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卡培他滨、伊立替康、吉西他滨和贝伐单抗作为晚期胆管癌二线治疗的疗效和安全性:一项II期研究。

Efficacy and Safety of Capecitabine, Irinotecan, Gemcitabine, and Bevacizumab as Second-Line Treatment in Advanced Biliary Tract Cancer: A Phase II Study.

作者信息

Larsen Finn Ole, Markussen Alice, Diness Laura V, Nielsen Dorte

机构信息

Department of Oncology, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark.

出版信息

Oncology. 2018;94(1):19-24. doi: 10.1159/000479970. Epub 2017 Sep 21.

DOI:10.1159/000479970
PMID:28930749
Abstract

OBJECTIVE

Since 2010, gemcitabine and cisplatin have been considered standard first-line treatment in patients with advanced biliary tract cancer. Many centers have replaced cisplatin with oxaliplatin, which seems to obtain similar results. While first-line treatment has been well established, there are no phase III trials supporting second-line treatment, and the phase II trials with chemotherapy do not show any clear benefit. In this study, we investigated the effect of adding bevacizumab to chemotherapy in second-line treatment.

METHODS

From November 2013 to January 2016, 50 patients with advanced biliary tract cancer were enrolled in this prospective phase II trial. All patients had received a gemcitabine-platinum combination as first-line treatment. The patients received capecitabine, irinotecan, gemcitabine, and bevacizumab in a 2-week schedule as second-line treatment.

RESULTS

The combination was well tolerated with a median progression-free survival of 3.6 months, a median overall survival of 6.4 months, and a response rate of 6%.

CONCLUSION

The combination of capecitabine, irinotecan, gemcitabine, and bevacizumab as a second-line treatment for advanced biliary tract cancer is well tolerated but with a modest, if any, benefit.

摘要

目的

自2010年以来,吉西他滨和顺铂一直被视为晚期胆管癌患者的标准一线治疗方案。许多中心已用奥沙利铂取代顺铂,似乎能取得相似的结果。虽然一线治疗已确立,但尚无支持二线治疗的III期试验,且化疗的II期试验未显示出任何明确益处。在本研究中,我们调查了在二线治疗中添加贝伐单抗至化疗方案的效果。

方法

2013年11月至2016年1月,50例晚期胆管癌患者纳入这项前瞻性II期试验。所有患者均接受过吉西他滨 - 铂类联合方案作为一线治疗。患者接受卡培他滨、伊立替康、吉西他滨和贝伐单抗,每2周为一个疗程,作为二线治疗。

结果

该联合方案耐受性良好,中位无进展生存期为3.6个月,中位总生存期为6.4个月,缓解率为6%。

结论

卡培他滨、伊立替康、吉西他滨和贝伐单抗联合作为晚期胆管癌的二线治疗方案耐受性良好,但益处不大(若有)。

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