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

A. Fabi, R. Tonachella, A. Savarese, S. Cirulli, S. Tomao, E. Conte, F. Cognetti

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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: anthracycline-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 tolerated. It should be considered a reasonable option for patients with metastatic disease who have already been treated with anthracyclines.

Original languageEnglish
Pages (from-to)187-189
Number of pages3
JournalAnnals of Oncology
Issue number2
Publication statusPublished - 1995


  • Metastatic breast cancer
  • Vinorelbine + thiotepa

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Statistics, Probability and Uncertainty
  • Applied Mathematics
  • Public Health, Environmental and Occupational Health
  • Neuropsychology and Physiological Psychology
  • Hematology


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