Abstract:
The objective of this pilot protocol is to evaluate the efficacy and toxicity of combining chemotherapy with AZT and GM-CSF for the treatment of AIDS-associated NHL. HIV-seropositive patients (pts) with untreated intermediate- or high-grade systemic NHL were enrolled. Pts had Karnofsky performance status greater than or equal to 30%, with no active opportunistic infections or visceral Kaposi's sarcoma. Chemotherapy consisted of 21-day cycles: day 1 cyclophosphamide (CTX) 500 mg/m2, VP-16 100 mg/m2, doxorubicin (DOX) 15 mg/m2; day 8 vincristine (VCR) 1.4 mg/m2, methotrexate (MTX) 120 mg/m2 and leucovorin rescue. AZT (500 mg/day) was administered daily and GM-CSF (10 ug/kg/day sc) was given on days 2-7 and 9-14. CTX, VP-16, and DOX were escalated by 10% in cycle 3 or later when previous cycles had resulted in absolute neutrophil nadirs of greater than or equal to 1000 cells/mm3. Intrathecal MTX and cytarabine were given to all pts. Pts with lymphomatous meningitis were given whole brain radiation. All pts received monthly inhaled pentamidine. Fourteen pts have been enrolled. Eight pts had a previous diagnosis of ARC, 3 had AIDS and 3 were asymptomatic HIV-positive. Ten pts had Stage IV disease, 2 pts had Stage I disease and 1 pt each had Stage II and III disease. Eleven pts presented with extranodal disease, 10 had 'B' symptoms, and 1 had lymphomatous meningitis. All pts were evaluable for toxicity. 11 pts had grade 3 or 4 hematologic toxicity. Of the 10 pts who received greater than 2 cycles of chemotherapy, 8 required dose reductions of at least 25% or dose delay of at least 1 wk because of hematologic toxicity. Dose escalation was achieved in 2 pts. In 1 pt a peripheral neuropathy required discontinuation of VCR. One pt had grade 4 mucositis. Constitutional symptoms related to GM-CSF were common. No pt had an opportunistic infection during chemotherapy. Ten pts were evaluable for response. Four pts achieved a complete response (40%), which continued for 10, 10, 17 and 18 mo, respectively, after completing chemotherapy. AZT and GM-CSF can safely be administered with chemotherapy. AZT and inhaled pentamidine administered with chemotherapy may prevent opportunistic infections. The addition of antiretroviral therapy and chemotherapy deserves further study.
Keywords: Acquired Immunodeficiency Syndrome/*COMPLICATIONS/*DRUG THERAPY Antineoplastic Agents, Combined/*THERAPEUTIC USE Brain Neoplasms/ETIOLOGY/RADIOTHERAPY Cyclophosphamide/ADMINISTRATION & DOSAGE Doxorubicin/ADMINISTRATION & DOSAGE Etoposide/ADMINISTRATION & DOSAGE Granulocyte-Macrophage Colony-Stimulating Factor/*THERAPEUTIC USE Human *HIV Seropositivity Leucovorin/ADMINISTRATION & DOSAGE Lymphoma, Non-Hodgkin's/*DRUG THERAPY/*ETIOLOGY Methotrexate/ADMINISTRATION & DOSAGE Vincristine/ADMINISTRATION & DOSAGE Zidovudine/*THERAPEUTIC USE ABSTRACT
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