Abstract P3-17-06: LORIS trial of active monitoring for DCIS: How does the online pathology eligibility review process work?

Abstract

Abstract Introduction The LORIS Trial is a UK randomized clinical trial comparing active monitoring with surgery for low risk ductal carcinoma in situ (DCIS), defined as low or low-intermediate grade DCIS without comedo necrosis, as diagnosed on vacuum-assisted (wide bore) core needle samples. Because of the inconsistency of grading DCIS, we have underpinned this trial with a Central Histopathology Review (CHR) before randomisation. The process of the CHR for the first 22 months of a two year pilot study between July 2014 and May 2016 is reported here. Patients and methods Patients were eligible for CHR if they satisfied all of the eligibility criteria and had locally reported low or intermediate grade DCIS. Patients were identified at 28 pilot sites and were registered for potential trial entry following written informed consent before being subjected to CHR. CHR comprised online examination of digitally scanned histology slides of all material from all diagnostic biopsies and was performed by at least two of the three LORIS specialist breast pathologists. Histology slides were submitted using Royal Mail Safebox® to the University of Birmingham where they were digitally scanned and made available for review via the Leica digital image hub. The outcome of the review was reported in a separate secure online database by completion of a Central Pathology Review Form. Access to both online systems is password protected. Eligibility was confirmed if two pathologists agreed that there was low or low to intermediate grade DCIS and no comedo necrosis. A maximum of 7 calendar days from receipt of the diagnostic material was allowed for the central review process. The digital images of the histology slides are stored by the Leica system for future reference. Results 100 patients were registered and their slides reviewed. 55 of these were deemed eligible by CHR; of these 38 have been randomised. 45 patients were deemed ineligible, most commonly due to grade being in the upper half of the intermediate category and/or comedo necrosis. In addition, 9 patients were deemed not to have DCIS and 1 patient had invasive disease. Grouping the grade categories as low and low to intermediate grade (low risk and eligible for randomisation) Vs intermediate to high and high cytonuclear grade (ineligible for randomisation) showed 91% agreement on grade category amongst the reviewing pathologists. Results of the central review were made available to sites within 7 days for 97% of cases submitted. On average, central review was completed within 4 days. Average time between registration and randomisation was 3 weeks. The LORIS central review pathologists found online viewing and reporting of sections acceptable. Conclusions Central Histopathology Review using online viewing of digital slides provides timely and efficient pathology Quality Assurance in this clinical trial setting, with acceptable turnaround times and good agreement between reviewing specialist breast pathologists. This process will be continued in the main phase of the trial. Citation Format: Thomas J, Hanby A, Pinder S, Pirrie S, Rea D, Gaunt C, Young J, Francis A. LORIS trial of active monitoring for DCIS: How does the online pathology eligibility review process work? [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-17-06.