Abstract 679P
Background
Platinum agents and anti-PD-1 antibodies are key drugs in front-line chemotherapy (CTx) for recurrent or metastatic head and neck squamous cell carcinoma (RM-HNSCC). In Japan, nivolumab was reimbursed for RM-HNSCC previously treated with platinum-based CTx in March 2017. However, clinical outcomes for RM-HNSCC patients (pts) after failure with platinum agents and anti-PD-1 antibodies have not been elucidated.
Methods
We retrospectively analyzed clinical data of RM-HNSCC pts who started nivolumab from March 2017 to December 2019 and experienced failure with both platinum and nivolumab treatment at ten institutions in Japan.
Results
A total of 480 pts were enrolled in this study. Of 236 pts who received the best supportive care, the median overall survival (OS) was 3.1 (95% confidence interval [CI], 2.5 -3.7) months. Of 244 pts who received salvage-line chemotherapy (SLC), 72 pts (29.5%) were treated with paclitaxel+cetuximab (PTX+Cmab), 89 (36.5%) with taxane, and 48 (19.7%) with S-1. The overall response rate was 54.9% for PTX+Cmab, 27.9% for taxane, and 25.5% for S-1. Median progression-free survival (PFS) and OS in SLC pts were 5.4 and 13.0 months, respectively. Multivariate analysis revealed that disease stabilization with prior nivolumab (hazard ratio [HR]: 0.534; 95%CI: 0.385-0.740, p<.001) and SLC with PTX+Cmab (HR: 0.501, 95%CI: 0.332-0.757, p=0.001 [vs. taxane]) were independent prognostic factors for OS. These factors were also prognostic factors in multivariate analysis for PFS.
Conclusions
This multi-institutional retrospective study revealed the potential contribution of SLC, especially with PTX+Cmab regimen, after the failure of both platinum-based CTx and nivolumab. Pts who obtained disease stabilization with prior nivolumab might be promising candidates for SLC.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
K. Nagashima: Financial Interests, Personal, Other, Recieved consulting fees: Fujimoto Pharmaceutical Corporation, Senju Pharmaceutical Co., Ltd., Toray Industries, Inc.; Financial Interests, Personal, Other, Received lecture fees: Pfizer R&D Japan G.K. Y. Shimizu: Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Invited Speaker: Ono Pharmaceutical Co., Ltd., Eli Lilly and Company, GlaxoSmithKline, Adlai Nortye. N. Oridate: Financial Interests, Personal, Speaker’s Bureau: Ono Pharmaceutical, Bristol Myers Squibb Japan, Merck Biopharma/Japan, Taiho Pharmaceutical, MSD; Financial Interests, Institutional, Funding: Ono Pharmaceutical, Merck Biopharma/Japan, Taiho Pharmaceutical, Daiichi Sankyo Japan. T. Yokota: Financial Interests, Personal, Advisory Board: Merck Biopharma, MSD, Rakuten Medical; Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical Co., Ltd., Merck Biopharma, Bristol-Myers Squibb, AstraZeneca, Chugai, MSD, Eisai; Financial Interests, Institutional, Funding: AstraZeneca, Chugai Pharma, MSD, Syneos Health, Lilly, Incyte, Novartis, GlaxoSmithKline, Merck Biopharma, Boehringer Ingelheim, Ascent; Financial Interests, Personal and Institutional, Research Grant: Japan Agency for Medical Research and Development; Non-Financial Interests, Principal Investigator: Japan Agency for Medical Research and Development. N. Kiyota: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical, Bristol Meyers Squibb, Bayer, MSD, Eisai, Lilly; Financial Interests, Personal, Advisory Board: Shift Zero; Financial Interests, Institutional, Invited Speaker: Ono Pharmaceutical, AstraZeneca, Rakuten Medical, Roche, Bayer, Adlai Nortye, Boehringer Ingelheim, Lilly. S. Kadowaki: Financial Interests, Personal, Invited Speaker: Taiho, Eli Lilly, MSD, Ono, Daiichi Sankyo, BMS, Bayer, Merck Serono, Eisai; Financial Interests, Institutional, Funding: Taiho, Eli Lilly, MSD, Ono, Daiichi Sankyo, Chugai, Nobelpharma, Yansen. Y. Honma: Financial Interests, Personal, Advisory Board: Janssen, Eisai; Financial Interests, Personal and Institutional, Invited Speaker: Taiho Pharmaceutical, Chugai Pharma, MSD, Novartis, GlaxoSmithKline, Jannsen. All other authors have declared no conflicts of interest.