Orgotein in radiation treatment of bladder cancer. A report on allergic reactions and lack of radioprotective effect.

The possible protective effect of orgotein (a superoxide dismutase) on radiation cystitis and proctitis was studied in patients with carcinoma of the urinary bladder. A double-blind study in 60 patients was planned but due to unacceptable side effects only 30 patients were included. Radiation treatment was given with curative intent at a dose of 63 Gy in 30 fractions. Orgotein was injected 15 min after each daily radiation treatment at a dose of 4 or 8 mg. No effect of orgotein on tumour radiation response or on the acute radiation reactions in the bladder and rectum was detected. Marked subcutaneous infiltration and redness was seen at the local injection site in 5 patients. No general symptoms were observed. Intradermal tests and antibody titration tests showed that the local reactions were due to allergic reactions to the drug itself. The lack of radioprotective effect and the high frequency of unacceptable side effects makes orgotein an unsuitable drug in clinical radiation therapy.

RCT Entities:   Population Interventions Outcomes