Identification of a Prognostic Clinical Score for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Treated With Systemic Therapy Including Cetuximab.

Cetuximab-based chemoimmunotherapy has been the standard of care for recurrent or metastatic squamous cell carcinoma of the head and neck (r/m SCCHN) for more than a decade. To date, no predictive or prognostic biomarkers have been established to further guide the systemic treatment with cetuximab-based chemoimmunotherapy in r/m SCCHN. Against this background, we retrospectively analyzed clinical and blood-based parameters from 218 r/m SCCHN patients treated with chemoimmunotherapy including cetuximab. Multivariate Cox-regression models were used to assess their prognostic or predictive value. Eastern Co-operative Oncology Group (ECOG) performance status (≥2), older age (≥61.8 years), anemia (hemoglobin <11.80), and increased neutrophil-to-lymphocyte ratio (NLR ≥5.73) were independently and strongly associated with inferior overall survival (OS). To group patients according to risk profiles we established a prognostic clinical score (PCS) that can easily be used in clinical practice. The PCS stratified the cohort into low, intermediate, poor or very poor risk subgroups with median OS times of 23.4, 12.1, 7.5, and 4.0 months, respectively. Patients with low risk PCS had a prolonged progression-free survival (PFS) and increased overall response rate (ORR) under first-line cetuximab-based therapy. Interestingly, only patients with low and intermediate risk benefitted from the more intensive first-line cisplatin/cetuximab combination compared to carboplatin/cetuximab therapy, whereas the intensity of first-line treatment had no impact in the poor and very poor risk subgroups. Following external validation, particularly in the context of newly established first-line options, the PCS may guide clinical decision making and serve for stratification of patients with r/m SCCHN in future clinical trials.

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Copyright © 2021 Pogorzelski, Hilser, Ting, Kansy, Gauler, Stuschke, Schmid, Lang, Grünwald, Schuler and Kasper.

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MSc: Consultancy: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), Lilly, Novartis; Honoraria for CME presentations: Alexion, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Lilly, Novartis; Research funding to institution: Boehringer Ingelheim, Bristol Myers-Squibb, Novartis; Other: Universität Duisburg-Essen (Patents). SK: Consultancy, Honoraria and Travel Support: Roche, Bristol-Myers Squibb, Merck Sharp & Dohme, Amgen, Merck Serono, Sanofi Aventis, Astra Zeneca, Janssen Pharmaceuticals, Celgene, Lilly, Servier. MP: Consultancy, Honoraria and Travel Support: Boehringer Ingelheim, Bristol Myers-Squibb, Merck Healthcare KGaA, Merck Sharp & Dohme. TG: Consultancy, Honoraria and Travel Support: Astra Zeneca, Bristol Myers-Squibb, Merck Healthcare KGaA, Merck Sharp & Dohme, Roche. VG: grants, personal fees and non-financial support from Astra Zeneca, Bristol-Myers Squibb, Ipsen, Pfizer; grants and personal fees from Novartis, personal fees from Eisai, EUSAPharm, Roche, Janssen-Cilag, Merck Serono, MSD Sharp & Dohme, Lilly, PharmaMar, Asklepios Clinic, Clinic of Oldenburg, Diakonie Clinic, Dortmund Hospital, and Onkowissen. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.