Paclitaxel(Drug information on paclitaxel) (Taxol) provides a nearly 40% improvement in survival with good quality of life in patients with metastatic breast cancer, according to a landmark study led by James F. Bishop, MD, director of the Sydney Cancer Centre and Professor of Cancer Medicine at the University of Sydney, Australia.
The phase III, multicenter trial randomized 209 patients with previously untreated metastatic breast cancer to either single-agent paclitaxel or combination cyclophosphamide(Drug information on cyclophosphamide), methotrexate(Drug information on methotrexate), fluorouracil(Drug information on fluorouracil), and prednisone(Drug information on prednisone) (CMFP). Results showed a 39% 2-year survival rate in patients treated with the paclitaxel regime, as compared with a 20% rate in those given the CMFP regimen.
Improved Survival Plus Better Quality of Life
According to the study, patients treated with paclitaxel had nearly double the chance of being alive after 2 years. The median survival for the paclitaxel group was 17.3 months vs 13.9 months for the CMFP group. Paclitaxel-treated patients were shown to have approximately a 30% improvement in survival rate after adjustment was made for such factors as visceral disease, performance status, and years since initial diagnosis.
Patients taking paclitaxel also reported an improved overall quality of life, compared to patients on the CMFP arm, who experienced a decline in quality of life. Compared to the CMFP-treated patients, the paclitaxel-treated patients reported significantly less toxicities, such as nausea and vomiting, mucositis, leukopenia, and thrombocytopenia, as well as fewer infections and hospitalizations for subsequent infections.General side effects attributable to paclitaxel included alopecia, peripheral neuropathy and arthralgia/myalgia.
“This study is part of a growing body of scientific research demonstrating the value of Taxol across all stages of breast cancer. Taxol has clearly shown a survival benefit for early stage, as well as metastatic breast cancer patients,” said Dr. Bishop.
“As the more favorable regimen, Taxol should be considered a standard of care for first-line treatment of metastatic breast cancer, ” he added.
The study was published in the August 1999 issue of the Journal of Clinical Oncology.
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