Pooled analysis of nivolumab treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck in the United States and Germany

Head Neck. 2021 Nov;43(11):3540-3551. doi: 10.1002/hed.26853. Epub 2021 Sep 6.

Abstract

Background: In the Phase-III clinical trial, CheckMate 141, nivolumab significantly improved survival versus standard of care in patients with platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).

Methods: This pooled analysis investigated the real-world effectiveness of nivolumab, following prior platinum-based therapy, in patients with R/M SCCHN from the United States (US) Flatiron Health database and German HANNA prospective observational study.

Results: Overall, 782 patients (56% US; 44% Germany) were included. Median overall survival (OS) was 8.71 months, and progression-free survival was 4.11 months. Eastern Cooperative Oncology Group Performance Status 0 or 1, platinum sensitivity, and older age were associated with longer OS, in which number of prior lines of therapy had no significant effect.

Conclusion: These findings demonstrate survival benefits of nivolumab in patients with R/M SCCHN in the real-world setting. The observed real-world effectiveness of nivolumab aligns with the efficacy of nivolumab in CheckMate 141.

Keywords: PD-1 targeting agent; SCCHN; nivolumab; overall survival; progression-free survival.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Carcinoma, Squamous Cell* / drug therapy
  • Head and Neck Neoplasms* / drug therapy
  • Humans
  • Neoplasm Recurrence, Local / drug therapy
  • Nivolumab / therapeutic use
  • Squamous Cell Carcinoma of Head and Neck / drug therapy
  • United States

Substances

  • Nivolumab