期刊
CONTEMPORARY CLINICAL TRIALS
卷 34, 期 1, 页码 1-9出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2012.09.003
关键词
Breast cancer; Comparative effectiveness research; OncotypeDX; Everolimus; Stakeholder
资金
- Center for Comparative Effectiveness Research in Cancer Genomics (CANCERGEN) through the American Recovery and Reinvestment Act by the National Cancer Institute, National Institutes of Health [5UC2CA148570-02]
- National Cancer Institute [CA32102, CA38926]
Women with breast cancer involving the lymph nodes are typically treated with cytotoxic chemotherapy. Retrospective evaluations of prior studies suggest that the 21-gene test (OncotypeDX (R)), may allow identification of those who can safely avoid chemotherapy. To better understand the performance of the 21-gene test, the RxPONDER (Rx for Positive Node, Endocrine Responsive breast cancer) study was designed, a multicenter Phase III trial randomizing women with hormone receptor-positive and HER2-negative breast cancer involving 1-3 lymph nodes and a 21-gene assay recurrence score (RS) of 25 or less to endocrine therapy alone versus chemotherapy followed by endocrine therapy. As one of the first large-scale comparative-effectiveness studies in oncology, RxPONDER utilized an external stakeholder group to help inform the design of the trial. Stakeholders met with representatives of SWOG over several months through a structured discussion process. The stakeholder engagement process resulted in several changes being made to the trial design. In addition, stakeholder representatives from the health insurance industry provided guidance regarding a mechanism whereby the costs of OncotypeDX (R) would be paid by the majority of health insurers as part of the trial. The process may serve as a template for future studies evaluating the comparative effectiveness of genomic tests in oncology, particularly those that are conducted within cooperative clinical trials groups. (c) 2012 Elsevier Inc. All rights reserved.
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