PURPOSE: A major challenge in treating early-stage hormone receptor (HR)(+) breast cancer is selecting women who, after initial surgery, do not require chemotherapy. Better prognostic and predictive tests are needed. The 21-gene assay is the only widely commercially available gene signature that can be performed on formalin-fixed paraffin-embedded tissue. METHODS: We conducted a review of the literature supporting the prognostic and predictive ability of the 21-gene assay in HR(+) node-negative and node-positive breast cancer patients in chemotherapy-/endocrine-treated and untreated populations. We considered: (a) How accurate is the recurrence score (RS) as a prognostic factor for distant recurrence? (b) How accurate is the RS as a predictive factor for benefit from systemic therapy? (c) How does the RS compare with other prognostic/predictive factors such as tumor size, tumor grade, patient age, and integrated decision aids such as Adjuvant! Online? (d) How do patients and physicians view the 21-gene assay? (e) What are the cost implications of the 21-gene assay? RESULTS: The 21-gene assay: (a) provided accurate risk information; (b) predicted response to cyclophosphamide, methotrexate, and 5-fluorouracil and to cyclophosphamide, doxorubicin, and 5-fluorouracil chemotherapy; (c) added additional information to traditional biomarkers; (d) was viewed positively by both physicians and patients; and (e) fell within the cost-effectiveness values in North America. CONCLUSION: This assay may be offered to patients with node-negative HR(+) breast cancer to assist in adjuvant treatment decisions. Data are accumulating to support the use of the 21-gene assay in HR(+) node-positive patients.
PURPOSE: A major challenge in treating early-stage hormone receptor (HR)(+) breast cancer is selecting women who, after initial surgery, do not require chemotherapy. Better prognostic and predictive tests are needed. The 21-gene assay is the only widely commercially available gene signature that can be performed on formalin-fixed paraffin-embedded tissue. METHODS: We conducted a review of the literature supporting the prognostic and predictive ability of the 21-gene assay in HR(+) node-negative and node-positive breast cancerpatients in chemotherapy-/endocrine-treated and untreated populations. We considered: (a) How accurate is the recurrence score (RS) as a prognostic factor for distant recurrence? (b) How accurate is the RS as a predictive factor for benefit from systemic therapy? (c) How does the RS compare with other prognostic/predictive factors such as tumor size, tumor grade, patient age, and integrated decision aids such as Adjuvant! Online? (d) How do patients and physicians view the 21-gene assay? (e) What are the cost implications of the 21-gene assay? RESULTS: The 21-gene assay: (a) provided accurate risk information; (b) predicted response to cyclophosphamide, methotrexate, and 5-fluorouracil and to cyclophosphamide, doxorubicin, and 5-fluorouracil chemotherapy; (c) added additional information to traditional biomarkers; (d) was viewed positively by both physicians and patients; and (e) fell within the cost-effectiveness values in North America. CONCLUSION: This assay may be offered to patients with node-negative HR(+) breast cancer to assist in adjuvant treatment decisions. Data are accumulating to support the use of the 21-gene assay in HR(+) node-positive patients.
Authors: Masahide Kondo; Shu Ling Hoshi; Hiroshi Ishiguro; Hiroshi Yoshibayashi; Masakazu Toi Journal: Breast Cancer Res Treat Date: 2007-12-13 Impact factor: 4.872
Authors: Shelly S Lo; Patricia B Mumby; John Norton; Karen Rychlik; Jeffrey Smerage; Joseph Kash; Helen K Chew; Ellen R Gaynor; Daniel F Hayes; Andrew Epstein; Kathy S Albain Journal: J Clin Oncol Date: 2010-01-11 Impact factor: 44.544
Authors: Laurel A Habel; Steven Shak; Marlena K Jacobs; Angela Capra; Claire Alexander; Mylan Pho; Joffre Baker; Michael Walker; Drew Watson; James Hackett; Noelle T Blick; Deborah Greenberg; Louis Fehrenbacher; Bryan Langholz; Charles P Quesenberry Journal: Breast Cancer Res Date: 2006-05-31 Impact factor: 6.466
Authors: William B Wong; Scott D Ramsey; William E Barlow; Louis P Garrison; David L Veenstra Journal: Contemp Clin Trials Date: 2012-08-18 Impact factor: 2.226
Authors: Brian Godman; Alexander E Finlayson; Parneet K Cheema; Eva Zebedin-Brandl; Inaki Gutiérrez-Ibarluzea; Jan Jones; Rickard E Malmström; Elina Asola; Christoph Baumgärtel; Marion Bennie; Iain Bishop; Anna Bucsics; Stephen Campbell; Eduardo Diogene; Alessandra Ferrario; Jurij Fürst; Kristina Garuoliene; Miguel Gomes; Katharine Harris; Alan Haycox; Harald Herholz; Krystyna Hviding; Saira Jan; Marija Kalaba; Christina Kvalheim; Ott Laius; Sven-Ake Lööv; Kamila Malinowska; Andrew Martin; Laura McCullagh; Fredrik Nilsson; Ken Paterson; Ulrich Schwabe; Gisbert Selke; Catherine Sermet; Steven Simoens; Dominik Tomek; Vera Vlahovic-Palcevski; Luka Voncina; Magdalena Wladysiuk; Menno van Woerkom; Durhane Wong-Rieger; Corrine Zara; Raghib Ali; Lars L Gustafsson Journal: BMC Med Date: 2013-08-13 Impact factor: 8.775