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Annals of Oncology 13:1730-1736, 2002
© 2002 European Society for Medical Oncology

Original Paper

A phase II study of cisplatin and vinorelbine in patients with metastatic breast cancer

G. Mustacchi+, M. Muggia, S. Milani, R. Ceccherini, M. L. Leita and C. Dellach

Centro Oncologico, Azienda per i Servizi Sanitari 1, Università di Trieste, Trieste, Italy

Received 18 December 2001; revised 6 May 2002; accepted 24 May 2002

Background:

To evaluate the efficacy and safety of the combination of cisplatin and vinorelbine in metastatic breast cancer.

Patients and methods:

Cisplatin (80 mg/m2 day 1) and vinorelbine (25 mg/m2 days 1 and 8) were administrated every 3 weeks to 52 patients (mean age 57 years; range 35–75 years) with metastatic breast cancer. Thirty-two patients were previously untreated for metastatic disease. Treatment was repeated for a maximum of six cycles.

Results:

Objective responses were obtained in 27 patients (52.9%; complete response 9.8%). The response rate was similar in pretreated and untreated patients (50% and 54.7%, respectively; P = 0.7). ECOG performance status was good (grade 0 or 1) in 55.7% of patients at baseline assessment and in 90.3% at the end of treatment (P = 0.0001). Median time to progression was 8.5 months (8.5 months in first-line and 8.7 months in second-line patients). Median survival was 16.6 months (21.2 months in first-line and 16.1 months in second-line patients). Grade 3/4 toxicity included neutropenia (44% in first-line, 60% in second-line patients), nausea (17.3%), anemia (17%), asthenia (3.8%) and thrombocytopenia (1.9%). There were no cases of febrile neutropenia or treatment-related deaths. Alopecia did not develop in any of the patients.

Conclusions:

Cisplatin plus vinorelbine is active and tolerable in metastatic breast cancer, in untreated and pretreated patients.

Key words: chemotherapy, cisplatin, metastatic breast cancer, vinorelbine


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