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吉西他滨和顺铂联合化疗用于转移性胰腺癌患者的II期研究。

Phase II study of combination chemotherapy with gemcitabine and cisplatin for patients with metastatic pancreatic cancer.

作者信息

Ueno Hideki, Okusaka Takuji, Ikeda Masafumi, Morizane Chigusa, Ogura Takashi, Hagihara Atsushi, Tanaka Tsutomu

机构信息

Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan.

出版信息

Jpn J Clin Oncol. 2007 Jul;37(7):515-20. doi: 10.1093/jjco/hym060. Epub 2007 Aug 2.

DOI:10.1093/jjco/hym060
PMID:17675286
Abstract

OBJECTIVE

The objectives of this study were to evaluate the efficacy and toxicity of combination chemotherapy with gemcitabine and cisplatin in patients with metastatic pancreatic cancer.

METHODS

Patients naïve to chemotherapy who had histologically or cytologically confirmed metastatic pancreatic adenocarcinoma were entered. Gemcitabine was given at a dose of 1000 mg/m2 over 30 min on days 1, 8 and 15, and cisplatin was given at a dose of 80 mg/m2 over 150 min on day 1, in 28-day cycles.

RESULTS

A total of 38 patients were enrolled in this study between August 2001 and December 2003. There were no complete responses and 10 partial responses, resulting in an overall response rate of 26% (95% CI: 13.4-43.1%]. Twenty-one patients (55%) had stable disease, whereas 7 (18%) had progressive disease. The median time to progression was 4.2 months and the median overall survival was 7.5 months with a 1-year survival rate of 24%. Grade 3-4 toxicities included neutropenia in 26 patients (68%), thrombocytopenia in 19 (50%), anorexia in 15 (39%) and nausea in nine (24%). There was only one episode of neutropenic fever and there were no significant bleeding episodes or treatment-related deaths.

CONCLUSION

The combination of gemcitabine and cisplatin administered by this schedule produced a good response rate associated with moderate but manageable toxicities in patients with metastatic pancreatic cancer.

摘要

目的

本研究旨在评估吉西他滨和顺铂联合化疗对转移性胰腺癌患者的疗效和毒性。

方法

纳入未经化疗且经组织学或细胞学确诊为转移性胰腺腺癌的患者。吉西他滨在第1、8和15天以1000mg/m²的剂量在30分钟内静脉滴注,顺铂在第1天以80mg/m²的剂量在150分钟内静脉滴注,每28天为一个周期。

结果

2001年8月至2003年12月期间,共有38例患者纳入本研究。无完全缓解病例,10例部分缓解,总缓解率为26%(95%CI:13.4-43.1%)。21例患者(55%)疾病稳定,7例(18%)疾病进展。中位疾病进展时间为4.2个月,中位总生存期为7.5个月,1年生存率为24%。3-4级毒性包括26例患者(68%)出现中性粒细胞减少,19例(50%)出现血小板减少,15例(39%)出现厌食,9例(24%)出现恶心。仅发生1次中性粒细胞减少性发热,无明显出血事件或与治疗相关的死亡。

结论

按此方案给予吉西他滨和顺铂联合化疗,对转移性胰腺癌患者产生了良好的缓解率,且毒性中等但可控。

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