On August 12, 2019 Gencurix, Inc., a company dedicated in development and market of innovative molecular diagnostics, reported the publication of a new study on Frontiers in Oncology comparing GenesWell BCT, a prognostic multigene test, with Genomic Health’s Oncotype DX in patients with early-stage breast cancer (Press release, Gencurix, AUG 12, 2019, View Source [SID1234538614]). This is the first study that compares GenesWell BCT score with the Oncotype DX recurrence score (RS) for risk classification. A key finding from the study is that the overall concordance between the BCT score and RS was moderate but the concordance was low in women aged 50 years or younger, or with lymph node-positive breast cancer.

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"Although there are already several multigene expression prognostic assays available in the market, most of them are developed based on post-menopausal women," said Youngkee Shin, M.D., Ph.D., Laboratory of Molecular Pathology and Cancer Genomics, Seoul National University and the corresponding author of this article. "However, as breast cancer patients are getting younger there are concerns regarding their prognostic or predictive value in premenopausal breast cancer patients."

GenesWell BCT is a qRT-PCR-based assay developed to reflect all age groups. It measures the relative expression levels of six prognostic genes and two clinical variables (tumor size and nodal status) using FFPE tumor tissues. GenesWell BCT is a prognostic multigene assay that has been approved by Korean Ministry of Food and Drug Safety (MFDS) and its prognostic value and ability to predict chemo-benefit have been validated by a number of studies.

In the article, Mi Jeong Kwon et al. compared the risk classification by the two tests in a large sample of Asian breast cancer patients from multiple institutions in South Korea. The analysis included data from 771 patients from five institutions with HR+/HER2- and pN0/1 which is the most common form of early breast cancer. The results show that in all patients, the overall concordance between the two risk classifications was 71.9%. Especially, overall concordance was higher in the lymph node-negative subgroup (76.6%) than that in the node-positive subgroup (52.6%). Importantly, of patients in the BCT low-risk group, 91.9% were classified as non-high risk according to the RS.

The risk classification of the two tests were found to be different for patients aged 50 years or younger. This is because two different RS ranges were used to classify patients for the Oncotype DX upon age 50. The overall concordance was higher in women aged over 50 (72.8%) than in those aged 50 years or younger (52.9%). When comparing the proportion of chemobenefit group between the two test, 31.9% of patients aged 50 years or younger were classified as chemobenefit group by GenesWell BCT, whereas 55.6% by Oncotype DX based on TAILORx study presented at ASCO (Free ASCO Whitepaper) 2018. However, according to the second analysis of TAILORx study recently presented in ASCO (Free ASCO Whitepaper) 2019, patients aged 50 years or younger should take into account their clinical pathological factors in chemotherapy decisions. Based on this new RS ranges, 39.1% of patients aged 50 years or younger are expected to have chemotherapy benefit. The overall concordance in patients aged 50 years or younger was 66.3% and a higher concordance was overserved in lymph node-negative subgroup (69.3%) than node-positive subgroup (54.8%).

"These results reveals the importance of including clinical pathologic factors in predicting recurrence and deciding on whether to add chemotherapy. From the very beginning of algorithm design for GenesWell BCT, clinical pathological factors have been taken into account," said Sang-rae Cho, the CEO of Gencurix. "The findings build on prior studies that demonstrated the clinical utility of GenesWell BCT for predicting which women will benefit from adjunctive chemotherapy at diagnosis in all ages."

The Frontiers in Oncology publication can be accessed at: View Source

Publication Information

Title: Comparison of GenesWell BCT Score With Oncotype DX Recurrence Score for Risk Classification in Asian Women With Hormone Receptor-Positive, HER2-Negative Early Breast Cancer
Authors: Mi Jeong Kwon, Jeong Eon Lee, Joon Jeong, Sang Uk Woo, Jinil Han, Byeong-il Kang, Jee-Eun Kim, Youngho Moon, Sae Byul Lee, Seonghoon Lee, Yoon-La Choi, Youngmi Kwon, Kyoung Song, Gyungyub Gong and Young Kee Shin
Publication Date: Wednesday, July 24, 2019
Journal: Frontiers in Oncology