ESMO Congress 2023 | OncologyPRO

Abstract 896P

Background

This study aimed to explore the efficacy and safety of pembrolizumab combined with chemotherapy as neoadjuvant therapy in patients with resectable locally advanced head and neck squamous cell carcinomas (LA-HNSCCs).

Methods

In this prospective, single-arm, single-centre clinical trial, patients meeting the inclusion criteria were treated neoadjuvant therapy of preoperatively with 200 mg pembrolizumab combined with 75 mg/m² cisplatin and 175 mg/m² paclitaxel. This was followed by surgery and postoperative adjuvant therapy. The primary endpoint was the postoperative pathological complete response (PCR) rate. All statistical analyses were performed using SPSS 26.

Results

A total of 22 patients were enrolled, and the baseline characteristics were shown in Fig. 1. The postoperative PCR rate, was 36.4% (8/22), and there was no delay to surgery due to adverse drug reactions. The rate of laryngeal function preservation was 90.9% (20/22). Delayed wound healing was the main surgical complication, with an incidence of 22.7% (5/22). The median follow-up time was 9.5 months, and only 1 patient (4.55%) suffered a regional recurrence.

Table: 896P

Variables	Number of patients	%
Male/Female	21/1
Age (mean ± SD, years)	58.1±10.49 (22∼69)	--
Primary site
Oropharynx	6	27.3
hypopharynx	15	68.2
Oral Cavity	1	4.5
Hypopharynx invasion (N=15)
Fixed vocal cord	9	60
Extend to esophagus	2	13.3
Tobacco
YES	16	72.7
NO	6	27.3
Alcohol
YES	15	68.2
NO	7	31.8
P16 states
Positive	4	18.2
Negative	18	81.8
T stage
T1-T2	8	36.4
T3	7	31.8
T4	7	31.8
N stage
N0-N1	3	13.6
N2	19	86.4
Stage
II	3	13.6
III	3	13.6
IV	16	72.7
PD-L1 combined positive score
＜5	7	31.8
5-10	2	9.1
≥10	13	59.1

Conclusions

Preoperative treatment with pembrolizumab and chemotherapy in resectable LA-HNSCC has a high PCR rate with no significant impact on surgical safety. This treatment was found to increase the rate of laryngeal function preservation. However, the effects of neoadjuvant immunotherapy on long-term prognosis in LA-HNSCCs require further study.