TREATMENT OF POOR-PROGNOSIS EPIDEMIC KAPOSIS-SARCOMA WITH DOXORUBICIN, BLEOMYCIN, VINDESINE AND RECOMBINANT HUMAN GRANULOCYTE-MONOCYTE COLONY-STIMULATING FACTOR (RH GM-CSF)

The efficacy and toxicity of doxorubicin, bleomycin and vindesine in e pidemic Kaposi's sarcoma, and the role of rh GM-CSF in chemotherapy-in duced neutropenia were evaluated in this Phase II study. Patients with progressive Kaposi's sarcoma were eligible, and were staged according to ACTG criteria. Treatment consisted of 20 mg/m(2) doxorubicin, and a fixed dose of 15 mg bleomycin and 4 mg vindesine every 2 weeks. All patients continued antiretroviral medication with severe myelosuppress ion, patients received subcutaneous 5 mu g/kg rh GM-CSF (Leucomax) fro m days 2-12. Response and toxicity were measured according to ACTG and WHO criteria. 27 patients were evaluable, 25 patients classified as h aving a poor prognosis. The response rate was 70% (3 CR, 16 PR), the d uration of response was 18 weeks (range 8-25) and the median survival 30 weeks (range 4-63+). The cause of death was mostly opportunistic in fection. 4 patients died of pulmonary Kaposi's sarcoma. The toxicity o f this regimen was mainly myelosuppression and 13 patients were treate d with rh GM-CSF. Complete recovery of the white blood cells occurred in seven of the 27 courses of rh GM-CSF (26%). No bacterial infections were recorded, but 5 patients (19%) developed an opportunistic infect ion during treatment. Peripheral neuropathy occurred in 16% of patient s. Combination chemotherapy is effective in poor prognosis Kaposi's sa rcoma but has a shortlasting effect. The main toxicity of this treatme nt is severe myelosuppression which can be ameliorated by rh GM-CSF. I t remains to be established whether rh GM-CSF is also able to reduce t he incidence of opportunistic infections.