George Ben, Kent Matthew, Surinach Andy, Lamarre Neil, Cockrum Paul
Department of Medical Oncology, Froedtert & the Medical College of Wisconsin, Milwaukee, WI, United States.
Real World Data Analytics, Genesis Research, Hoboken, NJ, United States.
Front Oncol. 2021 Oct 4;11:754687. doi: 10.3389/fonc.2021.754687. eCollection 2021.
Pancreatic cancer is expected to be the third deadliest cancer in the US in 2021. Evaluation of treatment response in patients with mPDAC necessitates scheduled clinical and radiographic assessments along with monitoring serum CA 19-9 levels. Currently available single-institution data examining the importance of CA 19-9 monitoring cannot be generalized to real-world settings. We investigated the impact of serum CA 19-9 monitoring and its association with clinical outcomes in patients with mPDAC in a population-based setting.
Data were extracted from the Flatiron Health electronic health record (EHR)-derived de-identified database for patients diagnosed with mPDAC between January 1, 2015, and June 30, 2020. Serum CA 19-9 levels at baseline - defined as the values obtained ≤ 60 days prior to treatment initiation - and during treatment were extracted. CA 19-9 levels > 40 IU/mL were considered elevated. Survival outcomes were compared based on testing frequency, baseline CA 19-9 levels, and change in CA 19-9.
6,118 patients with mPDAC who received treatment were included in the analysis. The median age at diagnosis was 68 years (IQR: 61-75). Patients with normal baseline CA 19-9 experienced longer median survival than patients with elevated levels [1L: 8.8 months (95% CI: 7.9 - 10) 7.2 months (6.8 - 7.5), p < 0.001; 2L: 7.2 months (6.1 - 9.2) 5.2 months (4.9 - 5.6), p < 0.001; 3L: 6.1 months (5.4 - 9.1) 3.9 months (3.4 - 4.3), p < 0.001]. Patients with decreasing/stable CA 19-9 during treatment experienced longer survival than patients who experienced an increase in CA 19-9 levels [1L: 10.9 months (10.5 - 11.3) 5.4 months (5.1 - 5.9), p < 0.0001; 2L: 8.2 months (7.7 - 8.5) 4.3 months (4.1 - 4.7), p < 0.001; 3L: 7.5 months (6.6 - 9.2) 3.7 months (3.4 - 4.3), p < 0.001].
In one of the largest, contemporary, real-world studies of patients with mPDAC, elevated CA 19-9 level at treatment initiation demonstrated a prognostic impact. Routine serial monitoring of CA 19-9 levels during treatment may be warranted, in addition to clinical and radiographic assessment, and may translate into better patient outcomes. Further validation studies are needed to understand the generalizability of these results.
预计2021年胰腺癌将成为美国第三大致命癌症。评估转移性胰腺癌（mPDAC）患者的治疗反应需要定期进行临床和影像学评估，并监测血清CA 19-9水平。目前可用的单机构数据研究了CA 19-9监测的重要性，但无法推广到现实世界环境中。我们在基于人群的环境中调查了血清CA 19-9监测对mPDAC患者的影响及其与临床结局的关联。
从Flatiron Health电子健康记录（EHR）衍生的去识别数据库中提取2015年1月1日至2020年6月30日期间诊断为mPDAC的患者的数据。提取基线时（定义为治疗开始前≤60天获得的值）和治疗期间的血清CA 19-9水平。CA 19-9水平>40 IU/mL被视为升高。根据检测频率、基线CA 19-9水平和CA 19-9的变化比较生存结局。
6118例接受治疗的mPDAC患者纳入分析。诊断时的中位年龄为68岁（四分位间距：61-75岁）。基线CA 19-9正常的患者中位生存期长于水平升高的患者[一线治疗：8.8个月（95%置信区间：7.9-10）对7.2个月（6.8-7.5），p<0.001；二线治疗：7.2个月（6.1-9.2）对5.2个月（4.9-5.6），p<0.001；三线治疗：6.1个月（5.4-9.1）对3.9个月（3.4-4.3），p<0.001]。治疗期间CA 19-9降低/稳定的患者生存期长于CA 19-9水平升高的患者[一线治疗：10.9个月（10.5-11.3）对5.4个月（5.1-5.9），p<0.0001；二线治疗：8.2个月（7.7-8.5）对4.3个月（4.1-4.7），p<0.001；三线治疗：7.5个月（6.6-9.2）对3.7个月（3.4-4.3），p<0.001]。
在一项针对mPDAC患者的最大规模、当代、现实世界研究中，治疗开始时CA 19-9水平升高显示出预后影响。除了临床和影像学评估外，治疗期间常规连续监测CA 19-9水平可能是必要的，这可能转化为更好的患者结局。需要进一步的验证研究来了解这些结果的普遍性。
