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基因组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浸润性乳腺癌患者队列的比较。

The Comparison of Newly Diagnosed Invasive Breast Patient Cohorts in Genomics Evidence Neoplasia Information Exchange Biopharma Collaborative (GENIE-BPC) and Other Real-World Databases.

机构信息

Epidemiology, Biostatistics and Research Decision Sciences, Merck & Co., Inc., West Point, Pennsylvania, USA.

Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, Florida, USA.

出版信息

Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5851. doi: 10.1002/pds.5851.

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.

摘要

背景

整合基因组和临床数据的肿瘤学数据库已成为精准医学的宝贵资源。然而,这些数据库的泛化能力尚未得到全面评估。

目的

描述 GENIE-BPC 及其他三个数据库中乳腺癌队列的人口统计学、临床特征、治疗方法和总生存情况。

方法

本研究利用了 GENIE-BPC、SEER、SEER-Medicare 和 Merative MarketScan 研究数据库。通过电子病历、癌症登记处或 ICD-9/10-CM 代码识别患有浸润性乳腺癌的女性。年龄为 18 岁及以上或符合各数据库要求。治疗方法基于索赔中的电子病历或 HCPCS/NDC 代码。总生存时间从诊断到死亡的时间来估计。

结果

在 GENIE-BPC(n=775)、SEER(n=548336)、SEER-Medicare(n=68914)和 Marketscan(n=109499)数据库中,女性乳腺癌患者的中位初诊年龄分别为 44、62、74 和 57 岁。与 SEER/SEER-Medicare 相比,GENIE-BPC 中有更高比例的患者核分级较高(%III-%IV:57% vs. 26%/24%)、疾病分期较晚(%IV:25.3% vs. 5%/3.6%)、三阴性乳腺癌比例较高(19.7% vs. 10.2%/8.5%)和接受化疗的比例较高(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 中的乳腺癌患者年龄较小,疾病较晚期,三阴性乳腺癌和接受化疗的比例较高,总生存率较差。当将 GENIE-BPC 的结果(例如生物标志物的流行率)外推到更大的乳腺癌人群时,研究人员必须使用统计调整。

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