A Multicenter Phase II Study of Gemcitabine plus S-1 Chemotherapy for Advanced Biliary Tract Cancer
A Multicenter Phase II Study of Gemcitabine plus S-1 Chemotherapy for Advanced Biliary Tract Cancer
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DOI：
10.21873/anticanres.11398
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发表时间：
2017-02-01
影响因子：
2
通讯作者：
Furuse, Junji
中科院分区：
文献类型：
--
作者：
Arima, Shiho;Shimizu, Kyoko;Furuse, Junji
背景资料：吉西他滨（GEM）联合顺铂（CDDP）化疗已被世界范围内用作晚期胆道癌（BTC）的标准一线治疗。一项II期临床试验也表明GEM加S-1化疗对晚期BTC具有良好的活性。本研究的目的是评价吉西他滨联合替吉奥治疗晚期BTC的疗效和安全性。患者和方法：合格性标准如下：组织学证实的BTC、不可切除或复发性疾病、ECOG体能状态（PS）0-1（不考虑既往治疗）。吉西他滨在第1天和第8天以1，000 mg/m2的剂量在30分钟内静脉给药，S-1从第1天至第14天以60/80/100 mg/天的剂量（基于BSA）口服给药，每3周一次。主要终点是根据RECIST，ver. 1.1，次要终点是毒性的频率/严重程度、无进展生存期（PFS）和总生存期（OS）。结果：2008年8月至2011年11月期间共入组38例患者。有19名男性和19名女性，中位年龄为66岁（范围= 44-81岁）。7例患者既往有术后一线或辅助化疗史。30例患者的PS为0，7例患者的PS为1。6例患者（15.8%）的治疗缓解被归类为部分缓解，18例患者（47.4%）被归类为疾病稳定。中位PFS和OS分别为5.8和15.9个月。毒性一般较轻，最常见的3/4级毒性为白细胞减少（31.6%）、中性粒细胞减少（36.8%）、恶心/呕吐（2.6%）和腹泻（2.6%）。有1例因间质性肺炎导致的治疗相关死亡。结论：我们的研究表明，吉西他滨联合S-1化疗在晚期BTC患者中耐受性良好，并显示出良好的抗肿瘤活性。
Background: Gemcitabine (GEM) plus cisplatin (CDDP) chemotherapy has been used worldwide as the standard first-line treatment for advanced biliary tract cancer (BTC). A phase II trial has also suggested promising activity of GEM plus S-1 chemotherapy against advanced BTC. The aim of this study was to evaluate the efficacy and safety of GEM plus S-1 chemotherapy in patients with advanced BTC. Patients and Methods: The eligibility criteria were as follows: histologically-proven BTC, unresectable or recurrent disease, ECOG performance status (PS) 0-1 regardless of previous treatment. Gemcitabine was administered intravenously at the dose of 1,000 mg/m(2) over 30 min on days 1 and 8, and S-1 was administered orally at doses of 60/80/100 mg/day based on the BSA, from day 1 to day 14, every 3 weeks. The primary endpoint was the response rate according to RECIST, ver. 1.1, and the secondary endpoints were the frequency/severity of toxicities, progression-free survival (PFS) and overall survival (OS). Results: A total of 38 patients were enrolled between August 2008 and November 2011. There were 19 men and 19 women, with a median age of 66 years (range = 44-81 years). Seven patients had a previous history of first-line or adjuvant chemotherapy after surgery. The PS was 0 and 1 in 30 and 7 patients, respectively. The treatment response was classified as partial response in 6 patients (15.8%) and as stable disease in 18 patients (47.4%). The median PFS and OS were 5.8 and 15.9 months, respectively. The toxicity was generally mild, and the most common grade 3/4 toxicities were leukopenia (31.6%), neutropenia (36.8%), nausea/vomiting (2.6%), and diarrhea (2.6%). There was one treatment-related death due to interstitial pneumonia. Conclusion: Our study revealed that gemcitabine plus S-1 chemotherapy was well-tolerated and exhibited favorable antitumor activity in patients with advanced BTC.