Background A recent phase III study (Keynote-048) demonstrated survival benefit of platinum, 5-FU and pembrolizumab in 1st line treatment of recurrent and/or metastatic head and neck squamous cell carcinoma (RM-HNSCC).1 However, administration of 5-FU has been a challenge for logistics and toxicities. As platinum, paclitaxel and pembrolizumab has been shown to be an effective and safe treatment for non-small cell lung cancer,2 we hypothesized that carboplatin, paclitaxel and pembrolizumab would be safe and effective for 1st line treatment of RM-HNSCC.
Methods We performed a retrospective study of RM-HNSCC patients who received carboplatin, paclitaxel and pembrolizumab for first line systemic therapy, treated between December 2015 and January 2020 at the University of California, San Francisco. Patients who received at least 1 cycle of treatment with pre-treatment and post-treatment images were included in the analyses. Response to the treatment was assessed using RECIST criteria version 1.1. We also estimated overall survival and progression free survival using Kaplan-Meier method.
Results Nine patients who received carboplatin, paclitaxel and pembrolizumab as first line systemic therapy for RM-HNSCC were identified. Two patients had HPV positive oropharyngeal SCC, the other patients unknown primary SCC in head and neck (2), oral cavity SCC (2), laryngeal SCC (1), hypopharyngeal SCC (1) and SCC of orbit (1). There were 1 complete response (CR, 11%), 6 partial responses (PR, 55%), 1 stable disease (SD, 11%) and 1 progressive disease (PD, 11%). Overall response rate (ORR) was 78%, and median progression free survival and median overall survival have not reached with median follow-ups of 6 months and 8 months, respectively. Two patients discontinued chemotherapy after 1 cycle for grade 4 acute kidney injury and grade 4 anaphylaxis, yet achieved CR and PR, respectively.
Conclusions The retrospective analysis suggests that first line carboplatin, paclitaxel and pembrolizumab for RM-HNSCC is an active regimen and can be considered in place of platinum, 5-FU and pembrolizumab, which merits further investigation.
Ethics Approval The study was approved by UCSF’s Institutional Review Board, approval number 19-29365.
Burtness B, Harrington K, Greil R, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet 2019;394:1915–1928.
Paz-Ares L, Luft A, Vincente D, et al. Pembrolizumab plus Chemotherapy for Squamous Non–Small-Cell Lung Cancer. New Engl J Med 2018; 379:2040–2051.
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