No Survival Benefit for 5-FU/Docetaxel After Preoperative Epirubicin/Cyclophosphamide in Inflammatory Breast Cancer: Presented at SABCS
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No Survival Benefit for 5-FU/Docetaxel After Preoperative Epirubicin/Cyclophosphamide in Inflammatory Breast Cancer: Presented at SABCS

By Jennifer Reising

SAN ANTONIO, Tex -- December 12, 2009 -- Four cycles of postoperative 5-fluorouracil plus docetaxel (D-5FU) after preoperative, high-dose epirubicin plus cyclophosphamide and loco-regional treatment does not improve survival in women with inflammatory breast cancer, researchers said here at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS).

The benefit of taxane-based adjuvant chemotherapy after preoperative treatment in disease-free survival (DFS) and overall survival (OS) for patients with inflammatory breast cancer was evaluated in the Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) - Programme d’Etude de la Greffe Autologue dans les Cancers du Sein (PEGASE) 07 trial.

The study included 174 women aged younger than 60 years with nonmetastatic inflammatory breast cancer, all of whom had a life expectancy of >3 months.

All patients received 4 cycles of epirubicin 150 mg/m2 plus cyclophosphamide 4000 mg/m2 every 3 weeks. The women were then randomised to receive either a mastectomy with axillary lymph-node dissection and radiotherapy (EC; n =87) or 4 cycles of docetaxel 75 mg/m2 (day 1) plus 5-FU 2500 mg/m2/day continuous infusion for days 1 to 5, every 3 weeks (D-FU; n = 87).

The primary endpoint of the study was DFS after 5 years of follow-up.

“There was no difference between the 2 arms of the trial, indicating that 4 cycles of postoperative fluorouracil and docetaxel have no survival benefit in inflammatory breast cancer,” said Patrice Viens, MD, Institut Paoli Calmettes, Marseille, France, on December 11. “However, we also found there was a 5-year survival rate of 70%, which is significant.”

After a mean follow-up of 59.8 months, all patients experienced at least 1 event including loco-regional relapses (6.9%); metastases (55%); and contralateral breast cancers (2.9%). There were 3 (2.9%) deaths.

The estimated 3-year and 5-year DFS rates were 63.0 % and 55.5% in the D-5FU arm compared with 59.8% and 55.0% in the EC only group.

No differences were observed in survival rates (P = .94), with 27 patients in each arm dying during the follow-up period, and an estimated 70% 5-year survival rate in both arms.

“This is the largest study of inflammatory breast cancer that we know of, and we need more randomised studies on this disease, said Dr. Viens. “Although inflammatory breast cancer is rare, it is a very, very aggressive disease. We are already building an international consortium to work on this disease.”

Funding for this study was provided by The Ligue Nationale Contre Le Cancer, The French Health Ministry (PHRC), Sanofi-aventis France, Pfizer, and Amgen France.

[Presentation title: 5FU-Docetaxel Maintenance Regimen after High-Dose of Pre-Operative Epirubicin-Cyclophosphamide for Treatment of Inflammatory Breast Cancer: Results of the FNCLCC-PEGASE 07 Trial. Abstract 2081]

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