Simulation Model–Based Clinical Decision Tool for Predicting Benefit of Adjuvant Chemoendocrine vs Endocrine Therapy in HR-Positive, HER2-Negative Breast Cancer
As reported in the Journal of Clinical Oncology, Jayasekera et al have developed a clinical decision tool called BTxChoice that can be used with or without the 21-gene recurrence score to estimate the potential benefit of adjuvant chemoendocrine vs endocrine therapy in women with node-negative, invasive, hormone receptor (HR)-positive, HER2-negative early breast cancer.
The tool provides estimates of 10-year risk of distant recurrence, breast cancer–specific mortality, other-cause mortality, and life-years gained with chemoendocrine vs endocrine therapy for individual women based on age, tumor size, grade, and comorbidity level with and without 21-gene recurrence scores. The tool can also estimate the likelihood of particular recurrence scores.
The tool was used to simulate outcomes for 1,512 different patient subgroups based on all possible combinations of age, tumor size, grade, and comorbidity level, with simulations performed with and without recurrence score. Model input sources were clinical trials, large U.S. cohort studies, registry, and claims data. The tool was externally validated by comparing predicted outcomes with observed outcome rates in two independent cohorts.
Our validated clinical decision tool is flexible, readily adaptable to include new therapies, and can support discussions about genomic testing and early breast cancer treatment.— Jayasekera et al
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The investigators presented two scenarios of application of the clinical decision tool in predicting 10-year risk of distant recurrence: an older woman for whom treatment choice may be unclear, and a younger woman.
For a woman aged 65 to 69 years with a small (≤ 2 cm), intermediate-grade tumor and mild comorbidities, chemoendocrine vs endocrine therapy was predicted to provide a 1.3% absolute reduction in 10-year risk of distant recurrence and 0.23 life-years gained. The likelihood of recurrence scores predicted by the model were 28% for a score of 16 to 20, 18% for a score of 21 to 25, and 11% for a score of 26 or higher. If the woman undergoes recurrence score testing and has a score of 16 to 20, the predicted absolute reduction in risk is 1% with 0.20 life-years gained, a result similar to that predicted without testing. If the score is 26 to 30, the predicted absolute reduction in risk recurrence with chemoendocrine vs endocrine therapy is 4.8% with 0.63 life-years gained.
For a woman aged 40 to 44 years with a small (≤ 2 cm), intermediate-grade tumor and no comorbidities, the estimated absolute reduction in 10-year risk of distant recurrence with chemoendocrine vs endocrine therapy was 2.6%. Predicted recurrence score probabilities were 18% for a score of 21 to 25 and 11% for a score of 25 or higher. If the woman undergoes testing and has a score of 21 to 25, the predicted absolute reduction in risk is 6.1% with 1.47 life-years gained.
In external validation of the clinical decision tool, the Lin concordance correlation values for 10-year distant recurrence rates in the Kaiser Permanente Pathways dataset (n = 2,071) were 0.968 for age ≤ 50 years and 0.886 for age > 50 years. Correlation values for 10-year breast cancer–related mortality in a Surveillance, Epidemiology, and End Results (SEER) dataset (n = 59,826) were 0.957 in the younger and 0.968 in the older subgroups.
The investigators concluded, “Our validated clinical decision tool is flexible, readily adaptable to include new therapies, and can support discussions about genomic testing and early breast cancer treatment.”
Jinani Jayasekera, PhD, of the Cancer Prevention and Control Program, Georgetown Lombardi Comprehensive Cancer Center, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by grants from the National Cancer Institute. For full disclosures of the study authors, visit ascopubs.org.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.