ABERDEEN, Scotland, Dec. 4 /PRNewswire/ -- Taxotere(R) (docetaxel) administered as neo-adjuvant (pre-surgery) chemotherapy has been shown to significantly increase the five-year survival rates of women with large or locally advanced breast cancer when compared to standard neo-adjuvant chemotherapy, according to the results of a landmark University of Aberdeen study presented today at the 26th Annual San Antonio Breast Cancer Symposium in the United States. The study also showed that women receiving Taxotere had significantly higher tumor rates, and had significantly higher rates of breast conserving surgery.
In the randomized group, women receiving four cycles of neo-adjuvant anthracycline-based chemotherapy followed by Taxotere had a five-year survival of 97% compared to 78% among patients who received four more cycles of anthracycline-based chemotherapy (p = 0.04). In addition, women treated with Taxotere had a disease-free survival of 90% compared to 72% for women treated with four more cycles of anthracycline-based chemotherapy (p=0.04). The study also showed that patients receiving neo-adjuvant Taxotere chemotherapy had a higher complete pathological response (31% vs. 15%, p=0.06) than those receiving standard therapy. This resulted in significantly more breast conserving surgery in women who received Taxotere. Breast conserving surgery was possible in 67% of women who received Taxotere compared with only 48% in patients who received anthracycline-based chemotherapy (p=0.01). However it is not known what type of surgery these patients would have had if they had not received neo-adjuvant chemotherapy.
“These results are very promising and suggest that patients may benefit by receiving sequential Taxotere as part of their neo-adjuvant regime. However, these are early results from a small study and await confirmation from larger studies,” stated Dr. Andrew Hutcheon, Consultant Medical Oncologist, Grampian University Hospital Trust, Scotland, UK.
Study design
All patients in the study initially received four cycles of anthracycline-based chemotherapy (cyclophosphamide 1000 mg/m2, vincristine 1.5 mg/m2 [max 2 mg], doxorubicin 50 mg/m2, prednisolone 40 mg/day for five days every 21 days). Following this initial treatment, tumor response was assessed and graded. Patients who had demonstrated a partial or complete response to treatment were randomized to either four more cycles of anthracycline-based chemotherapy or four cycles of Taxotere (100 mg/m2 every 21 days).
Study results
After 162 patients were enrolled, and following four cycles of anthracycline-based chemotherapy, the breast cancers in 102 patients (66%) achieved a partial or complete clinical response. The 102 patients were then randomized to receive four additional cycles of chemotherapy. Forty-seven patients received Taxotere and 50 patients received anthracycline-based chemotherapy. Patients who received Taxotere had significantly higher response rates than those who received anthracycline-based chemotherapy both in terms of the overall clinical response (85% vs. 64%, p=0.03) and complete pathologic response (31% vs. 15%, p=0.06). At a median follow-up of 65 months, 97% in the Taxotere group were still alive compared with 78% in the anthracycline-based chemotherapy group (p=0.04). There were four deaths in the Taxotere arm and 12 deaths in anthracycline-based chemotherapy arm.
Additionally, Taxotere was better tolerated than the anthracycline-based treatment with women in the Taxotere arm of the study experiencing significantly less hematologic events (p=0.029 for leukopenic events and p= 0.006 for granulocytopenic events). Taxotere patients received a significantly higher percentage (92% vs. 86%) of the total intended drug, requiring less dose reduction due to hematologic toxicity than patients who received the anthracycline-based regimen.
Taxotere
Taxotere is currently globally indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. It is being evaluated in clinical trials as a neo-adjuvant and adjuvant breast cancer treatment.
About The University of Aberdeen
Aberdeen Royal Infirmary is the largest hospital within the Grampian University Hospitals NHS Trust. Situated on a self-contained 125 acre site at Foresterhill in Aberdeen which also contains a Children’s’ Hospital and Maternity Hospital. It is believed to be one of the largest health complexes in Europe. Very close links with the University of Aberdeen Medical School has made the Trust a centre of pioneering medical research in a number of fields. Substantial capital investment in property and medical equipment has been made at the hospital in recent years including the upgrade and refurbishment of public and ward areas.
Editor’s Note: This press release has been previously distributed in Europe.
University of Aberdeen
CONTACT: Fiona Buraimoh of Cohn & Wolfe, +1-212-798-9512,Fiona_Buraimoh@nyc.cohnwolfe.com, for University of Aberdeen
