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

Karen M Gil; Stephanie L Pugh; Ann H Klopp; Anamaria R Yeung; Lari Wenzel; Shannon N Westin; David K Gaffney; William Small Jr; Spencer Thompson; Desiree E Doncals; Guilherme H C Cantuaria; Brian P Yaremko; Amy Chang; Vijayananda Kundapur; Dasarahally S Mohan; Michael L Haas; Yong Bae Kim; Catherine L Ferguson; Snehal Deshmukh; Lisa A Kachnic; Deborah W Bruner

doi:10.1016/j.ygyno.2019.04.682

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

Gynecol Oncol. 2019 Jul;154(1):183-188. doi: 10.1016/j.ygyno.2019.04.682. Epub 2019 May 16.

Authors

Karen M Gil¹, Stephanie L Pugh², Ann H Klopp³, Anamaria R Yeung⁴, Lari Wenzel⁵, Shannon N Westin⁶, David K Gaffney⁷, William Small Jr⁸, Spencer Thompson⁹, Desiree E Doncals¹⁰, Guilherme H C Cantuaria¹¹, Brian P Yaremko¹², Amy Chang¹³, Vijayananda Kundapur¹⁴, Dasarahally S Mohan¹⁵, Michael L Haas¹⁶, Yong Bae Kim¹⁷, Catherine L Ferguson¹⁸, Snehal Deshmukh², Lisa A Kachnic¹⁹, Deborah W Bruner²⁰

Affiliations

¹ Summa Health, 525 East Market Street, Akron, OH 44304, USA. Electronic address: gilk@summahealth.org.
² NRG Oncology Statistics and Data Management Center, 1818 Market Street, Suite 1720, Philadelphia, PA 19103, USA.
³ M D Anderson Cancer Center, Division of Radiation Oncology, 1515 Holcombe Boulevard, The University of Texas Unit 1422, Houston, TX 77030, USA.
⁴ University of Florida, Davis Cancer Center-Radiation Oncology, 2000 Southwest Archer Road, PO Box 100385, Gainesville, FL 32610, USA.
⁵ University of California Medical Center at Irvine, 100 Theory Street, Suite 110, Irvine, CA 92697, USA.
⁶ M D Anderson Cancer Center, Department of Gynecologic Oncology, 1515 Holcombe Boulevard, The University of Texas Unit 1362, Houston, TX 77030, USA.
⁷ Huntsman Cancer Institute/University of Utah, Department of Radiation Oncology, 1950 Circle of Hope Drive, Huntsman Cancer Hospital, Salt Lake City, UT 84112, USA.
⁸ Loyola University Medical Center, Radiation Oncology Department, 2160 South First Avenue, Maguire Center Suite 2944, Maywood, IL 60153, USA.
⁹ University of Oklahoma Health Sciences Center, Department of Radiation Oncology, 800 NE 10th St L100, Oklahoma City, OK, 73104, USA.
¹⁰ Summa Akron City Hospital/Cooper Cancer Center, 161 North Forge Street, Suite G90, Akron, OH 44304, USA.
¹¹ Northside Hospital, Gynecologic Oncology, 960 Johnson Ferry Road Northeast, Suite 130, Atlanta, GA 30342, USA.
¹² London Regional Cancer Program, Department of Radiation Oncology, 790 Commissioners Road East, London Health Sciences Centre, London, ON N6A 4L6, Canada.
¹³ Pamela Youde Nethersole Eastern Hospital, Department of Clinical Oncology, 3 Lok Man Road, Room 051 LG1 East Block, Chai Wan, Hong Kong, PR China.
¹⁴ Saskatoon Cancer Centre, 20 Campus Drive, Saskatoon, SK S7N 4H4, Canada.
¹⁵ Kaiser Permanente Cancer Treatment Center, Department of Radiation Oncology, 220 Oyster Point Boulevard, South San Francisco, CA 94080, USA.
¹⁶ Reading Hospital, Radiation Oncology Department, Sixth Avenue and Spruce Street, N Building Ground, West Reading, PA 19611, USA.
¹⁷ Yonsei University Health System-Severance Hospital accruals for M D Anderson Cancer Center, Department of Radiation Oncology, 50-1 Yonsei-ro Seodaemun-gu, Seoul, 03722, South Korea.
¹⁸ Georgia Regents University, Section of Hematology and Oncology, 1120 15th Street, BAA-5407, Augusta, GA 30912, USA.
¹⁹ Vanderbilt University School of Medicine, 2220 Pierce Avenue, Vanderbilt Clinic B-1003 TVC, Nashville, TN 37232, USA.
²⁰ Emory University, 1520 Clifton Road Northeast, Room 232, Atlanta, GA 30322, USA.

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.

Keywords: Bowel and urinary toxicity; Cervical and endometrial cancer; Patient reported outcomes; Pelvic radiation.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

MeSH terms

Adult
Aged
Aged, 80 and over
Endometrial Neoplasms / radiotherapy*
Endometrial Neoplasms / surgery
Female
Humans
Hysterectomy
Intestinal Diseases / diagnosis
Intestinal Diseases / etiology*
Intestines / radiation effects
Middle Aged
Patient Reported Outcome Measures
Postoperative Care
Quality of Life
Radiation Injuries / diagnosis
Radiotherapy, Intensity-Modulated
Reproducibility of Results
Urethra / radiation effects
Urologic Diseases / diagnosis
Urologic Diseases / etiology*
Uterine Cervical Neoplasms / radiotherapy*
Uterine Cervical Neoplasms / surgery

Abstract

Publication types

MeSH terms

Grants and funding