作者
Thierry André, Kai-Keen Shiu, Tae Won Kim, Benny Vittrup Jensen, Lars Henrik Jensen, Cornelis Punt, Denis Smith, Rocio Garcia-Carbonero, Manuel Benavides, Peter Gibbs, Christelle de la Fouchardiere, Fernando Rivera, Elena Elez, Johanna Bendell, Dung T Le, Takayuki Yoshino, Eric Van Cutsem, Ping Yang, Mohammed ZH Farooqui, Patricia Marinello, Luis A Diaz Jr
发表日期
2020/12/3
期刊
New England Journal of Medicine
卷号
383
期号
23
页码范围
2207-2218
出版商
Massachusetts Medical Society
简介
Background
Programmed death 1 (PD-1) blockade has clinical benefit in microsatellite-instability–high (MSI-H) or mismatch-repair–deficient (dMMR) tumors after previous therapy. The efficacy of PD-1 blockade as compared with chemotherapy as first-line therapy for MSI-H–dMMR advanced or metastatic colorectal cancer is unknown.
Methods
In this phase 3, open-label trial, 307 patients with metastatic MSI-H–dMMR colorectal cancer who had not previously received treatment were randomly assigned, in a 1:1 ratio, to receive pembrolizumab at a dose of 200 mg every 3 weeks or chemotherapy (5-fluorouracil–based therapy with or without bevacizumab or cetuximab) every 2 weeks. Patients receiving chemotherapy could cross over to pembrolizumab therapy after disease progression. The two primary end points were progression-free survival and overall survival.
Results
At the second interim analysis, after a …
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T André, KK Shiu, TW Kim, BV Jensen, LH Jensen… - New England Journal of Medicine, 2020