Treatment of poor prognosis epidemic Kaposi's sarcoma (KS) with doxorubicin, bleomycin, vindesine and recombinant human granulocyte-monocyte colony-stimulating factor (rGM-CS) (Meeting abstract).

Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.

Treatment of poor prognosis epidemic Kaposi's sarcoma (KS) with doxorubicin, bleomycin, vindesine and recombinant human granulocyte-monocyte colony-stimulating factor (rGM-CS) (Meeting abstract).

Proc Annu Meet Am Soc Clin Oncol; 12:A2 1993. Unique Identifier : AIDSLINE ICDB/93694402
Bakker PJ; Danner SA; ten Napel CH; van Leusen RM; Muusers JA; Veenhof CH; Div. of Medical Oncology, Academic Medical Center, Center,; Amsterdam, The Netherlands

Abstract: Chemotherapy with doxorubicin, bleomycin and vincristine has been reported to result in high response rates and durable remissions in patients (pts) with KS. This treatment has, however, significant side effects such as myelosuppression neurotoxicity. Infectious complications have been reported in approx 40% and neurotoxicity in approx 30% of the pts. rGM-CSF can be safely applied in pts with AIDS provided that it is combined with antiretroviral therapy and has been demonstrated to mitigate therapy-induced neutropenia. To evaluate the role of rGM-CSF, pts with Stages III-IV (NYU Staging System) and histopathologically proven KS were eligible. All pts had a WHO performance status of 0-2, WBC greater than or equal to 2.0 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L. Pts received DBV: doxorubicin 20 mg/m2, bleomycin 15 mg and vindesine 4 mg every 2 wk. In case of severe myelosuppression, absolute neutrophil count of less than 500 or on two sequential occasions neutrophil counts between 500 and 1000, pts received 5 ug/kg rGM-CSF sc from day 2-11. Response and toxicity were measured according to WHO criteria. Pts were evaluable for response after at least 2 courses. Results: 28 pts entered this study. 21 pts are reviewed at this moment. All, but one IVDU, were homosexual males. All pts were on zidovudine. The median age was 40 yr (range 31-55). 17 pts are evaluable for response and toxicity. One pt was ineligible, 1 pt too early, 2 pts were nonevaluable for response. In 15/17 evaluable pts CD4 counts were less than 200 and 12/17 pts had prior opportunistic infections. Seven pts had pulmonary lesions. The pts received a median of 4 cycles (range 2-6). Objective tumor response was documented in 9/17 pts (53%). Two pts had histologically proven complete remission. Duration of response was short; median time to progression was 8.5 wk (range 7-16 wk). The median survival was 4.5 mo. In 3/12 pts, KS was the cause of death. Leukopenia occurred in 14/17 pts (WHO grade 3-4), thrombocytopenia of less than 50 x 10(9)/L in 1/17 pts; nausea and vomiting 2/17 pts (WHO grades 1-3), alopecia in 9/17 pts (WHO grades 1-3), neurotoxicity 2/17 pts (WHO grade 1). Ten pts received rGM-CSF, with complete recovery of WBC counts in 4/10 pts, 5/10 pts had WBC counts from 2 to 4 x 10(9)/L; all had greater than 1000 neutrophils. No bacterial infections were recorded during treatment. Two pts developed a CM retinitis. The use of rGM-CSF did not result in increased toxicity. Conclusions: DBV exhibits a good but short-lasting response in pts with poor prognosis KS. rGM-CSF was able to reverse therapy-induced neutropenia and probably reduced the risk of infection. In addition, by substituting vindesine for vincristine, less severe neurotoxicity was observed.

Keywords: Acquired Immunodeficiency Syndrome/DRUG THERAPY/MORTALITY Adult Antineoplastic Agents, Combined/ADVERSE EFFECTS/*THERAPEUTIC USE Bleomycin/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Combined Modality Therapy *Disease Outbreaks Doxorubicin/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Female Follow-Up Studies Granulocyte-Macrophage Colony-Stimulating Factor/*ADMINISTRATION & DOSAGE Human Male Middle Age Neutropenia/CHEMICALLY INDUCED/THERAPY Recombinant Proteins/ADMINISTRATION & DOSAGE Sarcoma, Kaposi's/*DRUG THERAPY/MORTALITY Skin Neoplasms/*DRUG THERAPY/MORTALITY Survival Rate Vindesine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Zidovudine/ADMINISTRATION & DOSAGE ABSTRACT
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M93C0806

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