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

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• 作者：Jae Y. Lee ; MD ; PhD^&lowast ; ; Stephanie Daignault-Newton ; PhD^&lowast ; ; Gerard Heath ; BS^&lowast ; ; Sarah Scarlett ; BS^&lowast ; ; Martin G. Sanda ; MD^&dagger ; ; Peter Chang ; MD^&Dagger ; ; Meredith M. Regan ; ScD^&sect ; ; Jeff M. Michalski ; MD^|| ; Howard M. Sandler ; MD^¶ ; ; Felix Y. Feng ; MD^&lowast ; ; Deborah A. Kuban ; MD ; FACR ; FASTRO^# ; Anthony L. Zietman ; MD ; FASTRO^&lowast ; &lowast ; ; Jay P. Ciezki ; MD^&dagger ; &dagger ; ; Irving D. Kaplan ; MD^&Dagger ; ; Catrina Crociani ; MPH^&Dagger ; ; William P. McLaughlin ; MD^&lowast ; ; Constantine A. Mantz ; MD^&Dagger ; &Dagger ; ; Steven E. Finkelstein ; MD^&sect ; &sect ; ; Simeng Suy ; PhD^|||| ; Sean P. Collins ; MD ; PhD^|||| ; Olatz Garin ; MPH^¶ ; ¶ ; ; Montserrat Ferrer ; MD ; PhD^¶ ; ¶ ; ; Daniel A. Hamstra ; MD ; PhD^&lowast ; ; Daniel E. Spratt ; MD^&lowast ; ; ^{sprattda@med.umich.edu" class="auth_mail" title="E-mail the corresponding author}
• 刊名：International Journal of Radiation Oncology*Biology*Physics
• 出版年：2016
• 出版时间：15 November 2016
• 年：2016
• 卷：96
• 期：4
• 页码：770-777
• 全文大小：445 K

文摘

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.