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晚期癌症成人患者的生物标志物检测方法、治疗选择及护理成本

Biomarker Testing Approaches, Treatment Selection, and Cost of Care Among Adults With Advanced Cancer.

作者信息

DaCosta Byfield Stacey, Bapat Bela, Becker Laura, Reyes Carolina, Chatzitheofilou Ismini, Schroeder Brock E, Hostin Damon, Fox John

机构信息

Optum, Eden Prairie, Minnesota.

Illumina Inc, San Diego, California.

出版信息

JAMA Netw Open. 2025 Jul 1;8(7):e2519963. doi: 10.1001/jamanetworkopen.2025.19963.

DOI:10.1001/jamanetworkopen.2025.19963
PMID:40643914
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12254893/
Abstract

IMPORTANCE

Clinical guidelines recommend biomarker testing to identify patients eligible for targeted therapy. However, evidence suggests that biomarker testing rates are below guideline recommendations, which has been associated with worsened clinical outcomes, including overall survival.

OBJECTIVES

To identify patients with newly diagnosed advanced cancer receiving comprehensive genomic profiling (CGP), non-CGP, or no biomarker testing and to explore the change in rates of testing over time and compare targeted therapy rates and health care costs during first-line therapy.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used the deidentified Optum Labs Data Warehouse, a claims database of longitudinal health information on commercial health plan and Medicare Advantage enrollees, to identify patients diagnosed with advanced cancer between January 1, 2018, and January 1, 2022. The study included 26 311 adults with newly diagnosed advanced cancer (breast, colorectal, gastric, non-small cell lung, ovarian, and pancreatic) and continuous enrollment in a commercial or Medicare Advantage health plan for 12 months before and 6 months after their first advanced cancer diagnosis. Data were analyzed between February 1, 2023, and March 31, 2024.

EXPOSURE

Biomarker testing.

MAIN OUTCOMES AND MEASURES

Evidence of biomarker testing, the receipt of targeted therapy during first-line therapy, and per-patient, per-month (PPPM) costs during first-line therapy.

RESULTS

Among 26 311 patients (mean [SD] age, 68 [11] years; 62% female; 70% Medicare Advantage enrollees), molecular testing rates were suboptimal (35% had evidence of molecular testing), but testing rates increased across time for most cancer types (from 32% in 2018 to 39% in 2021-2022). Patients with non-small cell lung cancer and colorectal cancer with CGP testing were more likely to receive targeted therapy (odds ratio [OR], 1.57; 95% CI, 1.31-1.90; P < .001) compared with patients who received non-CGP testing (OR, 2.34; 95% CI, 1.58-3.47; P < .001). Costs among patients with CGP testing were not statistically different from those with non-CGP testing (cost ratios of 1.03; 95% CI, 0.91-1.17 [P = .63] for breast cancer, 0.98; 95% CI, 0.89-1.09 [P = .71] for colorectal cancer, 1.10; 95% CI, 0.87-1.40 [P = .42] for gastric cancer, 1.06; 95% CI, 1.00-1.13 [P = .054] for non-small cell lung, 0.94; 95% CI, 0.76-1.15 [P = .55] for ovarian cancer, and 1.00; 95% CI, 0.83-1.21 [P = .98] for pancreatic cancer).

CONCLUSIONS AND RELEVANCE

In this cohort study, although increasing over time, biomarker testing rates were suboptimal despite guideline recommendations and increasing insurance coverage for testing. Given the potential benefits of CGP testing, such as increasing rates of targeted therapy without increased treatment-related costs, increasing CGP testing may improve outcomes.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a1bf/12254893/9261b86f2be8/jamanetwopen-e2519963-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a1bf/12254893/bc510330fe56/jamanetwopen-e2519963-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a1bf/12254893/37f145c330fd/jamanetwopen-e2519963-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a1bf/12254893/7c07584ea077/jamanetwopen-e2519963-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a1bf/12254893/9261b86f2be8/jamanetwopen-e2519963-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a1bf/12254893/bc510330fe56/jamanetwopen-e2519963-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a1bf/12254893/37f145c330fd/jamanetwopen-e2519963-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a1bf/12254893/7c07584ea077/jamanetwopen-e2519963-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a1bf/12254893/9261b86f2be8/jamanetwopen-e2519963-g004.jpg
摘要

重要性

临床指南推荐进行生物标志物检测,以确定适合接受靶向治疗的患者。然而,有证据表明,生物标志物检测率低于指南建议水平,这与包括总生存期在内的临床结局恶化相关。

目的

识别接受全面基因组分析(CGP)、非CGP或未进行生物标志物检测的新诊断晚期癌症患者,探讨检测率随时间的变化,并比较一线治疗期间的靶向治疗率和医疗保健成本。

设计、背景和参与者:这项回顾性队列研究使用了去识别化的Optum Labs数据仓库,这是一个关于商业健康保险计划和医疗保险优势计划参保者纵向健康信息的索赔数据库,以识别2018年1月1日至2022年1月1日期间被诊断为晚期癌症的患者。该研究纳入了26311名新诊断为晚期癌症(乳腺癌、结直肠癌、胃癌、非小细胞肺癌、卵巢癌和胰腺癌)的成年人,他们在首次晚期癌症诊断前12个月和诊断后6个月持续参加商业或医疗保险优势健康计划。数据于2023年2月1日至2024年3月31日进行分析。

暴露因素

生物标志物检测。

主要结局和测量指标

生物标志物检测的证据、一线治疗期间接受靶向治疗的情况以及一线治疗期间的人均每月成本。

结果

在26311名患者中(平均[标准差]年龄为68[11]岁;62%为女性;70%为医疗保险优势计划参保者),分子检测率不理想(35%有分子检测证据),但大多数癌症类型的检测率随时间有所增加(从2018年的32%增至2021 - 2022年的39%)。与接受非CGP检测的患者相比,接受CGP检测的非小细胞肺癌和结直肠癌患者更有可能接受靶向治疗(优势比[OR]为1.57;95%置信区间[CI]为1.31 - 1.90;P <.001)(接受非CGP检测患者的OR为2.34;95% CI为1.58 - 3.47;P <.001)。CGP检测患者的成本与非CGP检测患者的成本在统计学上无差异(乳腺癌的成本比为1.03;95% CI为0.91 - 1.17[P = 0.63],结直肠癌为0.98;95% CI为0.89 - 1.09[P = 0.71],胃癌为1.10;95% CI为0.87 - 1.40[P = 0.42],非小细胞肺癌为1.06;95% CI为1.00 - 1.13[P = 0.054],卵巢癌为0.94;95% CI为0.76 - 1.15[P = 0.55],胰腺癌为1.00;95% CI为0.83 - 1.21[P = 0.98])。

结论与意义

在这项队列研究中,尽管生物标志物检测率随时间有所增加,但尽管有指南建议且检测的保险覆盖范围不断扩大,检测率仍不理想。鉴于CGP检测的潜在益处,如提高靶向治疗率而不增加与治疗相关的成本,增加CGP检测可能改善结局。

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Opportunities for Improving System-Level Barriers to Biomarker Testing for Metastatic Colorectal Cancer.改善转移性结直肠癌生物标志物检测系统层面障碍的机遇。
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