Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 521
© 2008 American Society of Clinical Oncology

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Abstract

Randomized phase III trial comparing the sequential administration of docetaxel followed by epirubicin plus cyclophosphamide versus FE₇₅C as adjuvant chemotherapy in axillary lymph node-positive breast cancer

Breast Cancer Investigators of the Hellenic Oncology Research Group, Heraklion, Greece

521

Background: The role of adding docetaxel to an anthracycline-based regimen in the adjuvant setting of node-positive early breast cancer was investigated in this multicenter study. Methods: Women with axillary node-positive operable breast cancer who had lumpectomy or mastectomy with axillary lymph node dissection, performance status 0–2 (WHO) and good organ function were randomized to receive either docetaxel 100 mg/m² every 21 days for 4 cycles followed by epirubicin 75 mg/m² plus cyclophosphamide 700 mg/m² on day 1 every 21 days for 4 cycles (T-EC) or FEC (5-fluorouracil 700 mg/m² plus epirubicin 75 mg/m² plus cyclophosphamide 700 mg/m²) every 21 days for 6 cycles without primary growth factor support. This was a prospective, randomized, stratified study with 5-year relapse-free survival (RFS) rate as the primary endpoint. Planned sample size was 376 women/arm with power 0.8 and alpha error 0.05. Results: A total of 756 women were randomized to T-EC (n=378) and FEC (n=378). 30% and 27% of women were premenopausal while 37% and 32% had 1–3 positive axillary nodes on T-EC and FEC groups. Treatment was completed as per protocol for 98.1% and 98.4% of patients on the T-EC and FEC arms, respectively. Median follow-up was 62.5 (range 3.4–132.7) months for T-EC and 52.7 (range 2.8–136.2) for FEC patients. The 5-year RFS rate was 74.8% vs 68.9% (log-rank test; p=0.029) for T-EC and FEC patients, respectively. There were 94 (24.9%) vs 115 (30.4%) relapses (p=0.08) and 69 (18%) vs 64 (17%) deaths (p=0.6) in T-EC vs FEC patients, respectively. Severe toxicity included grade 3–4 neutropenia 72% vs 42% (p=0.0001), febrile neutropenia 8% vs 3% (p=0.003), diarrhea 3.7% vs 0% (p=0.0001) for T-EC and FEC patients, respectively. Secondary G-CSF support was used in 342 (90.5%) T-EC and 281 (74.3%) FEC patients (p=0.0001). Conclusions: T-EC is more effective and more toxic than FEC as adjuvant chemotherapy for women with axillary node-positive early breast cancer.

No significant financial relationships to disclose.

Abstract presentation from the 2008 ASCO Annual Meeting