Trial reportEsophagus : official journal of the Japan Esophageal Society2022
Second-line pembrolizumab versus chemotherapy in Japanese patients with advanced esophageal cancer: subgroup analysis from KEYNOTE-181.
Trial report in Esophagus : official journal of the Japan Esophageal Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 4 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
14 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Safety Profiles of Immune Checkpoint Inhibitor Strategies in Gastrointestinal Cancers and Their Association With Clinical Outcomes: A Systematic Review and Meta-Analysis.Cancer medicine · 2026Pooled it
- Sex-based responses to immunotherapy in esophageal cancer: insights from a meta-analysis.BMC gastroenterology · 2026Pooled it
- Overall survival with immune checkpoint inhibitors across treatment settings and clinical and PD-L1-defined subgroups in advanced esophageal squamous cell carcinoma: a systematic review and meta-analysis of randomized trials.Frontiers in immunology · 2026Pooled it
- Predictive value of PD-L1 expression in response to immune checkpoint inhibitors for esophageal cancer treatment: A systematic review and meta-analysis.Frontiers in oncology · 2022Pooled it
- First-line nivolumab plus ipilimumab or chemotherapy versus chemotherapy alone in advanced esophageal squamous cell carcinoma: a Japanese subgroup analysis of open-label, phase 3 trial (CheckMate 648/ONO-4538-50).Esophagus : official journal of the Japan Esophageal Society · 2023Trial
- Review
- Japanese prospective registry study of particle therapy for esophageal cancer including comparison with clinical trials in Japan.Esophagus : official journal of the Japan Esophageal Society · 2026Observational
- Automated tumor regression grade assessment and survival prediction in esophageal cancer via weakly supervised multiple instance learning.Frontiers in medicine · 2026Article
- Efficacy and Safety of Anti-PD-(L)1 Treatments: A Systematic Review and Meta-Analysis of Asian vs Non-Asian Patients with Esophageal Squamous Cell Carcinoma.Gastro hep advances · 2026Review
- Treatment-related pneumonitis after thoracic radiotherapy/chemoradiotherapy combined with anti-PD-1 monoclonal antibodies in advanced esophageal squamous cell carcinoma.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2024Article
- Review
- Development of an Interpretable Deep Learning Model for Pathological Tumor Response Assessment After Neoadjuvant Therapy.Biological procedures online · 2024Article
- Second-line tislelizumab versus chemotherapy in Japanese patients with advanced or metastatic esophageal squamous cell carcinoma: subgroup analysis from RATIONALE-302.Esophagus : official journal of the Japan Esophageal Society · 2024Article
- An updated review of immunotherapy in esophageal cancer: PD-L1 footprint.Central-European journal of immunology · 2024Review
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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