Real-world clinical impact of first-line immune checkpoint inhibitor-based therapy in advanced esophageal squamous cell carcinoma
Background: Chemotherapy (chemo) combined with an immune checkpoint inhibitor (ICI) or dual ICI therapy with nivolumab and ipilimumab (nivo + ipi) is the standard first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC). In this study, we evaluated real-world clinica...
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Elsevier
2025-06-01
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| Series: | ESMO Gastrointestinal Oncology |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2949819825000408 |
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| author | M. Tamba K. Chin H. Osumi M. Ogura S. Fukuoka S. Udagawa K. Shimozaki K. Yoshino T. Wakatsuki E. Shinozaki K. Yamaguchi A. Ooki |
| author_facet | M. Tamba K. Chin H. Osumi M. Ogura S. Fukuoka S. Udagawa K. Shimozaki K. Yoshino T. Wakatsuki E. Shinozaki K. Yamaguchi A. Ooki |
| author_sort | M. Tamba |
| collection | DOAJ |
| description | Background: Chemotherapy (chemo) combined with an immune checkpoint inhibitor (ICI) or dual ICI therapy with nivolumab and ipilimumab (nivo + ipi) is the standard first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC). In this study, we evaluated real-world clinical outcomes for first-line ICI-based therapy and explored its prognostic factors. Patients and methods: This single-center retrospective study included patients with ESCC who received ICI-based therapy between January 2021 and July 2024. Results: In total, 92 patients received either ICI + chemo (n = 60) or nivo + ipi (n = 32). The median progression-free survival and overall survival (OS) were 5.0 and 16.0 months for ICI + chemo and 3.5 and 16.9 months for nivo + ipi, respectively. Of the 70 patients with measurable lesions, early tumor shrinkage (ETS) was achieved in 37% for ICI + chemo and 33% for nivo + ipi. ETS was significantly associated with a lower performance status and neutrophil-to-lymphocyte ratios, but not with the treatment regimen or programmed death-ligand 1 (PD-L1) status. Patients who achieved ETS showed significant tumor reduction and a durable response. ETS was an independent predictor of favorable OS (hazard ratio 0.34, 95% confidence interval 0.11-0.88, P = 0.04), whereas neither the treatment regimen nor the PD-L1 status influenced OS. Immune-related adverse events of grade ≥3 occurred in 12% of patients. Conclusions: First-line immunotherapy is effective and safe for the treatment of patients with ESCC. Rapid and deep tumor shrinkage may serve as an early predictive biomarker for longer survival. |
| format | Article |
| id | doaj-art-1374028e68314a2bb7eb85b94a1ce74c |
| institution | DOAJ |
| issn | 2949-8198 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | ESMO Gastrointestinal Oncology |
| spelling | doaj-art-1374028e68314a2bb7eb85b94a1ce74c2025-08-20T03:21:32ZengElsevierESMO Gastrointestinal Oncology2949-81982025-06-01810017110.1016/j.esmogo.2025.100171Real-world clinical impact of first-line immune checkpoint inhibitor-based therapy in advanced esophageal squamous cell carcinomaM. Tamba0K. Chin1H. Osumi2M. Ogura3S. Fukuoka4S. Udagawa5K. Shimozaki6K. Yoshino7T. Wakatsuki8E. Shinozaki9K. Yamaguchi10A. Ooki11Department of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, JapanDepartment of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, JapanDepartment of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, JapanDepartment of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, JapanDepartment of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, JapanDepartment of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, JapanDepartment of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, JapanDepartment of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, JapanDepartment of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, JapanDepartment of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, JapanDepartment of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, JapanDepartment of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan; Correspondence to: Dr Akira Ooki, Department of Gastroenterological Chemotherapy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan. Tel: +81-3-3520-0111Background: Chemotherapy (chemo) combined with an immune checkpoint inhibitor (ICI) or dual ICI therapy with nivolumab and ipilimumab (nivo + ipi) is the standard first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC). In this study, we evaluated real-world clinical outcomes for first-line ICI-based therapy and explored its prognostic factors. Patients and methods: This single-center retrospective study included patients with ESCC who received ICI-based therapy between January 2021 and July 2024. Results: In total, 92 patients received either ICI + chemo (n = 60) or nivo + ipi (n = 32). The median progression-free survival and overall survival (OS) were 5.0 and 16.0 months for ICI + chemo and 3.5 and 16.9 months for nivo + ipi, respectively. Of the 70 patients with measurable lesions, early tumor shrinkage (ETS) was achieved in 37% for ICI + chemo and 33% for nivo + ipi. ETS was significantly associated with a lower performance status and neutrophil-to-lymphocyte ratios, but not with the treatment regimen or programmed death-ligand 1 (PD-L1) status. Patients who achieved ETS showed significant tumor reduction and a durable response. ETS was an independent predictor of favorable OS (hazard ratio 0.34, 95% confidence interval 0.11-0.88, P = 0.04), whereas neither the treatment regimen nor the PD-L1 status influenced OS. Immune-related adverse events of grade ≥3 occurred in 12% of patients. Conclusions: First-line immunotherapy is effective and safe for the treatment of patients with ESCC. Rapid and deep tumor shrinkage may serve as an early predictive biomarker for longer survival.http://www.sciencedirect.com/science/article/pii/S2949819825000408esophageal canceresophageal squamous cell carcinomachemotherapyimmunotherapyearly tumor shrinkagedepth of response |
| spellingShingle | M. Tamba K. Chin H. Osumi M. Ogura S. Fukuoka S. Udagawa K. Shimozaki K. Yoshino T. Wakatsuki E. Shinozaki K. Yamaguchi A. Ooki Real-world clinical impact of first-line immune checkpoint inhibitor-based therapy in advanced esophageal squamous cell carcinoma ESMO Gastrointestinal Oncology esophageal cancer esophageal squamous cell carcinoma chemotherapy immunotherapy early tumor shrinkage depth of response |
| title | Real-world clinical impact of first-line immune checkpoint inhibitor-based therapy in advanced esophageal squamous cell carcinoma |
| title_full | Real-world clinical impact of first-line immune checkpoint inhibitor-based therapy in advanced esophageal squamous cell carcinoma |
| title_fullStr | Real-world clinical impact of first-line immune checkpoint inhibitor-based therapy in advanced esophageal squamous cell carcinoma |
| title_full_unstemmed | Real-world clinical impact of first-line immune checkpoint inhibitor-based therapy in advanced esophageal squamous cell carcinoma |
| title_short | Real-world clinical impact of first-line immune checkpoint inhibitor-based therapy in advanced esophageal squamous cell carcinoma |
| title_sort | real world clinical impact of first line immune checkpoint inhibitor based therapy in advanced esophageal squamous cell carcinoma |
| topic | esophageal cancer esophageal squamous cell carcinoma chemotherapy immunotherapy early tumor shrinkage depth of response |
| url | http://www.sciencedirect.com/science/article/pii/S2949819825000408 |
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