Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer

By J. Sparano, R. Gray, D. Makower, K. Pritchard, K. Albain, D. Hayes, C. Geyer, E. Dees, M. Goetz, J. Olson and 20 more. New England Journal of Medicine, 2018

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BACKGROUND The recurrence score based on the 21‐gene breast cancer assay predicts chemotherapy benefit if it is high and a low risk of recurrence in the absence of chemotherapy if it is low; however, there is uncertainty about the benefit of chemotherapy for most patients, who have a midrange score. METHODS We performed a prospective trial involving 10,273 women with hormone‐receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, axillary node–negative breast cancer. Of the 9719 eligible patients with follow‐up information, 6711 (69%) had a midrange recurrence score of 11 to 25 and were randomly assigned to receive either chemoendocrine therapy or endocrine therapy alone. The trial was designed to show noninferiority of endocrine therapy alone for invasive disease–free survival (defined as freedom from invasive disease recurrence, second primary cancer, or death). RESULTS Endocrine therapy was noninferior to chemoendocrine therapy in the analysis of invasive disease–free survival (hazard ratio for invasive disease recurrence, second primary cancer, or death [endocrine vs. chemoendocrine therapy], 1.08; 95% confidence interval, 0.94 to 1.24; P=0.26). At 9 years, the two treatment groups had similar rates of invasive disease–free survival (83.3% in the endocrine‐therapy group and 84.3% in the chemoendocrine‐therapy group), freedom from disease recurrence at a distant site (94.5% and 95.0%) or at a distant or local–regional site (92.2% and 92.9%), and overall survival (93.9% and 93.8%). The chemotherapy benefit for invasive disease–free survival varied with the combination of recurrence score and age (P=0.004), with some benefit of chemotherapy found in women 50 years of age or younger with a recurrence score of 16 to 25. CONCLUSIONS Adjuvant endocrine therapy and chemoendocrine therapy had similar efficacy in women with hormone‐receptor–positive, HER2‐negative, axillary node–negative breast cancer who had a midrange 21‐gene recurrence score, although some benefit of chemotherapy was found in some women 50 years of age or younger. (Funded by the National Cancer Institute and others; TAILORx ClinicalTrials.gov number, NCT00310180.)

Subfields: Cancer Research, Pathology and Forensic Medicine, Pulmonary and Respiratory Medicine

View Paper: https://www.semanticscholar.org/paper/4827b10ed40c373e232ae5518bf166cc580069ee

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Citations in the corpus

Insights into molecular classifications of triple-negative breast cancer: improving patient selection for treatment (2019, background): “, 21-gene recurrence score, oncotype) to predict chemotherapy benefit in ER-positive breast cancer (127), remains to be seen.”
Estrogen and Progesterone Receptor Testing in Breast Cancer: ASCO/CAP Guideline Update. (2020, methodology): “Some panel-based gene-expression assays, like Oncotype DX (Genomic Health, Redwood City, CA), have already been incorporated into standard treatment algorithms for IHC ER-positive cancers as a tool to assess the likelihood of clinical benefit offered by chemotherapy when added to endocrine therapy.(”
Predicting cancer outcomes with radiomics and artificial intelligence in radiology (2021, background): “Besides being prognostic, Oncotype DX is also a predictive biomarker validated in a prospective clinical trial to determine benefit from chemotherapy in women with early-stage breast cancer 17 .”
Survival analysis across the entire transcriptome identifies biomarkers with the highest prognostic power in breast cancer (2021, background): “The decision to administer chemotherapy can be based on clinical features including high stage or node positivity, or designation of high risk via gene expression proﬁles including Oncotype DX [24,25] or EndoPredict [26].”
Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021 (2021, background): “Even with contemporary management of breast-conserving surgery and radiation therapy, isolated, in-breast recurrences account for 5%-15% of all recurrent cancer events in women with early-stage breast cancer.(59,60) In addition, some patients develop true, second cancers in the ipsilateral breast.”