Taxotere boosts survival in breast cancer study

Aventis said on Friday that Taxotere after chemotherapy improves survival in patients with early stage breast cancer.

Aventis, a unit of French drug maker Sanofi-Aventis, said early stage breast cancer patients receiving treatment with Taxotere showed a 23% lower risk of death and a 17% lower risk of relapse than patients receiving standard care.Data from the phase III clinical study on 1,999 women who had operable, node positive early stage breast cancer was presented at the 27th Charles A. Coltman, Jr. San Antonio Breast Cancer Symposium.Patients enrolled in the study received either six cycles of the standard chemotherapy regimen FEC-100 (i.e., 5-fluorouracil, epirubicin and cyclophosphamide) or three cycles of Taxotere after 3 cycles of FEC-100.Aventis said the study is the first to show the survival benefit with Taxotere in a regimen containing epirubicin.The study demonstrated an improvement in the primary endpoint of disease-free survival for patients treated with Taxotere containing regimen as compared to FEC-100 of 78.3% versus 73.2%, respectively.This benefit translated into an improvement of overall survival after 60 months follow-up, with 90.7% and 86.7% of patients alive in the arm with Taxotere versus the control arm.Five-year follow-up of women in the study did not identify any unexpected safety concerns. Patients receiving the treatment including Taxotere had higher incidence of low white blood cell count and nail disorders compared with those receiving standard treatment.However patients receiving FEC-100 alone had higher rates of neutropenia, anemia, nausea/vomiting, and higher rates of decreased and subnormal left ventricular ejection fraction (LVEF) at the end of their chemotherapy treatments.The study, which is known as PACS 01, is also the second to show a long-term survival advantage for including Taxotere as part of an adjuvant treatment for breast cancer.All the patients in the study received radiation therapy within four weeks of their last week of chemotherapy and some patients were given tamoxifen daily for five years.(Source: Reuters Health: Oncolink: December 2004.)