Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
Phase III trial of chemotherapy (CT) concomitantly with didanosine (DDI) versus chemotherapy alone in patients (pts) with AIDS-non Hodgkin's lymphoma (NHL) (Meeting abstract).
Proc Annu Meet Am Soc Clin Oncol; 13:A1265 1994. Unique Identifier : AIDSLINE ICDB/94601261 Ucar A; Harrington WJ; Cabral L; Hurley J; Cohen J; Lai S; Byrnes J; Sylvester Comprehensive Cancer Center, Miami, FL
Abstract:
This study was designed to explore the hypothesis that combined antiretroviral and antitumor chemotherapy is feasible and more effective in terms of response and survival. Eligibility criteria included: HIV seropositivity; measurable Stage II-IV intermediate or high grade lymphoma; no prior therapy; Karnofsky PS greater than or equal to 60%; ANC greater than or equal to 1000/mm3, Hb greater than or equal to 8 mg/dl; platelet count greater than or equal to 50,000/mm3, SGOT less than or equal to 2x upper limit of normal, CR less than or equal to 1.5. 30 pts were accrued, 16 pts were randomized to the DDI (+) arm and 14 to the DDI (-) arm. The median absolute CD4 count was 73 (1-993) at diagnosis. 50% of the pts had immunoblastic lymphoma, 45% diffuse large cell lymphoma and 5% diffuse mixed cell lymphoma. IV chemotherapy was delivered weekly over 12 wk. Pts received mitoxantrone (8 mg/m2) and VP-16 (100 mg/m2) on odd weeks; cyclophosphamide 350 mg/m2 on wk 1, 5, and 9; bleomycin (10 u/m2) and vincristine 2 mg on even weeks; and methylprednisolone (1 g/m2) weekly. In addition, pts received daily oral prophylaxis with Bactrim, difluconazole and acyclovir. 80% of the planned CT dose was delivered; 88% in the DDI (+) arm and 77% in the DDI (-) arm. The response rate was 84% (57% CR and 27% PR). The response rate in the DDI (+) arm was 85% (61% CR and 25% PR) versus 71% (43% CR and 28% PR) in the DDI (-) arm. The median duration of CR has been 50+ wk. 10 pts are alive (29-94 wk). With a median follow up of 6+ months no statistically significant difference in survival has been detected, but there is a trend in favor of the DDI (+) arm. DDI toxicities included: pancreatitis, paresthesias, and diarrhea. Four pts in the DDI (+) arm experienced episodes of febrile neutropenia versus 6 pts in the DDI (-) arm. Concurrent CT and DDI is feasible and well tolerated. This treatment program is delivered over a short period of time (12 wk), with acceptable toxicity and a high response rate.
Keywords: Antineoplastic Agents, Combined/ADVERSE EFFECTS/*THERAPEUTIC USE Comparative Study Didanosine/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Feasibility Studies Follow-Up Studies Human Lymphoma, AIDS-Related/*DRUG THERAPY/MORTALITY/PATHOLOGY Neoplasm Staging Survival Rate ABSTRACT CLINICAL TRIAL, PHASE III CLINICAL TRIAL RANDOMIZED CONTROLLED TRIAL
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Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
