Excisional treatment comparison for in situ endocervical adenocarcinoma (EXCISE): A phase 2 pilot randomized controlled trial to compare histopathological margin status, specimen size and fragmentation after loop electrosurgical excision procedure and cold knife cone biopsy

Paul A. Cohen, Yee Leung, Lyndal Anderson, Rachael van der Griend, Paola Chivers, Sanela Bilic, Sophie Bittinger, Alison Brand, Max K. Bulsara, Jim Codde, Lois Eva, Louise Farrell, Dianne Harker, Unine Herbst, Stephanie Jeffares, Diane Loh, Orla McNally, Ganendra Raj Mohan, Tarryn Nicholson, Aime PowellStuart G. Salfinger, Bryony Simcock, Colin Stewart, Julie Silvers, Martin R. Stockler, Peter Sykes, Pennie Stoyles, Adeline Tan, Ai Ling Tan, C. David H. Wrede

Research output: Contribution to journalArticle

Abstract

Objective
Adenocarcinoma in situ (AIS) of the cervix is a precursor to cervical adenocarcinoma. When AIS is detected by cervical screening an excision biopsy is mandatory to exclude invasion. We aimed to compare margins status, specimen size and fragmentation after loop electrosurgical excision procedure (LEEP) and ‘cold knife cone biopsy’ (CKC).

Methods
The EXCISE Trial was an investigator-initiated, multicenter, open-label, parallel-group, phase 2, randomized study. Patients were enrolled at seven hospitals in Australia and New Zealand. We randomly assigned women aged ≥18 to ≤45 years with screen detected AIS to LEEP or CKC. Co-primary endpoints were margin status, specimen size and fragmentation. Analysis was by intention-to-treat.

Results
Between August 2, 2017 and September 6, 2019, 40 patients were randomly assigned 2:1 to LEEP or CKC. Margin status was evaluable in 36 cases. The proportion of patients with involved margins did not differ between groups. 25 of 26 LEEP and all 14 CKC biopsies were excised as single specimens (p = 1·00). There were no differences in specimen dimensions. Patients in the CKC group had more post-operative complications (64.3% compared to 15.4% for LEEP p = ·00). There were no differences in grade three complications (p = ·65).

Conclusions
LEEP was not associated with a greater likelihood of positive margins, specimen fragmentation or smaller excision compared to CKC when performed according to a standardized protocol. However, the study was not powered to establish non-inferiority of LEEP and a definitive phase 3 trial to compare margin status and rates of treatment failure after LEEP and CKC is warranted.
Original languageEnglish
JournalGynecologic Oncology
DOIs
Publication statusAccepted/In press - 5 Oct 2020

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