Expanded validation of the EPIC bowel and urinary domains for use in women with gynecologic cancer undergoing postoperative radiotherapy

• Authors: Karen M. Gil, Summa Health System; Stephanie L. Pugh, NRG Oncology Statistics and Data Management Center; Ann H. Klopp, University of Texas MD Anderson Cancer Center; Anamaria R. Yeung, University of Florida; Lari Wenzel, University of California Irvine; Shannon N. Westin, University of Texas MD Anderson Cancer Center; David K. Gaffney, University of Utah; William Small, Emory University; Spencer Thompson, University of Oklahoma; Desiree E. Doncals, Summa Akron City Hospital; Guilherme H. C. Cantuaria, Northside Hospital; Brian P. Yaremko, London Health Sciences Center; Amy Chang, Pamela Youde Nethersole Eastern Hospital; Vijayananda Kundapur, Saskatoon Cancer Centre; Dasarahally Mohan, Kaiser Permanente; Michael L. Haas, Reading Hospital; Yong Bae Kim, Yonsei University Health System; Catherine L. Ferguson, Georgia Regents University; Snehal Deshmukh, NRG Oncology Statistics and Data Management Center; Lisa A. Kachnic, Vanderbilt University; Deborah Bruner, Emory University
• Journal Title: Gynecologic Oncology
• Volume: Volume 154, Number 1
• Publisher: Academic Press Inc. Elsevier Science | 2019-07-01, Pages 183-188
• Type of Work: Article | Post-print: After Peer Review
• Publisher DOI: http://doi.org/10.1016/j.ygyno.2019.04.682
• Subjects: Health Sciences, Oncology; Health Sciences, Obstetrics and Gynecology; Health Sciences, Radiology; Health Sciences, Rehabilitation and Therapy
• Keywords: Science & Technology; Life Sciences & Biomedicine; Oncology; Obstetrics & Gynecology; Bowel and urinary toxicity; Pelvic radiation; Cervical and endometrial cancer; Patient reported outcomes; Quality of life; Pelvic radiation therapy; Phase III trial; Adverse events; Endometrial cancer; Randomized trial; Prostate cancer; Patient; Carcinoma; Outcomes

Abstract

Objective: Women with endometrial or cervical cancer at risk for recurrence receive postoperative radiation therapy (RT). A patient reported outcomes (PRO) instrument to assess bowel and urinary toxicities is the Expanded Prostate Cancer Index Composite (EPIC), which has been validated in men with prostate cancer. As this instrument specifically measures bowel toxicity and the degree to which this is a problem, it was used in NRG Oncology/RTOG 1203 to compare intensity modulated RT (IMRT) to standard RT. This paper reports on the expanded validation of EPIC for use in women receiving pelvic RT. Methods: In addition to the EPIC bowel domain, urinary toxicity (EPIC urinary domain), patient reported bowel toxicities (PRO-CTCAE) and quality of life (Functional Assessment of Cancer Therapy (FACT)) were completed before, during and after treatment. Sensitivity, reliability and concurrent validity were assessed. Results: Mean bowel and urinary scores among 278 women enrolled were significantly worse during treatment and differed between groups. Acceptable to good reliability for bowel and urinary domain scores were obtained at all time points with the exception of one at baseline. Correlations between function and bother scores within the bowel and urinary domains were consistently stronger than those across domains. Correlations between bowel domain scores and PRO-CTCAE during treatment were stronger than those with the FACT. Conclusion: Correlations within and among the instruments indicate EPIC bowel and urinary domains are measuring conceptually discrete components of health. These EPIC domains are valid, reliable and sensitive instruments to measure PRO among women undergoing pelvic radiation.