Preoperative Radiotherapy Does Not Increase the Risk for Early Complications Following Surgery for Oral Cancer: A Study on Data From the Randomized ARTSCAN 2 Trial

Importance The management of complications following oral cavity squamous cell carcinoma (OCSCC) surgery can be challenging. Previous studies show conflicting results on complication risks after preoperative radiotherapy (RT), necessitating a randomized controlled trial (RCT).Objective To compare early complications during hospitalization for OCSCC surgery between patients receiving preoperative accelerated fractionated RT and those planned for but not yet exposed to RT.Design A part of the ARTSCAN 2 RCT comparing preoperative accelerated RT with postoperative conventionally fractionated RT for OCSCC.Setting A multicentre trial in 6 tertiary care hospitals in Sweden.Participants Untreated and resectable OCSCC patients of all stages recommended combination treatment by the local multidisciplinary board.Intervention Preoperative accelerated RT was administered twice daily to a total dose of 68 Gy, completed 4 to 6 weeks before surgery.Main Outcome Measures Complications during hospitalization included wound infection, neck flap necrosis, chyle leakage, oro/pharyngocutaneous fistula, free flap necrosis, tracheostomy, revision surgery, and medical complications. Length of surgery, perioperative blood loss, and transfusions were also monitored.Results Two hundred and twenty-one patients were eligible for analysis: 103 in the preoperative RT group and 118 not yet exposed to RT. Complication rates were low, with no statistically significant differences between groups. Patients receiving preoperative RT had similar wound infection rates (12/103; 11.7%) to those not exposed (9/118; 7.6%) (P = .31). Among free flap patients, 1/40 (2.5%) in the preoperative RT group and 3/52 (5.8%) in the unirradiated group had free flap necrosis (P = .63). No differences were found in oro/pharyngocutaneous fistula frequency (3/103; 2.9% vs 3/118; 2.5%) (P = 1.00).Conclusion and Relevance Preoperative accelerated RT at 68 Gy, administered 4 to 6 weeks before surgery, does not increase early complications. Although survival rates, morbidities, quality of life, and societal costs need consideration in the ARTSCAN 2 assessment, our findings show that early postoperative complication risks remain unchanged by preoperative RT.Trial Registration ISRCTN, ISRCTN00608410, Registered 20 March 2008-Retrospectively registered, https://www.isrctn.com/ISRCTN00608410.