1 Norris Comprehensive Cancer Center, University of Southern California, Los Angles, CA, USA.
2 Global Patient Outcomes and Real-World Evidence, Eli Lilly and Company, Indianapolis, IN, USA.
Cancer Control. 2019 Jan-Dec;26(1):1073274819847642. doi: 10.1177/1073274819847642.
This retrospective observational study was designed to evaluate overall survival in a real-world patient population and to identify predictive factors associated with receipt of second-line therapy. A retrospective analysis of electronic medical records (Flatiron Health, New York) was conducted among patients initiating first-line therapy from January 1, 2013, through April 30, 2018. Eligible patients were diagnosed with advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma and ≥18 years of age at the time of treatment initiation. Patients alive 45 days after discontinuation of first-line therapy were considered potentially eligible for continued therapy and were categorized into those who received and those who did not receive second-line therapy. Survival analyses were conducted using Kaplan-Meier method and log-rank test without adjusting for any baseline covariates. Factors associated with further treatment were evaluated using logistic regression. A total of 3850 patients met eligibility criteria. Among the 2516 patients available to receive second-line therapy, 1515 (60.2%) received second-line therapy and 1001 (39.8%) did not receive further therapy. Among those potentially eligible to receive second-line therapy, median survival was 15.4 months (95% confidence interval [CI]: 14.6-16.0) from initiation of first-line therapy for those who received second-line therapy and 10.0 months (95% CI: 9.3-10.7) for those who did not. Longer duration of first-line therapy (≥169 vs ≤84 days), HER2-positive tumors, initially diagnosed with stage IV disease, less weight loss during first-line therapy, and younger age were associated with receipt of second-line therapy (all P < .001). Longer survival was associated with multiple lines of therapy; however, these results should be interpreted with caution, and no causal relationship can be inferred.
这项回顾性观察研究旨在评估真实世界患者人群的总生存率,并确定与接受二线治疗相关的预测因素。对 2013 年 1 月 1 日至 2018 年 4 月 30 日期间接受一线治疗的患者的电子病历(Flatiron Health,纽约)进行了回顾性分析。符合条件的患者被诊断为晚期胃、胃食管交界处或食管腺癌,在开始治疗时年龄≥18 岁。在停止一线治疗后 45 天仍存活的患者被认为有资格继续接受治疗,并分为接受和未接受二线治疗的患者。使用 Kaplan-Meier 方法和对数秩检验进行生存分析,未调整任何基线协变量。使用逻辑回归评估与进一步治疗相关的因素。共有 3850 名患者符合入选标准。在 2516 名有资格接受二线治疗的患者中,1515 名(60.2%)接受了二线治疗,1001 名(39.8%)未接受进一步治疗。在那些有资格接受二线治疗的患者中,对于接受二线治疗的患者,从开始一线治疗到中位生存时间为 15.4 个月(95%置信区间[CI]:14.6-16.0),而对于未接受进一步治疗的患者,中位生存时间为 10.0 个月(95%CI:9.3-10.7)。更长的一线治疗时间(≥169 天 vs ≤84 天)、HER2 阳性肿瘤、最初诊断为 IV 期疾病、一线治疗期间体重减轻较少和年龄较小与接受二线治疗相关(均 P <.001)。更多的治疗线数与更长的生存时间相关;然而,这些结果应谨慎解释,并且不能推断出因果关系。