Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan.
Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan.
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DOI：
10.1038/sj.bjc.6605779
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发表时间：
2010-08-10
影响因子：
8.8
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中科院分区：
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英国一项关于吉西他滨+顺铂（GC）联合治疗胆道癌（BTC）患者的随机研究显示了有希望的结果。在我们的研究中，我们在日本BTC患者中评价了该联合治疗与吉西他滨单药治疗（G）相比的疗效和安全性。总体而言，84例晚期BTC患者被随机分配至顺铂25 mg m−2+吉西他滨1000 mg m−2（21天周期的第1、8天）（GC组）或吉西他滨1000 mg m−2单药（28天周期的第1、8和15天）（G组）。重复治疗至少12周，直至发生疾病进展或不可接受的毒性，最长48周。共有83名患者被纳入分析。GC组和G组的1年生存率分别为39.0%和31.0%，中位生存时间为11.2个月和7.7个月，中位无进展生存时间为5.8个月和3.7个月，总缓解率为19.5%和11.9%。最常见的3级或4级毒性（GC组/G组）为中性粒细胞减少（56.1%/38.1%）、血小板减少（39.0%/7.1%）、白细胞减少（29.3%/19.0%）、血红蛋白降低（36.6%/16.7%）和γ-GTP升高（29.3%/35.7%）。吉西他滨加顺铂联合治疗被认为是有效的，耐受性良好，这表明它也可能是日本患者的标准治疗方案。
A British randomised study of gemcitabine plus cisplatin (GC) combination showed promising results in biliary tract cancer (BTC) patients. In our study, we evaluated the efficacy and safety of this combination compared with gemcitabine alone (G) in Japanese BTC patients. Overall, 84 advanced BTC patients were randomised to either cisplatin 25 mg m−2 plus gemcitabine 1000 mg m−2 on days 1, 8 of a 21-day cycle (GC-arm), or single-agent gemcitabine 1000 mg m−2 on days 1, 8 and 15 of a 28-day cycle (G-arm). Treatments were repeated for at least 12 weeks until disease progression or unacceptable toxicity occurred, up to a maximum of 48 weeks. A total of 83 patients were included in the analysis. For the GC and G-arms, respectively, the 1-year survival rate was 39.0 vs 31.0%, median survival time 11.2 vs 7.7 months, median progression-free survival time 5.8 vs 3.7 months and overall response rate 19.5 vs 11.9%. The most common grade 3 or 4 toxicities (GC-arm/G-arm) were neutropenia (56.1%/38.1%), thrombocytopenia (39.0%/7.1%), leukopenia (29.3%/19.0%), haemoglobin decrease (36.6%/16.7%) and γ-GTP increase (29.3%/35.7%). Gemcitabine plus cisplatin combination therapy was found to be effective and well tolerated, suggesting that it could also be a standard regimen for Japanese patients.