E3311 trial of transoral surgery for oropharynx cancer: Implementation of a novel surgeon credentialing and quality assurance process.

摘要

6054 Background: ECOG-ACRIN (E3311) examines the role of transoral head and neck surgery in treatment deintensification for stage III/IV p16+ oropharyngeal cancer (OPC). Patients with lateralized, resectable T1-T2 OPC and N1-N2b with no matted nodes undergo transoral resection and neck dissection, followed by risk-based adjuvant therapy. Intermediate risk patients [negative margins, N2 ± extranodal extension (ENE) ≤ 1mm] are randomized to 50Gy vs. 60Gy radiation. We established credentialing criteria and ongoing quality assurance (QA) for transoral surgeons wishing to accrue to E3311. Methods: Each surgeon attests to experience of > 20 cases of transoral resection of OPC, using either transoral robotic or laser microsurgery. Surgeons then submit paired surgical pathology and operative reports for 10 transoral resections within the past 24 months. Nine experienced head and neck surgeons established criteria for approval, review case submissions, on-hold status and ongoing QA. Positive margin(s) were permitted on only 1 of 10 cases during initial credentialing or while accruing to E3311. Results: Since 2013, 107 surgeons applied for credentialing. After peer-review, 71 surgeons were credentialed for E3311 at 51 different centers, with 49 surgeons having accrued > 1 and 31 having accrued ≥ 3 patients (accrual per surgeon 1-24, median = 4). Twelve surgeons were asked to provide additional, replacement cases, where histology or margin status was unclear or deemed insufficient during review. Of these, 10 were approved upon re-review. Two surgeons withdrew their applications, and 22 have not submitted cases for credentialing review. Ongoing QA has led to review of two surgeons with positive margin(s) in their first 5 cases. The composite QA stopping rule of 22% combining grade III/IV bleeding and positive margins was not met during planned DSMC review (August 2015), with 8% grade III/IV bleed rate and 3% positive margins. Conclusions: Initial surgeon credentialing and ongoing QA results in low rates of positive margins and grade III/IV oral bleeding rates in a multicenter trial of transoral surgery. Clinical trial information: NCT01898494.