TAXOL(R)-Doxorubicin Combination Significantly Improves Survival In Metastatic Breast Cancer/ Large International Trial Defines Emerging First-Line Treatment St

The anti-cancer drug TAXOL given in combination with doxorubicin significantly prolongs median time to disease progression and survival in women with metastatic breast cancer, according to results of a large Phase III international clinical trial, presented today at the European Conference on Clinical Oncology (ECCO-10). The study enrolled 267 women at 29 sites throughout 9 countries in Central and Eastern Europe and Israel over a two- year period. Half of these women were randomized to receive FAC (5-fluorouracil, doxorubicin, cyclophosphamide), a drug regimen considered standard in many countries throughout the world for the first-line treatment of metastatic breast cancer. When directly compared to this control group, women who received the TAXOL/doxorubicin combination achieved significantly longer time to disease progression, greater response to treatment and superior overall survival. "It remains an unfortunate truth that most of the 600,000 women diagnosed worldwide each year with breast cancer eventually will fight metastatic disease," said Dr. Jacek Jassem, MD, PhD, Professor of Clinical Oncology, Head, Department of Oncology and Radiotherapy, Medical University of Gdansk, Poland and principal investigator of the trial. "The aggressive management of disease at this stage is one of our greatest clinical challenges in the fight against breast cancer." Dr. Jassem further noted that when metastatic breast cancer is diagnosed, the purpose of first-line treatment is to block disease progression as completely as possible and prolong patient survival. "Based on results of this trial, the TAXOL/doxorubicin combination has emerged an important first-line treatment strategy against metastatic breast cancer that warrants immediate further development." Trial Design and Results Patients enrolled in this study were selected only if they had no prior chemotherapy for metastatic disease and no prior treatment with anthracyclines (such as doxorubicin or epirubicin) or taxanes for earlier stages of disease. Patients could have received one previous nonanthracycline chemotherapy regimen as adjuvant therapy following surgery. Prior adjuvant chemotherapy was reported at randomization in 43% of patients in the AT arm and 44% in the FAC arm. Of the 264 women treated in the trial, 131 received the TAXOL/doxorubucin combination (AT) and 133 received 5- fluouroucil, doxorubicin and cyclophosphamide (FAC). Patients were treated every three weeks for up to eight cycles. The primary objective of the study was to determine time to disease progression, a commonly used efficacy endpoint that measures the length of time from the first day of randomization until the date disease progression is first noted. Analyses of both time to progression and overall survival were performed in all randomized patients. Median time to progression was significantly superior for AT compared with FAC (8.3 months vs. 6.2 months). Survival also was superior for patients in the TAXOL arm, who achieved median survival of 22.7 months compared to 18.3 months in the FAC arm. This difference represents a 25% improvement in survival time for AT over the standard control arm. An analysis of response rate demonstrated that 68% of patients in the AT arm experienced a favorable response to treatment, compared to 55% in the FAC arm. Twice as many patients treated with AT achieved a complete response, specifically 19% versus 8% of those patients treated with FAC. Therapy was reasonably well tolerated in both arms. Neutropenia was the most frequent and severe adverse event for both regimens, occurring in 99% of patients receiving AT and 94% of patients receiving FAC. This incidence did not translate into any significant difference in terms of infection (2% vs. 0%) or febrile neutropenia (8% vs. 5%). Grade 3-4 arthralgia/myalgia (10% vs. 0%), peripheral neuropathy (12% vs. 0%), and diarrhea (2% vs. 0%) were observed more frequently in the AT arm, while nausea/vomiting was observed more frequently in the FAC arm (8% vs. 18%). Significantly, no congestive heart failure was reported in patients receiving AT while on study, despite the achievement of maximum cumulative doses of doxorubicin. Cardiotoxicities are the most important side effect associated with doxorubucin- containing combination regimens. "This trial was carefully designed to assess efficacy in women who closely represent the real world of breast cancer patients who are diagnosed with metastatic disease before receiving any prior therapy -- or following non-anthracycline adjuvant chemotherapy," said Dr. Jassem. "The results unequivocally demonstrate, within the context of this clinical trial, the superior efficacy and survival achieved by the TAXOL/doxorubicin combination when compared to FAC -- which is considered standard first-line treatment for metastatic breast cancer in Central and Eastern Europe and in other regions of the world." Breast Cancer and its Treatment Breast cancer is the most common malignancy among women in Europe and is second only to lung cancer as the leading cause of cancer among women in the United States. Each year an estimated 60,000 recorded deaths are attributable to breast cancer and 250,000 new cases occur in the E.U. Like all individuals fighting solid tumors, women diagnosed with breast cancer are at risk for metastatic disease. It is this microscopic spread of disease (metastasis) that threatens survival, not the breast tumor itself. Breast cancer metastases occur when cancer cells spread beyond the original tumor site through the lymphatic and vascular systems to form new, distant areas of cancer, originating from the breast. Local treatment with surgery and/or radiotherapy, however radical, will not prevent or control metastases in most women with breast cancer. The threat of metastases and the need to control it, if it occurs, mandates the use of systemic treatment for breast cancer, frequently more than once if the cancer progresses. Chemotherapy treats the body systemically and can be used to achieve cure, prolong life when cure is not achievable, or to palliate symptoms. Chemotherapy can be administered in earlier stages of disease as neoadjuvant therapy (before surgery), adjuvant surgery (following surgery), and then following a diagnosis of metastatic disease as first-, second- or third-line therapy. It is estimated that approximately 55,000 women are treated for metastatic breast cancer in the E.U. each year. ots Original Text Service: Medical University of Gdansk - Department of Oncology and Radiotherapy Internet: Contact: Jeff Smith, +44-171-282-1246, or Garreth Hayes, +44-171- 282-1217, for the Medical University of Gdansk - Department of Oncology and Radiotherapy Company News On-Call: or fax, 800-758-5804, ext. 137916 Web site:

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