Docetaxel and epirubicin as first-line treatment for patients with metastatic breast cancer: a Minnie Pearl Cancer Research Network Phase II trial.
BACKGROUND
Taxanes and anthracyclines are the two most active classes of cytotoxic agents in the treatment of patients with metastatic breast cancer. Epirubicin, a doxorubicin analog, has shown modest toxicity advantages when compared to the parent compound. In this Phase II trial, we evaluated the activity and toxicity of a docetaxel/epirubicin combination.


METHODS
Thirty patients with previously untreated metastatic breast cancer were treated with docetaxel 60 mg/m2 one-hour IV infusion and epirubicin 90 mg/m2 IV bolus; both drugs were repeated at 21-day intervals. Patients were evaluated for response after 2 courses of treatment; responding and stable patients continued treatment for a total of 6 courses.


RESULTS
Fifteen patients (50 percent) had objective response to treatment; an additional 20 percent of patients had stable disease of more then 6 months duration. The median and 2-year progression-free survivals were 12 months and 34 percent, respectively. Median and 2-year overall survivals were 18 months and 42 percent, respectively. Myelosuppression was the most common Grade 3/4 toxicity, and 2 patients in this trial (6 percent) had treatment-related mortality associated with severe sepsis.


CONCLUSIONS
The results of this Phase II trial confirm previous observations regarding the efficacy and toxicity profile of the docetaxel/epirubicin combination. This combination has activity similar to other taxane/anthracycline combinations used in the first-line treatment of metastatic breast cancer.
Hainsworth
John D
JD
Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, TN 37203, USA. jhainsworth@tnonc.com
Yardley
Denise A
DA
Spigel
David R
DR
Meluch
Anthony A
AA
Rinaldi
David
D
Schnell
Frederick M
FM
Greco
F Anthony
FA
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D043823:Taxoids / Q000008:administration & dosage
D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin