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

Objectives: The aim of this study was to confirm the efficacy of the ERBITAX scheme (paclitaxel 80 mg/m ² weekly and cetuximab 400 mg/m ² loading dose, and then 250 mg/m ² 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/m ² (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.
Competing Interests: JR-C: Advisory role: Sanofi, Novartis and Merck. BCC: Support for this manuscript from Merck through TTCC Group. Speaker on behalf of BMS, MSD, and Merck. Meeting support from BMS and MSD. Member of TTCC Group unpaid. MP: Speaker on behalf of BMS. Meeting support from MSD Oncology. AG: Advisory board from MSD and Bristol Myers Squibb. AC: Speaker on behalf of Merck. Meeting support from Merck. LI: Speaker on behalf of Merck, MSD, Roche, Bayer, Eisai. Meeting support from Merck and MSD. Advisory board from Merck MSD, Roche, Lilly, and Ipsen. PP: Received grants from BMS, Merck, and MSD. Consulting fees from BMS, Merck, and MSD. Speaker on behalf of BMS, Merck, and MSD. Meeting support from BMS, Merck, and MSD. Member of TTCC Group. IC: Speaker on behalf of MSD, Merck, Roche, BMS, Seagen, and Pfizer. Meeting support in Pfizer, MSD, and Merck. CP: Speaker on behalf of Novartis, Merck, and MSD. Meeting support from Novartis, Merck, and MSD. IH: Speaker on behalf of Pierre Fabre educational event and Merck lecture. Meeting support from Merck support for an event and AztraZeneca support for educational expertise. MC: Participated in and received equipment for clinical trials from the institution. Speaker on behalf of MSD and Merck. Meeting support from MSD and Merck. EO: Speaker on behalf of GSK, AstraZeneca, Clovis, Merck, Pharmamar, and MSD. Expert testimony for GSK. Meeting support from Merck and MSD. Advisory board for Eisai. RM: Support for this manuscript from Merck for medical writing and article processing charges. Speaker on behalf of MSD and Merck. Meeting support from BMS, Merck, and MSD. Advisory board for MSD, Merck, Boehringer, Bayer, Roche, Nanobiotics and Sigean. 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.
(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.)