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

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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 http://hdl.handle.net/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

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