A phase II randomized study of topical intrarectal administration of amifostine for the prevention of acute radiation-induced rectal toxicity

Kouloulias, VE; Kouvaris, JR; Pissakas, G; Kokakis, JD; Antypas, C; Mallas, E; Matsopoulos, G; Michopouloss, S; Vosdoganis, S-P; Kostakopoulos, A; Vlahos, LJ

dc.contributor.author	Kouloulias, VE	en
dc.contributor.author	Kouvaris, JR	en
dc.contributor.author	Pissakas, G	en
dc.contributor.author	Kokakis, JD	en
dc.contributor.author	Antypas, C	en
dc.contributor.author	Mallas, E	en
dc.contributor.author	Matsopoulos, G	en
dc.contributor.author	Michopouloss, S	en
dc.contributor.author	Vosdoganis, S-P	en
dc.contributor.author	Kostakopoulos, A	en
dc.contributor.author	Vlahos, LJ	en
dc.date.accessioned	2014-03-01T01:19:46Z
dc.date.available	2014-03-01T01:19:46Z
dc.date.issued	2004	en
dc.identifier.issn	0179-7158	en
dc.identifier.uri	https://dspace.lib.ntua.gr/xmlui/handle/123456789/15709
dc.subject	Amifostine	en
dc.subject	Intrarectal	en
dc.subject	Radiotherapy	en
dc.subject	Randomized	en
dc.subject.classification	Oncology	en
dc.subject.classification	Radiology, Nuclear Medicine & Medical Imaging	en
dc.subject.other	amifostine	en
dc.subject.other	enema	en
dc.subject.other	adult	en
dc.subject.other	aged	en
dc.subject.other	aqueous solution	en
dc.subject.other	area under the curve	en
dc.subject.other	article	en
dc.subject.other	cancer patient	en
dc.subject.other	cancer radiotherapy	en
dc.subject.other	cell protection	en
dc.subject.other	clinical trial	en
dc.subject.other	controlled clinical trial	en
dc.subject.other	controlled study	en
dc.subject.other	drug tolerance	en
dc.subject.other	dysuria	en
dc.subject.other	hemorrhoid	en
dc.subject.other	human	en
dc.subject.other	incidence	en
dc.subject.other	irradiation	en
dc.subject.other	mucosa inflammation	en
dc.subject.other	nocturia	en
dc.subject.other	phase 2 clinical trial	en
dc.subject.other	prostate cancer	en
dc.subject.other	radiation injury	en
dc.subject.other	randomized controlled trial	en
dc.subject.other	rectum mucosa	en
dc.subject.other	scoring system	en
dc.subject.other	sigmoidoscopy	en
dc.subject.other	urinary tract disease	en
dc.subject.other	world health organization	en
dc.subject.other	Administration, Rectal	en
dc.subject.other	Administration, Topical	en
dc.subject.other	Aged	en
dc.subject.other	Amifostine	en
dc.subject.other	Feasibility Studies	en
dc.subject.other	Humans	en
dc.subject.other	Intestinal Mucosa	en
dc.subject.other	Male	en
dc.subject.other	Radiation Injuries	en
dc.subject.other	Radiation-Protective Agents	en
dc.subject.other	Radiotherapy	en
dc.subject.other	Rectal Diseases	en
dc.subject.other	Rectum	en
dc.subject.other	Treatment Outcome	en
dc.title	A phase II randomized study of topical intrarectal administration of amifostine for the prevention of acute radiation-induced rectal toxicity	en
heal.type	journalArticle	en
heal.identifier.primary	10.1007/s00066-004-1226-1	en
heal.identifier.secondary	http://dx.doi.org/10.1007/s00066-004-1226-1	en
heal.language	English	en
heal.publicationDate	2004	en
heal.abstract	Purpose: To investigate the cytoprotective effect of intrarectal amifostine administration on acute radiation-induced rectal toxicity. Patients and Methods: 67 patients with T1b-2 NO MO prostate cancer were randomized to receive amifostine intrarectally (group A, n = 33) or not (group B, n = 34) before irradiation. Therapy was delivered using a four-field technique with three-dimensional conformal planning. In group A, 1,500 mg amifostine was administered intrarectatly as an aqueous solution in a 40-ml enema. Two different toxicity scales were used: EORTC/RTOG rectal and urologic toxicity criteria along with a Subjective-RectoSigmoid (S-RS) scale based on the endoscopic terminology of the World Organization for Digestive Endoscopy. Objective measurements with rectosigmoidoscopy were performed at baseline and 1-2 days after the completion of radiotherapy. The area under curve for the time course of mucositis (RTOG criteria) during irradiation represented the mucositis index (MI). Results: Intrarectal amifostine was feasible and well tolerated without any systemic or Local side effects. According to the RTOG toxicity scale, five out of 33 patients showed grade 1 mucositis in group A versus 15 out of 34 patients with grade 1/2 in group B (p = 0.026). Mean rectal MI was 0.3 +/- 0.1 in group A versus 2.2 +/- 0.4 in group B (p < 0.001), while S-RS score was 3.9 +/- 0.5 in group A versus 6.3 +/- 0.7 in group B (p < 0.001). The incidence of urinary toxicity was the same in both groups. Conclusion: Intrarectal administration of amifostine seems to have a cytoprotective efficacy in acute radiation-induced rectal mucositis. Further randomized studies are needed for definitive therapeutic decisions.	en
heal.publisher	URBAN & VOGEL	en
heal.journalName	Strahlentherapie und Onkologie	en
dc.identifier.doi	10.1007/s00066-004-1226-1	en
dc.identifier.isi	ISI:000224063200003	en
dc.identifier.volume	180	en
dc.identifier.issue	9	en
dc.identifier.spage	557	en
dc.identifier.epage	562	en