Outcome Measures

The clinical impact of different treatment strategies (i.e., tamoxifen alone vs. systemic chemotherapy followed by tamoxifen) was assessed by estimating life-years saved (LYS) as estimated from NSABP B-20 and B-14. The impact of the treatment strategies on health-related quality of life was derived from published studies of patient preferences or health utilities for different treatment strategies (19,20). These studies are based on a time trade-off method where patients determine the maximum number of years of their life expectancy with disease that they would be willing to give up for an ability to live in full health. This game theory approach is based on the premise that many patients would be willing to give up some length of life for a higher quality (or disease free) survival. A utility index is calculated as the ratio

NSABP B-14 Prospective Clinical Validation Study Recurrence Score as a Continuous Predictor

NSABP B-14 Prospective Clinical Validation Study Recurrence Score as a Continuous Predictor

Recurrence Score

FIGURE 1 A recurrence score (RS) generated as a continuous measure by fitting a time-varying piece-wise log-hazard ratio model to the 10-year distant recurrence rate. Women with node negative, receptor positive, early-stage breast cancer are classified as high (RS >31), intermediate (RS 18-30), or low (RS <18) risk of distant recurrence at 10 years. Source: From Ref. 11.

Recurrence Score

FIGURE 1 A recurrence score (RS) generated as a continuous measure by fitting a time-varying piece-wise log-hazard ratio model to the 10-year distant recurrence rate. Women with node negative, receptor positive, early-stage breast cancer are classified as high (RS >31), intermediate (RS 18-30), or low (RS <18) risk of distant recurrence at 10 years. Source: From Ref. 11.

of disease-free years divided by the equivalent number of years in the current diseased state. The utility value will range from 0 (worst possible health or death) to 1 (perfect health). Clinical outcomes were then adjusted in the form of the QALY as a product of the actual life expectancy multiplied by the patient health utility.

The costs of cancer care were obtained from data available from the Centers for Medicare and Medicaid Services (CMS) and published literature (21). Chemotherapy costs were calculated using drug average wholesale price (AWP) and other treatment-related direct and indirect costs were not considered. Utility estimates for the quality of life impact of adjuvant breast cancer chemotherapy were derived from published literature for this disease state (19,20). Costs not considered in this analysis include additional direct costs associated with drug administration, professional fees, and laboratory testing along with indirect costs such as transportation and loss of productivity costs and patient out-of-pocket expenses.

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