吉西他滨和卡培他滨治疗不可切除或转移性胆囊癌或胆管癌患者的 II 期临床试验：西南肿瘤协作组研究 S0202。
A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma: Southwest Oncology Group study S0202.
机构信息
Norris Comprehensive Cancer Center, University of Southern California, 1441 Eastlake Ave, Rm 3457, Los Angeles, CA 90033, USA.
出版信息
Cancer Chemother Pharmacol. 2011 Dec;68(6):1595-602. doi: 10.1007/s00280-011-1657-1. Epub 2011 May 10.
PURPOSE
Patients with gallbladder cancer or cholangiocarcinoma were treated with the combination of gemcitabine 1,000 mg/m(2) IV over 100 min on days 1 and 8 and capecitabine 650 mg/m(2) BID PO on days 1-14, administered every 21 days.
METHODS
The primary objective of this study was to assess the response rate (confirmed complete and partial responses) of gemcitabine and capecitabine used in advanced/metastatic biliary neoplasms. Secondary objectives included overall survival and toxicities.
RESULTS
The study accrued 57 patients from September 2003 to April 2005. Three patients were ineligible, and two others received no treatment. Characteristics of analyzable patients: 35 (67%) cholangiocarcinoma, 17 (33%) gallbladder cancer; PS 0 (18 pts), 1 (26 pts), 2 (8 pts); 26 (50%) men; median age 58.8 years (29.5-85.6). Among 51 patients evaluated for toxicity, 6 experienced grade 4 toxicities. Among 52 patients, there were 7 confirmed partial responses for a confirmed response probability of 13% (95% CI: 6-26%). Six patients had an unconfirmed partial response for an overall response probability of 25% (95% CI: 14-39%). Twelve patients (23%) demonstrated stable disease. The 6-month overall survival was 55% (95% CI: 41-69%), and median survival was 7 months (95% CI: 5-8 months).
CONCLUSIONS
The combination of gemcitabine and capecitabine is a well-tolerated regimen with activity in patients with advanced gallbladder cancer and cholangiocarcinoma.
目的
对吉西他滨 1000mg/m2（静脉注射 100 分钟）联合卡培他滨 650mg/m2（每天两次口服）方案治疗胆囊癌或胆管癌患者进行研究，方案中吉西他滨和卡培他滨在第 1 天和第 8 天给药，卡培他滨在第 1-14 天给药，每 21 天给药一次。
方法
本研究的主要目的是评估吉西他滨和卡培他滨在晚期/转移性胆道肿瘤中的应用的客观缓解率（完全缓解和部分缓解的确认）。次要目标包括总生存期和毒性。
结果
该研究于 2003 年 9 月至 2005 年 4 月共纳入 57 例患者。3 例患者不符合条件，另外 2 例未接受治疗。可分析患者的特征：35 例（67%）胆管癌，17 例（33%）胆囊癌；PS 0（18 例）、1（26 例）、2（8 例）；26 例（50%）为男性；中位年龄为 58.8 岁（29.5-85.6）。在 51 例可评估毒性的患者中，有 6 例发生 4 级毒性。在 52 例患者中，有 7 例经确认存在部分缓解，确认缓解率为 13%（95%CI：6-26%）。6 例患者存在未经确认的部分缓解，总缓解率为 25%（95%CI：14-39%）。12 例（23%）患者疾病稳定。6 个月总生存率为 55%（95%CI：41-69%），中位总生存时间为 7 个月（95%CI：5-8 个月）。
结论
吉西他滨联合卡培他滨是一种耐受性良好的方案，在晚期胆囊癌和胆管癌患者中具有活性。
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