Prognostic factors of second-line nivolumab monotherapy for unresectable or metastatic esophageal cancer: a multi-institutional cohort study for 184 cases

• Published in: Journal of gastroenterology 2024-11, Vol.59 (11), p.979-985
• Main Authors: Sato, Sho, Suzuki, Takashi, Chinen, Takashi, Yamaguchi, Hironori, Suzuki, Yusuke, Hokamura, Nobukazu, Saze, Zenichiro, Kono, Koji, Takahashi, Keita, Yano, Fumiaki, Sato, Tsutomu, Kosaka, Takashi, Endo, Itaru, Ichikawa, Yasushi, Miyawaki, Yutaka, Sato, Hiroshi, Shimada, Hideaki
• Format: Article
• Language: English
• Subjects: Abdominal Surgery; Adult; Adverse events; Aged; Aged, 80 and over; Antineoplastic Agents, Immunological - adverse effects; Antineoplastic Agents, Immunological - therapeutic use; Antineoplastic drugs; C-reactive protein; C-Reactive Protein - metabolism; Cancer; Cancer therapies; Chemotherapy; Clinical trials; Cohort analysis; Colorectal Surgery; Disease control; Esophageal cancer; Esophageal Neoplasms - drug therapy; Esophageal Neoplasms - pathology; Esophagus; Female; Gastroenterology; Hepatology; Humans; Male; Medical prognosis; Medicine; Medicine & Public Health; Metastases; Metastasis; Middle Aged; Nivolumab - adverse effects; Nivolumab - therapeutic use; Original Article—Alimentary Tract; Patients; Prognosis; Progression-Free Survival; Retrospective Studies; Surgical Oncology; Survival; Treatment Outcome; Tumors
• ISSN: 0944-1174; 1435-5922; 1435-5922
• DOI: 10.1007/s00535-024-02141-8

Background The real-world efficacy, prognostic factors, and adverse events of second-line nivolumab monotherapy and subsequent third-line therapy for unresectable or metastatic esophageal cancer have not been fully evaluated. Methods This multi-institutional retrospective cohort study evaluated 184 consecutive patients treated with second-line nivolumab monotherapy for esophageal cancer between March 2021 and December 2022. We assessed tumor response, adverse events, long-term survival, and prognostic factors. Results Among 128 patients with measurable lesions, the response rate was 23% and the disease control rate for all enrolled patients was 45%. The incidence of grade 3 or higher adverse events was 14%, but no treatment-related deaths presented. Median progression-free survival was 5.1 months and overall survival was 14 months, respectively. C-reactive protein level and performance status were identified as significant prognostic factors of overall survival through Cox proportional hazards analysis. The group with two favorable prognostic factors showed better overall survival than the groups with either one or zero prognostic factors (median overall survival: 22, 15, and 4.4 months, respectively). Among 69 patients who received third-line taxane anticancer agents, the progression-free survival was 6.7 months. Conclusions Our study demonstrated that the real-world outcomes of second-line nivolumab monotherapy were comparable to those of previous randomized clinical trials in terms of tumor response, safety, and long-term survival. Furthermore, a good performance status and low C-reactive protein levels may identify patients who are likely to benefit from therapy. Third-line chemotherapy after nivolumab treatment may have an enhanced effect; however, further prospective studies are required to confirm this finding.