Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 515
© 2008 American Society of Clinical Oncology

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Abstract

Interim results of Intergroup EC-Doc Trial: A randomized multicenter phase III trial comparing adjuvant CEF/CMF to EC- docetaxel in patients with 1–3 positive lymph nodes

West German Study Group, Moenchengladbach, Germany; University Hospital, Tuebingen, Germany; University Hospital, Hamburg, Germany; University Hospital, Munich, Germany; Protestant Hospital, Oberhausen, Germany; City Hospital Hoechst, Frankfurt, Germany; St. Josef Hospital, Wiesbaden, Germany; City Hospital, Deggendorf, Germany; City Hospital, Boeblingen, Germany; University Hospital, Bonn, Germany

515

Background: Taxanes and anthracyclines are the most active drugs in breast cancer. Taxane-based adjuvant chemotherapy is considered as standard in node-positive breast cancer, though a large body of evidence derives from trials testing taxanes versus a weak standard (4xAC). Subgroup analyses from several trials indicate that patients with 1 to 3 positive nodes, though at intermediate risk, will have a maximum benefit from taxane-based therapy. Methods: 2,011 patients with primary breast cancer and 1 to 3 positive lymph nodes were randomized from 3/2000 to 8/2005 to a phase III trial comparing 4 cycles E₉₀C₆₀₀ q3w followed by 4 cycles of docetaxel₁₀₀ q3w (n=1,008) (Arm A) versus a control Arm B: 6 cycles of E₁₀₀F₅₀₀ C₅₀₀ q3w (n=828) or C₆₀₀M₄₀F₆₀₀ d 1 and 8 q4w (n=175). The primary endpoint was the event-free survival (EFS). Secondary endpoints were overall survival, toxicity and quality of life. EC-Doc trial has a 80% power to detect 5 % difference in 5-year EFS. Survival rates will be compared by one-sided log-rank and Cox proportional hazard test. Results: Baseline characteristics were well balanced between both study arms. Median age of patients was 51 years in both arms. Median tumor size 2.0 and 2.05 cm (arm A/B), 69% and 71% of tumors were ER positive (A/B). Toxicity data have been presented earlier (St. Gallen 2005). 312 severe adverse events have been reported (198 in EC/Doc and 114 in CEF/CMF patients). There were 3 therapy-related deaths (2 in arm A and 1 in arm B). At the median follow-up of three years blind analysis of first primary events (34 vs. 64) and deaths (17 vs. 36) was made, so that the independent data safety committee decided to present interim analysis of the trial. Conclusions: Our preliminary data strongly suggest a superiority of one study arm in terms of EFS and early OS in an intermediate risk group. We will present a completely updated survival analysis for the comparison of EC-Doc versus FEC/CMF.

No significant financial relationships to disclose.

Abstract presentation from the 2008 ASCO Annual Meeting