Abstract
BackgroundSafe and effective treatments for advanced esophageal cancer are an unmet need in Japan. We report results of a subgroup analysis of Japanese patients enrolled in KEYNOTE-181, a randomized, open-label, phase 3 study of pembrolizumab versus chemotherapy as second-line therapy for patients with advanced or metastatic esophageal cancer whose disease progressed after standard first-line therapy.MethodsPatients were randomly assigned 1:1 to receive pembrolizumab 200 mg every 3 weeks or investigator’s choice of paclitaxel, docetaxel, or irinotecan. Efficacy was evaluated in all Japanese patients and in those with programmed death ligand 1 combined positive score ≥ 10.ResultsOf the 152 Japanese patients enrolled (pembrolizumab, n = 77; chemotherapy, n = 75), 150 (98.7%) had squamous cell carcinoma and 79 (52.0%) had combined positive score ≥ 10. At the final analysis, median overall survival was improved among all patients (12.4 vs 8.2 months with pembrolizumab and chemotherapy, respectively; hazard ratio, 0.68; 95% CI 0.48–0.97) and patients with combined positive score ≥ 10 (12.6 vs 8.4 months; hazard ratio, 0.68; 95% CI 0.42–1.10). Fewer patients had any-grade (74.0% vs 95.9%) or grade 3–5 (16.9 vs 50.0%) treatment-related adverse events with pembrolizumab than with chemotherapy.ConclusionConsistent with the global trial results, second-line pembrolizumab therapy showed a survival benefit and a favorable safety profile compared with chemotherapy in Japanese patients with advanced esophageal cancer.
Highlights
Esophageal cancer is the ninth most common cancer worldwide [1]
Prognosis is poor among Japanese patients with advanced esophageal cancer, and treatment options are limited after disease progression on first-line chemotherapy
In the current subgroup analysis of the phase 3 KEYNOTE-181 study, second-line therapy with pembrolizumab prolonged overall survival (OS) among Japanese patients with esophageal cancer compared with chemotherapy and demonstrated a robust response rate
Summary
Esophageal cancer is the ninth most common cancer worldwide [1]. In 2018, 572,000 incident cases of esophageal cancer and 509,000 deaths were reported worldwide [1]; in Japan, more than 22,000 cases and 11,000 deaths were reported [2]. The current standard of care for first-line therapy in patients with unresectable advanced or recurrent esophageal cancer in Japan is combination therapy with cisplatin and 5-fluorouracil [5]. Japanese patients with advanced esophageal cancer need more effective treatment options. We report results of a subgroup analysis of Japanese patients enrolled in KEYNOTE-181, a randomized, open-label, phase 3 study of pembrolizumab versus chemotherapy as second-line therapy for patients with advanced or metastatic esophageal cancer whose disease progressed after standard first-line therapy. Results Of the 152 Japanese patients enrolled (pembrolizumab, n = 77; chemotherapy, n = 75), 150 (98.7%) had squamous cell carcinoma and 79 (52.0%) had combined positive score ≥ 10. Conclusion Consistent with the global trial results, second-line pembrolizumab therapy showed a survival benefit and a favorable safety profile compared with chemotherapy in Japanese patients with advanced esophageal cancer
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