Assistant Professor University of Cincinnati Medical Center
Background: Pembrolizumab, a monoclonal antibody targeting the programmed death receptor-1 (PD-1) is currently FDA approved for recurrent unresectable or metastatic head and neck squamous cell carcinoma (HNSCC) including squamous cell carcinoma of the oral cavity. The potential neoadjuvant role of PD-1 inhibitors in primary surgical management of HNSCC and effects on surgical outcomes are poorly understood. As part of a multi-institutional clinical trial (NCT02641093) assessing the neoadjuvant use of pembrolizumab in the treatment of locally advanced HNSCC, this study seeks to elucidate surgical complications observed in patients with primary oral cavity SCC who have undergone surgical resection with neoadjuvant pembrolizumab.
Methods: We retrospectively reviewed available data from the clinical trial using a cohort of patients at a single tertiary medical center with a diagnosis of primary oral cavity SCC who received neoadjuvant treatment of pembrolizumab prior to surgical resection. Captured clinical trial adverse events and electronic medical records were queried to gather information regarding post-surgical treatment complications as well as rates of return to the operating room within 30 days after primary surgery.
Results: 34 patients with a diagnosis of oral cavity SCC who underwent primary surgical resection were included in this study. The average age was 58 years old with a range of 27 to 76 years old. The most common adverse event in this group was lymphedema (n=22, 64.7%). 7 patients (20.6%) returned to the operating room within 30 days of initial surgery. Other postoperative complications observed include trismus (n=8, 23.5%), wound infection (n=7, 20.6%), cutaneous fistulae (n=6, 17.6%), wound dehiscence (n=4, 11.7%), flap failure (n=3, 8.8%), and hematoma (n=2, 5.9%). The rates of adverse events in this cohort do not appear to be increased compared to available historical data with the use of pembrolizumab.
Conclusion: This study examined the most relevant surgical complications among patients with primary oral cavity SCC treated with neoadjuvant pembrolizumab. Surgical complications are common following resection of primary oral cavity cancer. However, our findings indicate neoadjuvant pembrolizumab does not increase serious surgical complications. Further studies evaluating larger cohorts of patients receiving pembrolizumab neoadjuvant therapy prior to surgical resection of primary oral cavity SCC are warranted.