TPS6139 Background: Surgery remains the preferred treatment option for locally advanced head and neck squamous cell carcinoma (LA HNSCC). However, its efficacy is still unsatisfactory, with local recurrence and distant metastasis rates as high as 20% and a 5-year survival rate of only about 50%. Immune checkpoint inhibitors (ICIs) have achieved success in recurrent/metastatic HNSCC (R/M HNSCC), laying the foundation for the application of immunotherapy in earlier-stage patients. Cetuximab, an anti-Epidermal Growth Factor Receptor (EGFR) antibody, is a standard treatment for both LA HNSCC and R/M HNSCC. Patients who experience Hyperprogressive Disease (HPD) have a poor prognosis, and various genetic mutations have been shown to predict the occurrence of HPD. Methods: This study was designed as a prospective, open label, multicenter, phase II trial (ChiCTR2500108701), and the primary endpoint was the postoperative pathological complete response (pCR) rate. The secondary endpoints included the objective response rate (ORR), major pathological response (MPR) rate, 1-year and 2-year event-free survival (EFS) rates, and 2-year overall survival (OS) rate. Eligible patients (pts) were over 18 years old with histologically or cytologically confirmed SCCHN (excluding nasopharyngeal carcinoma); had T1N2-3M0, T2N1-3M0, or T3/T4aNanyM0, according to the 8th Edition of the American Joint Committee on Cancer (AJCC) staging guidelines; had resectability of the tumor was evaluated by a head and neck surgeon; had no previous local and systemic treatment for SCCHN; had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; had measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST 1.1). All enrolled 40 pts received whole exome sequencing (WES), and were assigned to Cohort A (n=25, HPD-gene-negative) and Cohort B (n=15, HPD-gene-positive), respectively. All treatment was administered intravenously in 21-day cycles. Patients in Cohort A were given albumin-bound paclitaxel (260 mg/m², d1), cisplatin (25 mg/m², d1-d3), camrelizumab (200 mg, d1) and cetuximab (250 mg/m², d1;500 mg/m², d8). Patients who successfully completed 2~4 cycles of neoadjuvant treatment returned for surgical intervention 28~42 Endpoints days after the last cycle, and adjuvant radiotherapy was administered followed by 2~4 cycles of camrelizumab (200 mg, d1) and cetuximab (250 mg/m², d1;500 mg/m², d8) as adjuvant treatment.Cohort B received the same treatment regimen as Cohort A, excluding camrelizumab. Clinical trial information: ChiCTR2500108701.
Jiang et al. (Thu,) studied this question.