Document 0332
 DOCN  M9590332
 TI    Filgrastim, CEOP and antiretroviral therapy in HIV-related non-Hodgkins
       lymphoma (NHL).
 DT    9509
 AU    Goldstein D; Newell M; Milliken S; Lewis C; Hoy J; Thomson B; Dolan G;
       Ryan S; Sarr A; Cooper DA; Fairfield Hosp., Melbourne.
 SO    Annu Conf Australas Soc HIV Med. 1994 Nov 3-6;6:167 (unnumbered
       abstract). Unique Identifier : AIDSLINE ASHM6/95291767
 AB    Cytotoxic chemotherapy is necessary for effective palliation in
       HIV-related NHL, however frequent delays and dose reductions occur due
       to increased myelosuppression which usually necessitates the
       discontinuation of antiretroviral therapy. Filgrastim has been shown to
       shorten the duration of neutropenic nadir from cytotoxic and other
       chemotherapy. This phase I trial aimed to determine the MTD of CEOP with
       filgrastim support and maintenance of antiretroviral therapy. Fourteen
       HIV+ patients with biopsy-proven NHL, no previous chemotherapy and ECOG
       status 0-2 received initial treatment with filgrastim 1.0 mcg/kg sc
       daily for 3-7 days to achieve an ANC of > 1.2, followed by CEOP with
       filgrastim 10 mcg/kg sc given daily from day 2 to 14, continued if ANC <
       1.2. Two CEOP dose cohorts were used: A (5
       patients)--cyclophosphamide(C) 500mg/m2, epirubicin(E) 37.5mg/m2,
       vincristine(O) 2mg and prednisolone(P) 75mg/m2 on days 1-5; B (9
       patients)--C. 750 mg/m2, E. 50 mg/m2, same doses O.&P.). RESULTS: Cohort
       A--5 evaluable patients, 2 received > 3 courses of CEOP. RESPONSE:
       complete -1/5, progression--4/5. TOXICITY: Only 1 pt. had dose limiting
       toxicity (DLT) in cy.1 (gd.IV decreases ANC), therefore cohort B was
       opened. Cohort B--9 pts. RESPONSE: 8 pts. evaluable--complete 5/8,
       partial 1/8, progression 2/8. TOXICITY: 8 pts. evaluable. Febrile
       neutropenia as DLT--2 pts. Cardiac toxicity from epirubicin--1 pt.
       Overall, 10/14 patients are still alive. These preliminary results
       suggest the doses in cohort B define the MTD of CEOP which can be
       combined with filgrastim and antiretroviral treatment with acceptable
       haematological toxicities.
 DE    Antineoplastic Agents, Combined/*ADMINISTRATION & DOSAGE/ADVERSE
       EFFECTS  Antiviral Agents/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS
       Combined Modality Therapy  Comparative Study
       Cyclophosphamide/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS  Dose-Response
       Relationship, Drug  Drug Administration Schedule
       Epirubicin/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS  Granulocyte
       Colony-Stimulating Factor/*ADMINISTRATION & DOSAGE/  ADVERSE EFFECTS
       Human  Lymphoma, AIDS-Related/*DRUG THERAPY  Neutropenia/CHEMICALLY
       INDUCED/PREVENTION & CONTROL  Prednisone/ADMINISTRATION & DOSAGE/ADVERSE
       EFFECTS  Recombinant Proteins/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS
       Vincristine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS  CLINICAL TRIAL
       CLINICAL TRIAL, PHASE I  MEETING ABSTRACT

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).