Document 1082
 DOCN  M9471082
 TI    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).
 DT    9409
 AU    Ucar A; Harrington WJ; Cabral L; Hurley J; Cohen J; Lai S; Byrnes J;
       Sylvester Comprehensive Cancer Center, Miami, FL
 SO    Proc Annu Meet Am Soc Clin Oncol; 13:A1265 1994. Unique Identifier :
       AIDSLINE ICDB/94601261
 AB    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.
 DE    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  MEETING ABSTRACT  CLINICAL TRIAL, PHASE III  CLINICAL
       TRIAL  RANDOMIZED CONTROLLED TRIAL

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