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Sequential Adjuvant Treatment With Docetaxel Improves Outcomes for Node Positive Breast Cancer: Presented at SABCS

By Ed Susman

SAN ANTONIO, TX -- December 10, 2004 -- Breast cancer patients who receive adjuvant therapy that consists of 3 treatments of fluorouracil, epirubicin, and cyclophosphamide (FEC 100) followed by 3 treatments with docetaxel fare better than those who receive 6 cycles of FEC 100.

Principal investigator Henri Roché, MD, professor of medical oncology, Institut Claudius Regaud, Toulouse, France, and researchers at the Federation National des Centres de Lutte Contre le Cancer Women conducted a trial of 1999 women with operable, node-positive, early stage breast cancer.

In this cohort, 993 women were randomized to receive 6 cycles of FEC 100 and 1,003 were assigned to 3 cycles of FEC 100 and then 3 cycles of docetaxel 100 mg/m² on the first day of the cycle, with the cycles were repeated every 21 days.

The FEC 100 regimen consisted of 5-fluorouracil 500 mg/m², epirubicin 100 mg/m², and cyclophosphamide 500 mg/m² on the first day of the cycle and then repeating that regimen every 3 weeks.

"We saw a 23% increase in 5-year overall survival using the FEC 100 plus docetaxel regimen," said Dr. Roché in an oral presentation here on December 10th at the 27th San Antonio Breast Cancer Symposium.

The 5-year survival for patients taking the sequential treatment was 90.7% compared with 86.7% among patients taking 6 cycles of FEC (P =.017), Dr. Roché said. Patients receiving the sequential treatment achieved a disease-free survival rate of 78.3% in the sequential arm and 73.2% in the FEC100-only arm (P =.014), he said.

"These results may provide additional hope for women with node-positive, early stage breast cancer," Dr. Roché said.

"Women aged 50 years or older may particularly benefit from this regimen," he added. The finding that the benefit of the sequential treatment appeared to be better in older women than in younger women "came as a surprise to us," he said.

Clifford Hudis, MD, chief, Breast Cancer Medicine Service, and associate attending physician, Memorial Sloan-Kettering Cancer Center, New York, New York, said, "I would be cautious about putting too much emphasis on the age differences. We have to be wary about the findings in subsets of patients, especially when those findings are not what we would expect."

"I certainly wouldn't want anyone to withhold treatment with docetaxel from a young woman on the basis of this study," Dr. Hudis said.

He said that the fewer cycles of epirubicin in the sequential treatment might also be helpful in preventing heart problems that often occur with anthracycline-based chemotherapy regimens.

William Gradishar, MD, associate professor of medicine, Northwestern University Medical School, Chicago, Illinois, commented, "The study results reaffirm that epirubicin is an integral component of treatment of patients with node-positive breast cancer."

The independent study received partial funding from Pharmacia Corporation, now part of Pfizer Inc., the marketer of epirubicin (Ellence) and by Sanofi-Aventis, which markets docetaxel (Taxotere).


[Presentation title: Five Years Analysis of the PACS 01 trial: 6 Cycles of FEC100 Vs. 3 Cycles of FEC100 Followed by 3 Cycles of Docetaxel (D) for the Adjuvant Treatment of Node Positive Breast Cancer. Abstract 27]

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