Advancing Education, Research, and Quality of Care for the Head and Neck oncology patient.
Importance: There has been recent interest in the use of neoadjuvant immunotherapy (NI) prior to definitive surgical resection of oral cavity squamous cell carcinoma (OCSCC). To date, there remains limited understanding of its effect on surgical outcomes and overall survival.
Objective: To determine associations between NI and postoperative outcomes as well as overall survival following OCSCC resection.
Design, Setting, and Participants: This National Cancer Database (NCDB) study included patients aged 18-90 who underwent non-palliative OCSCC resection between 2010-2020 across 1,400 U.S. hospitals. Exclusion criteria included preoperative radiation and distant metastatic disease at presentation. A 3:1 propensity match (adjusting for age, sex, race, ethnicity, Charlson-Deyo Comorbidity Index, clinical T stage, clinical N stage, neoadjuvant chemotherapy, adjuvant chemotherapy, and adjuvant radiation) was performed between OCSCC surgery patients with and without NI.
Main Outcomes and Measures: The primary outcomes were surgical outcomes (30-day mortality, unplanned 30-day readmission, and hospital length of stay), surgical margin status, time to adjuvant radiation, and overall survival (OS). Cox proportional hazard analysis was used to calculate hazard ratios (HRs) for OS in the matched cohort by NI and propensity-matching variables.
Results: After exclusion, the total cohort included 31,175 OCSCC cases, of which 279 (0.92%) received NI, and 30,896 (99.08%) did not. In the propensity-matched cohort of 269 NI patients and 751 matched controls, there were no significant differences in 30-day mortality (1.1% vs 1.1%, p=1.000), unplanned 30-day readmission (3.7% vs 6.3%, p=.120), positive surgical margins (11.9% vs 12.9%, p=.666), median [IQR] hospital length of stay (8 days [6-11] vs 8 days [6-12], p=.861), and median [IQR] days from surgery to postoperative radiation therapy (49 days [42-61] vs 51 days [42-63], p=.594) between NI and non-NI patients. NI was associated with improved OS on Kaplan-Meier survival analysis (Figure 1; p=.009). On Cox proportional hazard analysis, OS was independently associated with NI (HR=0.68, 95% CI: 0.53-0.86, p=.002) after controlling for matching variables.
Conclusion: In this NCDB study, neoadjuvant immunotherapy for oral cavity squamous cell carcinoma patients was associated with similar postoperative surgical outcomes but improved overall survival. Future results from prospective clinical trials will inform whether this potentially practice-changing approach should be implemented into cancer care guidelines.
Figure 1. Kaplan Meier Survival Analysis by Neoadjuvant Immunotherapy