A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.
PURPOSE: Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA.
PATIENTS AND METHODS: E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition, 10 paired operative and surgical pathology reports from the preceding 24 months were reviewed by an expert panel. Ongoing QA required
RESULTS: 120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers. During QA on E3311, positive final pathologic margins were reported in 19 (3.8%) patients. Grade III/IV and grade V oropharyngeal bleeding was reported in 29 (5.9%) and 1 (0.2%) of patients.
CONCLUSIONS: We provide proof of concept that a comprehensive credentialing process can support multicenter transoral head and neck surgical oncology trials, with low incidence of positive margins and *grade III/V oropharyngeal bleeding.
Earle A. Chiles Research Institute
Ferris, Robert L; Flamand, Yael; Holsinger, F Christopher; Weinstein, Gregory S; Quon, Harry; Mehra, Ranee; Garcia, Joaquin J; Hinni, Michael L; Gross, Neil D; Sturgis, Erich M; Duvvuri, Umamaheswar; Méndez, Eduardo; Ridge, John A; Magnuson, J Scott; Higgins, Kerry A; Patel, Mihir R; Smith, Russel B; Karakla, Daniel W; Kupferman, Michael E; Malone, James P; Judson, Benjamin L; Richmon, Jeremy; Boyle, Jay O; Bayon, Rodrigo; O'Malley, Bert W; Ozer, Enver; Thomas, Giovana R; Koch, Wayne M; Bell, Richard Bryan; Saba, Nabil F; Li, Shuli; Sigurdson, Elin R; and Burtness, Barbara, "A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311." (2020). Articles, Abstracts, and Reports. 3619.