|The following article features coverage from the 2020 San Antonio Breast Cancer Symposium. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
A new online tool called RSClin™ that incorporates clinicopathological information and the results of the 21-gene recurrent score was shown to estimate risk of distant recurrence and adjuvant chemotherapy benefit for patients with early breast cancer with hormone receptor–positive, HER2-negative, node-negative disease.
Results detailing the performance of the tool were presented at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) and simultaneously reported in the Journal of Clinical Oncology.1,2
To develop the tool, study researchers conducted a patient-specific meta-analysis of more than 10,000 women with HR-positive, HER2-negative, node-negative disease who participated in clinical trials and received either endocrine therapy alone or endocrine therapy and chemotherapy.
RSClin had a significantly higher likelihood ratio of anticipating disease recurrence than recurrence score alone (P <.001) or clinical and pathological information (P <.001).
“Therefore, a likelihood ratio test confirmed that the RSClin model provides more prognostic information than either clin-path variables alone or RS alone,” said study presenter Joseph Sparano, MD, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.
RSClin was also shown to estimate absolute chemotherapy benefit at 10 years for individual patients.
Dr Sparano showed 2 patient examples to illustrate this point. For 1 patient, greater chemotherapy benefit was seen with higher recurrence score, and this was independent of tumor grade. For the other patient, greater chemotherapy benefit was seen with higher recurrence score, and this was independent of tumor size.
The tool was then externally validated in a real-world cohort of 1098 patients with node-negative disease, of whom 876 were treated with endocrine therapy alone and 22 were treated with endocrine therapy and chemotherapy (as determined by the 21-gene assay).2
In this real-world population, the estimated risk calculated using the tool significantly correlated with risk of distant recurrence (HR, 1.73; 95% CI, 1.40-2.15; P <.001), and the 10-year risk of distant recurrence for each quantile correlated with the Kaplan-Meier risk estimate (Lin concordance correlation, 0.962).
“It is our expectation and hope that this new tool will make it easier to predict the outcome and chemo benefit in patients with early breast cancer who have the 21-gene recurrence score — and with greater precision,” said Dr Sparano.
Disclosures: Some of the presenters disclosed financial relationships with the pharmaceutical industry and/or the medical device industry, including (but not limited to) Exact Sciences, Genomic Health Inc., and the National Cancer Institute. For a full list of disclosures, please refer to the presentation abstract.
Read more of Cancer Therapy Advisor‘s coverage of the 2020 SABCS meeting by visiting the conference page.
- Sparano JA, Crager MR, Tang G, et al. Development and validation of a tool integrating the 21-gene recurrence score and clinicopathlogic features to individualize prognosis for distant recurrence and prediction of absolute chemotherapy benefit in early breast cancer. Presented at: 2020 Virtual San Antonio Breast Cancer Symposium; December 8-11, 2020. Abstract GS4-10.
- Sparano JA, Crager MR, Tang G, Gray RJ, Stemmer SM, and Shak S. Development and validation of a tool integrating the 21-gene recurrence score and clinical-pathological features to individualize prognosis and prediction of chemotherapy benefit in early breast cancer. J Clin Oncol. Published online December 11, 2020. doi:10.1200/JCO.20.03007