The Comparison of Newly Diagnosed Invasive Breast Patient Cohorts in Genomics Evidence Neoplasia Information Exchange Biopharma Collaborative (GENIE-BPC) and Other Real-World Databases.
Xinyue Liu, Golnoosh Haris Alipour, Changxia Shao, Mehmet Burcu, Edward Bortnichak, Thao Vo, Chu-Ling Yu
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引用次数: 0
Abstract
Background: Oncology databases that integrate genomic and clinical data have become valuable resources for precision medicine. However, the generalizability of these databases has not been comprehensively assessed.
Objectives: To describe the demographics, clinical characteristics, treatments, and overall survival of breast cancer cohorts in GENIE-BPC and three other databases.
Methods: This study utilized GENIE-BPC, SEER, SEER-Medicare, and Merative MarketScan Research Databases. Women with invasive breast cancer were identified through EHR, cancer registries or ICD-9/10-CM codes. The ages were 18+ years or per database requirement. Treatments were based on EHR or HCPCS/NDC codes in claims. Overall survival was estimated as time from diagnosis to death.
Results: Of female breast cancer patients in GENIE-BPC (n = 775), SEER (n = 548 336), SEER-Medicare (n = 68 914), and Marketscan (n = 109 499) databases, the median ages at initial diagnosis were 44, 62, 74, and 57 years, respectively. A greater proportion of patients in GENIE-BPC, compared to SEER/SEER-Medicare, had higher nuclear grades (%III-%IV: 57% vs. 26%/24%), advanced disease stage (%IV: 25.3% vs. 5%/3.6%), percent of triple negative breast cancer (19.7% vs. 10.2%/8.5%), and receipt of chemotherapy (85.0% vs. NA/22.3%). The 1-, 3-, and 5-year overall survival rates were lower in GENIE-BPC (78.5%, 60.5%, 55.5%) than in SEER (95.8%, 89.5%, 85.5%) and SEER-Medicare (91.6%, 81.4%, 75.0%).
Conclusion: Breast cancer patients in GENIE-BPC were younger, had more advanced disease, had a higher proportion of triple negative breast cancer and recipients of chemotherapy, and had poorer overall survival. Researchers must use statistical adjustment when extrapolating results (e.g., biomarker prevalence) from GENIE-BPC to the larger breast cancer population.
基因组学证据肿瘤信息交换生物制药合作组织（GENIE-BPC）和其他真实世界数据库中新诊断出的浸润性乳腺患者队列的比较》（The Comparison of Newly Diagnosed Invasive Breast Patient Cohorts in Genomics Evidence Neoplasia Information Exchange Biopharma Collaborative (GENIE-BPC) and Other Real-World Database）。
背景：整合了基因组和临床数据的肿瘤数据库已成为精准医疗的宝贵资源。然而，这些数据库的普适性尚未得到全面评估：描述 GENIE-BPC 和其他三个数据库中乳腺癌队列的人口统计学、临床特征、治疗和总生存率：本研究利用了 GENIE-BPC、SEER、SEER-Medicare 和 Merative MarketScan Research 数据库。患有浸润性乳腺癌的女性通过电子病历、癌症登记处或 ICD-9/10-CM 编码确定。年龄在 18 岁以上或符合数据库要求。治疗以电子病历或报销单中的 HCPCS/NDC 编码为依据。总生存期按从诊断到死亡的时间估算：在GENIE-BPC（n = 775）、SEER（n = 548 336）、SEER-Medicare（n = 68 914）和Marketscan（n = 109 499）数据库中的女性乳腺癌患者中，初次诊断时的中位年龄分别为44岁、62岁、74岁和57岁。与SEER/SEER-Medicare相比，GENIE-BPC中更多患者的核分级更高（%III-%IV：57% vs. 26%/24%），疾病分期更晚（%IV：25.3% vs. 5%/3.6%），三阴性乳腺癌比例更高（19.7% vs. 10.2%/8.5%），接受化疗的比例更高（85.0% vs. NA/22.3%）。GENIE-BPC的1年、3年和5年总生存率（78.5%、60.5%、55.5%）低于SEER（95.8%、89.5%、85.5%）和SEER-Medicare（91.6%、81.4%、75.0%）：结论：GENIE-BPC 中的乳腺癌患者更年轻、病情更晚期、三阴性乳腺癌和接受化疗的比例更高、总生存率更低。研究人员在将 GENIE-BPC 的结果（如生物标志物的流行率）推断到更大范围的乳腺癌人群时，必须进行统计调整。
期刊介绍：
The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report.
Particular areas of interest include:
design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology;
comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world;
methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology;
assessments of harm versus benefit in drug therapy;
patterns of drug utilization;
relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines;
evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
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