Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer: ASCO Guideline Update

Varga, Andrea; Ismaila, Nofisat; Allison, Kimberly H.; Barlow, William E.; Collyar, Deborah; Damodaran, Senthil; Henry, N. Lynn; Jhaveri, Komal; Kalinsky, Kevin; Kuderer, Nicole M.; Litvak, Anya M.; Mayer, Erica L.; Pusztai, Lajos; Raab, Rachel; Wolff, Antonio C.; Stearns, Vered

doi:10.1200/jco.22.00069

Cited by 221 publications

(254 citation statements)

References 94 publications

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“…49 With respect to biomarker testing in particular, clinicians should educate patients, and/or caregivers and family members about the results of pathology evaluations and specific genomic tests, including how the results of this testing are used to develop a treatment plan tailored to their cancer biology. 50 A White Paper from the Consistent Testing Terminology Working Group recommends using consistent terminology to maximize communication and understanding between patient and clinician. 51 The terminology around testing is complex; simplifying and explaining this terminology is essential to enhancing patient understanding of the role of biomarker testing in their cancer care.…”

Section: Patient and Clinician Communicationmentioning

confidence: 99%

Biomarkers for Systemic Therapy in Metastatic Breast Cancer: ASCO Guideline Update

Henry

Somerfield

Dayao

et al. 2022

JCO

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PURPOSE To update the ASCO biomarkers to guide systemic therapy for metastatic breast cancer (MBC) guideline. METHODS An Expert Panel conducted a systematic review to identify randomized clinical trials and prospective-retrospective studies from January 2015 to January 2022. RESULTS The search identified 19 studies informing the evidence base. RECOMMENDATIONS Candidates for a regimen with a phosphatidylinositol 3-kinase inhibitor and hormonal therapy should undergo testing for PIK3CA mutations using next-generation sequencing of tumor tissue or circulating tumor DNA (ctDNA) in plasma to determine eligibility for alpelisib plus fulvestrant. If no mutation is found in ctDNA, testing in tumor tissue, if available, should be used. Patients who are candidates for poly (ADP-ribose) polymerase (PARP) inhibitor therapy should undergo testing for germline BRCA1 and BRCA2 pathogenic or likely pathogenic mutations to determine eligibility for a PARP inhibitor. There is insufficient evidence for or against testing for a germline PALB2 pathogenic variant to determine eligibility for PARP inhibitor therapy in the metastatic setting. Candidates for immune checkpoint inhibitor therapy should undergo testing for expression of programmed cell death ligand-1 in the tumor and immune cells to determine eligibility for treatment with pembrolizumab plus chemotherapy. Candidates for an immune checkpoint inhibitor should also undergo testing for deficient mismatch repair/microsatellite instability-high to determine eligibility for dostarlimab-gxly or pembrolizumab, as well as testing for tumor mutational burden. Clinicians may test for NTRK fusions to determine eligibility for TRK inhibitors. There are insufficient data to recommend routine testing of tumors for ESR1 mutations, for homologous recombination deficiency, or for TROP2 expression to guide MBC therapy selection. There are insufficient data to recommend routine use of ctDNA or circulating tumor cells to monitor response to therapy among patients with MBC. Additional information can be found at www.asco.org/breast-cancer-guidelines .

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Section: Patient and Clinician Communicationmentioning

confidence: 99%

Biomarkers for Systemic Therapy in Metastatic Breast Cancer: ASCO Guideline Update

Henry

Somerfield

Dayao

et al. 2022

JCO

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“…Clinical utility has been shown prospectively for two signatures (Recurrence Score and 70-gene assay), with a marked reduction up to 20–35% in chemotherapy usage and no negative effect in long-term survival for postmenopausal patients with ER-positive, HER2-negative BC and low to intermediate risk of gene-expression-based recurrence [ 10 , 11 , 12 ]. Several of these signatures, including the 70-gene assay/MammaPrint (Agendia Inc., Amsterdam, The Netherlands), Oncotype Dx recurrence score (RS) (Exact Sciences Corp., Madison, WI, USA), EndoPredict/EPclin (EP, Myriad Genetics Inc., Salt Lake City, UT, USA), and Prosigna ® /risk of recurrence (ROR) (Veracyte Inc., South San Francisco, CA, USA) are recommended for clinical use by the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) [ 7 , 13 , 14 , 15 ].…”

Section: Introductionmentioning

confidence: 99%

Real World Evaluation of the Prosigna/PAM50 Test in a Node-Negative Postmenopausal Swedish Population: A Multicenter Study

Kjällquist

Ács

Margolin

et al. 2022

Cancers

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Molecular signatures to guide decisions for adjuvant chemotherapy are recommended in early ER-positive, HER2-negative breast cancer. The objective of this study was to assess what impact gene-expression-based risk testing has had following its recommendation by Swedish national guidelines. Postmenopausal women with ER-positive, HER2-negative and node negative breast cancer at intermediate clinical risk and eligible for chemotherapy were identified retrospectively from five Swedish hospitals. Tumor characteristics, results from Prosigna® test and final treatment decision were available for all patients. Treatment recommendations were compared with the last version of regional guidelines before the introduction of routine risk signature testing. Among the 360 included patients, 41% (n = 148) had a change in decision for adjuvant treatment based on Prosigna® test result. Out of the patients with clinical indication for adjuvant chemotherapy, 52% (n = 118) could avoid treatment based on results from Prosigna® test. On the contrary, 23% (n = 30) of the patients with no indication were escalated to receive adjuvant chemotherapy after testing. Ki67 could not distinguish between the Prosigna® risk groups or intrinsic subtypes and did not significantly differ between patients in which decision for adjuvant therapy was changed based on the test results. In conclusion, we report the first real-world data from implementation of gene-expression-based risk assessment in a Swedish context, which may facilitate the optimization of future versions of the national guidelines.

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“…OncotypeDx is a genomics-based 21-gene Recurrence Score assay that has been validated for prognosis and prediction of chemotherapy benefit or recurrence in early stage, ER+ breast cancer ( 90 ). The assay has been used to guide treatment decisions, is widely included in clinical trials, and its implementation is recommended in ASCO and NCCN treatment guidelines ( 91 , 92 ). Omics-based assays and big data analysis have paved the way for personalized medicine as a whole and in knowledge-based mathematical/AI models.…”

Section: Beyond the Benchtop: Mathematical Models And Artificial Inte...mentioning

confidence: 99%

Functional Drug Screening in the Era of Precision Medicine

2022

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The focus of precision medicine is providing the right treatment to each unique patient. This scientific movement has incited monumental advances in oncology including the approval of effective, targeted agnostic therapies. Yet, precision oncology has focused largely on genomics in the treatment decision making process, and several recent clinical trials demonstrate that genomics is not the only variable to be considered. Drug screening in three dimensional (3D) models, including patient derived organoids, organs on a chip, xenografts, and 3D-bioprinted models provide a functional medicine perspective and necessary complement to genomic testing. In this review, we discuss the practicality of various 3D drug screening models and each model’s ability to capture the patient’s tumor microenvironment. We highlight the potential for enhancing precision medicine that personalized functional drug testing holds in combination with genomic testing and emerging mathematical models.

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Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer: ASCO Guideline Update

Cited by 221 publications

References 94 publications

Biomarkers for Systemic Therapy in Metastatic Breast Cancer: ASCO Guideline Update

Biomarkers for Systemic Therapy in Metastatic Breast Cancer: ASCO Guideline Update

Real World Evaluation of the Prosigna/PAM50 Test in a Node-Negative Postmenopausal Swedish Population: A Multicenter Study

Functional Drug Screening in the Era of Precision Medicine

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