Roche Diagnostics, Santa Clara, CA, USA.
Adv Ther. 2021 Mar;38(3):1552-1566. doi: 10.1007/s12325-020-01617-2. Epub 2021 Feb 4.
Although clinical guidelines are broadly available, the relationship between adherence and outcomes is not well studied. This study aimed to assess the association between adherence to National Comprehensive Cancer Network (NCCN) guidelines and clinical outcomes for adult patients with advanced non-small-cell lung cancer (aNSCLC).
This was a retrospective cohort study of adult patients with aNSCLC (stages IIIB, IIIC, and IV) from a de-identified real-world database. The objective was accomplished in a two-step analysis process. We first assessed adherence to NCCN recommendations for biomarker testing and overall survival (OS). Next, we assessed adherence to NCCN-recommended first-line therapy and time to treatment discontinuation (TTD). Multivariable Cox regression analyses were conducted to evaluate the association between guideline adherence and patient outcomes. Kaplan-Meier analyses were used to assess median OS and TTD.
A total of 28,784 patients with a diagnosis for aNSCLC between January 1, 2011 and July 31, 2019 met the inclusion criteria for the analysis of NCCN-recommended biomarker testing adherence. Two-thirds of these patients (n = 19,787) had evidence of biomarker testing (adherent). Multivariable Cox models found that testing-adherent patients had a significantly lower risk of mortality [hazard ratio (HR) = 0.89, 95% confidence interval (CI) 0.86, 0.92; p < 0.01]. Median OS was modestly longer in the testing-adherent group compared to the testing-non-adherent group (15.4 vs. 14.2 months; p < 0.01). For the first-line therapy analysis, 15,898 patients met the inclusion criteria, of which 69.9% had evidence of appropriate first-line therapy (first-line-adherent). The multivariable Cox model found that adherent patients had significantly lower risk of treatment discontinuation versus non-adherent patients (HR = 0.60, 95% CI 0.57, 0.62; p < 0.01). First-line-adherent patients had a modest, yet significantly longer median TTD compared to first-line-non-adherent patients (3.45 vs. 2.40 months; p < 0.01).
Improved clinical outcomes were observed in patients who were adherent to NCCN-recommended biomarker testing and first-line therapy. This study demonstrated the value of following NCCN guideline recommendations and the need to prioritize timely access to biomarker testing and individualized treatment.
尽管临床指南广泛可用,但依从性与结局之间的关系尚未得到充分研究。本研究旨在评估美国国家综合癌症网络(NCCN)指南的依从性与成人晚期非小细胞肺癌(aNSCLC)患者的临床结局之间的关联。
这是一项回顾性队列研究,纳入了来自一个去识别的真实世界数据库的患有 aNSCLC(IIIb、IIIC 和 IV 期)的成年患者。该研究的目的是通过两步分析过程来完成。我们首先评估了 NCCN 推荐的生物标志物检测和总生存期(OS)的依从性。接下来,我们评估了 NCCN 推荐的一线治疗和治疗终止时间(TTD)的依从性。多变量 Cox 回归分析用于评估指南依从性与患者结局之间的关联。Kaplan-Meier 分析用于评估中位 OS 和 TTD。
2011 年 1 月 1 日至 2019 年 7 月 31 日期间,共有 28784 名患有 aNSCLC 的患者符合分析 NCCN 推荐的生物标志物检测依从性的纳入标准。这些患者中有三分之二(n=19787)有生物标志物检测证据(依从)。多变量 Cox 模型发现,检测依从性患者的死亡率风险显著降低[风险比(HR)=0.89,95%置信区间(CI)0.86,0.92;p<0.01]。与检测不依从组相比,检测依从组的中位 OS 略长(15.4 与 14.2 个月;p<0.01)。对于一线治疗分析,符合纳入标准的患者有 15898 名,其中 69.9%有适当的一线治疗证据(一线治疗依从)。多变量 Cox 模型发现,与不依从患者相比,依从患者的治疗终止风险显著降低(HR=0.60,95%CI 0.57,0.62;p<0.01)。与一线治疗不依从患者相比,一线治疗依从患者的中位 TTD 略长,但差异具有统计学意义(3.45 与 2.40 个月;p<0.01)。
依从 NCCN 推荐的生物标志物检测和一线治疗的患者观察到临床结局改善。本研究证明了遵循 NCCN 指南建议的价值,以及优先及时获得生物标志物检测和个体化治疗的必要性。