Safety Results of a Multi-Institutional Phase 1 Clinical Trial of Afatinib in Combination with Docetaxel and Postoperative Radiation Therapy for High-Risk Squamous Cell Carcinoma of the Head and Neck

Abstract

patients received adjuvant CRT. On multivariable logistic regression, female sex, younger age, academic treatment facility, higher comorbidity index, and lower clinical T and N stages were associated with higher odds of receiving primary surgery. Three-year OS in the CRT cohort was 90.8% vs. 92.5% in patients receiving primary surgery (log-rank P Z .92). On multivariable Cox regression, upfront surgery was not associated with improved OS when compared with CRT (hazard ratio [HR] 1.10, 95% confidence interval [CI] 0.84-1.43, P Z .48). Increasing clinical T and N stage, older age, and non-private insurance were significantly associated with inferior OS. Lack of OS benefit with upfront surgery persisted in a subset analysis of patients with margin-negative resection, with a 3-year OS of 90.1% in patients undergoing CRT vs. 93.5% in primary surgery patients (log-rank P Z .14). Propensity score-matching identified a cohort of 2,618 patients and redemonstrated similar OS (HR, 1.11; 95% CI 0.83-1.49; P Z 0.49). Conclusion: Upfront surgery was not associated with improved OS compared to CRT in this patient cohort. The majority of surgical patients received trimodal therapy with adjuvant CRT. Efforts to improve patient selection in order to minimize the need for trimodal therapy are justified given the lack of observed survival benefit with surgery.