A prospective evaluation of rectal bleeding after dose-escalated three-dimensional conformal radiation therapy using an intrarectal balloon for prostate gland localization and immobilization.
OBJECTIVE
To estimate the rates of rectal bleeding after dose-escalated three-dimensional conformal radiation therapy (3D-CRT) on a prospective, Phase II study in which a modified intrarectal balloon was used for prostate gland localization and immobilization.


METHODS
The study cohort comprised 100 men with biopsy-proven adenocarcinoma of the prostate and at least one high-risk feature (prostate-specific antigen level greater than 10 ng/mL, Gleason score 7 or higher, or clinical or radiographic T3 disease). Treatment consisted of androgen suppression therapy and four-field 3D-CRT with an intrarectal balloon for the initial 15 treatments. Planning treatment volume dose was 75.6 Gy. The primary endpoint of time to grade 3 rectal bleeding was estimated with the Kaplan-Meier method for 57 men with a minimum follow-up of 1 year.


RESULTS
For 57 men with a median (range) follow-up of 1.8 (1.0 to 3.3) years, the median (range) volume of rectum exceeding 70 Gy was 3.7 (0.6 to 14.7) cm3, and the 2-year estimate of grade 3 rectal bleeding rate was 10%. This rate was 100% as compared with 0 (P < 0.0001) for men who were taking warfarin (n = 3) or high-dose aspirin (n = 1) as compared with neither, respectively. All grade 3 rectal bleeding events were controlled with argon plasma coagulation.


CONCLUSIONS
Dose-escalated 3D-CRT with an intrarectal balloon technique for prostate localization and immobilization produced no measurable grade 3 rectal bleeding unless the patient was taking anticoagulants.
D'Amico
Anthony V
AV
Department of Radiation Oncology, Brigham and Women's Hospital, Dana Farber Cancer Institute, Boston, Massachusetts, USA. adamico@lroc.harvard.edu
Manola
Judith
J
McMahon
Elizabeth
E
Loffredo
Marian
M
Lopes
Lynn
L
Ching
Jane
J
Albert
Michele
M
Hurwitz
Mark
M
Suh
Wonsuk Warren
WW
Vivenzio
Todd A
TA
Beard
Clair
C
D000230:Adenocarcinoma / Q000532:radiotherapy*; D000368:Aged; D000369:Aged, 80 and over; D006471:Gastrointestinal Hemorrhage / Q000209:etiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D012002:Rectal Diseases / Q000209:etiology*; D012007:Rectum