To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ECCO: Taxol®/Doxorubicin Improves Survival In Metastatic Breast Cancer URL: http://www.pslgroup.com/dg/13144A.htm Doctor's Guide September 22, 1999
VIENNA, AUSTRIA -- September 22, 1999 -- 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, recently presented at the European Conference on Clinical Oncology (ECCO-10).
The study enrolled 267 women who received either Taxol in combination with doxorubicin or 5-fluorouracil, doxorubicin, cyclophosphamide (FAC) a drug regimen considered a standard for the first-line treatment of metastatic breast cancer. 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 as an important first-line 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.
Of the 264 women treated in the trial, 131 received the Taxol/doxorubicin combination and 133 received the FAC regimen. 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.
Median time to progression was significantly superior for the Taxol/doxorubicin arm 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 percent improvement in survival time for the Taxol combination regimen over the standard control arm. An analysis of response rate demonstrated that 68 percent of patients in the Taxol/doxorubicin arm experienced a favorable response to treatment, compared to 55 percent in the FAC arm. Twice as many patients treated with the Taxol combination regimen achieved a complete response, specifically 19 percent versus 8 percent 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 percent of patients receiving AT and 94 percent of patients receiving FAC. This incidence did not translate into any significant difference in terms of infection (2 percent vs. 0 percent) or febrile neutropenia (8 percent vs. 5 percent). Grade 3-4 arthralgia/myalgia (10 percent vs. 0 percent), peripheral neuropathy (12 percent vs. 0 percent), and diarrhea (2 percent vs. 0 percent) were observed more frequently in the Taxol/doxorubicin arm, while nausea/vomiting was observed more frequently in the FAC arm (8 percent vs. 18 percent). Significantly, no congestive heart failure was reported in patients receiving the Taxol/doxorubicin regimen, despite the achievement of maximum cumulative doses of doxorubicin. Cardiotoxicities are the most important side effect associated with doxorubicin-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 a 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
More than 180,000 new cases of breast cancer are diagnosed in the United States every year. There are an estimated 164,000 women living with metastatic breast cancer.
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.
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