• Nestor F Esnaola, Raju Chelluri, Jason Castellanos, Ariella Altman, ChenDavid Y TDYTDepartment of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, PA., Christina Chu, Jeffrey M Farma, Alan Haber, Fathima Sheriff, Christine Huang, Alexander Kutikov, Sameer Patel, Kenneth Patrick, Sanjay Reddy, Stephen Rubin, Rosalia Viterbo, John A Ridge, Martin Edelman, Eric Ross, Marc Smaldone, and Robert G Uzzo.
• Department of Surgery, Houston Methodist Hospital, Houston, TX.
• Ann. Surg. 2024 Jul 24.

ObjectiveWe evaluated the efficacy of risk-based, protocol-driven management versus (vs) usual management after elective major cancer surgery to reduce 30-day rates of postoperative death or serious complications (DSC) .Summary Background DataMajor cancer surgery is associated with significant perioperative risks which result in worse long-term outcomes.MethodsAdults scheduled for elective major cancer surgery were stratified/randomized to risk-based escalating levels of care, monitoring, and co-management vs usual management. The primary study outcome was 30-day rate of DSC. Additional outcomes included complications, adverse events, health care utilization, health-related quality of life (HRQOL), and disease-free and overall survival (DFS and OS).ResultsBetween August 2014 and June 2020, 1529 patients were enrolled and randomly allocated to the study arms; 738 patients in the Intervention Arm and 732 patients in the Control Arm were eligible for analysis. 30-day rate of DSC with the intervention was 15.0% (95% CI, 12.5-17.6%) vs 14.1%, (95% CI, 11.6-16.6%) with usual management (P=0.65). There were no differences in 30-day rates of complications or adverse events (including return to the operating room); postoperative length of stay; rate of discharge to home; or 30, 60, or 90-day HRQOL or rates of hospital readmission or receipt of anti-neoplastic therapy between the study arms. At median follow-up of 48 months, OS (P=0.57) and DFS (P=0.91) were similar.ConclusionsRisk-based, protocol-driven management did not reduce 30-day rate of DSC after elective major cancer surgery compared to usual management, nor improve postoperative health care utilization, HRQOL, or cancer outcomes. Trials are needed to identify cost-effective, tailored perioperative strategies to optimize outcomes after major cancer surgery.Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.

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