Randomized trial of doxorubicin versus cyclophosphamide in diffuse malignant pleural mesothelioma.

The effect of doxorubicin and cyclophosphamide in the treatment of diffuse, malignant pleural mesothelioma was evaluated in a randomized study. All patients were treated on an outpatient basis and none had previously received antineoplastic treatment. All patients had a measurable lesion other than pleural effusion. The treatment consisted of doxorubicin at a dose of 60 mg/m2 every 3 weeks, to a total dose of 550 mg/m2, or cyclophosphamide at a dose of 1500 mg/m2 every 3 weeks for 1 year. At disease progression the treatment was changed to the alternate drug. The dose was increased or decreased according to hematologic effects. Thirty of 32 patients were evaluable for response. Remissions were not achieved in any patient. During treatment with doxorubicin, none of the patients developed cardiotoxicity, while one patient developed hemorrhagic cystitis during treatment with cyclophosphamide. Sepsis or bleeding was not observed in either of the treatment arms. Thus, the trial showed no antineoplastic activity of either doxorubicin or cyclophosphamide in the treatment of malignant pleural mesothelioma.