Authors/Creators
Paul A. Cohen
Yee Leung
Lyndal Anderson
Rachael van der Griend
Paola Chivers, Edith Cowan UniversityFollow
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 Powell
Stuart G. Salfinger
Bryony Simcock
Colin Stewart
Julie Silvers
Martin R. Stockler
Peter Sykes
Pennie Stoyles
Adeline Tan
Ai Ling Tan
C. David H. Wrede
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.
RAS ID
35296
Document Type
Journal Article
Date of Publication
12-31-2020
ISSN
00908258
Funding Information
Australia New Zealand Gynaecological Oncology Group
School
Exercise Medicine Research Institute / School of Medical and Health Sciences
Publisher
Elsevier
Comments
This is an author's accepted manuscript of:
Cohen, P. A., Leung, Y., Anderson, L., van der Griend, R., Chivers, P., Bilic, S., ... Wrede, D. D. H. (2020). 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. Gynecologic Oncology, 159(3), 623-629. https://doi.org/10.1016/j.ygyno.2020.09.053