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      Integrating comparative effectiveness design elements and endpoints into a phase III, randomized clinical trial (SWOG S1007) evaluating oncotypeDX-guided management for women with breast cancer involving lymph nodes.

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          Abstract

          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®), 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® 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.

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          Author and article information

          Journal
          Contemp Clin Trials
          Contemporary clinical trials
          Elsevier BV
          1559-2030
          1551-7144
          Jan 2013
          : 34
          : 1
          Affiliations
          [1 ] Fred Hutchinson Cancer Research Center, Seattle, WA 98109–1024, United States. sramsey@fhcrc.org
          Article
          S1551-7144(12)00210-8 NIHMS409002
          10.1016/j.cct.2012.09.003
          3525786
          23000081
          f67f89e5-e526-47e4-b93a-b2f099dc9bce
          History

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