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Gene expression–based survival prediction in lung adenocarcinoma: a multi-site, blinded validation study
TLDR
A large, training–testing, multi-site, blinded validation study to characterize the performance of several prognostic models based on gene expression for 442 lung adenocarcinomas, providing the largest available set of microarray data with extensive pathological and clinical annotation for lungAdenocARCinomas.
Assessment of Ki67 in breast cancer: recommendations from the International Ki67 in Breast Cancer working group.
TLDR
Comprehensive recommendations on preanalytical and analytical assessment, and interpretation and scoring of Ki67 were formulated based on current evidence, geared toward achieving a harmonized methodology, create greater between-laboratory and between-study comparability, and allow earlier valid applications of this marker in clinical practice.
Prospective Validation of a 21-Gene Expression Assay in Breast Cancer.
TLDR
Among patients with hormone-receptor-positive, HER2-negative, axillary node-negative breast cancer who met established guidelines for the recommendation of adjuvant chemotherapy on the basis of clinicopathologic features, those with tumors that had a favorable gene-expression profile had very low rates of recurrence at 5 years with endocrine therapy alone.
Adjuvant Chemotherapy Guided by a 21‐Gene Expression Assay in Breast Cancer
TLDR
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.
Criteria for the use of omics-based predictors in clinical trials
TLDR
A checklist of criteria that can be used to determine the readiness of omics-based tests for guiding patient care in clinical trials and issues relating to specimens, assays, mathematical modelling, clinical trial design, and ethical, legal and regulatory aspects are developed.
Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration
TLDR
A checklist of criteria to consider when evaluating the body of evidence supporting the clinical use of a predictor to guide patient therapy is presented, including issues pertaining to specimen and assay requirements, the soundness of the process for developing predictor models, expectations regarding clinical study design and conduct, and attention to regulatory, ethical, and legal issues.
Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer.
TLDR
Clinical-risk stratification provided prognostic information that, when added to the 21-gene recurrence score, could be used to identify premenopausal women who could benefit from more effective therapy.
Cancer Diagnostics
TLDR
The successful application of the PACCT algorithm is described in the discussion of the recent development of the OncotypeDX™ assay and plan for a prospective trial of this assay by the NCI-supported Clinical Trials Cooperative Groups.
Use of Next-Generation Sequencing Tests to Guide Cancer Treatment: Results From a Nationally Representative Survey of Oncologists in the United States
TLDR
In 2017, most oncologists in the United States were using NGS tests to guide treatment decisions for their patients, and more research is needed to establish the clinical usefulness of these tests, to develop evidence-based clinical guidelines for their use in practice, and to ensure that patients who can benefit from these new technologies receive appropriate testing and treatment.
Circulating Tumor DNA Assays in Clinical Cancer Research
TLDR
The topics of the workshop covered in the presentations and points made in the discussions that followed were 1) background on ctDNA, 2) potential clinical utility of ct DNA assays, 3) assay technology, 4) assay clinical and analytical validation, and 5) industry perspectives.
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