J Breast Cancer.  2022 Dec;25(6):473-484. 10.4048/jbc.2022.25.e49.

Predicting the Response of Neoadjuvant Chemotherapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer With Axillary Lymph Node Metastasis by Multigene Assay

• Lee JH
• Ryu JM
• Ahn JH
• Cho SY
• Lee SK
• Yu J
• Chae BJ
• Nam SJ
• Han J
• Lee JE
• Kim SW

• KMID: 2537644
• DOI: http://doi.org/10.4048/jbc.2022.25.e49

Abstract

Purpose
The GenesWell™ breast cancer test (BCT) is a recently developed multigene assay that predicts the risk of distant recurrence in patients with hormone receptor-positive (HR+) and human epidermal growth factor-2 negative (HER2−) early breast cancer (BC). The ability of this assay to predict the response to neoadjuvant chemotherapy (NACT) has not been established to date.
Methods
Biopsy specimens from HR+/HER2− BC patients with axillary lymph node (LN) metastasis who underwent NACT were analyzed using the BCT score. The modified BCT score was developed and patients classified into high-and low-response groups. A total of 88 patients were available for the BCT score among the 108 eligible patients. The median followup duration was 35.9 (7.8–128.5) months.
Results
Among them, 61 (65.1%) had cN1 and 53 (60.2%) had cT1 or cT2 disease. The BCT score was low in 25 (28.4%) patients and high in 63 (71.6%). Among the 50 patients with pathologic complete response or partial response, 41 (82.0%) were in the high BCT score group and 9 (18.0%) were in the low BCT score group. Among the 38 patients with stable or progressive disease, 22 (57.9%) were in the high BCT score group and 16 (42.1%) were in the low BCT score group (p = 0.025). Ki-67 before NACT was a significant factor for predicting tumor response (p = 0.006; 3.81 [1.50–10.16]). The BCT score showed a significant response to NACT (p = 0.016; 4.18 [1.34–14.28]). Distant metastasis-free survival was significantly different between the high- and low-response groups (p = 0.004).
Conclusion
We demonstrated that the BCT score predicts NACT responsiveness in HR+/ HER2− BC with LN metastasis and might help determine whether NACT should be performed. Further studies are required to validate these results.

Keyword

Breast Neoplasms; Genomics; Lymphatic Metastasis; Neoadjuvant Therapy; Recurrence