BibTex format
@article{Chung:2022:10.1158/1078-0432.CCR-21-3849,
author = {Chung, CH and Li, J and Steuer, CE and Bhateja, P and Johnson, M and Masannat, J and Poole, MI and Song, F and Hernandez-Prera, JC and Molina, H and Wenig, BM and Kumar, S and Kuperwasser, C and Stephens, PJ and Farinhas, JM and Shin, DM and Kish, JA and Muzaffar, J and Kirtane, K and Rocco, JW and Schell, MJ and Saba, NF and Bonomi, M},
doi = {10.1158/1078-0432.CCR-21-3849},
journal = {Clin Cancer Res},
pages = {2329--2338},
title = {Phase II Multi-institutional Clinical Trial Result of Concurrent Cetuximab and Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.},
url = {http://dx.doi.org/10.1158/1078-0432.CCR-21-3849},
volume = {28},
year = {2022}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - PURPOSE: 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 AND METHODS: 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. RESULTS: 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). CONCLUSIONS: The combination of cetuximab and nivolumab is effective in patients with both previously treated and untreated R/M HNSCC and warrants further evaluation.
AU - Chung,CH
AU - Li,J
AU - Steuer,CE
AU - Bhateja,P
AU - Johnson,M
AU - Masannat,J
AU - Poole,MI
AU - Song,F
AU - Hernandez-Prera,JC
AU - Molina,H
AU - Wenig,BM
AU - Kumar,S
AU - Kuperwasser,C
AU - Stephens,PJ
AU - Farinhas,JM
AU - Shin,DM
AU - Kish,JA
AU - Muzaffar,J
AU - Kirtane,K
AU - Rocco,JW
AU - Schell,MJ
AU - Saba,NF
AU - Bonomi,M
DO - 10.1158/1078-0432.CCR-21-3849
EP - 2338
PY - 2022///
SP - 2329
TI - Phase II Multi-institutional Clinical Trial Result of Concurrent Cetuximab and Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.
T2 - Clin Cancer Res
UR - http://dx.doi.org/10.1158/1078-0432.CCR-21-3849
UR - https://www.ncbi.nlm.nih.gov/pubmed/35344035
VL - 28
ER -
