Document 2780
 DOCN  M94A2780
 TI    Randomized comparison of granisetron vs ondansetron in patients with
       HIV-related malignant tumors receiving moderately emetogenic
       chemotherapy regimens.
 DT    9412
 AU    Spina M; Fedele P; Valentini M; Vaccher E; Errante D; Tavio M; Nasti G;
       Bernardi D; Polizzi P; Tirelli U; Division of Medical Oncology and AIDS,
       C.R.O., Aviano (PN) Italy.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):226 (abstract no. PB0332). Unique
       Identifier : AIDSLINE ICA10/94369795
 AB    OBJECTIVES: Patients (pts) receiving antineoplastic chemotherapy (CT)
       usually experience nausea (N) and vomiting (V) among its most
       distressing side effects. There are no data published in the literature
       regarding the evaluation of both granisetron and ondansetron in pts with
       HIV infection and under CT for malignant tumors. METHODS: From June to
       October 1993 we enrolled 16 consecutive pts (15 males and 1 female) with
       HIV infection and malignant tumors (14 non-Hodgkin's Lymphoma, 1
       Kaposi's Sarcoma, 1 lung cancer) in a prospective randomized study
       comparing granisetron (3 mg/day) and ondansetron (8 mg prior to CT, 4
       and 8 hours post CT): pts received one of the antiemetogenic drugs at
       the odd cycles and the alternative drug at the even cycles. RESULTS: The
       vast majority of these pts were intravenous drug abusers (13/16), but at
       the time of CT they were not reporting the use of illicit drugs. All pts
       were treated with moderately emetogenic CT regimens including
       cyclophosphamide, doxorubicin, vincristine, bleomycin, etoposide,
       cisplatin, mitoxantrone and prednimustine. The median age of our pts was
       36 years (range 28-79 years) and the total number of administered cycles
       was 50 (25 with ondansetron and 25 with granisetron). During CT no
       significant difference between the two groups were observed: 5 episodes
       of N-V with ondansetron (4 G1 and 1 G2 according WHO) and 10 episodes of
       N-V with granisetron (6 G1, 3 G2 and 1 G4). The overall incidence and
       nature of adverse events was similar between the groups with headache
       and constipation occurring more frequently in both groups. DISCUSSION
       AND CONCLUSIONS: Our data show that both ondansetron and granisetron are
       highly effective agents for prophylaxis of emesis in patients with HIV
       infection and tumors receiving moderately emetogenic CT regimens.
       Granisetron may be preferred both for the single dose administration and
       the less expense, especially in pts with HIV infection with related
       socio-economic problems.
 DE    Antiemetics/*THERAPEUTIC USE  Antineoplastic Agents, Combined/*ADVERSE
       EFFECTS/THERAPEUTIC USE  Bleomycins/ADMINISTRATION & DOSAGE/ADVERSE
       EFFECTS  Cisplatin/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS  Comparative
       Study  Cyclophosphamide/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS
       Doxorubicin/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS
       Etoposide/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS  Female
       Granisetron/*THERAPEUTIC USE  Human  Lung Neoplasms/DRUG THERAPY
       Lymphoma, AIDS-Related/*DRUG THERAPY  Male  Mitoxantrone/ADMINISTRATION
       & DOSAGE/ADVERSE EFFECTS  Nausea/CHEMICALLY INDUCED/*PREVENTION &
       CONTROL  Ondansetron/*THERAPEUTIC USE  Prednimustine/ADMINISTRATION &
       DOSAGE/ADVERSE EFFECTS  Prospective Studies  Sarcoma, Kaposi's/DRUG
       THERAPY  Support, Non-U.S. Gov't  Treatment Outcome
       Vincristine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS  Vomiting/CHEMICALLY
       INDUCED/*PREVENTION & CONTROL  CLINICAL TRIAL  MEETING ABSTRACT
       RANDOMIZED CONTROLLED TRIAL

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       protected by Copyright Law (Title 17, U.S.Code).