Clinical impact of a 31-gene expression profile test for cutaneous melanoma in 156 prospectively and consecutively tested patients
Clinical impact of a 31-gene expression profile test for cutaneous melanoma in 156 prospectively and consecutively tested patients
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DOI：
10.1080/03007995.2016.1192997
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发表时间：
2016-09-01
影响因子：
2.3
通讯作者：
Miller, Alexander R.
中科院分区：
文献类型：
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作者：
Berger, Adam C.;Davidson, Robert S.;Miller, Alexander R.
目标：DecisionDx-Melanoma* 是一种31基因表达谱检测，可预测原发性皮肤黑色素瘤（CM）患者的转移风险。本研究的目的是确定临床管理的变化所确定的测试结果，其中分类CM患者在低（1类）或高（2类）risk for recurrence.Research design and methods：病历进行了审查，从156 CM患者从六个机构（三个皮肤科和三个外科肿瘤学的做法）谁是连续测试2013年5月和2015年12月之间。临床管理数据的汇编和比较之前和之后收到的31个基因的表达检测结果包括体检频率，频率和成像方式，并转介到外科和内科肿瘤学家。结果：百分之四十二的患者是第一阶段，47%是第二阶段和8%是第三阶段。总体而言，95例患者（61%）为1级，61例（39%）为2级。在82名（53%）患者中观察到记录的管理变化，其中大多数2级患者（77%）经历了管理变化，而1级患者的这一比例为37%（Fisher精确检验，p < 0.0001）。大多数（77/82，94%）这些变化与测试结果所指示的风险一致（P < 0.0001的Fisher精确检验），增加管理强度为2类患者和减少管理强度为1类patients.Conclusions：基因表达谱的分子风险分类有临床影响，并影响医生直接临床管理CM患者。在收到检测结果后实施的绝大多数变更反映了与患者分子分类相关的低或高复发风险。由于未收集该患者队列的随访数据，因此本研究仅限于评估基于基因表达谱的管理变更对医疗资源利用和患者结局的影响。
Objective: DecisionDx-Melanoma* is a 31-gene expression profile test that predicts the risk of metastasis in patients with primary cutaneous melanoma (CM). This study was designed to ascertain clinical management changes determined by the test outcome, which classifies CM patients being at low (Class 1) or high (Class 2) risk for recurrence.Research design and methods: Medical charts were reviewed from 156 CM patients from six institutions (three dermatology and three surgical oncology practices) who were consecutively tested between May 2013 and December 2015. Clinical management data that were compiled and compared before and after receipt of the 31-gene expression test result included frequency of physical exams, frequency and modality of imaging, and referrals to surgical and medical oncologists.Results: Forty-two percent of patients were Stage I, 47% were Stage II and 8% were Stage III. Overall, 95 patients (61%) were Class 1 and 61 (39%) were Class 2. Documented changes in management were observed in 82 (53%) patients, with the majority of Class 2 patients (77%) undergoing management changes compared to 37% of Class 1 patients (p < 0.0001 by Fisher's exact test). The majority (77/82, 94%) of these changes were concordant with the risk indicated by the test result (p < 0.0001 by Fisher's exact test), with increased management intensity for Class 2 patients and reduced management intensity for Class 1 patients.Conclusions: Molecular risk classification by gene expression profiling has clinical impact and influences physicians to direct clinical management of CM patients. The vast majority of the changes implemented after the receipt of test results were reflective of the low or high recurrence risk associated with the patient's molecular classification. Because follow-up data was not collected for this patient cohort, the study is limited for the assessment of the impact of gene expression profile based management changes on healthcare resource utilization and patient outcome.