journal contribution
posted on 2023-03-31, 23:44 authored by Christine H. Chung, Jiannong Li, Conor E. Steuer, Priyanka Bhateja, Matthew Johnson, Jude Masannat, Maria I. Poole, Feifei Song, Juan C. Hernandez-Prera, Helen Molina, Bruce M. Wenig, Sunil Kumar, Charlotte Kuperwasser, Philip J. Stephens, Joaquim M. Farinhas, Dong M. Shin, Julie A. Kish, Jameel Muzaffar, Kedar Kirtane, James W. Rocco, Michael J. Schell, Nabil F. Saba, Marcelo Bonomi Supplementary Table from Phase II Multi-institutional Clinical Trial Result of Concurrent Cetuximab and Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
Funding
James and Esther King Biomedical Research Grant
H. Lee Moffitt Cancer Center & Research Institute
NCI-designated Comprehensive Cancer Center
History
ARTICLE ABSTRACT
A phase II multi-institutional clinical trial was conducted to determine overall survival (OS) in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) treated with a combination of cetuximab and nivolumab.
Patients with R/M HNSCC were treated with cetuximab 500 mg/m2 i.v. on day 14 as a lead-in followed by cetuximab 500 mg/m2 i.v. and nivolumab 240 mg i.v. on day 1 and day 15 of each 28-day cycle. Expression of p16 and programmed cell death-ligand 1 (PD-L1) in archived tumors were determined. Tumor-tissue–modified human papillomavirus (TTMV) DNA was quantified in plasma.
Ninety-five patients were enrolled, and 88 patients were evaluable for OS with a median follow-up of 15.9 months. Median OS in the 45 patients who had prior therapy for R/M HNSCC (cohort A) was 11.4 months, with a 1 year OS 50% [90% confidence interval (CI), 0.43–0.57]. Median OS in the 43 patients who had no prior therapy (cohort B) was 20.2 months, with a 1-year OS 66% (90% CI, 0.59–0.71). In the combined cohorts, the p16-negative immunostaining was associated with higher response rate (RR; P = 0.02) but did not impact survival while higher PD-L1 combined positive score was associated with higher RR (P = 0.03) and longer OS (log-rank P = 0.04). In the p16-positive patients, lower median (1,230 copies/mL) TTMV DNA counts were associated with higher RR (P = 0.01) and longer OS compared with higher median (log-rank P = 0.05).
The combination of cetuximab and nivolumab is effective in patients with both previously treated and untreated R/M HNSCC and warrants further evaluation.
