Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina2Duke Cancer Institute, Duke University School of Medicine, Durham, North Carolina3Department of Medicine, Duke University School of Medicine, Durham, North Caroli.
Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
JAMA Oncol. 2015 Nov;1(8):1098-109. doi: 10.1001/jamaoncol.2015.2722.
Guidelines recommend consideration of chemotherapy for most patients with early-stage, estrogen receptor-positive, invasive breast cancer in the absence of additional prognostic information. The 21-gene recurrence score (RS) assay has been shown in limited academic settings to reduce physician recommendations for adjuvant chemotherapy. Associations between the adoption of the assay and receipt of chemotherapy in the general population have not been examined.
To examine whether adoption of the RS assay in a nationally representative sample of patients with early-stage breast cancer was associated with use of chemotherapy.
DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of Medicare beneficiaries who received a diagnosis of incident breast cancer between 2005 and 2009 using Surveillance, Epidemiology, and End Results data set with linked Medicare claims.
Receipt of chemotherapy within 12 months after diagnosis.
A total of 44,044 patients had low-risk (24.0%), intermediate-risk (51.3%), or high-risk disease (24.6%, lymph node positive) as defined by National Comprehensive Cancer Network (NCCN) guidelines and met the study criteria. We observed no overall association between receipt of the RS assay and chemotherapy (odds ratio [OR], 1.03 [99% CI, 0.88-1.19]). In multivariable analysis, there was a significant interaction between NCCN risk and use of the RS assay, with assay use associated with lower chemotherapy use in high-risk patients (OR, 0.36 [99% CI, 0.26-0.50]) and greater chemotherapy use in low-risk patients (OR, 3.71 [99% CI, 2.30-5.98]), compared with no receipt of the assay (P=.006 for the overall interaction). Results were similar in prespecified subgroup analyses of patients 70 years and younger, with the exception of a shift toward lower chemotherapy use during 2008 (OR, 0.90 [99% CI, 0.77-.1.05]; P=.09) and 2009 (OR, 0.81 [99% CI, 0.66-0.99]; P=.007). In unadjusted analyses, overall chemotherapy use decreased over time in patients 70 years or younger with high-risk disease and those receiving the assay.
The impact of the adoption of the RS assay on receipt of chemotherapy was strongly population dependent and was associated with relatively lower chemotherapy use in groups with high-risk disease and relatively higher chemotherapy use in patients with low-risk disease. Overall use of chemotherapy decreased during the study period in patients who were most likely to receive chemotherapy.
指南建议在没有其他预后信息的情况下，对大多数早期、雌激素受体阳性、浸润性乳腺癌患者考虑化疗。在有限的学术环境中，21 基因复发评分（RS）检测已被证明可降低医生对辅助化疗的建议。尚未研究一般人群中检测方法的采用与接受化疗之间的关联。
在一个具有全国代表性的早期乳腺癌患者样本中，研究 RS 检测的采用是否与化疗的使用相关。
设计、地点和参与者：使用监测、流行病学和最终结果数据集中的 Medicare 受益人的诊断为 2005 年至 2009 年间发生的乳腺癌的回顾性队列研究，该数据与 Medicare 索赔相关联。
诊断后 12 个月内接受化疗。
共有 44044 名患者根据美国国家综合癌症网络（NCCN）指南定义患有低危（24.0%）、中危（51.3%）或高危疾病（24.6%，淋巴结阳性），并符合研究标准。我们没有观察到 RS 检测的使用与化疗之间存在总体关联（比值比[OR]，1.03[99%CI，0.88-1.19]）。在多变量分析中，NCCN 风险与 RS 检测的使用之间存在显著的交互作用，与未接受检测相比，高危患者的化疗使用率较低（OR，0.36[99%CI，0.26-0.50]），低危患者的化疗使用率较高（OR，3.71[99%CI，2.30-5.98]）。（整体交互作用的 P 值为<.006）。在年龄为 70 岁及以下的患者的预设亚组分析中，结果相似，但在 2008 年（OR，0.90[99%CI，0.77-.1.05]；P=.09）和 2009 年（OR，0.81[99%CI，0.66-0.99]；P=.007），化疗使用率呈下降趋势。在未调整的分析中，患有高危疾病和接受检测的 70 岁及以下患者的总体化疗使用率随时间下降。
RS 检测的采用对接受化疗的影响在很大程度上取决于人群，并且与高危疾病患者的化疗使用率相对较低和低危疾病患者的化疗使用率相对较高有关。在最有可能接受化疗的患者中，研究期间的总体化疗使用率有所下降。
