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Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials BACKGROUND • Background Quinquennial overviews(19852000) of the randomized trails in early breast cancer have assessed the 5-year and 10-year effects of various systemic adjuvant therapies on breast cancer recurrence and survival. • Reporting 10-year and 15-year effects BACKGROUND • The Early Breast Cancer Trialists’ Collaborative Group coordinated the world's largest collaborative analysis of cancer trials, bringing together data from 145,000 women with early METHODS • Collaborative meta-analyses were undertaken of 194 unconfounded randomised trails of adjuvant chemotherpay or hormonal therapy that began by 1995 • Trails involved CMF(cyclophosphomide, methotrexate, fluorouracil), anthracyclinebased combinations such as FAC, FEC, Tamoxifen, or ovarian suppression:none involved taxanes, trastuzumab, raloxifene RESULTS • Finding Allocation to about 6 months of anthracycline-based chemotherapy reduces annual breast cancer death rate by about 38% <50 yrs women, 20% >50-69 • More significant thant CMF therapy RESULTS • that were being tested in the 1980s, and have since been widely used, such as 6 months of • anthracycline-based chemotherapy (in which an anthracycline is combined with two older drugs, .uorouracil and cyclophosphamide) and 5 years of tamoxifen. Results • The investigators found that where both chemotherapy and hormonal therapy are appropriate they can approximately halve the 15-year risk of death from breast cancer. RESULTS • if a 50-year-old women had a one in 5 risk of dying from her hormone-sensitive breast cancer, then this risk could be halved, to about one in 10. • For middle-aged wome with breast cancer, 6 months of anthracyclinebased chemotherapy reduces the breast cancer death rate over the next 10 or 15 years by about one third. RESULTS • For women of any age with hormonesensitive early breast cancer, the commonest form of the disease, 5 years of tamoxifen also reduces the breast cancer death rate over the next 10 or 15 years by about one third INTERPRETATION • Some of the widely practicable adjuvant drug treatments that were being tested in the 1980’s which substantially reduced 5 year recurrence rates(bu had somewhat less effect on 5-year mortality rates) • Also substantially reduce 15-year mortality rates Primary Validity Guidelines • Was the assignment of the patients randomized? Yes. Primary Validity Guidelines • Were all patients who entered the trial accounted for at its conclusion? Yes. Primary Validity Guidelines • Was the follow-up complete? Yes. Primary Validity Guidelines • Were the patients analyzed in groups to which they were randomized? Yes. Secondary Validity Guidelines • Were the patients and health workers blind to the treatment? Yes. Secondary Validity Guidelines • Were the groups similar at the start of the trial? Yes. Secondary Validity Guidelines • Aside from the experimental intervention, were the groups treated equally? Yes.