作者
DY Oh, AR He, S Qin, LT Chen, T Okusaka, A Vogel, JW Kim, T Suksombooncharoen, MA Lee, M Kitano, HA Burris, M Bouattour, S Tanasanvimon, RE Zaucha, A Avallone, JE Cundom, N Rokutanda, M Watras, G Cohen, JW Valle
发表日期
2022/9/1
期刊
Annals of Oncology
卷号
33
页码范围
S565-S566
出版商
Elsevier
简介
Background
Advanced BTC is a rare, heterogenous cancer with poor prognosis. At the preplanned interim analysis (data cutoff 11 August 2021) of TOPAZ-1 (NCT03875235), D+ GC significantly improved OS versus PBO+ GC in pts with advanced BTC (hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.66–0.97; p= 0.021). We report an updated OS and safety analysis for TOPAZ-1.
Methods
Pts previously untreated for unresectable locally advanced, recurrent, or metastatic BTC were randomised 1: 1 to receive D (1500 mg every 3 weeks [Q3W]) or PBO,+ G (1000 mg/m 2) and C (25 mg/m 2) on days 1 and 8 Q3W, for up to 8 cycles, followed by D (1500 mg Q4W) or PBO monotherapy until disease progression or unacceptable toxicity. The primary objective was to assess OS. This OS and safety analysis was conducted after 6 months (mo) of additional follow-up with 76.9% overall OS event maturity.
Results
At data …
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