Randomized phase III KEYNOTE-181 study of pembrolizumab vs chemotherapy in advanced esophageal cancer
Journal of Clinical Oncology Dec 11, 2020
Kojima T, Shah MA, Muro K, et al. - Since patients with advanced esophageal cancer carry a poor prognosis and have limited treatment choices following first-line chemotherapy, therefore, researchers performed this open-label, phase III study with 628 patients suffering from advanced/metastatic squamous cell carcinoma or adenocarcinoma of the esophagus that progressed following one prior therapy. These patients were randomized (1:1) to pembrolizumab 200 mg every 3 weeks for up to 2 years or chemotherapy (investigator’s choice of paclitaxel, docetaxel, or irinotecan). Primary endpoints included overall survival (OS) in cases with programmed death ligand-1 (PD-L1) combined positive score (CPS) ≥ 10, in cases with squamous cell carcinoma, and in all cases (one-sided α 0.9%, 0.8%, and 0.8%, respectively). According to findings, prolonged OS was achieved with fewer treatment-related adverse events in patients with PD-L1 CPS ≥ 10 who were treated with pembrolizumab vs chemotherapy as second-line therapy for advanced esophageal cancer.
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