Medical Oncology Service, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain.
Medical Oncology Service, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), CiberOnc, Madrid, Spain.
Clin Transl Oncol. 2020 May;22(5):717-724. doi: 10.1007/s12094-019-02176-x. Epub 2019 Jul 12.
The aim of this study is to evaluate the cost-effectiveness and impact of gene-expression assays (GEAs) on treatment decisions in a real-world setting of early-stage breast cancer (ESBC) patients.
This is a regional, prospective study promoted by the Council Health Authorities in Madrid. Enrolment was offered to women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, node-negative or micrometastatic, stage I or II breast cancer from 21 hospitals in Madrid. Treatment recommendations were recorded before and after knowledge of tests results. An economic model compared the cost-effectiveness of treatment, guided by GEAs or by common prognostic factors.
907 tests (440 Oncotype DX and 467 MammaPrint) were performed between February 2012 and November 2014. Treatment recommendation changed in 42.6% of patients. The shift was predominantly from chemohormonal (CHT) to hormonal therapy (HT) alone, in 30.5% of patients. GEAs increased patients' confidence in treatment decision making. Tumor grade, progesterone receptor positivity and Ki67 expression were associated with the likelihood of change from CHT to HT (P < 0.001) and from HT to CHT (P < 0.001). Compared with current clinical practice genomic testing increased quality-adjusted life years by 0.00787 per patient and was cost-saving from a national health care system (by 13.867€ per patient) and from a societal perspective (by 32.678€ per patient).
Using GEAs to guide adjuvant therapy in ESBC is cost-effective in Spain and has a significant impact on treatment decisions.
本研究旨在评估在早期乳腺癌（ESBC）患者的真实环境中，基因表达分析（GEAs）对治疗决策的成本效益和影响。
这是一项由马德里卫生当局推动的区域性前瞻性研究。为 21 家马德里医院的雌激素受体阳性、人表皮生长因子受体 2 阴性、淋巴结阴性或微转移、I 期或 II 期乳腺癌患者提供了入组机会。在了解测试结果前后记录了治疗建议。经济模型比较了基于 GEAs 或常见预后因素指导的治疗成本效益。
2012 年 2 月至 2014 年 11 月期间共进行了 907 次测试（440 次 Oncotype DX 和 467 次 MammaPrint）。42.6%的患者治疗建议发生了变化。变化主要是将 30.5%的患者从化疗联合激素治疗（CHT）转变为单独激素治疗（HT）。GEAs 增加了患者对治疗决策的信心。肿瘤分级、孕激素受体阳性和 Ki67 表达与从 CHT 转变为 HT（P<0.001）和从 HT 转变为 CHT（P<0.001）的可能性相关。与当前的临床实践相比，基因组测试使每个患者的质量调整生命年增加了 0.00787，并从国家卫生保健系统（每个患者节省 13.867 欧元）和社会角度（每个患者节省 32.678 欧元）节省成本。
在西班牙，使用 GEAs 指导 ESBC 的辅助治疗具有成本效益，并且对治疗决策有重大影响。
