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Sodium Butyrate Enema Favourable for Reducing Positive Endoscopic Findings in Treatment of Radiation Proctitis Following Radiation Therapy, a study Presented at EMUC.

Although sodium butyrate enema shows no efficacy in the acute setting, it shows a promising favourable trend for the reduction of positive endoscopic findings, which are of benefit for late rectal toxicity, in the treatment of radiation proctitis in patients with prostate cancer following 3-dimensional conformal radiation therapy.

In presenting this multicentre, randomised, placebo-controlled, prospective, phase 2 study here on November 27 at the 2nd European Multidisciplinary Meeting on Urological Cancers (EMUC), Tiziana Rancati, PhD, co-investigator and Radiobiologist in the Prostate Programme, Fondazione IRCCS National Tumour Institute, Milan, Italy, noted, "As an anti-inflammatory, it was thought that [sodium butyrate] would reduce irritation and inflammation in the anus and rectum, and would thus reduce the effects of radiation during the acute phase."

The aim of the study was to evaluate whether prophylactic use of sodium butyrate enemas reduces duration, incidence, and severity of radiation proctitis in patients treated with radiotherapy with radical intent to doses >=72 Gy.

Of the 171 patients who were randomised to receive placebo or sodium butyrate enema 1, 2, or 4 g/day, 160 were available with a minimum of 6 months follow-up. The baseline comorbidities distribution across the 4 arms showed no significant differences for all clinical risk factors.

The radiation doses received were between 72 and 78 Gy (median, 76 Gy), and treatments were administered during radiotherapy and up to 2 weeks after radiotherapy completion. The acute rectal toxicity evaluation was done through daily self-assessed questionnaires during the treatment and up to 1 month following treatment completion.

Five endpoints were considered: presence of grade >=1 proctitis for at least 10 days (G1+tox) and of grade >=2 proctitis for at least 5 days (G2+tox), use of sanitary pads and steroids, and endoscopy-measured damaging effects of radiotherapy on rectal mucosa (baseline to 6 weeks).

For the acute effects for which this study was designed, these endpoints saw 21.9% of patients with G1+tox, 17.5% with G2+tox, 3.8% used sanitary pads, and 10.6% used steroids, but there were no significant differences between the placebo and any active treatment arms.

Dr. Rancati also noted that in the multivariate analysis, haemorrhoids (odds ratio [OR], 3.01; P = .06) and the percentage of volume of the rectum receiving more than 50 Gy (continuous; OR, 1.055; P = .037) were the only G1+tox predictors, with androgen deprivation protective (OR, 0.15; P = .05) as the only G2+tox predictor. No correlations were found for sanitary pad and steroid use, and as Dr. Rancati said, "The drug had no effect on these."

However, there was a trend seen for enhanced endoscopy upgrading in the placebo arm as compared with the combined active treatment arms for the endoscopy results at 6 weeks after the start of radiotherapy (26.3% vs 18.3%).

Thus, Dr. Rancati stressed, "These effects are related to late toxicity, which is even more important than acute toxicity, but the trial was designed for acute toxicity." Therefore, these investigators now await the 3-year follow-up for the late toxicity to determine the extent of this important additional result.

EMUC was co-organised by the European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), and the European Society for Therapeutic Radiology and Oncology (ESTRO).

Source: EMUC

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