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M94A2780.TXT
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1994-10-25
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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
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).