Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer
2003

Gemcitabine and Mitoxantrone for Metastatic Breast Cancer

Sample size: 63 publication Evidence: moderate

Author Information

Author(s): Lorusso V, Crucitta E, Silvestris N, Catino A, Caporusso L, Mazzei A, Guida M, Latorre A, Sambiasi D, D'Amico C, Schittulli F, Calabrese P, De Lena M

Primary Institution: Oncology Institute, Bari, Italy

Hypothesis

The study aims to evaluate the maximum tolerated dose and the efficacy of gemcitabine plus mitoxantrone in patients with metastatic breast cancer previously treated with chemotherapy.

Conclusion

The combination of gemcitabine and mitoxantrone is active and safe for patients with advanced breast cancer who have been previously treated with chemotherapy.

Supporting Evidence

  • The combination therapy showed a manageable toxicity profile.
  • Partial responses were observed in 30% of patients in the phase II study.
  • Neutropenia was the most common side effect, occurring in 32.5% of patients.

Takeaway

This study tested a new combination of two cancer drugs to help women with advanced breast cancer, and it showed that the drugs can work well together without causing too many side effects.

Methodology

Patients received gemcitabine and mitoxantrone in a phased approach, with dose escalation based on toxicity and response.

Limitations

The study was limited to patients who had previously received anthracyclines and taxanes, which may affect the generalizability of the results.

Participant Demographics

The study included 63 women with a median age of 52 years, with varying performance statuses and previous treatments.

Statistical Information

Confidence Interval

95% CI: 21–53%

Digital Object Identifier (DOI)

10.1038/sj.bjc.6600780

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