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



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.



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.



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.
University of Michigan, Ann Arbor, Michigan.
Jae Y
JY
Lee
University of Michigan, Ann Arbor, Michigan.
Stephanie
S
Daignault-Newton
University of Michigan, Ann Arbor, Michigan.
Gerard
G
Heath
University of Michigan, Ann Arbor, Michigan.
Sarah
S
Scarlett
Emory University Department of Urology, Atlanta, Georgia.
Martin G
MG
Sanda
Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Peter
P
Chang
Dana-Farber Cancer Institute, Boston, Massachusetts.
Meredith M
MM
Regan
Washington University School of Medicine, St. Louis, Missouri.
Jeff M
JM
Michalski
Cedars-Sinai Medical Center, Los Angeles, California.
Howard M
HM
Sandler
University of Michigan, Ann Arbor, Michigan.
Felix Y
FY
Feng
MD Anderson Cancer Center, Houston, Texas.
Deborah A
DA
Kuban
Massachusetts General Hospital, Boston, Massachusetts.
Anthony L
AL
Zietman
Cleveland Clinic, Cleveland, Ohio.
Jay P
JP
Ciezki
Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Irving D
ID
Kaplan
Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Catrina
C
Crociani
University of Michigan, Ann Arbor, Michigan.
William P
WP
McLaughlin
21st Century Oncology, Fort Myers, Florida.
Constantine A
CA
Mantz
21st Century Oncology, Scottsdale, Arizona.
Steven E
SE
Finkelstein
Georgetown University Medical Center, Washington, DC.
Simeng
S
Suy
Georgetown University Medical Center, Washington, DC.
Sean P
SP
Collins
Health Services Research Group, Hospital del Mar Medical Research Institute, Barcelona, Spain; and CIBER en Epidemiología y Salud Pública, Spain.
Olatz
O
Garin
Health Services Research Group, Hospital del Mar Medical Research Institute, Barcelona, Spain; and CIBER en Epidemiología y Salud Pública, Spain.
Montserrat
M
Ferrer
University of Michigan, Ann Arbor, Michigan.
Daniel A
DA
Hamstra
University of Michigan, Ann Arbor, Michigan. Electronic address: sprattda@med.umich.edu.
Daniel E
DE
Spratt
D000368:Aged; D001918:Brachytherapy; D006471:Gastrointestinal Hemorrhage / Q000453:epidemiology / Q000209:etiology*; D006801:Humans; D008297:Male; D000071066:Patient Reported Outcome Measures; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011788:Quality of Life; D016634:Radiosurgery; D011879:Radiotherapy Dosage; D050397:Radiotherapy, Intensity-Modulated; D012007:Rectum / Q000528:radiation effects*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires