AUTHOR=Rubió-Casadevall Jordi , Cirauqui Cirauqui Beatriz , Martinez Trufero Javier , Plana Serrahima Maria , García Castaño Almudena , Carral Maseda Alberto , Iglesias Docampo Lara , Pérez Segura Pedro , Ceballos Lenza Isaac , Gutiérrez Calderón Vanesa , Fuster Salvà José , Pena Álvarez Carolina , Hernandez Irene , del Barco Morillo Edel , Chaves Conde Manuel , Martínez Galán Joaquina , Durán Sánchez Marisa , Quiroga Vanesa , Ortega Eugenia , Mesia Ricard 

TITLE=TTCC-2019-02: real-world evidence of first-line cetuximab plus paclitaxel in recurrent or metastatic squamous cell carcinoma of the head and neck

JOURNAL=Frontiers in Oncology

VOLUME=Volume 13 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1226939

DOI=10.3389/fonc.2023.1226939

ISSN=2234-943X

ABSTRACT=Objectives
To confirm the efficacy of ERBITAX scheme (paclitaxel 80 mg/m2 weekly and cetuximab 400mg/m2 loading dose, and then 250 mg/m2 weekly) as first-line treatment for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) who are medically unfit for cisplatin-based (PT) chemotherapy.

Materials and Methods
This retrospective, non-interventional study involved 16 centers in Spain. Inclusion criteria were to have started receiving ERBITAX regimen from January 2012 to December 2018, histologically confirmed SCCHN including oral cavity, oropharynx, hypopharynx, and larynx; age ≥18 years; platinum (PT) chemotherapy-ineligibility due to performance status, comorbidities, high accumulated dose of PT or PT refractoriness.

Results
531 patients from 16 hospitals in Spain were enrolled. The median age was 66 years, 82.7% were male and 83.5% were current/former smokers. Patients were ineligible to receive PT due to ECOG 2 (50.3%), comorbidities (32%), PT cumulative dose ≥ 225 mg/m2 (10.5%), or PT refractoriness (7.2%). Response rate was 37.7%. Median duration of response was 5.6 months (95% CI: 4.4-6.6). With a median follow-up of 8.7 months (95% CI: 7.7-10.2), median PFS and OS were 4.5 months (95% CI: 3.9-5.0) and 8.9 months (95% CI: 7.8-10.3). Patients treated with immunotherapy after ERBITAX had better OS with a median of 29.8 months compared to 13.8 months for those who received other treatments. The most common grade ≥ 3 toxicities were acne-like rash in 36 patients (6.8%) and oral mucositis in 8 patients (1.5%). Five (0.9%) patients experienced grade ≥ 3 febrile neutropenia.

Conclusion
This study confirms the real-world efficacy and tolerability of ERBITAX as first-line treatment in recurrent/metastatic SCCHN when PT is not feasible. Immunotherapy after treatment with ERBITAX showed remarkable promising survival, despite potential selection bias.