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
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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DOI：
10.1016/j.cct.2012.09.003
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发表时间：
2013-01-01
影响因子：
2.2
通讯作者：
Hortobagyi, Gabriel N.
中科院分区：
文献类型：
--
作者：
Ramsey, Scott D.;Barlow, William E.;Hortobagyi, Gabriel N.
患有涉及淋巴结的乳腺癌的妇女通常用细胞毒性化疗治疗。对先前研究的回顾性评估表明，21基因测试（OncotypeDX（R））可以识别那些可以安全避免化疗的人。为了更好地了解21基因检测的性能，设计了RxPONDER（Rx for Positive Node，Endocrine Responsive Breast Cancer）研究，这是一项多中心III期试验，将患有激素受体阳性和HER 2阴性乳腺癌的女性随机分为单独内分泌治疗与化疗，然后进行内分泌治疗，其中激素受体阳性和HER 2阴性乳腺癌涉及1-3个淋巴结，21基因检测复发评分（RS）为25或更低。作为肿瘤学领域最早的大规模比较有效性研究之一，RxPONDER利用外部利益相关者团体帮助为试验设计提供信息。利益攸关方与SWOG的代表通过有组织的讨论进程进行了数月的会晤。利益相关者参与过程导致对试验设计进行了几项变更。此外，来自健康保险行业的利益相关者代表提供了有关机制的指导，作为试验的一部分，OncotypeDX（R）的费用将由大多数健康保险公司支付。该过程可以作为未来研究的模板，评估肿瘤学基因组检测的比较有效性，特别是那些在合作临床试验组内进行的基因组检测。(c)2012 Elsevier Inc. All rights reserved.
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.