We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Review of the Clinical Studies Using the 21-Gene Assay.
- Authors
Kelly, Catherine M.; Warner, Ellen; Tsoi, Daphne T.; Verma, Sunil; Pritchard, Kathleen I.
- Abstract
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-/endocrinetreated 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 costeffectiveness 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.
- Subjects
BREAST cancer research; BREAST cancer chemotherapy; HORMONE receptors; BREAST cancer patients; CANCER relapse; CYCLOPHOSPHAMIDE
- Publication
Oncologist, 2010, Vol 15, Issue 5, p447
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1634/theoncologist.2009-0277