Bortezomib/docetaxel combination therapy in patients with anthracycline-pretreated advanced/metastatic breast cancer: a phase I/II dose-escalation study
2008

Bortezomib and Docetaxel for Advanced Breast Cancer

Sample size: 48 publication Evidence: moderate

Author Information

Author(s): Awada A, Albanell J, Canney P A, Dirix L Y, Gil T, Cardoso F, Gascon P, Piccart M J, Baselga J

Primary Institution: Institut Jules Bordet, Brussels, Belgium

Hypothesis

The study aimed to determine the dose-limiting toxicities and maximum tolerated dose of bortezomib plus docetaxel in patients with anthracycline-pretreated advanced/metastatic breast cancer.

Conclusion

Bortezomib plus docetaxel is an active and manageable treatment for patients with anthracycline-pretreated advanced/metastatic breast cancer.

Supporting Evidence

  • Five patients experienced dose-limiting toxicities, including grade 3 bone pain and febrile neutropenia.
  • The maximum tolerated dose was determined to be bortezomib 1.5 mg/m2 plus docetaxel 75 mg/m2.
  • Overall patient response rate was 29%, with a median time to progression of 5.4 months.

Takeaway

This study tested a new combination of two cancer drugs to see how well they work together and found that they can help some patients with breast cancer.

Methodology

A phase I/II dose-escalation study was conducted with 48 patients receiving bortezomib and docetaxel over multiple cycles, assessing safety and efficacy.

Limitations

The study was limited by the small sample size and the specific patient population, which may not be generalizable.

Participant Demographics

The study included 47 females and 1 male, all with advanced/metastatic breast cancer who had received prior anthracycline treatment.

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604347

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