Purpose: To evaluate the efficacy of sodium butyrate enemas (NABUREN) in prostate cancer radiation therapy (RT) in reducing the incidence, severity, and duration of acute RT-induced proctitis. Methods and Materials: 166 patients, randomly allocated to 1 of 4 groups (rectal sodium butyrate 1 g, 2 g, or 4 g daily or placebo), were treated with NABUREN during and 2 weeks after RT. The grade of proctitis was registered in a daily diary. The correlation between NABUREN and proctitis was investigated through c2 statistics. The toxicity endpoints considered were as follows: total number of days with grade 1 proctitis (G1); total number of days with grade 2 proctitis (G2); G1 and G2 proctitis lasting at least 3 and 5 consecutive days starting from week 4 (G1þ3d, G2þ3d); damaging effects of RT on rectal mucosa as measured by endoscopy. The relationship between endpoints and pretreatment morbidities, hormonal therapy, presence of diabetes or hypertension, abdominal surgery, or hemorrhoids was investigated by univariate analysis. Results: The patients were randomly allocated to the 4 arms. No difference in the distribution of comorbidities among the arms was observed (P>.09). The mean G1 and G2 proctitis were 7.8 and 4.9 for placebo and 8.9 and 4.7 for the NABUREN group, respectively. No favorable trend in reduction of incidence, severity, and duration of G1 and G2 proctitis was observed with NABUREN use. In univariate analysis, G1þ3d toxicity was found to be related to hemorrhoids (PZ.008), and a slight correlation was found between G2 proctitis and hormonal therapy (P=.06). The RT effects on rectal mucosa as based on endoscopic assess- ment were mainly related to diabetes (P= <.01) Endoscopy data at 6 week showed no significant difference between the placebo and butyrate arms. The other investi- gated endpoints were not correlated with any of the clinical risk factors analyzed. Conclusion: There was no evidence of efficacy of NABUREN in reducing the incidence, severity, and duration of acute radiation proctitis. There was a correlation between some endpoints and clinical risk factors.
Daily Sodium Butyrate Enema for the Prevention of Radiation Proctitis in Prostate Cancer Patients Undergoing Radical Radiation Therapy: Results of a Multicenter Randomized Placebo-Controlled Dose-Finding Phase 2 Study
Magli A;
2014-01-01
Abstract
Purpose: To evaluate the efficacy of sodium butyrate enemas (NABUREN) in prostate cancer radiation therapy (RT) in reducing the incidence, severity, and duration of acute RT-induced proctitis. Methods and Materials: 166 patients, randomly allocated to 1 of 4 groups (rectal sodium butyrate 1 g, 2 g, or 4 g daily or placebo), were treated with NABUREN during and 2 weeks after RT. The grade of proctitis was registered in a daily diary. The correlation between NABUREN and proctitis was investigated through c2 statistics. The toxicity endpoints considered were as follows: total number of days with grade 1 proctitis (G1); total number of days with grade 2 proctitis (G2); G1 and G2 proctitis lasting at least 3 and 5 consecutive days starting from week 4 (G1þ3d, G2þ3d); damaging effects of RT on rectal mucosa as measured by endoscopy. The relationship between endpoints and pretreatment morbidities, hormonal therapy, presence of diabetes or hypertension, abdominal surgery, or hemorrhoids was investigated by univariate analysis. Results: The patients were randomly allocated to the 4 arms. No difference in the distribution of comorbidities among the arms was observed (P>.09). The mean G1 and G2 proctitis were 7.8 and 4.9 for placebo and 8.9 and 4.7 for the NABUREN group, respectively. No favorable trend in reduction of incidence, severity, and duration of G1 and G2 proctitis was observed with NABUREN use. In univariate analysis, G1þ3d toxicity was found to be related to hemorrhoids (PZ.008), and a slight correlation was found between G2 proctitis and hormonal therapy (P=.06). The RT effects on rectal mucosa as based on endoscopic assess- ment were mainly related to diabetes (P= <.01) Endoscopy data at 6 week showed no significant difference between the placebo and butyrate arms. The other investi- gated endpoints were not correlated with any of the clinical risk factors analyzed. Conclusion: There was no evidence of efficacy of NABUREN in reducing the incidence, severity, and duration of acute radiation proctitis. There was a correlation between some endpoints and clinical risk factors.Pubblicazioni consigliate
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