Additional large population-based study indicates not all young women under 40 years with node negative breast cancer have aggressive disease-excellent survival without chemotherapy reported at five years for patients with low Recurrence Score® results
"The results presented at ESMO once again highlight the unique value of Oncotype DX® in providing critical information to personalize and improve the quality of treatment decisions in early breast cancer," said Calvin Chao, Vice President of Global Medical Affairs at Genomic Health. "These latest presentations reinforce our test’s ability to accurately predict clinical outcomes and the value of examining tumor biology in specific patient populations, such as younger women and those with clinically high-risk breast cancer."
Distant recurrence results from prospective ‘PlanB’ study presented for the first time
New results from the PlanB trial(1), one of the largest contemporary adjuvant breast cancer trials in Europe, showed that patients with low Breast Recurrence Score® results (0-11) treated with hormonal therapy alone had very low rates of distant recurrence (distant disease-free survival: DDFS) after 60 months median follow-up. DDFS rates were comparable in patients with node-positive (up to three nodes) disease and in those with clinically high-risk node-negative disease at 97.9 and 97.7 percent respectively.
In the study, the Recurrence Score result was the strongest independent predictor for DDFS in multivariable analysis (p<0.001), providing the greatest impact on prognosis and outperforming all the other factors, such as the traditional criteria of tumor size and tumor grade.
"These new study results show the unique value of adding biological information provided by the Oncotype DX test in order to identify low-risk breast cancer patients - among patients with 0-3 involved lymph nodes - who can safely be spared the toxicity and side effects of chemotherapy without compromising outcomes," said Dr Oleg Gluz, Scientific Coordinator of the West German Study Group that conducted the PlanB study. "This is especially important for patients who would be considered as intermediate to high risk of recurrence based on traditional clinical parameters. These results confirm previous retrospective studies with Oncotype DX as well as the prospective TAILORx trial."
The distant recurrence results presented at ESMO 2017 provide information beyond the five-year PlanB outcomes published recently in Breast Cancer Research and Treatment, which include disease-free survival (DFS) and overall survival (OS).
PlanB was conducted by the West German Study Group (WSG) in 93 centers across Germany and enrolled more than 3,100 patients who were considered candidates for chemotherapy by traditional parameters including those with node-positive disease. The study used the Oncotype DX Breast Recurrence Score results to identify patients who, despite high clinical risk, could be spared adjuvant chemotherapy.
Testing with Oncotype DX in women under 40 shows excellent survival with low Recurrence Score results and demonstrates important role of genomic testing in treatment of younger breast cancer patients
Breast cancer at a young age is generally associated with poor prognosis, more aggressive treatment, long-term toxicities, and unique psychosocial concerns(2). In the study, Recurrence Score results were provided to the National Cancer Institute’s population-based SEER registries, the premier source of cancer statistics in the United States, and linked to breast cancer cases. This analysis(3) looked at breast cancer specific survival (BCSS) in over 1,700 patients younger than age 40 with node-negative, HR+ breast cancer treated based on their Recurrence Score result.
Excellent five-year BCSS (100 percent) was observed in the 821 patients with Recurrence Score results less than 18, the vast majority of whom (83 percent) did not receive chemotherapy. Similarly, patients with Recurrence Score results up to 25 also had favorable five-year BCSS. An important minority (11 percent) of young women with high Recurrence Score results had poor outcomes despite chemotherapy use.
"This analysis provides important information for a small but greatly impacted group of patients with breast c...
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