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Docetaxel in combination with doxorubicin: a phase I dose-finding study
1Department of Medical Oncology, Institut Curie, Paris, France.
Oncology (Williston Park, N.Y.)
|June 1, 1997
Summary
This study found that combining doxorubicin and docetaxel is an active regimen for metastatic breast cancer. Recommended doses showed an 81% response rate with manageable toxicity, primarily neutropenia.
Area of Science:
- Medical Oncology
- Clinical Pharmacology
Background:
- Metastatic breast cancer (MBC) treatment often involves combination chemotherapy.
- Doxorubicin and docetaxel are commonly used agents in breast cancer therapy.
Purpose of the Study:
- To determine the maximum tolerated doses (MTD) and recommended doses (RD) of combination doxorubicin and docetaxel in women with MBC.
- To evaluate the safety and activity of this combination regimen.
Main Methods:
- Phase I, dose-finding study involving 42 women with MBC.
- Six different dose levels of doxorubicin and docetaxel were investigated.
- Safety (adverse events, MTD) and activity (response rate) were assessed.
Main Results:
- The MTD was doxorubicin 50 mg/m2 and docetaxel 85 mg/m2, with sepsis as the dose-limiting toxicity.
- An 81% response rate was observed at higher dose levels (e.g., 50/75 mg/m2).
- Neutropenia was the primary grade 3/4 adverse event; no cardiac toxicity or fluid retention occurred.
Conclusions:
- The recommended doses are doxorubicin 50 mg/m2 and docetaxel 75 mg/m2, or both at 60 mg/m2 every 3 weeks.
- This combination demonstrates significant activity in MBC with an acceptable safety profile, particularly regarding cardiotoxicity.