Expanded phase II trial of gemcitabine and capecitabine for advanced biliary cancer
Expanded phase II trial of gemcitabine and capecitabine for advanced biliary cancer
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DOI：
10.1002/cncr.22902
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发表时间：
2007-09-15
期刊：
影响因子：
6.2
通讯作者：
Knox, Jennifer J.
中科院分区：
文献类型：
--
作者：
Riechelmann, Rachel R.;Townsley, Carol A.;Knox, Jennifer J.
背景。吉西他滨和卡培他滨 (GemCap) 在晚期胆管癌患者中进行的一项 2 期试验使大约 30% 的患者出现客观缓解，中位生存期为 14 个月。在当前的研究中，作者报告了更多接受 GemCap 方案治疗的此类患者的疗效数据。年龄 > 18 岁并被诊断为局部晚期胆管癌的患者接受卡培他滨一线治疗，剂量为 650 mg/m(2)，每天两次，持续 14 天，并在第一天和第 8 天接受剂量为 1000 mg/m(2) 的吉西他滨治疗，每 3 周一次，直至疾病进展。肿瘤反应通过实体瘤反应评估标准（RECIST）标准进行评估。结果。 2001年7月至2005年1月期间，75名患者参加了这项研究。中位随访时间为 9.5 个月，总体缓解率为 29%（95% 置信区间 [95% CI]，19.4-41%），中位持续时间为 9.7 个月（范围为 3-36 个月）。 3 名患者获得完全缓解，中位持续时间为 17 个月（范围为 9-27 个月）。中位无进展生存期和总生存期分别为 6.2 个月（95% CI，4.4-8.3 个月）和 12.7 个月（95% CI，9.5-31 个月）。结论。 GemCap 方案对胆道癌患者有效。需要进行随机试验来确定这种治疗方案对患者生存和生活质量的影响。
BACKGROUND. A phase 2 trial of gemcitabine and capecitabine (GemCap) in patients with advanced biliary cancer led to an objective response in approximately 30% of patients and a median survival of 14 months. In the current study, the authors report further efficacy data of a larger cohort of such patients treated with the GemCap regimen.METHODS. Patients aged >18 years and who had a diagnosis of locally advanced biliary cancer received first-line treatment with capecitabine at a dose of 650 mg/m(2) twice daily for 14 days and gemcitabine at a dose of 1000 mg/m(2) on Day I and Day 8, every 3 weeks until disease progression. Tumor response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.RESULTS. Between July 2001 and January 2005, 75 patients were enrolled in the study. At a median follow-up of 9.5 months, the overall response rate was 29% (95% confidence interval [95% CI], 19.4-41%), with a median duration of 9.7 months (range, 3-36 months). Three patients achieved complete responses, with a median duration of 17 months (range, 9-27 months). The median progression-free survival and overall survivals were 6.2 months (95% CI, 4.4-8.3 months) and 12.7 months (95% CI, 9.5-31 months), respectively.CONCLUSIONS. The GemCap regimen is active in patients with biliary cancer. Randomized trials are warranted to define the impact of such a regimen on patient survival and quality of life.