Adverse Events Associated with Postsurgery of Early‐Stage Oral Cancer in a Phase III Surgical Trial

Abstract

Objectives: 1) Investigate the adverse events (AEs) associated with surgery for early-stage oral cancer. 2) Characterize surgical procedure and its related AEs. Methods: Based on the National Institute of Health/National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0), patient self-reported AEs post-surgery in a pan-Canadian multi-center phase III randomized controlled surgical trial (the COOLS trial) were captured during the follow-up visits. Results: From September 2010 to January 2013, 228 eligible patients were recruited and received surgeries, including tumor excision, and/or free flap or neck dissection. Among these, 188 (82%) patients had at least 3 months follow-up with an average of 24.8±19 months. There were 83 types and 593 counts of AEs from 148 (79%) patients. The most occurring AEs were oral pain (146 patients) and oral dysesthesia (64 patients). Thirty patients (20%) presented with prolonged oral pain (≥3 months) with an average duration of 6.5±10.5 months for Grade I and 2.0±5.6 months for Grade 2 or greater (77 patients). The average duration of oral dysethesia was 18.6±16.4 months with 52 (80%) over 3 months. Univariate analysis had shown that neck dissection and longer surgery time have significant impact on the reported Grade 2 oral pain ( P = 0.03 for both). Interestingly, excision type [cold knife (9%) vs. electric knife/laser (23%)] had significant effect on experiencing prolonged post-surgical oral pain (P = 0.01). Conclusions: Post-surgical AEs surveillance is critical to understand the factors impacting patients’ quality of life. Concurrent neck dissection has impacts on patients’ experience in prolonged post-surgical oral pain.