Sep 28

SS 15 - Immunotherapy Integration and Immuno Biomarkers Across Mucosal and Cutaneous SCC

175 - Induction Toripalimab and Chemotherapy for Organ Preservation in Locally Advanced Laryngeal and Hypopharyngeal Cancer: 3-Year Follow-Up of the INSIGHT Study

11:15am - 11:25am ET

Room 107

Presenter(s)

Xiaomin Ou, MD - Fudan University Shanghai Cancer Center, Shanghai, Shanghai

X. Ou^1,2, C. Hu^3,4, X. He^3,4, and Y. Wang⁵; ¹Department of Oncology, Fudan University Shanghai Medical College, Shanghai, Shanghai, China, ²Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China, ³Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China, ⁴Department of Oncology, Fudan University Shanghai Medical College, Shanghai, China, ⁵Department of Head and Neck Surgery, Fudan University Shanghai Cancer Center, Shanghai, China

Purpose/Objective(s): This phase II study evaluated the efficacy, toxicity, and larynx-preservation potential of induction chemotherapy combined with the PD-1 inhibitor 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.

Materials/Methods: This is a single-arm phase II study. Patients with histopathologic confirmed, resectable locally advanced laryngeal/hypopharyngeal squamous cell carcinoma and ECOG PS 0-1 were eligible. Three cycles of induction chemotherapy (paclitaxel 175mg/m² d1, cisplatin 25mg/m² d1-3) combined with PD-1 inhibitor (toripalimab 240mg d0) were administered. Response assessment was performed after induction chemoimmunotherapy using RECIST 1.1 criteria. Patients with complete/partial response 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 response of induction chemoimmunotherapy, adverse events, quality of life, overall survival (OS), progression-free survival (PFS), larynx preservation rate, and larynx-preservation survival (LPS), defined as time from enrollment to local recurrence, total laryngectomy, or death.

Results: Twenty-seven patients were enrolled. Most cases exhibited stage IV disease (81.5%), with T4 representing 37.0%. Five patients underwent pretreatment tracheostomy due to impaired larynx function. Overall response rate of induction chemoimmunotherapy was 85.2%. At three months post-radiation, the larynx preservation rate was 88.9%. The date of data cut-off was February 3, 2026. With a median follow-up of 50.0 [95%CI: 40.2-59.8] months, 3-year OS rate, PFS rate, larynx preservation rate and LPS rate was 70.2%, 63.0%, 84.3% and 73.6%, respectively. Excluding patients with pretreatment tracheostomy, 3-year OS rate, PFS rate, larynx preservation rate and LPS rate improved to 81.6%, 72.7%, 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). Among patients with disease progression or death, the proportion of local progression only was 16.7%. All patients with preserved larynx at last follow-up maintained functional laryngeal status, free from tracheostomy or feeding tube dependence.

Conclusion: Induction toripalimab combined with chemotherapy provided promising and durable larynx preservation rate in this cohort of extensively locally advanced laryngeal and hypopharyngeal cancer.