A multicenter prospective phase II randomized trial of epirubicin/vinorelbine versus pegylated liposomal doxorubicin/vinorelbine as first-line treatment in advanced breast cancer. A GOIM study
2011

Epirubicin/Vinorelbine vs Pegylated Liposomal Doxorubicin/Vinorelbine for Advanced Breast Cancer

Sample size: 104 publication Evidence: moderate

Author Information

Author(s): Vici Patrizia, Colucci Giuseppe, Giotta Francesco, Sergi Domenico, Filippelli Gianfranco, Perri Pasquale, Botti Claudio, Vizza Enrico, Carpino Armando, Pizzuti Laura, Latorre Agnese, Giannarelli Diana, Lopez Massimo, Di Lauro Luigi

Primary Institution: Regina Elena National Cancer Institute, Rome, Italy

Hypothesis

To evaluate the activity and tolerability of two anthracycline-containing regimens as first-line treatment for anthracycline-naïve relapsed breast cancer patients.

Conclusion

Both anthracycline-containing regimens evaluated in the present study seem to be active and with satisfactory tolerability in anthracycline-naïve relapsed breast cancer patients.

Supporting Evidence

  • Responses were 42.6% for arm A and 52% for arm B.
  • Median progression free survival was 10.7 months in arm A and 8.8 months in arm B.
  • Median overall survival was 34.6 months in arm A and 24.8 months in arm B.
  • Both treatment regimens were well tolerated with manageable toxicity.

Takeaway

This study looked at two types of chemotherapy for breast cancer and found that both worked well and were tolerated by patients.

Methodology

Patients with relapsed breast cancer not previously treated with adjuvant anthracyclines were randomly assigned to receive either epirubicin/vinorelbine or pegylated liposomal doxorubicin/vinorelbine.

Limitations

The study did not include a formal comparison between the two treatment arms.

Participant Demographics

Median age was 63 years for arm A and 61 years for arm B, with a mix of premenopausal and postmenopausal women.

Statistical Information

Confidence Interval

95% CI 29.3%-55.9% for arm A and 95% CI 38.2%-65.8% for arm B.

Digital Object Identifier (DOI)

10.1186/1756-9966-30-39

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