Clinical trial

Breast Cancer Research and Treatment

, Volume 127, Issue 1, pp 133-142

Comparison of the prognostic and predictive utilities of the 21-gene Recurrence Score assay and Adjuvant! for women with node-negative, ER-positive breast cancer: results from NSABP B-14 and NSABP B-20

  • Gong TangAffiliated withNational Surgical Adjuvant Breast and Bowel Project Operations and Biostatistical Centers, and Pathology DivisionDepartment of Biostatistics, Graduate School of Public Health, University of Pittsburgh Email author 
  • , Steven ShakAffiliated withGenomic Health Inc
  • , Soonmyung PaikAffiliated withNational Surgical Adjuvant Breast and Bowel Project Operations and Biostatistical Centers, and Pathology Division
  • , Stewart J. AndersonAffiliated withNational Surgical Adjuvant Breast and Bowel Project Operations and Biostatistical Centers, and Pathology DivisionDepartment of Biostatistics, Graduate School of Public Health, University of Pittsburgh
  • , Joseph P. CostantinoAffiliated withNational Surgical Adjuvant Breast and Bowel Project Operations and Biostatistical Centers, and Pathology DivisionDepartment of Biostatistics, Graduate School of Public Health, University of Pittsburgh
  • , Charles E. GeyerJr.Affiliated withNational Surgical Adjuvant Breast and Bowel Project Operations and Biostatistical Centers, and Pathology DivisionAllegheny General Hospital
  • , Eleftherios P. MamounasAffiliated withNational Surgical Adjuvant Breast and Bowel Project Operations and Biostatistical Centers, and Pathology DivisionAultman Health Foundation
  • , D. Lawrence WickerhamAffiliated withNational Surgical Adjuvant Breast and Bowel Project Operations and Biostatistical Centers, and Pathology DivisionAllegheny General Hospital
  • , Norman WolmarkAffiliated withNational Surgical Adjuvant Breast and Bowel Project Operations and Biostatistical Centers, and Pathology DivisionAllegheny General Hospital

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Abstract

The Oncotype DX® Recurrence Score® (RS) is a validated genomic predictor of outcome and response to adjuvant chemotherapy in ER-positive breast cancer. Adjuvant! was developed using SEER registry data and results from the Early Breast Cancer Clinical Trialists’ overview analyses to estimate outcome and benefit from adjuvant hormonal therapy and chemotherapy. In this report we compare the prognostic and predictive utility of these two tools in node-negative, ER-positive breast cancer. RS and Adjuvant! results were available from 668 tamoxifen-treated NSABP B-14 patients, 227 tamoxifen-treated NSABP B-20 patients, and 424 chemotherapy plus tamoxifen-treated B-20 patients. Adjuvant! results were also available from 1952 B-20 patients. The primary endpoint was distant recurrence-free interval (DRFI). Cox proportional hazards models were used to compare the prognostic and predictive utility of RS and Adjuvant!. Both RS (P < 0.001) and Adjuvant! (P = 0.002) provided strong independent prognostic information in tamoxifen-treated patients. Combining RS and individual clinicopathologic characteristics provided greater prognostic discrimination than combining RS and the composite Adjuvant!. In the B-20 cohort with RS results (n = 651), RS was significantly predictive of chemotherapy benefit (interaction P = 0.031 for DRFI, P = 0.011 for overall survival [OS], P = 0.082 for disease-free survival [DFS]), but Adjuvant! was not (interaction P = 0.99, P = 0.311, and P = 0.357, respectively). However, in the larger B-20 sub-cohort (n = 1952), Adjuvant! was significantly predictive of chemotherapy benefit for OS (interaction P = 0.009) but not for DRFI (P = 0.219) or DFS (P = 0.099). Prognostic estimates can be optimized by combining RS and clinicopathologic information instead of simply combining RS and Adjuvant!. RS should be used for estimating relative chemotherapy benefit.

Keywords

Breast cancer Oncotype DX Recurrence Score Adjuvant! Node-negative ER-positive