Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer
Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer
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DOI：
10.1002/bjs.10776
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发表时间：
2018-02-01
影响因子：
9.6
通讯作者：
Nagino, M.
中科院分区：
文献类型：
--
作者：
Ebata, T.;Hirano, S.;Nagino, M.
背景：虽然一些回顾性研究已经表明了辅助治疗的价值，但胆管癌的辅助治疗尚无推荐标准。本研究的目的是检验这一假设，辅助吉西他滨化疗将提高切除胆管cancer.Methods生存概率：这是一个随机III期试验。胆管癌切除患者被随机分配至吉西他滨组和观察组，两组在淋巴结状态、残留肿瘤状态和肿瘤位置方面保持平衡。吉西他滨以1000 mg/m2的剂量静脉给药，每4周在第1、8和15天给药，共6个周期。主要终点是总生存期，次要终点是无复发生存期，亚组分析和toxicity.Results：一些225例患者包括（117吉西他滨，108观察）。吉西他滨组和观察组之间的基线特征平衡良好。总生存期无显著差异（中位数分别为62.3和63.8个月;风险比1.01，95%置信区间）。0.70 P=0.964）和无复发生存期（中位数36.0对39.9个月;风险比0.93，0.66对1.32; P=0.693）。在按淋巴结状态和切缘状态分层的亚组中，两组之间的生存率无差异。虽然吉西他滨组经常发生血液学毒性，但大多数毒性是一过性的，3/4级非血液学毒性是罕见的。结论：吉西他滨辅助化疗组和观察组之间的胆管癌切除术患者的生存概率没有显着差异。
Background: Although some retrospective studies have suggested the value of adjuvant therapy, no recommended standard exists in bile duct cancer. The aim of this study was to test the hypothesis that adjuvant gemcitabine chemotherapy would improve survival probability in resected bile duct cancer.Methods: This was a randomized phase III trial. Patients with resected bile duct cancer were assigned randomly to gemcitabine and observation groups, which were balanced with respect to lymph node status, residual tumour status and tumour location. Gemcitabine was given intravenously at a dose of 1000 mg/m(2), administered on days 1, 8 and 15 every 4 weeks for six cycles. The primary endpoint was overall survival, and secondary endpoints were relapse-free survival, subgroup analysis and toxicity.Results: Some 225 patients were included (117 gemcitabine, 108 observation). Baseline characteristics were well balanced between the gemcitabine and observation groups. There were no significant differences in overall survival (median 62.3 versus 63.8 months respectively; hazard ratio 1.01, 95 per cent c.i. 0.70 to 1.45; P=0.964) and relapse-free survival (median 36.0 versus 39.9 months; hazard ratio 0.93, 0.66 to 1.32; P=0.693). There were no survival differences between the two groups in subsets stratified by lymph node status and margin status. Although haematological toxicity occurred frequently in the gemcitabine group, most toxicities were transient, and grade 3/4 non-haematological toxicity was rare.Conclusion: The survival probability in patients with resected bile duct cancer was not significantly different between the gemcitabine adjuvant chemotherapy group and the observation group.