SWOG S1815: A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers

吉西他滨 医学 内科学 危险系数 顺铂 胃肠病学 肿瘤科 化疗 胆道 胰腺癌 泌尿科 癌症 置信区间
作者
Rachna T. Shroff,Gentry Teng King,Sarah Colby,Aaron J. Scott,Mitesh J. Borad,Laura W. Goff,Khalid Matin,Amit Mahipal,Aparna Kalyan,Milind Javle,Imane El Dika,Benjamin Tan,P. Cheema,Anuj Patel,Renuka Iyer,Robin Kate Kelley,Jaykumar Thumar,Anthony B. El-Khoueiry,Katherine A. Guthrie,E. Gabriela Chiorean,Howard S. Höchster,Philip A. Philip
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
被引量:1
标识
DOI:10.1200/jco-24-01383
摘要

PURPOSE SWOG S1815 was a randomized, open label phase III trial, evaluating gemcitabine, nab-paclitaxel, and cisplatin (GAP) versus gemcitabine and cisplatin (GC) in patients with newly diagnosed advanced biliary tract cancers (BTCs). METHODS Patients with newly diagnosed locally advanced unresectable or metastatic BTC, including intrahepatic cholangiocarcinoma (ICC) and extrahepatic cholangiocarcinoma (ECC) and gallbladder carcinoma (GBC), were randomly assigned 2:1 to either GAP (gemcitabine 800 mg/m 2 , cisplatin 25 mg/m 2 , and nab-paclitaxel 100 mg/m 2 intravenously once per day on days 1 and 8 of a 21-day cycle) or GC (gemcitabine 1,000 mg/m 2 and cisplatin 25 mg/m 2 intravenously once per day on days 1 and 8 of a 21-day cycle). RESULTS Among 452 randomly assigned participants, 441 were eligible and analyzable, 67% with ICC, 16% with GBC, and 17% with ECC. There was no significant difference in overall survival (OS) between GAP versus GC. Median OS with GAP was 14.0 months (95% CI, 12.4 to 16.1) and 13.6 months with GC (95% CI, 9.7 to 16.6); hazard ratio (HR), 0.91 (95% CI, 0.72 to 1.14); P = .41. Median progression-free survival (PFS) was similar between groups with median PFS for GAP being 7.5 months (95% CI, 6.4 to 8.5) versus 6.3 months for GC (95% CI, 4.4 to 8.2); HR, 0.89 (95% CI, 0.71 to 1.12); P = .32. In exploratory subset analyses, the OS and PFS benefits of GAP versus GC treatment were greater in locally advanced disease compared with metastatic disease, although not statistically significant (interaction P = .14 for OS and P = .17 for PFS). Moreover, GAP versus GC showed greater improvement in PFS among participants with GBC than those with ICC or ECC (interaction P = .01), but not OS (interaction P = .28). CONCLUSION The addition of a taxane in the GAP regimen to the standard gemcitabine-cisplatin regimen did not improve OS in newly diagnosed BTC. More toxicity was encountered with GAP versus GC.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
顾矜应助赵三岁采纳,获得10
8秒前
yyy2025完成签到,获得积分10
12秒前
木雨亦潇潇完成签到,获得积分10
19秒前
香蕉觅云应助nine2652采纳,获得10
21秒前
量子星尘发布了新的文献求助10
25秒前
芳华如梦完成签到 ,获得积分10
27秒前
27秒前
28秒前
28秒前
土豆丝完成签到 ,获得积分10
28秒前
琦琦完成签到,获得积分10
37秒前
zzzz完成签到,获得积分20
42秒前
GEZIKU完成签到 ,获得积分10
43秒前
50秒前
57秒前
赵三岁发布了新的文献求助10
1分钟前
wwb完成签到,获得积分10
1分钟前
1分钟前
1分钟前
肯德基没有黄焖鸡完成签到 ,获得积分10
1分钟前
能干冰露完成签到,获得积分10
1分钟前
牛奶拌可乐完成签到 ,获得积分10
1分钟前
量子星尘发布了新的文献求助30
1分钟前
周小鱼完成签到 ,获得积分10
1分钟前
1分钟前
1分钟前
老张完成签到,获得积分10
1分钟前
1分钟前
zhugao完成签到,获得积分10
1分钟前
1分钟前
南风知我意完成签到,获得积分10
1分钟前
朴实寻琴完成签到 ,获得积分10
1分钟前
可可可爱完成签到 ,获得积分10
1分钟前
lsy完成签到,获得积分10
1分钟前
量子星尘发布了新的文献求助10
2分钟前
2分钟前
2分钟前
hwen1998完成签到 ,获得积分10
2分钟前
2分钟前
2分钟前
高分求助中
【提示信息,请勿应助】关于scihub 10000
Les Mantodea de Guyane: Insecta, Polyneoptera [The Mantids of French Guiana] 3000
徐淮辽南地区新元古代叠层石及生物地层 3000
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
Handbook of Industrial Diamonds.Vol2 1100
Global Eyelash Assessment scale (GEA) 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 550
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 4038029
求助须知:如何正确求助?哪些是违规求助? 3575740
关于积分的说明 11373751
捐赠科研通 3305559
什么是DOI,文献DOI怎么找? 1819224
邀请新用户注册赠送积分活动 892652
科研通“疑难数据库(出版商)”最低求助积分说明 815022