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.
Clinical trial identification
Trial registration: Chinese Clinical Trial Registry, ChiCTR2200055719, Registered 16 January 2022.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Beijing Hope Run Special Fund of Cancer Foundation of China (Grant No.LC2021A16).
Disclosure
All authors have declared no conflicts of interest.
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