients had a performance status of 0. The median number of chemotherapy cycles administered was 6 (range, 1-6). The median relative dose intensity was 86.4% for S-1 and 80.0% for cisplatin. With a median follow-up duration of 13.9 months, the median relapse-free survival (RFS) and overall survival (OS) have not yet been reached. Fifteen relapses (20.3%) were documented. Plus, the estimated RFS rate was 60.5% at 3 years. The treatments were generally well tolerated. The most frequently observed grade 3-4 hematological toxicity was neutropenia (35.1%), and only 1 cycle of neutropenic fever occurred. The most frequently observed grade 3-4 non-hematological toxicities were nausea (4.1%) and asthenia (4.1%), and all the other grade 3-4 non-hematological toxicities were observed in less than 3% of the patients.

CONCLUSIONS

Postoperative adjuvant S-1 plus cisplatin for 18 weeks was found to be feasible for patients with stage II-IV (M0) gastric adenocarcinoma following complete surgical resection.

摘要

目的

研究 S-1 和顺铂联合应用 3 周作为可切除胃癌辅助化疗的可行性。

实验设计

入组的韩国患者均为 II-IV 期(M0)胃腺癌患者,且接受了胃切除术及 D2 淋巴结清扫术。S-1 口服给药,剂量为 80mg/m2,分两次,每日一次,连用 14 天;顺铂静脉滴注,剂量为 60mg/m2,每 21 天一次,持续 2 小时。患者最多接受 6 个周期的治疗。

结果

从 2006 年 1 月至 2010 年 7 月,共有 74 例患者入组本研究。患者中位年龄为 56 岁(范围:22-71 岁),51.4%(38/74)的患者体力状态为 0 级。中位化疗周期数为 6(范围:1-6)。S-1 的中位相对剂量强度为 86.4%,顺铂为 80.0%。中位随访时间为 13.9 个月,中位无复发生存期(RFS)和总生存期(OS)尚未达到。共记录到 15 例复发(20.3%),预计 3 年 RFS 率为 60.5%。治疗总体上耐受良好。最常见的 3-4 级血液学毒性为中性粒细胞减少症(35.1%),仅发生 1 例中性粒细胞减少性发热。最常见的 3-4 级非血液学毒性为恶心(4.1%)和乏力(4.1%),所有其他 3-4 级非血液学毒性均少于 3%的患者发生。

结论

完全手术切除后,对 II-IV 期(M0)胃腺癌患者,术后辅助 S-1 联合顺铂化疗 18 周是可行的。

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