Anthracycline-Docetaxel Chemo as Effective, but Less Toxic Than Anthracycline Polychemotherapy

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Janette
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Anthracycline-Docetaxel Chemo as Effective, but Less Toxic Than Anthracycline Polychemotherapy

Postby Janette » Sat Dec 19, 2009 11:25 am

Presented at SABCS
By Jennifer Reising

SAN ANTONIO, Tex -- December 15, 2009 -- Sequential treatment with epirubicin plus cyclophosphamide followed by docetaxel (ECD), is less toxic and as effective as epirubicin plus 5-fluorouracil (5-FU) and cyclophosphamide (FEC), as adjuvant therapy in patients with breast cancer with extensive lymph node involvement.

Results of the multicentre, phase 3 Adjuvant Docetaxel Versus Epirubicin Based Regimen (ADEBAR) study were presented here at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS) on December 11.

"This is very good evidence that FEC has the same significant survival benefit as ECD, yet it is very toxic," said Wolfgang Janni, MD, Frauenklinik Universitätsklinikum, Düsseldorf, Germany, during a poster presentation. "Both haematologic and nonhaematologic toxicities were significantly higher in the FEC arm, compared with the ECD arm."

The study included 1,502 patients with breast cancer with >3 axillary lymph node metastases.

Patients were randomised to receive 4 cycles of a sequential anthracycline-docetaxel regimen comprised of epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 every 21 days followed by 4 cycles of docetaxel 100 mg/ m2 every 21 days or 6 cycles of a dose-intensive anthracycline-containing polychemotherapy comprised of epirubicin 60 mg/m2 on days 1 and 8, 5-FU 500 mg/m2 on days 1 and 8, and cyclophosphamide 75 mg/m2 on days 1 to 14, every 4 weeks.

The median follow-up time was 47 months.

Treatment was prematurely stopped in 3.7% of the patients in the ECD arm and in 8.0% of patients in the FEC arm due to toxicity (P = .0009). Antibiotic treatment was given in 10.4% of patients in the ECD arm versus 19.7% of patients in the FEC arm. Granulocyte colony-stimulating factor (G-CSF) support was given in 39.2% versus 61.4%, respectively, and erythropoietin stimulation in 8.7% versus 20.0%, respectively (P < .001).

Haematological toxicity, including leucopenia, neutropenic fever, thrombocytopenia, and anaemia, was significantly higher in the FEC arm.

Findings showed 281 events of breast cancer recurrence: 128 events in the FEC arm and 153 in the ECD arm. Overall survival in the 2 groups was not significantly different with 84 deaths in the FEC versus 88 deaths in the ECD arm (P = .99).

"ECD is a more feasible and safer option to dose-intensified FEC for these patients," said Dr. Janni.
Janette


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