(9R)-9-chloro-11-17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10-13-16-trimethyl-6-7-8-11-12-14-15-16-octahydrocyclopenta[a]phenanthren-3-one and Prostatic-Neoplasms

Radiotherapy is an established treatment modality for prostate cancer; however, up to a third of patients develops a radiation-induced proctopathy.. To assess the effect of topical beclomethasone dipropionate (BDP) in the prevention of radiation-induced proctopathy in patients undergoing radiotherapy for prostate cancer through a double-blind, placebo-controlled, randomised trial.. Patients were randomised either to BDP or to placebo (PL). Patients received daily a 3mg BDP enema or identical-looking PL during radiotherapy and, subsequently, two 3mg BDP suppositories or PL for 4 more weeks. Clinical and endoscopic evaluations before, 3 and 12months after the end of radiotherapy were assessed with the RTOG/EORTC toxicity scales, the modified Simple Clinical Colitis Activity Index (SCCAI), the modified Inflammatory Bowel disease Quality of Life Index (IBDQ) and the Vienna Rectoscopy Score (VRS).. From June 2007 to October 2008, 120 patients were randomised to the BDP (n=60) and PL (n=60) arms and were followed up for 12months. The overall assessment of rectal side effects did not show significant differences between the two groups of treatment. However, when only rectal bleeding was considered, a significantly reduced risk was observed in patients on BDP (OR 0.38; 95% CI 0.17-0.86; P=0.02; NNT=5). Patients on BDP had also significantly lower VRS scores (P=0.028) and significantly higher IBDQ scores (P=0.034).. Preventive treatment with topical rectal BDP during radiotherapy for prostate cancer significantly reduces the risk of rectal bleeding and radiation-induced mucosal changes and improves patient's quality of life, but does not influence other radiation-induced symptoms.

Topics: Administration, Topical; Anti-Inflammatory Agents; Beclomethasone; Double-Blind Method; Follow-Up Studies; Gastrointestinal Hemorrhage; Humans; Italy; Male; Odds Ratio; Prostatic Neoplasms; Radiation Injuries; Rectal Diseases; Rectum; Suppositories; Treatment Outcome; White People

To evaluate if topical support therapy during static-intensity modulated radiotherapy (sIMRT) course is able to equal the characteristic minimum risk for radiation proctitis of Image-guided volumetric modulated arc therapy (IG-VMAT) treatment among localized prostate cancer patients.. Rectal toxicity data of the above patients were retrospectively collected throughout three different clinical periods at our Radiotherapy Deparment: from October 2011 to December 2012, prostate cancer patients were treated with sIMRT and in advance supported by means of daily topical corticosteroids; from January 2013 to November 2016, topical corticosteroids were replaced by daily hyaluronic acid enemas; from December 2016 to May 2018 eligible patients were treated with newly introduced IG-VMAT supported by only on-demand topical corticosteroids.. Among 359 eligible patients, IG-VMAT was proven generally more effective than sIMRT supported by topical medications in terms of proctitis reduction, although without clinical and practical relevance.. Topical medications might have a role in radiation proctitis prevention.

Topics: Administration, Topical; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Beclomethasone; Enema; Humans; Hyaluronic Acid; Italy; Male; Middle Aged; Organ Sparing Treatments; Proctitis; Prostatic Neoplasms; Radiation Dose Hypofractionation; Radiation Injuries; Radiotherapy Planning, Computer-Assisted; Radiotherapy, Image-Guided; Radiotherapy, Intensity-Modulated; Retrospective Studies