Phase II multicenter randomized study of amifostine for prevention of acute radiation rectal toxicity: Topical intrarectal versus subcutaneous application

Kouloulias, VE; Kouvaris, JR; Pissakas, G; Mallas, E; Antypas, C; Kokakis, JD; Matsopoulos, G; Michopoulos, S; Mystakidou, K; Vlahos, LJ

dc.contributor.author	Kouloulias, VE	en
dc.contributor.author	Kouvaris, JR	en
dc.contributor.author	Pissakas, G	en
dc.contributor.author	Mallas, E	en
dc.contributor.author	Antypas, C	en
dc.contributor.author	Kokakis, JD	en
dc.contributor.author	Matsopoulos, G	en
dc.contributor.author	Michopoulos, S	en
dc.contributor.author	Mystakidou, K	en
dc.contributor.author	Vlahos, LJ	en
dc.date.accessioned	2014-03-01T01:22:55Z
dc.date.available	2014-03-01T01:22:55Z
dc.date.issued	2005	en
dc.identifier.issn	0360-3016	en
dc.identifier.uri	https://dspace.lib.ntua.gr/xmlui/handle/123456789/16720
dc.subject	Amifostine	en
dc.subject	Intrarectal	en
dc.subject	Radiotherapy	en
dc.subject	Randomized	en
dc.subject	Subcutaneous	en
dc.subject.classification	Oncology	en
dc.subject.classification	Radiology, Nuclear Medicine & Medical Imaging	en
dc.subject.other	Cytology	en
dc.subject.other	Irradiation	en
dc.subject.other	Patient treatment	en
dc.subject.other	Radiation	en
dc.subject.other	Radiation effects	en
dc.subject.other	Toxicity	en
dc.subject.other	Acute radiation toxicity	en
dc.subject.other	Cytoprotective effects	en
dc.subject.other	Local side effects	en
dc.subject.other	Multicenter randomized study	en
dc.subject.other	Oncology	en
dc.subject.other	amifostine	en
dc.subject.other	enema	en
dc.subject.other	tropisetron	en
dc.subject.other	adult	en
dc.subject.other	aged	en
dc.subject.other	aqueous solution	en
dc.subject.other	article	en
dc.subject.other	asthenia	en
dc.subject.other	cancer radiotherapy	en
dc.subject.other	clinical trial	en
dc.subject.other	controlled clinical trial	en
dc.subject.other	controlled study	en
dc.subject.other	defecation disorder	en
dc.subject.other	dose response	en
dc.subject.other	drug safety	en
dc.subject.other	drug tolerability	en
dc.subject.other	endoscopy	en
dc.subject.other	feasibility study	en
dc.subject.other	female	en
dc.subject.other	gynecologic cancer	en
dc.subject.other	human	en
dc.subject.other	incidence	en
dc.subject.other	major clinical study	en
dc.subject.other	male	en
dc.subject.other	morbidity	en
dc.subject.other	mucosa inflammation	en
dc.subject.other	nausea	en
dc.subject.other	phase 2 clinical trial	en
dc.subject.other	priority journal	en
dc.subject.other	prostate cancer	en
dc.subject.other	radiation injury	en
dc.subject.other	randomized controlled trial	en
dc.subject.other	rating scale	en
dc.subject.other	rectum disease	en
dc.subject.other	side effect	en
dc.subject.other	sigmoidoscopy	en
dc.subject.other	three dimensional imaging	en
dc.subject.other	urinary tract disease	en
dc.subject.other	Administration, Rectal	en
dc.subject.other	Amifostine	en
dc.subject.other	Female	en
dc.subject.other	Genital Neoplasms, Female	en
dc.subject.other	Humans	en
dc.subject.other	Injections, Subcutaneous	en
dc.subject.other	Male	en
dc.subject.other	Prostatic Neoplasms	en
dc.subject.other	Radiation Injuries	en
dc.subject.other	Radiation-Protective Agents	en
dc.subject.other	Radiotherapy, Conformal	en
dc.subject.other	Rectum	en
dc.subject.other	Statistics, Nonparametric	en
dc.subject.other	Urinary Bladder	en
dc.title	Phase II multicenter randomized study of amifostine for prevention of acute radiation rectal toxicity: Topical intrarectal versus subcutaneous application	en
heal.type	journalArticle	en
heal.identifier.primary	10.1016/j.ijrobp.2004.10.043	en
heal.identifier.secondary	http://dx.doi.org/10.1016/j.ijrobp.2004.10.043	en
heal.language	English	en
heal.publicationDate	2005	en
heal.abstract	Purpose: To investigate the cytoprotective effect of subcutaneous vs. intrarectal administration of amifostine against acute radiation toxicity. Methods and Materials: Patients were randomized to receive amifostine either intrarectally (Group A, n = 27) or a 500-mg flat dose subcutaneously (Group B, n = 26) before irradiation. Therapy was delivered using a four-field technique with three-dimensional conformal planning. In Group A, 1,500 mg of amifostine was administered intrarectally as an aqueous solution in 40 mL of enema. Two different toxicity scales were used: the European Organization for Research and Treatment of Cancer/Radiation Therapy Oncology Group (RTOG) rectal and urologic toxicity criteria and the Subjective-RectoSigmoid 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 radiotherapy completion. The area under the curve for the time course of mucositis (RTOG criteria) during irradiation represented the mucositis index. Results: Intrarectal amifostine was feasible and well tolerated without any systemic or local side effects. According to the RTOG toxicity scale, Group A had superior results with a significantly lower incidence of Grades I-II rectal radiation morbidity (11% vs. 42%, p = 0.04) but inferior results concerning urinary toxicity (48% vs. 15%, p = 0.03). The mean rectal mucositis index and Subjective-RectoSigmoid score were significantly lower in Group A (0.44 vs. 2.45 [p = 0.015] and 3.9 vs. 6.0 [p = 0.01], respectively), and the mean urinary mucositis index was lower in Group B (2.39 vs. 0.34, p &LT; 0.028). Conclusions: Intrarectal administration of amifostine (1,500 mg) seemed to have a cytoprotective efficacy in acute radiation rectal mucositis but was inferior to subcutaneous administration in terms of urinary toxicity. Additional randomized studies are needed for definitive decisions concerning the cytoprotection of pelvic irradiated areas. &COPY; 2005 Elsevier Inc.	en
heal.publisher	ELSEVIER SCIENCE INC	en
heal.journalName	International Journal of Radiation Oncology Biology Physics	en
dc.identifier.doi	10.1016/j.ijrobp.2004.10.043	en
dc.identifier.isi	ISI:000229082500024	en
dc.identifier.volume	62	en
dc.identifier.issue	2	en
dc.identifier.spage	486	en
dc.identifier.epage	493	en