Preliminary results of a phase I/II study of sodium pentosanpolysulfate in the treatment of chronic radiation-induced proctitis.
This is a report of a phase I/II study of 13 patients treated with sodium pentosanpolysulfate (PPS) for chronic radiation-induced proctitis. A complete response was obtained in 82%, a partial response occurred in 9%, and 9% failed to respond to therapy. No significant toxicity was observed. It is concluded that PPS is an effective treatment for chronic radiation-induced proctitis and a phase III randomized, double-blind study of PPS versus placebo is planned.
Grigsby
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PW
Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO 63110.
Pilepich
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MV
Parsons
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CL
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004341:Drug Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010426:Pentosan Sulfuric Polyester / Q000008:administration & dosage / Q000627:therapeutic use*; D011134:Polysaccharides / Q000627:therapeutic use*; D011349:Proctitis / Q000188:drug therapy* / Q000209:etiology; D011832:Radiation Injuries / Q000188:drug therapy* / Q000209:etiology; D011878:Radiotherapy / Q000009:adverse effects*; D012007:Rectum / Q000528:radiation effects; D012008:Recurrence; D012074:Remission Induction
D011134:Polysaccharides; D010426:Pentosan Sulfuric Polyester