857P - Safety and efficacy of neoadjuvant immunochemotherapy in patients with locally advanced head and neck squamous cell carcinoma: A prospective single-arm clinical trial

Background

Seeking out a more effective and less-toxic regimen is necessary for patients with locally advanced HNSCC. This study aimed to evaluate the efficacy and safety of tislelizumab in combination with APF (albumin-bound paclitaxel, platinum, and fluorouracil) neoadjuvant therapy followed by surgery or concurrent chemoradiotherapy.

Methods

In this prospective, single-center, phase II clinical study, patients aged 18-75 years old with locally advanced HNSCC (III-IVb (P16-) or II-III (P16+)) and without previously treated were enrolled. Eligible patients received A (200 mg/m² d1) P (60 mg/m² d1-d2) F (600 mg/m² CIV120h) induction chemotherapy along with tislelizumab (200 mg d1) every 3 weeks. The curative effect is evaluated after 3 cycles and a multidisciplinary team discusses whether to perform surgery. For patients who undergo surgery, the follow-up therapy plan will be determined based on postoperative pathology. Patients who are not candidates for surgery will receive radical concurrent chemoradiotherapy. The primary objective of this study is the pathological complete response (pCR) rate.

Results

From Apr 2023 to Jan 2024, 26 patients were recruited and 21 patients completed 3 cycles of neoadjuvant therapy. 10 patients (47.6%) underwent successful surgery, of which 6 patients (28.6%) achieved pCR and 1 patient (4.8%) achieved a major pathological response. For the other 11 patients, 6 patients (28.6%) received multipoint biopsy of the primary lesion, and 5 patients (23.8%) achieved pCR; Of the remaining 5 patients, 4 patients (19.0%) obtained radiologic partial response. The objective response rate is 81.0% (17/21) and the primary lesion pCR rate is 52.3% (11/21). Grade 2 or higher adverse events include grade 2 liver function damage (n=1, 3.8%), grade 2 myelosuppression (n=4, 15.4%), grade 3 myelosuppression (n=1, 3.8%), grade 3 diarrhea (n=1, 3.8%). No other obvious adverse events of radiotherapy, chemotherapy, or immunotherapy were observed.

Conclusions

Neoadjuvant immunochemotherapy offers promise for patients with locally advanced HNSCC. Larger clinical trials are needed in the future to determine the safety and efficacy of neoadjuvant immunochemotherapy.

Clinical trial identification

NCT05758389.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.