MedicalResearch.com Interview with:
Dr. Kelly K. Hunt, M.D., F.A.C.S.
Professor, Department of Surgical Oncology, Division of Surgery
Chief, Breast Surgical Oncology Section, Department of Surgical Oncology
The University of Texas MD Anderson Cancer Center, Houston, TX
MedicalResearch.com: What are the main findings of the study?
Dr. Hunt: The primary endpoint of the Z1041 trial was the proportion of patients who had pathological complete response in the
breast, defined as the percentage of women who started the neoadjuvant treatment with no histological evidence of disease in the breast at surgery. We found that high pathologic response rates were observed in both treatment groups with similar cardiac safety profiles in both arms of the trial. Specifically, 56.5% of patients in the sequential group (fluorouracil, epirubicin and cyclophosphamide on day one of a 21-day cycle for four cycles followed by paclitaxel plus trastuzumab weekly for 12 weeks) had a complete pathological response versus 54.2% of the patients who received the concurrent regimen (paclitaxel and trastuzumab weekly for 12 weeks followed by fluorouracil, epirubicin and cyclophosphamide on day one of a 21-day cycle with trastuzumab on days one, eight and 15 of the 21-day cycle for four cycles). The difference in pathologic complete response rates between the treatment arms was not statistically significant. Cardiac safety was a secondary endpoint of the trial and we found that both regimens had acceptable cardiac safety profiles.
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