Division of Clinical Oncology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
Department of Internal Medicine V: Hematology and Oncology, Medical University of Innsbruck, Innsbruck, Austria.
Eur J Cancer. 2021 Jul;151:3-13. doi: 10.1016/j.ejca.2021.03.040. Epub 2021 May 2.
Gemcitabine/nab-paclitaxel (GN) and FOLFIRINOX are standard first-line treatment options for advanced pancreatic ductal adenocarcinoma (aPDAC), but currently no prospective randomised head-to-head comparison between these treatments has yet been performed.
We conducted a comparative propensity score (PS) analysis of overall (OS) and progression-free survival (PFS) in a tri-centre cohort of patients with aPDAC undergoing palliative first-line treatment with either GN or FOLFIRINOX.
In unadjusted analysis, OS and PFS were highly similar between patients treated with GN (n = 297) and FOLFIRINOX (n = 158). In detail, median, 1- and 2-year OS estimates were 10.1 months, 42% and 18% in the GN group, as compared to 11.2 months, 45% and 12% in the FOLFIRINOX group, respectively (log-rank p = 0.783). Accordingly, median (4.6 versus 4.8 months), 6-month (40% versus 43%) and 1-year (9% versus 9%) PFS estimates did not significantly differ (log-rank p = 0.717). However, patients treated with FOLFIRINOX were significantly younger, had fewer comorbidities, and a better Eastern Cooperative Oncology Group performance status. These imbalances were accounted for by weighting the data with the PS. In PS analysis of survival outcomes, OS and PFS remained comparable between the two treatment groups. In detail, PS-weighted median, 1- and 2-year OS estimates were 10.1 months, 42% and 18% in the GN group, as compared to 10.1 months, 40% and 13% in the FOLFIRINOX group (PS-weighted log-rank p = 0.449). PS-weighted PFS estimates again did not differ (PS-weighted log-rank p = 0.329).
This real-world comparative effectiveness study indicates that FOLFIRINOX and GN have similar effectiveness in the palliative first-line treatment of aPDAC.
吉西他滨/白蛋白结合型紫杉醇（GN）和 FOLFIRINOX 是晚期胰腺导管腺癌（aPDAC）的标准一线治疗选择，但目前尚未对这两种治疗方法进行前瞻性随机头对头比较。
我们对在三中心接受姑息性一线治疗的 aPDAC 患者进行了整体（OS）和无进展生存期（PFS）的倾向评分（PS）比较分析，这些患者分别接受 GN 或 FOLFIRINOX 治疗。
在未调整的分析中，接受 GN（n=297）和 FOLFIRINOX（n=158）治疗的患者的 OS 和 PFS 高度相似。具体而言，GN 组的中位、1 年和 2 年 OS 估计值分别为 10.1 个月、42%和 18%，而 FOLFIRINOX 组分别为 11.2 个月、45%和 12%（对数秩检验 p=0.783）。相应地，中位（4.6 与 4.8 个月）、6 个月（40%与 43%）和 1 年（9%与 9%）PFS 估计值无显著差异（对数秩检验 p=0.717）。然而，接受 FOLFIRINOX 治疗的患者年龄明显更小，合并症更少，东部合作肿瘤学组表现状态更好。这些不平衡通过 PS 对数据进行加权来考虑。在生存结果的 PS 分析中，两组治疗之间的 OS 和 PFS 仍然相当。具体而言，GN 组的 PS 加权中位、1 年和 2 年 OS 估计值分别为 10.1 个月、42%和 18%，而 FOLFIRINOX 组分别为 10.1 个月、40%和 13%（PS 加权对数秩检验 p=0.449）。PS 加权 PFS 估计值再次没有差异（PS 加权对数秩检验 p=0.329）。
这项真实世界的比较有效性研究表明，FOLFIRINOX 和 GN 在晚期胰腺导管腺癌的姑息性一线治疗中具有相似的疗效。
