An exploratory study of neoadjuvant tislelizumab combined with TP regimen for the comprehensive treatment of resectable locally advanced oral squamous cell carcinoma.

Abstract

e18034 Background: The landscape of neoadjuvant immunotherapy for resectable locally advanced head and neck squamous cell carcinoma has improved significantly recently. However, there is still lack of studies to evaluate whether the combination of neoadjuvant immunotherapy plus TP regimen is safe and effective in down-staging to reduce the extent of surgery in locally advanced oral squamous cell carcinoma (LA OSCC). Methods: In this exploratory study, eligible patients with untreated locally advanced, resectable OSCC (T3-4bN0-3M0; stage III-IVb, AJCC 8th Edition) were enrolled to receive Tislelizumab (200mg) and platinum-doublet chemotherapy[albumin-bound paclitaxel (240 mg/m 2 ) plus cisplatin (70 mg/m 2 )] on day 1 Q3W for three cycles, followed by surgery and postoperative adjuvant therapy. After neoadjuvant therapy, the TNM stage was re-evaluated by MR. Surgery was performed according to the new stage with R0 resection. Adjuvant therapy was based on pathologic staging. The primary endpoint was pathologic complete response (pCR). Secondary endpoints included objective response rate (ORR) per RECIST1.1 during neoadjuvant treatment, major pathologic response (MPR), progress-free survival (PFS), overall survival (OS) and safety. An additional health-related quality of life analysis was performed before and after neoadjuvant immunochemotherapy, to evaluate the effect of the changed extent of surgery for quality of life of patients according to the QLQ-C30 and QLQ-H&N 35. Results: Between February 2023 and November 2024, 20 pts were enrolled. Median age was 44.5 (18-71) yrs, and 80% male. All pts completed neoadjuvant therapy. 20 pts received surgery with 100% R0 resection rate. 14 pts were allowed for reductions in the extent of surgery. The combination of tislelizumab and TP regimen did not increase the incidence of adverse events, and no treatment-related adverse events for grade 3/4 were observed. A significant improvement in dysphagia, eating and pain symptoms in all patients after treatment, indicating that the treatment can improve the quality of life of patients without the risk of aggravating other symptoms. Symptoms such as insomnia, fatigue, nausea and vomiting, and functional indicators to deterioration significantly during treatment, probably due to treatment-related adverse reactions. Conclusions: The current findings, along with acceptable safety and reduction in the extent of surgery, suggests that tislelizumab combined with TP regimen represents a potential treatment for LA OSCC. But the evaluation of response and long-term efficacy is still needed collected and follow-up. Clinical trial information: ChiCTR2200064609 .