A phase II trial of vinorelbine and thiotepa in metastatic breast cancer

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Abstract

Background: Vinorelbine as single-agent has achieved an overall response rate of >20% as second-line treatment and 40%-50% as first-line treatment. The aim of this study was to evaluate the activity and toxicity of the combination of vinorelbine and thiotepa as second-line treatment in patients with metastatic breast cancer. Patients and methods: Thirty-three patients (31: anthra-cycline-based chemotherapy, 16: high-dose epirubicin) were given vinorelbine 30 mg/m2 and thiotepa 12 mg/m2 d 1 and 8 every 21 days. Results: Among the 32 evaluable patients two complete responses and seven partial responses were observed, for an overall response rate of 28% (C.I. 12-44). The median duration of response was 9 months and the median time to progression 6 months. Significant toxicity was primarily leukopenia (72%); anemia was also frequent (48%) as well as local phlebitis (39%). Conclusion: The present study has shown this combination to be active as second-line treatment, and its toxic effects have been well tolerate. It should be considered a reasonable option for patients with metastatic disease who have already been treated with anthracyclines. © 1995 Kluwer Academic Publishers.

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Fabi, A., Tonachella, R., Savarese, A., Cirulli, S., Tomao, S., Conte, E., & Cognetti, F. (1995). A phase II trial of vinorelbine and thiotepa in metastatic breast cancer. Annals of Oncology, 6(2), 187–189. https://doi.org/10.1093/oxfordjournals.annonc.a059115

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