Multinational Prospective Study of Patient-Reported Outcomes After Prostate Radiation Therapy: Detailed Assessment of Rectal Bleeding

Jae Y. Lee, Stephanie Daignault-Newton, Gerard Heath, Sarah Scarlett, Martin G. Sanda, Peter Chang, Meredith M. Regan, Jeff M. Michalski, Howard M. Sandler, Felix Y. Feng, Deborah A. Kuban, Anthony L. Zietman, Jay P. Ciezki, Irving D. Kaplan, Catrina Crociani, William P. McLaughlin, Constantine A. Mantz, Steven E. Finkelstein, Simeng Suy, Sean P. CollinsOlatz Garin, Montserrat Ferrer, Daniel A. Hamstra, Daniel E. Spratt

Research output: Contribution to journalArticlepeer-review

10 Scopus citations


Purpose The new short Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) patient-reported health-related quality of life (HRQOL) tool has removed the rectal bleeding question from the previous much longer version, EPIC-26. Herein, we assess the impact of losing the dedicated rectal bleeding question in 2 independent prospective multicenter cohorts. Methods and Materials In a prospective multicenter test cohort (n=865), EPIC-26 patient-reported HRQOL data were collected for 2 years after treatment from patients treated with prostate radiation therapy from 2003 to 2011. A second prospective multicenter cohort (n=442) was used for independent validation. A repeated-effects model was used to predict the change from baseline in bowel summary scores from longer EPIC instruments using the change in EPIC-CP bowel summary scores with and without rectal bleeding scores. Results Two years after radiation therapy, 91% of patients were free of bleeding, and only 2.6% reported bothersome bleeding problems. Correlations between EPIC-26 and EPIC-CP bowel scores were very high (r2=0.90-0.96) and were statistically improved with the addition of rectal bleeding information (r2=0.94-0.98). Considering all patients, only 0.2% of patients in the test cohort and 0.7% in the validation cohort reported bothersome bleeding and had clinically relevant HRQOL changes missed with EPIC-CP. However, of the 2.6% (n=17) of men with bothersome rectal bleeding in the test cohort, EPIC-CP failed to capture 1 patient (6%) as experiencing meaningful declines in bowel HRQOL. Conclusions Modern prostate radiation therapy results in exceptionally low rates of bothersome rectal bleeding, and <1% of patients experience bothersome bleeding and are not captured by EPIC-CP as having meaningful HRQOL declines after radiation therapy. However, in the small subset of patients with bothersome rectal bleeding, the longer EPIC-26 should strongly be considered, given its superior performance in this patient subset.

Original languageEnglish
Pages (from-to)770-777
Number of pages8
JournalInternational Journal of Radiation Oncology Biology Physics
Issue number4
StatePublished - Nov 15 2016


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