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Oncol."],"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>The aim of this study was to confirm the efficacy of the ERBITAX scheme (paclitaxel 80 mg\/m<jats:sup>2<\/jats:sup> weekly and cetuximab 400 mg\/m<jats:sup>2<\/jats:sup> loading dose, and then 250 mg\/m<jats:sup>2<\/jats:sup> 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and methods<\/jats:title><jats:p>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 \u226518 years; and platinum (PT) chemotherapy ineligibility due to performance status, comorbidities, high accumulated dose of PT, or PT refractoriness.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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 \u2265 225 mg\/m<jats:sup>2<\/jats:sup> (10.5%), or PT refractoriness (7.2%). Response rate was 37.7%. Median duration of response was 5.6 months (95% CI: 4.4\u20136.6). With a median follow-up of 8.7 months (95% CI: 7.7\u201310.2), median PFS and OS were 4.5 months (95% CI: 3.9\u20135.0) and 8.9 months (95% CI: 7.8\u201310.3), 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 \u2265 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 \u2265 3 febrile neutropenia.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fonc.2023.1226939","type":"journal-article","created":{"date-parts":[[2023,8,1]],"date-time":"2023-08-01T17:03:09Z","timestamp":1690909389000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":15,"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"],"prefix":"10.3389","volume":"13","author":[{"given":"Jordi","family":"Rubi\u00f3-Casadevall","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beatriz","family":"Cirauqui Cirauqui","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Javier","family":"Martinez 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