Neoadjuvant chemoimmunotherapy for laryngeal preservation in locally advanced hypopharyngeal cancer.

Objectives: To retrospectively investigate the pathological response rate, laryngeal preservation surgery (LPS) rate and progression free survival (PFS) of neoadjuvant chemoimmunotherapy in the treatment of locally advanced hypopharyngeal cancer (LAHPC).

Materials And Methods: In this study, LAHPC patients, who were first diagnosed and underwent surgery at the First Affiliated Hospital of Naval Medical University between January 2021 and January 2024, preoperatively administered PD-1 inhibitor and TP induction regimen (albumin-bound paclitaxel 260 mg/m and cisplatin 80 mg/m). The primary endpoint was major pathological response (MPR), with ORR rate, LPS rate and PFS as the secondary endpoints. Then, the correlation between MPR and overall response rate (ORR) was further validated.

Results: A total of 46 patients satisfied the inclusion criteria, with the median follow-up period of 10.5 months. After neoadjuvant chemoimmunotherapy, the ORR was observed to be 71.9 %, and the LPS rate reached 80.4 % (76.5 % in stage IV patients). The pathological response indicated a favorable response, with the MPR ratio at 52.2 % and pathological complete response (pCR) ratio at 32.6 %. The imaging score highly correlated with pathological response (Kappa = 0.058, P<0.001), while the MPR and ORR shared a strong positive linear relationship (r = 0.753, P<0.001). The 1-year and 2-year PFS rates were 97.1 % and 93.8 % for all patients, with stage IV patients having a 1-year PFS of 92.2 %. Patients who achieved MPR demonstrated a significant prognostic advantage (P=0.008), with no recurrence instances or mortality reported. Grade 3 adverse events were observed in 8.7 % of the cohort. The most common Grade 1-2 adverse events were alopecia, reactive telangiosis and loss of appetite, and no delayed surgery occurred.

Conclusion: Neoadjuvant therapy of PD-1 inhibitor combined with TP effectively improved the MPR and LPS rates of LAHPC patients, especially in those at clinical stage IV.