Open AccessReview of the Clinical Studies Using the 21‐Gene Assay
Author(s) -
Kelly Catherine M.,
Warner Ellen,
Tsoi Daphne T.,
Verma Sunil,
Pritchard Kathleen I.
Publication year - 2010
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2009-0277
Subject(s) - medicine , cyclophosphamide , breast cancer , oncology , chemotherapy , fluorouracil , methotrexate , doxorubicin , adjuvant , cancer
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.