6086 Background: This phase II study evaluated the efficacy and larynx-preservation potential of induction chemotherapy combined with the toripalimab in patients with locally advanced laryngeal and hypopharyngeal squamous cell carcinoma (LA-L/HPSCC). Primary and 1-year survival outcomes were previously reported; here we present the 3-year follow-up results. Methods: This is a single-arm phase II study. Patients with histopathologic confirmed, resectable LA-L/HPSCC and ECOG PS 0-1 were eligible. Three cycles of induction chemotherapy (paclitaxel 175mg/m 2 d1, cisplatin 25mg/m 2 d1-3) combined with toripalimab (240mg d0) were administered. Response assessment was performed after induction chemoimmunotherapy using RECIST 1.1 criteria. Patients with CR/PR of primary tumor received concurrent chemoradiation, followed by maintenance therapy of toripalimab. Otherwise, patients were referred to surgery, followed by adjuvant (chemo)radiation, and maintenance therapy of toripalimab. The primary endpoint is larynx-preservation rate at three months post-radiation. Secondary endpoints included overall survival (OS), progression-free survival (PFS), larynx preservation rate, and larynx-preservation survival (LPS), etc. Results: Twenty-seven patients were enrolled. Most cases exhibited stage IV disease (81.5%), with T4 representing 37.0%. Five patients underwent pretreatment tracheostomy. The date of data cut-off was Jan 23, 2026. With a median follow-up of 36.4 95%CI: 33.4-39.4 months, 3-year OS rate, PFS rate, larynx preservation rate and LPS rate was 73.5%, 61.1%, 84.3% and 73.6%, respectively. Excluding patients with pretreatment tracheostomy, these rates improved to 86.4%, 70.8%, 90.2% and 81.1%. The 3-year larynx preservation rate for T2/3 and T4 disease was 92.9% and 70.0%, respectively ( p =0.081). All patients with preserved larynx at last follow-up maintained functional laryngeal status, free from tracheostomy or feeding tube dependence. Conclusions: Induction toripalimab combined with chemotherapy provided promising and durable larynx preservation rate in this cohort of extensively LA-L/HPSCC. Clinical trial information: NCT04995120 . Comparison of patients enrollment and survival among pivotal clinical trials. Study Phase Clinical Stage Larynx preservation rate at 3 year Progression-free rate at 3 year GORTEC 2000-01 III Stage III, IVHypopharynx 54.0%, larynx 46.0% 70.1% for TPF and 57.5% for PF 58% for TPF and 44% for PF Subgroup analysis ofTAX324 II Stage III 26.5%Stage IV 73.5%,Hypopharynx 46.4%, larynx l 64.5% Not available 43% for TPF and 29% for PF This study II Stage III 18.5%Stage IVa 33.3%Stage IVb 48.1%Hypopharynx 66.7%, larynx 33.3% 84.3% for whole cohort and 90.2% when excluding patients with pretreatment tracheostomy 61.1% for whole cohort and 70.8% when excluding patients with pretreatment tracheostomy
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