TY - JOUR
TI - Phase II multicenter randomized study of amifostine for prevention of
acute radiation rectal toxicity: Topical intrarectal versus subcutaneous
application
AU - Kouloulias, VE
AU - Kouvaris, JR
AU - Pissakas, G
AU - Mallas, E and
AU - Antypas, C
AU - Kokakis, JD
AU - Matsopoulos, G
AU - Michopoulos, S and
AU - Mystakidou, K
AU - Vlahos, LJ
JO - International Journal of Radiation, Oncology, Biology, Physics
PY - 2005
VL - 62
TODO - 2
SP - 486-493
PB - EXCERPTA MEDICA INC-ELSEVIER SCIENCE INC
SN - 0360-3016
TODO - 10.1016/j.ijrobp.2004.10.043
TODO - amifostine; intrarectal; radiotherapy; randomized; subcutaneous
TODO - 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 < 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. (c)
2005 Elsevier Inc.
ER -