Ketoconazole prophylaxis in patients with solid tumours receiving aggressive immunosuppressive therapy. An open randomized comparison between 200 mg/d and 400 mg/d doses.
Forty-three patients, most with solid tumours, were included in a study comparing the antifungal prophylactic effect of ketoconazole (Nizoral; Janssen) 200 mg/d and 400 mg/d during the period of immunosuppressive therapy. Seven patients were not seen for follow-up and 6 died of their underlying disease without clinical evidence of mycosis. Twelve of the patients who could be evaluated received ketoconazole 200 mg/d and 18 received 400 mg/d. No infections occurred during the period of prophylactic treatment. In the group receiving 200 mg/d 10 of 36 cultures (28%) were positive for Candida albicans before prophylaxis. During prophylaxis 5 of 18 cultures (28%) were positive and at the end of the prophylactic regimen 1 out of 37 cultures (3%) was positive. In the 400 mg/d group, 13 of 47 cultures (28%) were positive at the start, 2 out of 20 (10%) were positive during prophylaxis and 1 out of 45 (2%) was still positive at the end. The drug was clinically well tolerated. Twenty of the 30 evaluable patients had no significant biochemical abnormalities, 5 had an increased serum transaminase level, 2 had an increased alkaline phosphatase level, and 3 had combined increases of serum transaminase and alkaline phosphatase levels. These abnormalities are regularly seen in patients with metastatic malignant disease, and are not necessarily related to the ketoconazole prophylaxis.
D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D007654:Ketoconazole / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D009181:Mycoses / Q000209:etiology / Q000517:prevention & control*; D009369:Neoplasms / Q000188:drug therapy*; D011897:Random Allocation
D000970:Antineoplastic Agents; D007166:Immunosuppressive Agents; D007654:Ketoconazole