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吉西他滨联合 nab-紫杉醇对比 FOLFIRINOX 方案用于不可切除胰腺癌:退伍军人中的疗效比较和肿瘤生长评估。

Gemcitabine plus nab-paclitaxel versus FOLFIRINOX for unresected pancreatic cancer: Comparative effectiveness and evaluation of tumor growth in Veterans.

机构信息

The Mount Sinai School of Medicine, New York, NY.

The College of Physicians and Surgeons at Columbia University, New York, NY.

出版信息

Semin Oncol. 2021 Feb;48(1):69-75. doi: 10.1053/j.seminoncol.2021.02.001. Epub 2021 Feb 23.

Abstract

PURPOSE

Advanced, unresectable pancreatic cancer is often treated with either gemcitabine plus nab-paclitaxel (Gem/NabP) or FOLFIRINOX, although these regimens have never been compared in a head-to-head trial. In this study, we compared these two regimens using Veterans Administration (VA) data and evaluated the use of a novel tumor growth formula to predict outcomes.

METHODS

We identified 670 Veterans from national VA data with unresected stage II-IV pancreatic adenocarcinoma diagnosed between 2003 and 2016 who were treated with either first-line Gem/NabP or FOLFIRINOX. We compared overall survival (OS) and adverse events by treatment using propensity scores (PS) to account for allocation bias. Using longitudinal CA19-9 biomarker information we then fit the data to a novel tumor growth equation, comparing growth with OS.

RESULTS

We found no difference in PS-adjusted (hazard ratio [HR] 1.00; 95% confidence interval [95% CI] 0.84-1.20) or PS-matched (HR: 0.93; 95% CI: 0.76-1.13) OS between the two treatment groups. Tumor growth analysis revealed similar growth parameter values for Gem/NabP and FOLFIRINOX (P = .074 for difference).

CONCLUSIONS

Gem/NabP appeared noninferior to FOLFIRINOX for survival outcomes for advanced pancreatic adenocarcinoma based on national VA data. Biomarker-based growth equations may be useful for monitoring treatment response and predicting prognosis for pancreatic cancer.

摘要

目的

晚期不可切除的胰腺癌通常采用吉西他滨联合 nab-紫杉醇(Gem/NabP)或 FOLFIRINOX 治疗,尽管这两种方案从未在头对头试验中进行比较。在这项研究中,我们使用退伍军人事务部(VA)的数据比较了这两种方案,并评估了一种新的肿瘤生长公式在预测结果方面的应用。

方法

我们从国家 VA 数据中确定了 670 名患有 2003 年至 2016 年间诊断为 II-IV 期未切除的胰腺腺癌的退伍军人,他们接受了一线 Gem/NabP 或 FOLFIRINOX 治疗。我们使用倾向评分(PS)比较了治疗方法对总生存期(OS)和不良事件的影响,以纠正分配偏差。然后,我们利用纵向 CA19-9 生物标志物信息,将数据拟合到一个新的肿瘤生长方程中,比较生长与 OS 的关系。

结果

我们发现 PS 调整后(风险比 [HR] 1.00;95%置信区间 [95% CI] 0.84-1.20)或 PS 匹配后(HR:0.93;95% CI:0.76-1.13),两组治疗方法之间的 OS 无差异。肿瘤生长分析显示,Gem/NabP 和 FOLFIRINOX 的生长参数值相似(差异的 P 值=0.074)。

结论

基于国家 VA 数据,Gem/NabP 在晚期胰腺腺癌的生存结果方面似乎不劣于 FOLFIRINOX。基于生物标志物的生长方程可能有助于监测治疗反应和预测胰腺癌的预后。

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