Toripalimab Plus TPF as Induction Chemoimmunotherapy for the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Prospective Phase II Study

BACKGROUND: This study was aimed to assess the efficacy and potential role of laryngeal function preservation of toripalimab combined with TPF in locally advanced hypopharyngeal squamous cell carcinoma (LA HSCC) patients. METHODS: Patients with histologically confirmed LA HSCC received three cycles of toripalimab combined with TPF as induction chemoimmunotherapy (I-CI) in this single-arm phase II study. The primary endpoint was the CR rate at 3-months after definitive local treatment. RESULTS: Of 29 enrolled patients (62.1% N3b), CR rate was 80.0% (16/20) among the non-surgical patients and 100% (9/9) surgical patients maintained disease-free, at 3-month after definitive local treatment. The CR rate for the cohort was 86.2% (25/29). The laryngeal-preservation rate was 86.2% (25/29). Overall response rate of I-CI was 81.5%. With a median follow-up of 38.3 months, the 3-year progression-free survival rate, overall survival, and larynx preservation survival were 64.0%, 76.3%, and 68.8%, respectively. CONCLUSIONS: Toripalimab combined with TPF showed encouraging efficacy, promising larynx preservation and acceptable toxicity in this cohort of LA HSCC.