TY - JOUR
T1 - Multinational Prospective Study of Patient-Reported Outcomes After Prostate Radiation Therapy
T2 - Detailed Assessment of Rectal Bleeding
AU - Lee, Jae Y.
AU - Daignault-Newton, Stephanie
AU - Heath, Gerard
AU - Scarlett, Sarah
AU - Sanda, Martin G.
AU - Chang, Peter
AU - Regan, Meredith M.
AU - Michalski, Jeff M.
AU - Sandler, Howard M.
AU - Feng, Felix Y.
AU - Kuban, Deborah A.
AU - Zietman, Anthony L.
AU - Ciezki, Jay P.
AU - Kaplan, Irving D.
AU - Crociani, Catrina
AU - McLaughlin, William P.
AU - Mantz, Constantine A.
AU - Finkelstein, Steven E.
AU - Suy, Simeng
AU - Collins, Sean P.
AU - Garin, Olatz
AU - Ferrer, Montserrat
AU - Hamstra, Daniel A.
AU - Spratt, Daniel E.
N1 - Funding Information:
The authors thank the PROSTQA Consortium study group (Study Investigators, DCC and Coordinators). The PROSTQA Consortium includes contributions in cohort design, patient accrual, and follow-up from the following investigators: Meredith Regan (Dana Farber Cancer Institute, Boston, MA); Larry Hembroff and Douglas Roberts (Michigan State University, East Lansing, MI); John T. Wei, Dan Hamstra, Rodney Dunn, Laurel Northouse and David Wood (University of Michigan, Ann Arbor, MI); Eric A. Klein and Jay Ciezki (Cleveland Clinic, Cleveland, OH); Jeff Michalski and Gerald Andriole (Washington University, St. Louis, MO); Mark Litwin and Chris Saigal (University of California—Los Angeles Medical Center, Los Angeles, CA); Thomas Greenfield, PhD (Public Health Institute, Emeryville, CA), Louis Pisters and Deborah Kuban (MD Anderson Cancer Center, Houston, TX); Howard Sandler (Cedars Sinai Medical Center, Los Angeles, CA); Jim Hu and Adam Kibel (Brigham and Women's Hospital, Boston, MA); Douglas Dahl and Anthony Zietman (Massachusetts General Hospital, Boston, MA); Peter Chang, Andrew Wagner, and Irving Kaplan (Beth Israel Deaconess Medical Center, Boston, MA); and Martin G. Sanda (Emory, Atlanta, GA). The authors also thank PROSTQA Data Coordinating Center Project Management by Kyle Davis and Jill Hardy, MS (Michigan State University, East Lansing, MI); Erin Najuch and Jonathan Chipman (Dana Farber Cancer Institute, Boston, MA); Datta Patil, MBBS, MPH (Emory, Atlanta, GA); and Catrina Crociani, MPH (Beth Israel Deaconess Medical Center, Boston, MA); grant administration by Beth Doiron, BA (Beth Israel Deaconess Medical Center, Boston, MA); and technical support from coordinators at each clinical site. They also thank the study participants, without whom this study would not have been possible. They also thank the Multicentric Spanish Group of Clinically Localized Prostate Cancer, whose participants include Jordi Alonso, Olatz Garín, Angels Pont (IMIM Hospital del Mar Medical Research Institute); Ana Boladeras, Ferran Ferrer, Ferran Guedea, Evelyn Martínez, Joan Pera, Montse Ventura (Institut Català d'Oncologia); Ferran Aguiló, Manel Castells (Hospital Universitari de Bellvitge); Humberto Villavicencio (Fundación Puigvert); Jordi Craven-Bratle (Hospital de la Santa Creu i Sant Pau); Belen de Paula, (Instituto Oncológico de Guipúzcoa); Benjamin Guix (Fundación IMOR); Helena Hernández, Víctor Muñoz (Hospital Meixoeiro-Complejo CHUVI); Alfredo Ramos (Hospital Ramon y Cajal); and Pedro J. Prada (Hospital Universitario Central de Asturias).
Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2016/11/15
Y1 - 2016/11/15
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84992512281&partnerID=8YFLogxK
U2 - 10.1016/j.ijrobp.2016.07.038
DO - 10.1016/j.ijrobp.2016.07.038
M3 - Article
C2 - 27663760
AN - SCOPUS:84992512281
SN - 0360-3016
VL - 96
SP - 770
EP - 777
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
IS - 4
ER -