Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer: A Japan Clinical Oncology Group trial (JCOG 0805)
Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer: A Japan Clinical Oncology Group trial (JCOG 0805)
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DOI：
10.1111/cas.12218
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发表时间：
2013-09-01
期刊：
影响因子：
5.7
通讯作者：
Furuse, Junji
中科院分区：
文献类型：
--
作者：
Morizane, Chigusa;Okusaka, Takuji;Furuse, Junji
口服氟尿嘧啶（S-1）联合或不联合吉西他滨被认为是治疗晚期胆道癌的有前景的药物;吉西他滨联合顺铂是目前的标准方案。这项随机II期临床试验旨在评估两种方案的安全性和有效性：吉西他滨加S-1（GS）吉西他滨1000 mg/m2，第1、8天; S-1 60 mg/m2，每日2次，第1-14天，每3周重复一次; S-1（80 mg/m2，第1-28天，口服，2次/d，共4周，停药2周，每6周重复一次）。具有较高1年生存率的方案将被选择用于随后的III期试验。2009年2月至2010年4月期间，101例患者接受了随机化。GS组（n=51）和S-1组（n=50）的1年生存率分别为52.9%（95%置信区间，38.5-65.5）和40.0%（95%置信区间，26.5-53.1），中位生存时间分别为12.5和9.0个月。GS组（白细胞29.4%，中性粒细胞60.8%，血红蛋白11.8%，血小板11.8%）中3/4级血液学毒性的发生率高于S-1组（白细胞2.0%，中性粒细胞4.0%，血红蛋白4.0%，血小板4.0%）。尽管GS组发生了2例治疗相关死亡，但所有其他3/4级非血液学毒性均可逆。总之，GS被认为是更有前途的，并被选为后续III期试验的试验方案，比较GS与吉西他滨+顺铂联合治疗。本研究在UMIN临床试验注册中心注册为UMIN 000001685（http：//www.umin.ac.jp/ctr/index.htm）。
The oral fluoropyrimidine, S-1, combined with or without gemcitabine is considered to be a promising agent for treating advanced biliary tract cancer; gemcitabine plus cisplatin is the current standard regimen. This randomized phase II trial was designed to evaluate the safety and efficacy of two regimens: gemcitabine plus S-1 (GS) (gemcitabine: 1000mg/m(2), day 1 and day 8; S-1: 60mg/m(2), twice daily on days 1-14, repeated every 3weeks); and S-1 (80mg/m(2), days 1-28, given orally twice daily for 4weeks, followed by a 2-week rest, repeated every 6weeks). The regimen with a higher 1-year survival would be selected for a subsequent phase III trial. Between February 2009 and April 2010, 101 patients were randomized. For the GS (n=51) and S-1 (n=50) arms, the 1-year survival was 52.9% (95% confidence interval, 38.5-65.5) and 40.0% (95% confidence interval, 26.5-53.1), and the median survival times were 12.5 and 9.0months, respectively. Grade 3/4 hematological toxicities were more frequent in the GS arm (leucocytes 29.4%, neutrophils 60.8%, hemoglobin 11.8%, platelets 11.8%) than in the S-1 arm (leucocytes 2.0%, neutrophils 4.0%, hemoglobin 4.0%, platelets 4.0%). Although two treatment-related deaths occurred in the GS arm, all other grade 3/4 non-hematological toxicities were reversible. In conclusion, GS was considered to be more promising and was selected as the test regimen for a subsequent phase III trial comparing GS with gemcitabine plus cisplatin combination therapy. This study was registered at the UMIN Clinical Trials Registry as UMIN 000001685 (http://www.umin.ac.jp/ctr/index.htm).