Development and Validation of the RSClinN+ Tool to Predict Prognosis and Chemotherapy Benefit for Hormone Receptor-Positive, Node-Positive Breast Cancer
- Lajos Pusztai 1, Jess R Hoag 2, Kathy S Albain 3, William E Barlow 4, Salomon M Stemmer 5,6, Allison Meisner 7, Gabriel N Hortobagyi 8, Steven Shak 2, James M Rae 9, Rick Baehner 2, Priyanka Sharma 10, Kevin M Kalinsky 11
- Lajos Pusztai 1, Jess R Hoag 2, Kathy S Albain 3
- 1Yale University School of Medicine, New Haven, CT.
- 2Exact Sciences Corporation, Madison, WI.
- 3Loyola University Chicago Stritch School of Medicine, Maywood, IL.
- 4SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center, Seattle, WA.
- 5Tel Aviv University, Tel Aviv, Israel.
- 6Rabin Medical Center, Petah Tikva, Israel.
- 7Fred Hutchinson Cancer Center, Seattle, WA.
- 8The University of Texas MD Anderson Cancer Center, Houston, TX.
- 9University of Michigan, Ann Arbor, MI.
- 10University of Kansas Medical Center, Westwood, KS.
- 11Emory University School of Medicine, Atlanta, GA.
- 0Yale University School of Medicine, New Haven, CT.
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December 2, 2024
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View abstract on PubMed
Summary
This summary is machine-generated.A new tool, RSClinN+, improves breast cancer recurrence risk prediction by integrating the 21-gene Oncotype DX Breast Recurrence Score (RS) with clinicopathological factors. This personalized approach aids treatment decisions for HR+/HER2- node-positive breast cancer patients.
Area Of Science
- Oncology
- Genomics
- Biostatistics
Background
- Prognosis in HR+/HER2- breast cancer is influenced by clinicopathological factors and the 21-gene Oncotype DX Breast Recurrence Score (RS).
- Accurate prediction of recurrence risk and chemotherapy benefit is crucial for personalized treatment strategies.
Purpose Of The Study
- To develop and validate RSClinN+, a novel tool integrating RS with clinicopathological factors (grade, tumor size, age).
- To individualize recurrence risk and chemotherapy benefit predictions based on menopausal status for HR+/HER2- lymph node-positive breast cancer patients.
Main Methods
- Utilized patient-level data from 5,283 patients in the S1007 and S8814 trials treated with chemoendocrine therapy (CET) or endocrine therapy (ET) alone.
- Employed Cox proportional hazards regression models stratified by trial to estimate 5-year invasive disease-free survival for pre- and postmenopausal women.
- Validated RSClinN+ in an external cohort of 592 patients with node-positive disease.
Main Results
- RSClinN+ demonstrated superior prognostic information compared to RS alone or clinicopathological models alone in both premenopausal (P = .034) and postmenopausal (P < .001) women.
- In postmenopausal women, RSClinN+ estimated absolute chemoendocrine therapy (CET) benefit ranging from <0.1% to 21.5% across RS scores 0-50, showing significant interaction (P = .016).
- External validation confirmed RSClinN+ risk estimates were prognostic (HR, 1.75 [95% CI, 1.38-2.20]) and highly concordant with observed risk (Lin's concordance, 0.92).
Conclusions
- RSClinN+ offers improved prognostic estimates and absolute CET benefit predictions for individual HR+/HER2- breast cancer patients.
- The tool enhances patient counseling by providing more personalized risk and treatment benefit information than RS or clinical data alone.
- RSClinN+ represents a valuable advancement in precision medicine for breast cancer management.
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