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紫杉醇与顺铂联合方案每周给药治疗晚期或复发性胃癌的II期研究

Phase II study of weekly paclitaxel and cisplatin combination therapy for advanced or recurrent gastric cancer.

作者信息

Nagata Naoki, Kimura Masayuki, Hirabayashi Naoki, Tuburaya Akira, Murata Teruo, Kondo Ken, Fukuda Yasuhiko, Kobayashi Michiya, Miyashita Yumi, Nakao Akimasa, Sakamoto Junichi

机构信息

Department of surgery 1, University of Occupational and Environmental Health, Iseigaoka, Yahatanishi-ku, Kitakyushu-shi, 807-8555, Japan.

出版信息

Hepatogastroenterology. 2008 Sep-Oct;55(86-87):1846-50.

PMID:19102406
Abstract

BACKGROUND/AIMS: This study was performed to assess the efficacy and safety of weekly paclitaxel and cisplatin combination chemotherapy in patients with advanced or recurrent gastric cancer.

METHODOLOGY

Patients with advanced or recurrent gastric cancer were required to have ECOG performance status of 0 to 2, to be over 20 years of age, and to have adequate organ function. Paclitaxel 80 mg/m2 was administered intravenous over 1.5 h, followed by cisplatin 25 mg/m2 on day 1, 8 and 15 every 4 weeks.

RESULTS

All of the 52 patients enrolled, 49 patients were eligible. One patient had complete response. Nineteen had partial response, 13 had stable disease, 8 had progressive disease and 8 had not been evaluated. The median progression-free survival time was 166.5 days and median survival time was 323 days. The most common grade 3 to 4 hematological toxicies were leucopenia (14.3%), neutropenia (32.7%), and anemia (16.3%). The most common grade 3 non-hematological toxicities included anorexia (6.1%), nausea (4.1%), vomiting (2.0%) and fatigue (2.0%). No grade 4 non-hematological toxicities were reported.

CONCLUSIONS

Combination chemotherapy of weekly paclitaxel and cisplatin was highly active and well tolerated in patients with advanced or recurrent gastric cancer.

摘要

背景/目的:本研究旨在评估每周一次紫杉醇和顺铂联合化疗在晚期或复发性胃癌患者中的疗效和安全性。

方法

晚期或复发性胃癌患者要求其东部肿瘤协作组(ECOG)体能状态为0至2,年龄超过20岁,且器官功能良好。紫杉醇80mg/m²静脉滴注1.5小时,随后在第1、8和15天给予顺铂25mg/m²,每4周重复一次。

结果

纳入的52例患者中,49例符合条件。1例患者完全缓解,19例部分缓解,13例病情稳定,8例病情进展,8例未评估。无进展生存期的中位数为166.5天,总生存期的中位数为323天。最常见的3至4级血液学毒性为白细胞减少(14.3%)、中性粒细胞减少(32.7%)和贫血(16.3%)。最常见的3级非血液学毒性包括厌食(6.1%)、恶心(4.1%)、呕吐(2.0%)和疲劳(2.0%)。未报告4级非血液学毒性。

结论

每周一次紫杉醇和顺铂联合化疗对晚期或复发性胃癌患者具有高活性且耐受性良好。

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