Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
Low-dose oral etoposide (E) + DDI in patients (pts) with AIDS-related neoplasias (Meeting abstract).
Proc Annu Meet Am Soc Clin Oncol; 13:A12 1994. Unique Identifier : AIDSLINE ICDB/94600009 Schmilovich A; Perez H; Gil Deza E; Cahn P; Casiro A; Grinberg N; Fundacion Huesped, Arcos 2626, 428, Buenos Aires, Argentina
Abstract:
E is a topoisomerase II inhibitor whose activity is schedule-dependent. Previous studies suggest that prolonged exposition to low concentrations are more cytotoxic than short exposition to high concentrations. Recent studies had shown also that E is active by oral route. AIDS pts have an increased incidence of E sensible neoplasia (Kaposi Sarcoma (KS)) and Non-Hodgkin's lymphoma (NHL), but it's not feasible to combine with AZT due to severe myelotoxicity and/or infections. In this Phase II trial E was given at the dose of 30 mg/m2 bid for 14 days every weeks. Up to now 24 pts (15 KS, 8 NHL, 1 small-cell lung cancer (SCLC)) were included. Median age was 31 years (r23-45) KS: Stage IIIB: 3; IIIA: 6; IVB: 6 (according NY/U criteria). NHL: Stage IVA: 5; IVB:3 (according to Ann Arbor criteria) and SCLC Stage IV (according to TNM system). All pts received DDI plus cotrimoxazole during all courses, 6/15 KS relapsed after interferon therapy and 2/8 NHL relapsed after radiotherapy were included. Median performance status (ECOS) was 2 (r2-3). A median of 4 courses per pt (r2-5) was given. Overall response (CR+PR) was 37% (9/24). One pt achieved CR (SCLC). Median time to progression was 6 mo (r4 +/- 10). 5 pts developed opportunistic infections (tuberculosis: 3, toxoplasmosis; 1, pneumocystis: 1). Major toxicities were leukopenia (WHO Grade III-IV 62/80 courses) alopecia (WHO Grade III: 10 pts). No pt except 4 were admitted to the hospital except for the treatment of opportunistic infection. Hematological support (GM-CSF) was required in 12 pts. Preliminary results suggest that E by oral route combined with DDI is an active regimen in AIDS related neoplasias suitable for outpatient administration, main toxicity is hematological but manageable with GM-CSF.
Keywords: Acquired Immunodeficiency Syndrome/*DRUG THERAPY/PATHOLOGY Administration, Oral Adult Carcinoma, Small Cell/DRUG THERAPY/PATHOLOGY Didanosine/*ADMINISTRATION & DOSAGE Dose-Response Relationship, Drug Drug Therapy, Combination Etoposide/*ADMINISTRATION & DOSAGE Human Lung Neoplasms/DRUG THERAPY/PATHOLOGY Lymphoma, AIDS-Related/*DRUG THERAPY/PATHOLOGY Neoplasm Staging Sarcoma, Kaposi's/*DRUG THERAPY/PATHOLOGY Skin Neoplasms/*DRUG THERAPY/PATHOLOGY ABSTRACT CLINICAL TRIAL CLINICAL TRIAL, PHASE II 940830
M9480789
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