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Background: Immune checkpoint inhibitors are widely used in recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC). We aimed to describe response rates to taxanes after progression on nivolumab in R/M HNSCC patients., Methods: In this multicentric retrospective comparative study, we included patients treated with taxane monotherapy from 2014 to 2020. Patients were divided into two groups depending on whether they received nivolumab before taxanes (post-nivolumab group) or not (control group). The primary end-point was objective response rate (ORR) comparison between the two groups. The secondary end-points included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and PFS ratio (PFSr=PFS associated with taxanes divided by PFS associated with the previous line of treatment), a survival marker used for comparison of different treatment lines., Results: Between July 2014 and August 2020, 185 patients were included (114 in the control group and 71 in the post-nivolumab group). ORR was significantly higher in the post-nivolumab group (39.4% versus 26.3%, p = 0.03) as was DCR (69% versus 50%, P = 0.06). The median OS (7.5 months) and PFS (3.5 months) were not significantly different in the two groups, whereas PFSr was significantly improved in the post-nivolumab group (1.63 versus 1.11, P = 0.004)., Conclusion: Response and DCRs with taxanes are improved after prior exposure to nivolumab. Thus, taxane monotherapy could be a good choice as third-line therapy after nivolumab following a platinum-based first line. These results currently apply to patients without access to or potential benefit from first-line pembrolizumab., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: In the TAX 323 (EORTC 24971) phase III trial enrolling patients with unresectable locoregionally advanced squamous cell carcinoma of the head and neck (LA-SCCHN), the addition of docetaxel (T) to cisplatin and 5-fluorouracil (PF)-based induction chemotherapy prior to definite radiotherapy significantly improved progression-free survival (PFS) and overall survival (OS)., Methods: The data were updated for PFS, OS and treatment-related long-term side-effects. Baseline clinical and laboratory data of 17 variables were collected and subjected to univariate and multivariate prognostic factor analyses for OS., Results: All 358 patients randomised between 1999 and 2002 were included in the long-term analysis with a median follow-up of 8.6 years. The primary end-point of PFS remained significantly improved with TPF compared with PF (adjusted hazard ratio [HR], 0.70; 95% CI, 0.56-0.88, p = 0.002), translating into a persisting benefit in OS (adjusted HR, 0.75; 95% CI, 0.60-0.95, p = 0.015). Long-term side-effects in the TPF/PF arms comprised tracheostomy (7%/5%), feeding tube dependency (3%/6%) and gastrostomy (11%/11%). Second malignancy occurred in 8%/3%, respectively. Out of 177 patients randomised to the TPF arm, 160 were included in the multivariate analysis. Grade 2 or more dysphagia (p = 0.002) and grade 2 or more pain (p = 0.004) at baseline were identified as independent negative prognostic factors. In addition, OS differed across primary tumour sites (p = 0.027) and was worse in patients with a higher N-stage (p = 0.025)., Conclusions: In LA-SCCHN patients treated with sequential chemoradiotherapy, TPF induction chemotherapy demonstrated long-lasting efficacy, superior to the PF regimen. Higher-grade dysphagia and pain are unfavourable prognosticators., Competing Interests: Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Petr Szturz: Has had in the last 3 years or has advisory relationships with: Merck-Serono, Servier, and BMS. Marie Vinches has nothing to declare. Éva Remenár has nothing to declare. Carla M L van Herpen: Has had in the last 3 years or has advisory/consultant relationships with: Bayer, Bristol-Myers Squibb, Ipsen, MSD and Regeneron and research grant/funding relationships with: Astra Zeneca, Bristol-Myers Squibb, MSD, Merck, Ipsen, Novartis and Sanofi. Cyril Abdeddaim: Has had in the last 3 years consulting/advisory relationships with GlaxoSmithKline. John S Stewart has nothing to declare. Catherine Fortpied has nothing to declare. Jan B. Vermorken: Has had in the last 3 years or has consulting/advisory relationships with: Immunomedics, Innate Pharma, Merck-Serono, Merck Sharp & Dome Corp, PCI Biotech, Synthon Biopharmaceuticals, Debiopharm, Cue Biopharma, Nanobiotix, and WntResearch and received lecture fees from Merck-Serono, MSD and BMS., (Copyright © 2021. Published by Elsevier Ltd.)