The standardized definitions for efficacy end points (STEEP) criteria were used for end-point definitions.9 (link) One end point was the distant recurrence–free interval, referred to here as distant recurrence (defined as the time from registration to the date of distant recurrence of breast cancer, or of death with distant recurrence, if death was the first manifestation of distant recurrence). Another end point was invasive disease–free survival, defined as the time from registration to the first event of recurrence (distant or locoregional), second primary cancer (excluding nonmelanoma skin cancers), or death without evidence of recurrence.
A prespecified secondary trial objective was to determine whether clinical risk, as assessed with the use of the Adjuvant! algorithm, added information regarding prognosis for recurrence and prediction of chemotherapy benefit to that projected by the Oncotype DX test.7 (link) Classic pathologic information and outcome results were also used to refine models based on classic information and genomic tests. Adjuvant! is a tool that uses clinicopathological characteristics to provide estimates of breast cancer outcomes at 10 years on the basis of the Surveillance, Epidemiology, and End Results registry data and treatment effects associated with adjuvant chemotherapy and endocrine therapy derived by the Early Breast Cancer Trialists’ Collaborative Group meta-analysis that has been validated in several data sets.10 (link),11 (link)Since Adjuvant! is no longer available for clinical use, we assessed the prognostic information provided by a binary clinical-risk categorization based on the Adjuvant! algorithm as used in the MINDACT (Microarray in Node-Negative Disease May Avoid Chemotherapy) trial.12 (link) A low clinical risk was defined as the probability of breast cancer–specific survival at 10 years without systemic therapy among more than 92% of women with estrogen receptor–positive tumors who received endocrine therapy alone, as projected by Adjuvant! (version 8.0).11 (link) Clinical risk was defined as low if the tumor was 3 cm in diameter or smaller and had a low histologic grade, 2 cm or smaller and had an intermediate grade, or 1 cm or smaller and had a high grade; the clinical risk was defined as high if the low-risk criteria were not met.
A prespecified secondary trial objective was to determine whether clinical risk, as assessed with the use of the Adjuvant! algorithm, added information regarding prognosis for recurrence and prediction of chemotherapy benefit to that projected by the Oncotype DX test.7 (link) Classic pathologic information and outcome results were also used to refine models based on classic information and genomic tests. Adjuvant! is a tool that uses clinicopathological characteristics to provide estimates of breast cancer outcomes at 10 years on the basis of the Surveillance, Epidemiology, and End Results registry data and treatment effects associated with adjuvant chemotherapy and endocrine therapy derived by the Early Breast Cancer Trialists’ Collaborative Group meta-analysis that has been validated in several data sets.10 (link),11 (link)Since Adjuvant! is no longer available for clinical use, we assessed the prognostic information provided by a binary clinical-risk categorization based on the Adjuvant! algorithm as used in the MINDACT (Microarray in Node-Negative Disease May Avoid Chemotherapy) trial.12 (link) A low clinical risk was defined as the probability of breast cancer–specific survival at 10 years without systemic therapy among more than 92% of women with estrogen receptor–positive tumors who received endocrine therapy alone, as projected by Adjuvant! (version 8.0).11 (link) Clinical risk was defined as low if the tumor was 3 cm in diameter or smaller and had a low histologic grade, 2 cm or smaller and had an intermediate grade, or 1 cm or smaller and had a high grade; the clinical risk was defined as high if the low-risk criteria were not met.
