'Domestic' Breast Cancer Prognostic Test Shows Higher Accuracy in Younger Patient Groups

OncoFREE Shows Prognosis Prediction Performance Comparable to OncotypeDX in Breast Cancer

The next-generation breast cancer prognosis prediction test developed domestically, 'OncoFREE,' has been reported to show prognosis prediction performance similar to OncotypeDX, the most widely used test worldwide. In particular, OncoFREE is expected to enable personalized treatment by more accurately distinguishing between high-risk and low-risk groups in patients aged 50 and under.

[From left in the photo] Professor Kang Eun-hye, Seoul National University Hospital; Professor Cheon Jong-ho, Seoul Boramae Hospital; Professor Lee Sae-byeol, Asan Medical Center; Professor Yoo Jae-min, Samsung Seoul Hospital. Seoul National University Hospital

Professor Eunhye Kang from Seoul National University Hospital, Professor Jongho Cheon from Seoul Metropolitan Boramae Hospital, Professor Saebyeol Lee from Asan Medical Center, and Professor Jaemin Yoo from Samsung Medical Center, along with their research team, announced on the 16th the results of a study comparing the prognosis prediction performance of OncotypeDX and OncoFREE based on data from 838 hormone receptor-positive, HER2-negative early breast cancer patients collected from four hospitals between 2012 and 2022.

Breast cancer has the highest incidence rate among female cancers worldwide, with hormone receptor-positive, HER2-negative breast cancer accounting for the largest proportion. Accurate prognosis prediction in breast cancer treatment is a crucial criterion for avoiding unnecessary chemotherapy in patients with a low risk of recurrence and for planning personalized treatment. However, the existing OncotypeDX predicts recurrence risk by analyzing 21 genes but has high testing costs, leading to demands for more accurate tests. In contrast, OncoFREE, based on next-generation sequencing (NGS), analyzes 179 genes, providing more information and enabling more precise prognosis prediction.

The research team conducted OncoFREE testing on tumor samples from patients who had undergone OncotypeDX and analyzed how the prognosis prediction scores from the two tests correlated with recurrence risk. The results showed a high correlation of about 83% between the prognosis prediction scores of OncoFREE and OncotypeDX, suggesting that both tests can similarly distinguish between high-risk and low-risk groups.

Additionally, during a median follow-up period of 54 months, the OncoFREE high-risk group had a 5.73 times higher risk of distant metastasis compared to the low-risk group (p<0.001). This indicates that OncoFREE can more accurately differentiate between high-risk and low-risk groups.

Notably, a clear difference between the two tests was observed in the younger patient group aged 50 and under, which accounts for half of Korean patients. While the OncotypeDX score showed no significant difference in distant metastasis-free survival (p=0.792), the OncoFREE score revealed a significant difference between high-risk and low-risk groups (hazard ratio 3.98, p=0.035). This demonstrates that OncoFREE exhibited more accurate prognosis prediction performance in the younger patient group.

Professor Eunhye Kang, a breast endocrine surgery specialist at Seoul National University Hospital, stated, "It is highly meaningful that OncoFREE showed superior prognosis prediction performance compared to the existing OncotypeDX," adding, "This test method will play an important role in providing more patients with opportunities for personalized treatment in the future."

Meanwhile, this study was published in the recent issue of the international academic journal Cancer Research and Treatment (CRT).