Richard Scott, Wells Alan, Connor Joseph, Price Fredric
Department of Obstetrics and Gynecology, Hahnemann University Hospital, Philadelphia, PA, USA.
Department of Pathology, University of Pittsburgh; and Pittsburgh VA Health System, Pittsburgh, PA, USA.
PLoS Curr. 2015 Jul 13;7:ecurrents.eogt.8b0b6fffc7b999b34bc4c8152edbf237. doi: 10.1371/currents.eogt.8b0b6fffc7b999b34bc4c8152edbf237.
Selection of appropriate chemotherapy, including identification of platinum resistance, is critical to effective management of advanced epithelial ovarian cancer (EOC). ChemoFx®, a multiple treatment marker (chemoresponse assay), has been developed to address this challenge and to improve outcomes in patients with advanced EOC. While much work has been done that has demonstrated the analytical validity of this assay, more recent studies have highlighted the unique clinical benefits offered by the assay. A prospective, multicenter trial has shown an increase in overall survival (OS) of 14 months and an increase in progression-free survival (PFS) by 3 months in patients with recurrent EOS treated by a "sensitive" therapy based on ChemoFx results. Along with other studies showing similar gains in OS and PFS, ChemoFx has been shown to be both a prognostic and predictive marker in patients with recurrent EOC where current treatment options are sorely lacking. In addition to these clinical benefits, economic analyses have shown that ChemoFx is a cost-effective intervention. Current guidelines and technology assessments relating to ChemoFx are largely outdated and refer primarily to metrics of analytical validity. Thus, in addition to analytical validity, the clinical validity, clinical utility and economic impact of ChemoFx are reviewed herein, including published literature, technology assessments by independent parties, and regulatory approvals of this marker.
选择合适的化疗方案，包括识别铂耐药性，对于晚期上皮性卵巢癌（EOC）的有效管理至关重要。ChemoFx®是一种多重治疗标志物（化疗反应检测法），旨在应对这一挑战并改善晚期EOC患者的治疗效果。虽然已经开展了大量工作来证明该检测法的分析有效性，但最近的研究突出了该检测法所带来的独特临床益处。一项前瞻性多中心试验表明，根据ChemoFx结果接受“敏感”疗法治疗的复发性EOS患者，其总生存期（OS）增加了14个月，无进展生存期（PFS）增加了3个月。连同其他显示OS和PFS有类似改善的研究一起，ChemoFx已被证明在目前治疗选择严重缺乏的复发性EOC患者中既是一种预后标志物也是一种预测标志物。除了这些临床益处外，经济分析表明ChemoFx是一种具有成本效益的干预措施。目前与ChemoFx相关的指南和技术评估在很大程度上已过时，且主要涉及分析有效性指标。因此，除了分析有效性外，本文还对ChemoFx的临床有效性、临床实用性和经济影响进行了综述，包括已发表的文献、独立机构的技术评估以及该标志物的监管批准情况。
