Efficacy and Safety of Salvage-line Nivolumab Monotherapy for Advanced Esophageal Squamous Cell Carcinoma: Comparison of 240 mg Versus 480 mg Doses

• Published in: Journal of gastrointestinal cancer 2024-09, Vol.55 (3), p.1345-1351
• Main Authors: Murashima, Yuko, Yamamoto, Shun, Hirose, Toshiharu, Kadono, Toru, Ikeda, Go, Ohara, Akihiro, Itoyama, Mai, Yokoyama, Kazuki, Honma, Yoshitaka, Ishiyama, Koshiro, Oguma, Jyunya, Daiko, Hiroyuki, Kato, Ken
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Immunological - administration & dosage; Antineoplastic Agents, Immunological - adverse effects; Antineoplastic Agents, Immunological - therapeutic use; Cancer Research; Esophageal Neoplasms - drug therapy; Esophageal Neoplasms - mortality; Esophageal Neoplasms - pathology; Esophageal Squamous Cell Carcinoma - drug therapy; Esophageal Squamous Cell Carcinoma - mortality; Esophageal Squamous Cell Carcinoma - pathology; Female; Gastroenterology; Humans; Internal Medicine; Male; Medicine; Medicine & Public Health; Middle Aged; Nivolumab - administration & dosage; Nivolumab - therapeutic use; Oncology; Progression-Free Survival; Radiotherapy; Retrospective Studies; Salvage Therapy - methods; Treatment Outcome
• ISSN: 1941-6628; 1941-6636; 1941-6636
• DOI: 10.1007/s12029-024-01092-w

Background Nivolumab monotherapy is the standard second-line treatment for advanced esophageal squamous cell carcinoma (ESCC) after failure of platinum-based chemotherapy without anti-PD-1 antibody. Fixed dosing with 240 mg every 2 weeks was approved initially, followed by fixed dosing with 480 mg every 4 weeks based on pharmacokinetics data. However, information on the comparative efficacy and safety of the two doses remains limited. Methods We compared progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and the incidence of adverse events (AEs) between the two doses in 117 patients who received second-line ( n  = 85) or later-line ( n  = 32) nivolumab monotherapy at our institution between January 2016 and December 2021. Results In the second-line group, patient characteristics for the 240 mg and 480 mg groups were as follows (240 mg vs. 480 mg): performance status (PS) 0/1/2 was 34/61/5% vs. 54/42/4%, and prior fluoropyrimidine plus platinum therapy (FP) was 81.3% vs. 42.3%. In the later-line group, the characteristics were: PS 0/1/2 was 28/60/12% vs. 14/86/0%, and prior FP was 60.0% vs. 42.8%. ORR was 11.9 vs. 24.0% in the second-line group ( p  = 0.19) and 0 vs. 14.3% in the later-line group ( p  = 0.22). Median PFS was 1.7 vs. 4.1 months on second-line (hazard ratio [HR] 0.60, 95% confidence interval [CI] 0.35–1.01, p  = 0.056) and 1.4 vs. 1.8 months on later-line (HR 0.58, 95% CI 0.23–1.46, p  = 0.25); AEs of any grade were observed in 58.3 vs. 69.7%, respectively. Conclusions The efficacy and safety of the two doses of nivolumab monotherapy were comparable in patients with advanced ESCC.