Randomized phase II exploratory study of prophylactic amifostine in cancer patients who receive radical radiotherapy to the pelvis.
BACKGROUND
This study aimed to investigate the efficacy of prophylactic amifostine in reducing the risk of severe radiation colitis in cancer patients receiving radical radiotherapy to the pelvis.


METHODS
Patients with pelvic tumours referred for radical radiotherapy who consented participation in this trial, were randomly assigned to receive daily amifostine (A) (subcutaneously, 500 mg flat dose) before radiotherapy or radiotherapy alone (R). Sigmoidoscopy and blinded biopsies were scheduled to conduct prior to initiation and following completion of radiotherapy and again 6 to 9 months later. Radiation colitis was assessed by clinical, endoscopic and histolopathological criteria.


RESULTS
A total 44 patients were enrolled in this trial, the majority with rectal (20 patients) and cervical cancer (12 patients) and were assigned 23 in R arm and 21 in the A arm. In total 119 sigmoidoscopies were performed and 18 patients (18/44, 40.9%) were diagnosed with radiation colitis (15 grade 1 and 2, and 3 grade 3 and 4). Of them, 6 patients belonged to the A group (6/21, 28.6%) and 12 to the R group (12/23, 52.2%). Acute and grade IV radiation colitis was only developed in four patients (17.4%) in the R group. Amifostine side effects were mild. Amifostine treated patients were less likely to develop histologically detectable mucosal lesions, which indicate protection from acute mucosal injury.


CONCLUSIONS
Amifostine given subcutaneously can lower the risk of acute severe radiation colitis in patients who receive radical radiotherapy to pelvic tumors.
Katsanos
Konstantinos H
KH
1st Department of Internal Medicine & Hepato-Gastroenterology Unit, Medical School of Ioannina, Leoforos Stavrou Niarxou, Ioannina, 451 10, Greece. etsianos@uoi.gr
Briasoulis
Evangelos
E
Tsekeris
Pericles
P
Batistatou
Anna
A
Bai
Maria
M
Tolis
Christos
C
Capizzello
Antonio
A
Panelos
Ioannis
I
Karavasilis
Vasileios
V
Christodoulou
Dimitrios
D
Tsianos
Epameinondas V
EV
D000328:Adult; D000368:Aged; D004999:Amifostine / Q000627:therapeutic use*; D003092:Colitis / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D003131:Combined Modality Therapy; D016889:Endometrial Neoplasms / Q000150:complications / Q000532:radiotherapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010386:Pelvic Neoplasms / Q000150:complications / Q000532:radiotherapy*; D011379:Prognosis; D011471:Prostatic Neoplasms / Q000150:complications / Q000532:radiotherapy; D011832:Radiation Injuries / Q000175:diagnosis / Q000188:drug therapy*; D011837:Radiation-Protective Agents / Q000627:therapeutic use*; D012004:Rectal Neoplasms / Q000150:complications / Q000532:radiotherapy; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000150:complications / Q000532:radiotherapy
D011837:Radiation-Protective Agents; D004999:Amifostine