Amifostine as radioprotective agent for the rectal mucosa during irradiation of pelvic tumors: A phase II randomized study using various toxicity scales and rectosigmoidoscopy

Kouvaris, JR; Kouloulias, V; Malas, E; Antypas, C; Kokakis, J; Michopoulos, S; Matsopoulos, G; Vlahos, L

dc.contributor.author	Kouvaris, JR	en
dc.contributor.author	Kouloulias, V	en
dc.contributor.author	Malas, E	en
dc.contributor.author	Antypas, C	en
dc.contributor.author	Kokakis, J	en
dc.contributor.author	Michopoulos, S	en
dc.contributor.author	Matsopoulos, G	en
dc.contributor.author	Vlahos, L	en
dc.date.accessioned	2014-03-01T01:18:37Z
dc.date.available	2014-03-01T01:18:37Z
dc.date.issued	2003	en
dc.identifier.issn	0179-7158	en
dc.identifier.uri	https://dspace.lib.ntua.gr/xmlui/handle/123456789/15112
dc.subject	Amifostine	en
dc.subject	Radiotherapy	en
dc.subject	Randomized trial	en
dc.subject	Rectal mucosa	en
dc.subject	Rectosigmoidoscopy	en
dc.subject	Toxicity grade	en
dc.subject.classification	Oncology	en
dc.subject.classification	Radiology, Nuclear Medicine & Medical Imaging	en
dc.subject.other	amifostine	en
dc.subject.other	radioprotective agent	en
dc.subject.other	acute toxicity	en
dc.subject.other	area under the curve	en
dc.subject.other	article	en
dc.subject.other	cell protection	en
dc.subject.other	clinical article	en
dc.subject.other	clinical trial	en
dc.subject.other	controlled clinical trial	en
dc.subject.other	controlled study	en
dc.subject.other	disease duration	en
dc.subject.other	dose response	en
dc.subject.other	drug efficacy	en
dc.subject.other	drug tolerability	en
dc.subject.other	endometrium cancer	en
dc.subject.other	female	en
dc.subject.other	gynecologic cancer	en
dc.subject.other	histogram	en
dc.subject.other	human	en
dc.subject.other	incidence	en
dc.subject.other	male	en
dc.subject.other	mucosa inflammation	en
dc.subject.other	phase 2 clinical trial	en
dc.subject.other	prostate cancer	en
dc.subject.other	radiation injury	en
dc.subject.other	radiation protection	en
dc.subject.other	randomization	en
dc.subject.other	randomized controlled trial	en
dc.subject.other	rectum mucosa	en
dc.subject.other	sigmoidoscopy	en
dc.subject.other	statistical significance	en
dc.subject.other	toxicity testing	en
dc.subject.other	treatment planning	en
dc.subject.other	uterine cervix cancer	en
dc.subject.other	Aged	en
dc.subject.other	Amifostine	en
dc.subject.other	Chi-Square Distribution	en
dc.subject.other	Data Interpretation, Statistical	en
dc.subject.other	Endometrial Neoplasms	en
dc.subject.other	Female	en
dc.subject.other	Humans	en
dc.subject.other	Intestinal Mucosa	en
dc.subject.other	Male	en
dc.subject.other	Middle Aged	en
dc.subject.other	Prostatic Neoplasms	en
dc.subject.other	Radiation-Protective Agents	en
dc.subject.other	Radiotherapy	en
dc.subject.other	Rectum	en
dc.subject.other	Sigmoidoscopy	en
dc.subject.other	Uterine Cervical Neoplasms	en
dc.title	Amifostine as radioprotective agent for the rectal mucosa during irradiation of pelvic tumors: A phase II randomized study using various toxicity scales and rectosigmoidoscopy	en
heal.type	journalArticle	en
heal.identifier.primary	10.1007/s00066-003-0970-y	en
heal.identifier.secondary	http://dx.doi.org/10.1007/s00066-003-0970-y	en
heal.language	English	en
heal.publicationDate	2003	en
heal.abstract	Aim: To evaluate the cytoprotective effect of amifostine against radiation-induced acute toxicity to the rectal mucosa. Patients and Methods: 36 patients irradiated for prostate or gynecologic cancer were randomized to receive amifostine (n = 18, group A) or not (n = 18, group 13). The radiation-induced acute rectal toxicity was evaluated by using three different toxicity scales: WHO scale, EORTC/RTOG toxicity criteria, and a modified toxicity scale based on the LENT-SOMA grading scale and the endoscopic terminology of the World Organization for Digestive Endoscopy. The objective measurements were coming from flexible rectosigmoidoscopy performed at baseline and 1-2 days after completion of the radiotherapy schedule. Anterior-posterior fields were used in the gynecologic patients while 3-D conformal 4-field technique was applied in the prostate cancer patients. The area under the curve (AUC) for dose-volume histograms (DVHs) of the rectum was also assessed during a 3-D treatment planning schedule, and no significant differences were assessed between the two groups, indicating a homogeneous dose-volume effect. Results: Amifostine was well tolerated. No grade 2 or higher WHO and EORTC/RTOG acute toxicity was noted in group A, while acute rectal toxicity (greater than or equal to grade 1) was observed in 16/18 patients of group B versus 2/18 of group A (p < 0.001). The onset as well as the duration of acute rectal toxicity were significantly improved in group A (p = 0.002). Rectosigmoidoscopy revealed more severe rectal mucositis in noncytoprotected patients (group 13), and modified LENT-SOMA overall mucositis grading score was significantly Lower in group A (p = 0.003). Conclusion: Amifostine seems to have a significant cytoprotective efficacy in acute radiation-induced rectal mucositis in terms of symptomatic and objective endpoints.	en
heal.publisher	URBAN & VOGEL	en
heal.journalName	Strahlentherapie und Onkologie	en
dc.identifier.doi	10.1007/s00066-003-0970-y	en
dc.identifier.isi	ISI:000181635800004	en
dc.identifier.volume	179	en
dc.identifier.issue	3	en
dc.identifier.spage	167	en
dc.identifier.epage	174	en