Abstract 2764: Creating a review process of a digital photo database collected on NRG NSABP B39/RTOG 0413 phase III clinical trial for evaluation of cosmetic results from breast conserving therapy (BCT)
Authors: Sekhon Ashley , Zhao Ruiqi , Wang Yan , Grant Debora , Winter Kathryn A. , Moughan Jennifer , Arthur Douglas W. , Chmura Stephen J. , Khan Atif J. , Shaitelman Simona F. , Martinez Aleix M. , Vicini Frank A. , White Julia R. 
Published: July 2017

Abstract
Introduction:
After local control and overall survival, acceptable cosmesis is the next most important goal of BCT. Digital photos (DP) are commonly used for assessing cosmesis on clinical trials. On NRG NSABP B39/RTOG 0413, DP at baseline, 1, and 3 years post-radiation were submitted for review by a panel of breast cancer specialists. Given no current standards for central DP review, this project seeks to develop a standard for subjective DP evaluation. The initial standardization of the photo database and reliability of the panel review is described.
Methods:
De-identified DP submitted and stored at NRG SDMC were downloaded to a secure FTP site. Cases with only 1 time point, no baseline, or photos from different patients were excluded. A minimum photo quality was set, including pre-specified criteria for contrast/light, breast/torso size, and cropping to exclude anatomy above the clavicle and below the umbilicus. DP were edited with MATLAB™ and saved in a Reformatted Digital Photo Database (RDPD). A training set was created defining 4 global cosmetic scores, and each individually assessed criteria of breast symmetry, shape, skin color, nipple, and scar appearance. A 14 case calibration set followed the training set. The process for panel review was adapted from the methods reported in the START and RAPID trials. The review panel consisted of 6 breast-specific radiation oncologists, who reviewed in groups of 3. For each session, the training set was reviewed and calibration set scored. A separate 30 case test set randomly selected from the RDPD was reviewed by 2 groups of 3. The calibration and test sets were evaluated for agreement of categorized scores (excellent/good vs. fair/poor).
Results:
There were 2064 DP from 892 patients on NRG NSABP B39/RTOG 0413 documenting the anterior view of both breasts. After exclusions, 1,717 reformatted DP were saved in the RDPD. Five 1-3 hour review sessions resulted in scoring of 777 DP (~ 155 per session). Only 2/777 (0.1%) DP were deemed poor quality and not able to be scored. There was full agreement in categorized scores for 12/14 cases (86%; kappa=0.82) across the 5 calibration sets; and 27/30 (90%; kappa=0.71) for the 2 test set reviews.
Conclusions:
Cosmesis DP prospectively collected on a large phase III clinical trial can be digitally formatted in a systematic fashion for consistent photo quality, allowing for cosmesis consensus panel review without photo quality bias. High agreement in categorized scores allowed reviews to be completed by multiple 3-person review groups. Future work will focus on creating an updated, semi-automatic analysis tool of these photos for objective evaluation of cosmesis using the same scoring guidelines that can then be compared to physician reported outcomes.
Grant Support: FUJIFILM Medical Systems/RSNA Research Resident, NCI U10CA180868, U10CA180822
Note: This abstract was not presented at the meeting.
Citation Format: Ashley Sekhon, Ruiqi Zhao, Yan Wang, Debora Grant, Kathryn A. Winter, Jennifer Moughan, Douglas W. Arthur, Stephen J. Chmura, Atif J. Khan, Simona F. Shaitelman, Aleix M. Martinez, Frank A. Vicini, Julia R. White. Creating a review process of a digital photo database collected on NRG NSABP B39/RTOG 0413 phase III clinical trial for evaluation of cosmetic results from breast conserving therapy (BCT) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 2764. doi:10.1158/1538-7445.AM2017-2764