Τίτλος:
A phase II randomized study of topical intrarectal administration of
amifostine for the prevention of acute radiation-induced rectal toxicity
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
Kouloulias, VE
Kouvaris, JR
Pissakas, G
Kokakis, JD and
Antypas, C
Mallas, E
Matsopoulos, G
Michopoulos, S and
Vosdoganis, SP
Kostakopoulos, A
Vlahos, LJ
Περιοδικό:
Strahlentherapie und Onkologie
Εκδότης:
Springer Berlin Heidelberg
Λέξεις-κλειδιά:
randomized; amifostine; intrarectal; radiotherapy
DOI:
10.1007/s00066-004-1226-1
