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(1985-2000) 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% <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 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.