TY - JOUR
T1 - Effect of oral sucralfate on late rectal injury associated with radiotherapy for prostate cancer
T2 - A double-blind, randomized trial
AU - Kneebone, Andrew
AU - Mameghan, Hedy
AU - Bolin, Terry
AU - Berry, Martin
AU - Turner, Sandra
AU - Kearsley, John
AU - Graham, Peter
AU - Fisher, Richard
AU - Delaney, Geoff
PY - 2004/11/15
Y1 - 2004/11/15
N2 - Purpose To assess whether oral sucralfate is effective in preventing late rectal injury in prostate cancer patients treated with radiotherapy. Methods and materials A double-blind, placebo-controlled, randomized trial was conducted across four institutions in Australia. Patients receiving definitive radiotherapy for prostate cancer were randomized to receive either 3 g of oral sucralfate suspension or placebo twice daily. Data on patients' symptoms were collected for 2 years, and flexible sigmoidoscopy was scheduled at 12 months after treatment. Results A total of 338 patients were randomized, of whom 298 had adequate follow-up data available for an analysis of late symptoms. Of the 298 patients, 143 were randomized to receive sucralfate and 155 placebo. The cumulative incidence of Radiation Therapy Oncology Group Grade 2 or worse late rectal toxicity at 2 years was 28% for placebo and 22% for the sucralfate arm (p = 0.23; 95% confidence interval for the difference -3% to 16%). Seventeen percent of patients in the sucralfate group had significant bleeding (Grade 2 or worse) compared with 23% in the placebo group (p = 0.18, 95% confidence interval -15% to 3%). No statistically significant difference was found between the two groups with respect to bowel frequency (p = 0.99), mucus discharge (p = 0.64), or fecal incontinence (p = 0.90). Sigmoidoscopy findings showed a nonstatistically significant reduction in Grade 2 or worse rectal changes from 32% with placebo to 27% in the sucralfate group (p = 0.25). Conclusion This trial demonstrated no statistically significant reduction in the incidence of late rectal toxicity in patients randomized to receive sucralfate. However, this result was considered inconclusive, because the trial was unable to exclude clinically important differences in the late toxicity rates.
AB - Purpose To assess whether oral sucralfate is effective in preventing late rectal injury in prostate cancer patients treated with radiotherapy. Methods and materials A double-blind, placebo-controlled, randomized trial was conducted across four institutions in Australia. Patients receiving definitive radiotherapy for prostate cancer were randomized to receive either 3 g of oral sucralfate suspension or placebo twice daily. Data on patients' symptoms were collected for 2 years, and flexible sigmoidoscopy was scheduled at 12 months after treatment. Results A total of 338 patients were randomized, of whom 298 had adequate follow-up data available for an analysis of late symptoms. Of the 298 patients, 143 were randomized to receive sucralfate and 155 placebo. The cumulative incidence of Radiation Therapy Oncology Group Grade 2 or worse late rectal toxicity at 2 years was 28% for placebo and 22% for the sucralfate arm (p = 0.23; 95% confidence interval for the difference -3% to 16%). Seventeen percent of patients in the sucralfate group had significant bleeding (Grade 2 or worse) compared with 23% in the placebo group (p = 0.18, 95% confidence interval -15% to 3%). No statistically significant difference was found between the two groups with respect to bowel frequency (p = 0.99), mucus discharge (p = 0.64), or fecal incontinence (p = 0.90). Sigmoidoscopy findings showed a nonstatistically significant reduction in Grade 2 or worse rectal changes from 32% with placebo to 27% in the sucralfate group (p = 0.25). Conclusion This trial demonstrated no statistically significant reduction in the incidence of late rectal toxicity in patients randomized to receive sucralfate. However, this result was considered inconclusive, because the trial was unable to exclude clinically important differences in the late toxicity rates.
KW - Prostate cancer
KW - Radiotherapy
KW - Rectal injury
KW - Sucralfate
UR - http://www.scopus.com/inward/record.url?scp=7444256126&partnerID=8YFLogxK
U2 - 10.1016/j.ijrobp.2004.04.033
DO - 10.1016/j.ijrobp.2004.04.033
M3 - Article
C2 - 15519779
AN - SCOPUS:7444256126
SN - 0360-3016
VL - 60
SP - 1088
EP - 1097
JO - International Journal of Radiation Oncology, Biology, Physics
JF - International Journal of Radiation Oncology, Biology, Physics
IS - 4
ER -