by
Karen M. Gil;
Stephanie L. Pugh;
Ann H. Klopp;
Anamaria R. Yeung;
Lari Wenzel;
Shannon N. Westin;
David K. Gaffney;
William Small;
Spencer Thompson;
Desiree E. Doncals;
Guilherme H. C. Cantuaria;
Brian P. Yaremko;
Amy Chang;
Vijayananda Kundapur;
Dasarahally Mohan;
Michael L. Haas;
Yong Bae Kim;
Catherine L. Ferguson;
Snehal Deshmukh;
Lisa A. Kachnic;
Deborah Bruner
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.
by
Ann H. Klopp;
Anamaria R. Yeung;
Snehal Deshmukh;
Karen M. Gil;
Lari Wenzel;
Shannon N. Westin;
Kent Gifford;
David K. Gaffney;
William Small;
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;
Stephanie L. Pugh;
Lisa A. Kachnic;
Deborah W. Bruner
Purpose: NRG Oncology/RTOG 1203 was designed to compare patient-reported acute toxicity and healthrelated quality of life during treatment with standard pelvic radiation or intensity-modulated radiation therapy (IMRT) in women with cervical and endometrial cancer.
Methods: Patients were randomly assigned to standard four-field radiation therapy (RT) or IMRT radiation treatment. The primary end point was change in patient-reported acute GI toxicity from baseline to the end of RT, measured with the bowel domain of the Expanded Prostate Cancer Index Composite (EPIC). Secondary end points included change in patient-reported urinary toxicity, change in GI toxicity measured with the Patient-Reported Outcome Common Terminology Criteria for Adverse Events, and quality of life measured with the Trial Outcome Index.
Results: From 2012 to 2015, 289 patients were enrolled, of whom 278 were eligible. Between baseline and end of RT, the mean EPIC bowel score declined 23.6 points in the standard RT group and 18.6 points in the IMRT group (P = .048), the mean EPIC urinary score declined 10.4 points in the standard RT group and 5.6 points in the IMRT group (P = .03), and the mean Trial Outcome Index score declined 12.8 points in the standard RT group and 8.8 points in the IMRT group (P = .06). At the end of RT, 51.9% of women who received standard RT and 33.7% who received IMRT reported frequent or almost constant diarrhea (P = .01), and more patients who received standard RT were taking antidiarrheal medications four or more times daily (20.4% v 7.8%; P = .04).
Conclusion: Pelvic IMRT was associated with significantly less GI and urinary toxicity than standard RT from the patient's perspective.