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( ) 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), anthracycline- based 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% 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 anthracycline- based 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 hormone- sensitive 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.

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. Primary Validity Guidelines

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.