Intrarectal amifostine suspension may protect against acute proctitis during radiation therapy for prostate cancer: a pilot study.
OBJECTIVE
Our goal was to test the ability of intrarectal amifostine to limit symptoms of radiation proctitis.


METHODS
The first 18 patients received 1 g of intrarectal amifostine suspension placed 30-45 min before each radiation treatment. The following 12 patients received 2 g of amifostine. Total dose prescribed ranged from 66 to 76 Gy. All patients were treated with three-dimensional conformal radiation therapy. The suspension remained intrarectal during treatment and was expelled after treatment. For gastrointestinal symptoms, during treatment and follow-up, all patients had a Radiation Therapy Oncology Group (RTOG) grade recorded.


RESULTS
Median follow-up was 18 months (range, 6-24 months). With 2 g vs. 1 g amifostine, there was a nearly significant decrease in RTOG Grade 2 acute rectal toxicity. Seven weeks after the start of radiation therapy, the incidence of Grade 2 toxicity was 33% in the 1-g group (6/18) compared with 0% (0/12) in the 2-g group (p=0.06). No Grade 3 toxicity or greater occurred in this study.


CONCLUSIONS
This trial suggests greater rectal radioprotection from acute effects with 2 g vs. 1 g amifostine suspension. Further studies should be conducted in populations at higher risk for developing symptomatic acute and late proctitis.
Singh
Anurag K
AK
Radiation Oncology Branch, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD 20892, USA.
Ménard
Cynthia
C
Guion
Peter
P
Simone
Nicole L
NL
Smith
Sharon
S
Crouse
Nancy Sears
NS
Godette
Denise J
DJ
Cooley-Zgela
Theresa
T
Sciuto
Linda C
LC
Coleman
Jonathan
J
Pinto
Peter
P
Albert
Paul S
PS
Camphausen
Kevin
K
Coleman
C Norman
CN
D000285:Administration, Rectal; D000368:Aged; D004999:Amifostine / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011349:Proctitis / Q000209:etiology / Q000517:prevention & control*; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000517:prevention & control*; D011837:Radiation-Protective Agents / Q000008:administration & dosage*; D020266:Radiotherapy, Conformal; D012007:Rectum / Q000528:radiation effects*; D018709:Statistics, Nonparametric
D011837:Radiation-Protective Agents; D004999:Amifostine