Ifosfamide given by continuous-intravenous infusion in association with vinorelbine in patients with anthracycline-resistant metastatic breast cancer: A phase I–II clinical trial

被引：0

作者：

C. Campisi

A. Fabi

P. Papaldo

S. Tomao

B. Massidda

A. Zappala

M. T. Ionta

F. Cognetti

机构：

[1] National Research Council,

[2] Institute of Biomedical Technologies,undefined

[3] Rome,undefined

[4] Italy,undefined

[5] First Department of Medical Oncology,undefined

[6] Regina Elena Cancer Institute,undefined

[7] Viale Regina Elena,undefined

[8] 291 I-00161 Rome,undefined

[9] Italy,undefined

[10] National Institute for Cancer Research,undefined

[11] Genoa,undefined

[12] Italy,undefined

[13] Medical Oncology Institute,undefined

[14] University of Cagliari,undefined

[15] Cagliari,undefined

[16] Italy,undefined

[17] Fourth General Surgery Institute,undefined

[18] `La Sapienza' University of Rome,undefined

[19] Rome,undefined

[20] Italy,undefined

[21] Divisione Oncologia Medica I Istituto Regina Elena Viale Regina Elena 291 00161 Roma,undefined

[22] Italy Italy,undefined

来源：

Cancer Chemotherapy and Pharmacology | 1999年 / 44卷

关键词：

Key words Ifosfamide; Metastatic breast cancer; Vinorelbine;

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摘要：

Background: Vinorelbine (VNR) is highly active in metastatic breast cancer (MBC) and has shown an overall response rate of 40%–50% as first-line treatment. In vitro, a synergy has been observed between this drug and ifosfamide (IFX). In addition, the pharmacokinetics of IFX suggest that it may have greater activity when given by continuous-intravenous infusion (C.I.V.I.). The aim of this study was therefore to assess the antitumor efficacy and toxicity of the combination of bolus VNR and C.I.V.I. IFX as second-line therapy in anthracycline-resistant breast cancer patients. Patients and methods: Forty-two patients with MBC who had already received anthracycline-based chemotherapy were treated with a regimen consisting of IFX, by C.I.V.I. for 72 hours and bolus VNR. The courses were repeated every three weeks for a maximum of eight cycles. Four dose intensification steps were planned. IFX, 1.5 g/m2 on days 1–3 + VNR, 30 mg/m2 on day 1 (six patients); IFX, 2 g/m2 on days 1–3 + VNR, 25 mg/m2 on day 1 (six patients); IFX, 1.8 g/m2 on days 1–3 + VNR, 25 mg/m2 on days 1 and 8 (six patients); IFX, 2 g/m2 on days 1–3 + VNR, 25 mg/m2 on days 1 and 8 (24 patients). Sodium-2-mercaptoethane sulfonate (mesna) was associated with IFX at an infusion ratio of 1:1 and, once the infusion was completed, per os every four hours for three times. Results: All of the 42 patients entered were assessable for toxicity, and 41 of them for response. Neutropenia was the most frequently-occurring toxicity, but only five patients at the highest dose level (11.9%) presented grade 4, and none of those at the first three steps. Other significant toxic effects were mild (only grade I–II). The median relative dose intensity was 95% at the highest dose level and all the treatments were administered on an out-patient basis. The overall response rate was 36.5% with a CR rate of 4.8% (two of 41 patients, all at the highest dose level) and a PR rate of 31.7% (13 of 41 patients). The median response duration was 7.0 months (range 2–13 months). Conclusions: The present phase I–II study shows that the IFX and VNR combination is an active and well-tolerated treatment in MBC and provides an alternative to taxanes for patients previously treated with anthracyclines.

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