Using the 21‐gene assay from core needle biopsies to choose neoadjuvant therapy for breast cancer: A multicenter trial

• Published in: Journal of surgical oncology Vol. 115; no. 8; pp. 917 - 923
• Main Authors: Bear, Harry D., Wan, Wen, Robidoux, André, Rubin, Peter, Limentani, Steven, White, Richard L., Granfortuna, James, Hopkins, Judith O., Oldham, Dwight, Rodriguez, Angel, Sing, Amy P.
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 15.06.2017
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Agents - therapeutic use; Aromatase Inhibitors - therapeutic use; Biopsy; Biopsy, Large-Core Needle; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - genetics; Breast Neoplasms - pathology; Breast Neoplasms - surgery; Cancer surgery; chemotherapy; Chemotherapy, Adjuvant; Clinical Decision-Making; Female; gene expression; Gene Expression Profiling - methods; hormonal therapy; Humans; Mastectomy, Segmental; Middle Aged; neoadjuvant; Neoadjuvant Therapy; Pilot Projects; Prospective Studies; Receptors, Estrogen; Receptors, Progesterone; Tumors; hormonal therapy; breast cancer; neoadjuvant; chemotherapy; gene expression
• ISSN: 0022-4790; 1096-9098; 1096-9098
• DOI: 10.1002/jso.24610

Objective We hypothesized that the Oncotype Dx® 21‐gene Recurrence Score (RS) could guide neoadjuvant systemic therapy (NST) to facilitate breast conserving surgery (BCS) for hormone receptor positive (HR+) breast cancers. Methods This study enrolled patients with HR+, HER2‐negative, invasive breast cancers not suitable for BCS (size ≥ 2 cm). Core needle biopsy blocks were tested. For tumors with RS < 11, patients received hormonal therapy (NHT); patients with RS > 25 tumors received chemotherapy (NCT); patients with RS 11‐25 were randomized to NHT or NCT. Primary endpoint was whether 1/3 or more of randomized patients refused assigned treatment. Results Sixty‐four patients were enrolled. Of 33 patients with RS 11‐25, 5 (15%) refused assignment to NCT. This was significantly lower than the 33% target (binomial test, P = 0.0292). Results for clinical outcomes (according to treatment received for 55 subjects) included successful BCS for 75% of tumors with RS < 11 receiving NHT, 72% for RS 11‐25 receiving NHT, 64% for RS 11‐25 receiving NCT, and 57% for RS > 25 receiving NCT. Conclusions Using the RS to guide NST is feasible. These results suggest that for patients with RS < 25 NHT is a potentially effective strategy.