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Author Notes:

Correspondence: Karen M. Gil, Ph.D., Summa Health, 525 East Market Street, Akron, OH 44304 US, (330) 375-3083, gilk@summahealth.org

Author contributions: Conception and design: Ann H. Klopp, Karen M. Gil, Lari Wenzel, Kent Gifford, David K. Gaffney, William Small Jr, Stephanie L. Pugh, Lisa A. Kachnic, Deborah W. Bruner. Provision of study materials or patients: Shannon N. Westin, Spencer Thompson.

Collection and assembly of data: Ann H. Klopp, Anamaria R. Yeung, Shannon N. Westin, William Small Jr, Spencer Thompson, Desiree E. Doncals, Amy Chang, Vijayananda Kundapur, Michael L. Haas, Yong Bae Kim, Catherine L. Ferguson, Stephanie L. Pugh, Deborah W. Bruner.

Data analysis and interpretation: Ann H. Klopp, Anamaria R. Yeung, Snehal Deshmukh, Karen M. Gil, Lari Wenzel, Shannon N. Westin, David K. Gaffney, William Small Jr, Guilherme H.C. Cantuaria, Brian R Yaremko, Dasarahally S. Mohan, Yong Bae Kim, Stephanie L. Pugh, Lisa A. Kachnic, Deborah W. Bruner;

Disclosures: Dr(s). Bruner, Cantuaria, Chang, Doncals, Ferguson, Gaffney, Gil, Haas, Kachnic, Kim, Klopp, Kundapur, Mohan, Wenzel, Yaremko, Yeung, and Snehal Deshmukh have nothing to disclose. Dr. Pugh discloses funding from Millenium to her institution for a prostate cancer trial.

Dr. Small discloses he is co-chair of the NRG BYN committee and receives a salary that is forwarded to his institution for this position. Dr. Thompson discloses employment with the University of Oklahoma.

Dr. Westin reports grants, personal fees and non-financial support from AstraZeneca, personal fees from Takeda, personal fees from BioAscend, personal fees and non-financial support from Clovis Oncology, personal fees from ACI Clinical/Xenetic Biosciences, personal fees from Syndax/Watermark, personal fees and non-financial support from Genentech, grants from Bayer, grants from COTI, grants from Novartis, grants from Tesaro, outside the submitted work.

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Research Funding:

This project was supported by grants U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC), UG1CA189867 (NCORP) from the National Cancer Institute (NCI).

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

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

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Journal Title:

Gynecologic Oncology

Volume:

Volume 154, Number 1

Publisher:

, Pages 183-188

Type of Work:

Article | Post-print: After Peer Review

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.

Copyright information:

© 2019 Elsevier Inc. All rights reserved.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/).
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