Randomized comparison of granisetron vs ondansetron in patients with HIV-related malignant tumors receiving moderately emetogenic chemotherapy regimens.

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Randomized comparison of granisetron vs ondansetron in patients with HIV-related malignant tumors receiving moderately emetogenic chemotherapy regimens.

Int Conf AIDS. 1994 Aug 7-12;10(1):226 (abstract no. PB0332). Unique Identifier : AIDSLINE ICA10/94369795
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.

Abstract: 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.

Keywords: Antiemetics/*THERAPEUTIC USE Antineoplastic Agents, Combined/*ADVERSE EFFECTS/THERAPEUTIC USE Bleomycin/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 ABSTRACT RANDOMIZED CONTROLLED TRIAL
941230
M94C3590

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