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

作者信息

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

机构信息

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

出版信息

Ann Oncol. 2002 Nov;13(11):1730-6. doi: 10.1093/annonc/mdf290.

DOI:10.1093/annonc/mdf290
PMID:12419744
Abstract

BACKGROUND

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

PATIENTS AND METHODS

Cisplatin (80 mg/m(2) day 1) and vinorelbine (25 mg/m(2) 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.

摘要

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