City of Hope Comprehensive Cancer Center, Duarte, CA.
Merck & Co., Inc., Rahway, NJ.
J Manag Care Spec Pharm. 2023 Jul;29(7):749-757. doi: 10.18553/jmcp.2023.29.7.749.
Intermediate endpoints, such as disease-free survival (DFS), have shown good correlation with overall survival (OS) in early-stage non-small cell lung cancer (NSCLC) clinical trials. However, real-world data are limited, and no previous real-world study has quantified the clinical and economic burden of disease recurrence. To examine the association between real-world DFS (rwDFS) and OS and quantify the association between NSCLC recurrence and health care resource utilization (HCRU), health care costs, and OS in patients with resected early-stage NSCLC in the United States. Data from the Surveillance, Epidemiology, and End Results-Medicare database (2007-2019) for patients with newly diagnosed stage IB (tumor size ≥ 4 cm) to IIIA (American Joint Committee on Cancer 7th edition) NSCLC who underwent surgery for primary NSCLC were analyzed in this retrospective observational study. Baseline patient demographic and clinical characteristics were described. rwDFS and OS were compared between patients with vs without recurrence using Kaplan-Meier curves and the log-rank test; their correlation was assessed using normal scores rank correlation. All-cause and NSCLC-related HCRU and health care costs were summarized, and mean monthly allcause and NSCLC-related health care costs were compared between cohorts using generalized linear models. Of the 1,761 patients who underwent surgery, 1,182 (67.1%) had disease recurrence; these patients had shorter OS from the index date and shorter subsequent OS at each postsurgery landmark (ie, 1, 3, and 5 years) than those without recurrence (all < 0.001). OS and rwDFS were significantly correlated (0.57; < 0.001). Patients with recurrence also had significantly higher all-cause and NSCLC-related HCRU and mean monthly all-cause and NSCLC-related health care costs during the study period. Postsurgery rwDFS was significantly correlated with OS in patients with early-stage NSCLC. Patients with postsurgery recurrence had a higher risk of death and incurred higher HCRU and health care costs than those without recurrence. These findings highlight the importance of preventing or delaying recurrence in patients with resected NSCLC. Dr West is Senior Medical Director at AccessHope and an Associate Professor at City of Hope. He also serves on the advisory board for Amgen, AstraZeneca, Genentech/Roche, Gilead, Merck, Mirati Therapeutics, Regeneron, Summit Therapeutics, and Takeda and as a speaker for AstraZeneca and Merck. Drs Hu, Chirovsky, and Samkari are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and own stock/stock options in Merck & Co., Inc., Rahway, NJ, USA. Drs Zhang, Song, Gao, and Signorovitch, Mr Lerner, and Ms Jiang are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, which funded the development and conduct of this study and article. This study used the linked SEER-Medicare database. The interpretation and reporting of these data are the sole responsibility of the authors. The collection of cancer incidence data used in this study was supported by the California Department of Public Health pursuant to California Health and Safety Code Section 103885; Centers for Disease Control and Prevention's National Program of Cancer Registries, under cooperative agreement 5NU58DP006344; the National Cancer Institute's SEER Program under contract HHSN261201800032I awarded to the University of California, San Francisco, contract HHSN261201800015I awarded to the University of Southern California, and contract HHSN261201800009I awarded to the Public Health Institute. The ideas and opinions expressed herein are those of the authors and do not necessarily reflect the opinions of the State of California, Department of Public Health, the National Cancer Institute, and the Centers for Disease Control and Prevention or their contractors and subcontractors.
中间终点，如无疾病生存（DFS），在早期非小细胞肺癌（NSCLC）临床试验中与总生存（OS）有很好的相关性。然而，实际数据有限，以前没有真实世界的研究量化疾病复发的临床和经济负担。本研究旨在检查真实世界 DFS（rwDFS）与 OS 的关系，并量化 NSCLC 复发与美国接受手术治疗的早期 NSCLC 患者的医疗资源利用（HCRU）、医疗保健成本和 OS 之间的关联。本回顾性观察性研究分析了 2007-2019 年监测、流行病学和最终结果-医疗保险数据库中接受手术治疗的新诊断为 IB 期（肿瘤大小≥4cm）至 IIIA 期（美国癌症联合委员会第 7 版）NSCLC 患者的数据。描述了患者的基线人口统计学和临床特征。Kaplan-Meier 曲线和对数秩检验比较了有复发和无复发患者的 rwDFS 和 OS；使用正态得分秩相关评估它们之间的相关性。总结了全因和 NSCLC 相关的 HCRU 和医疗保健成本，并使用广义线性模型比较了两个队列之间的平均每月全因和 NSCLC 相关医疗保健成本。在接受手术的 1761 名患者中，1182 名（67.1%）发生疾病复发；与无复发患者相比，这些患者从索引日期开始的 OS 较短，随后的每个术后里程碑（即 1、3 和 5 年）的 OS 也较短（均<0.001）。OS 和 rwDFS 显著相关（0.57；<0.001）。复发患者在研究期间的全因和 NSCLC 相关 HCRU 以及平均每月全因和 NSCLC 相关医疗保健成本也显著更高。早期 NSCLC 患者术后 rwDFS 与 OS 显著相关。术后复发的患者死亡风险更高，HCRU 和医疗保健成本也更高。这些发现强调了预防或延迟 NSCLC 患者复发的重要性。West 博士是 AccessHope 的高级医学总监，也是希望之城的副教授。他还是安进、阿斯利康、基因泰克/罗氏、吉利德、默克、米拉蒂治疗公司、Regeneron、Summit 治疗公司和武田的顾问委员会成员，也是阿斯利康和默克的演讲者。胡博士、奇罗夫斯基博士和 Samkari 博士是默克 Sharp & Dohme LLC（默克公司的子公司）的员工，位于新泽西州 Rahway，他们拥有默克公司的股票/股票期权，新泽西州 Rahway，他们为默克 Sharp & Dohme LLC 提供有偿咨询服务，默克公司的子公司，新泽西州 Rahway，该公司资助了这项研究和文章的开发和进行。本研究使用了链接的 SEER-医疗保险数据库。作者对这些数据的解释和报告负有全部责任。本研究中使用的癌症发病率数据是由加利福尼亚州公共卫生部根据加利福尼亚州健康和安全法典第 103885 条支持收集的；疾病控制和预防中心的国家癌症登记处计划，根据合作协议 5NU58DP006344；国家癌症研究所的 SEER 计划，根据授予加利福尼亚大学旧金山分校的合同 HHSN261201800032I，根据授予南加州大学的合同 HHSN261201800015I，以及根据授予公共卫生协会的合同 HHSN261201800009I。本文中提出的想法和意见是作者的意见，不一定反映加利福尼亚州公共卫生部、国家癌症研究所和疾病控制与预防中心或其承包商和分包商的意见。
