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

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

doi:10.3389/fonc.2023.1226939

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

Front Oncol. 2023 Aug 1:13:1226939. doi: 10.3389/fonc.2023.1226939. eCollection 2023.

Authors

Jordi Rubió-Casadevall¹, Beatriz Cirauqui Cirauqui², Javier Martinez Trufero³, Maria Plana Serrahima⁴, Almudena García Castaño⁵, Alberto Carral Maseda⁶, Lara Iglesias Docampo⁷, Pedro Pérez Segura⁸, Isaac Ceballos Lenza⁹, Vanesa Gutiérrez Calderón¹⁰, José Fuster Salvà¹¹, Carolina Pena Álvarez¹², Irene Hernandez¹³, Edel Del Barco Morillo¹⁴, Manuel Chaves Conde¹⁵, Joaquina Martínez Galán¹⁶, Marisa Durán Sánchez¹⁷, Vanesa Quiroga², Eugenia Ortega³, Ricard Mesia^{2

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Affiliations

¹ Medical Oncology Department, Institut Català d'Oncologia Girona, Girona Biomedical Research Institute (IDIBGI), Girona, Spain.
² Medical Oncology Department, Institut Català d'Oncologia Badalona, B-ARGO Group, IGTP, Badalona, Spain.
³ Medical Oncology Department, Hospital Universitario Miguel Servet, Zaragoza, Spain.
⁴ Medical Oncology Department, Institut Català d'Oncologia (ICO-Hospitalet), IDIBELL, Hospitalet de Llobregat, Llobregat, Spain.
⁵ Medical Oncology Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain.
⁶ Medical Oncology Department, Hospital Universitario Lucus Augusti, Lugo, Spain.
⁷ Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
⁸ Medical Oncology Department, Hospital Clínico San Carlos, IdISSC, Madrid, Spain.
⁹ Medical Oncology Department, Hospital Universitario de Canarias, San Cristóbal de La Laguna, Spain.
¹⁰ UGCI Oncol. Hospital Universitario Regional y Virgen Victoria, IBIMA, Málaga, Spain.
¹¹ Medical Oncology Department, Hospital Universitario Son Espases, Palma de Mallorca, Spain.
¹² Medical Oncology Department, Centro Oncológico Galicia, A Coruña, Spain.
¹³ Medical Oncology Department, Hospital Universitario de Navarra, Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.
¹⁴ Medical Oncology Department, Hospital Universitario de Salamanca, IBSAL, Salamanca, Spain.
¹⁵ Medical Oncology Department, Hospital Universitario Virgen de Valme, Sevilla, Spain.
¹⁶ Medical Oncology Department, Hospital Universitario Virgen Nieves, Instituto de Investigación Biosanitaria ibs, Granada, Spain.
¹⁷ Spanish Group of Head and Neck Cancer Treatment (TTCC), Madrid, Spain.

Abstract

Objectives: The aim of this study was to confirm the efficacy of the ERBITAX scheme (paclitaxel 80 mg/m² weekly and cetuximab 400 mg/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; and platinum (PT) chemotherapy ineligibility due to performance status, comorbidities, high accumulated dose of PT, or PT refractoriness.

Results: A total of 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), respectively. 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.

Keywords: cetuximab; frail patients; paclitaxel; platinum ineligible; squamous cell carcinoma of head and neck.

Copyright © 2023 Rubió-Casadevall, Cirauqui Cirauqui, Martinez Trufero, Plana Serrahima, García Castaño, Carral Maseda, Iglesias Docampo, Pérez Segura, Ceballos Lenza, Gutiérrez Calderón, Fuster Salvà, Pena Álvarez, Hernandez, del Barco Morillo, Chaves Conde, Martínez Galán, Durán Sánchez, Quiroga, Ortega and Mesia.

Grants and funding

This work was sponsored by the Grupo Español de Tumores de Cabeza y Cuello (TTCC). The authors declare that this study received funding from Merck S.L.U. Madrid, Spain, an affiliate of Merck KGaA (Funder ID: 10.13039/100009945). The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article, or the decision to submit it for publication.