Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"-IRST, 47014 Meldola, Italy.
Unit of Oncology, IRCCS San Raffaele Scientific Institute, 20132 Milan, Italy.
Biomolecules. 2021 May 22;11(6):780. doi: 10.3390/biom11060780.
FOLFIRINOX (FFX) and gemcitabine + nab-paclitaxel (GN) are the most common chemotherapy regimens in first-line treatment of metastatic pancreatic cancer (PC). They have not been compared each other in a prospective trial, but only in retrospective studies, which can thus be affected by several biases. In order to overcome these biases, we took advantage of matching-adjusted indirect comparison (MAIC), that allows an indirect comparison by reducing cross-trial differences, and compared data from 268 patients treated with GN in a real-world setting with data from the 171 patients included in the FFX arm of the PRODIGE trial. Survival outcomes did not differ between the two populations. Overall survival was 11.1 months for both treatments (hazard ratio (HR) of FFX 1.10, 95% confidence interval (CI) 0.81-1.49; = 0.527). Progression-free survival was 6.0 months with GN and 6.4 months with FFX (HR of FFX 1.11, 95% CI 0.82-1.50; = 0.520). On the other hand, we observed a difference in the toxicity profiles: grade 3/4 anemia was more frequent with GN, whereas a higher occurrence of grade 3/4 vomiting and diarrhea was reported with FFX. FFX and GN show an equivalent efficacy but different safety profiles in the first-line therapy of metastatic pancreatic cancer. Searching for reliable predictive biomarkers is advised in order to improve therapeutic strategy in metastatic PC.
FOLFIRINOX (FFX) 和吉西他滨+白蛋白紫杉醇(GN)是转移性胰腺癌(PC)一线治疗中最常用的化疗方案。它们没有在前瞻性试验中进行相互比较,而只是在回顾性研究中进行了比较,这些研究可能受到多种偏倚的影响。为了克服这些偏倚,我们利用了匹配调整间接比较(MAIC),通过减少试验间差异来进行间接比较,并将在真实环境中接受 GN 治疗的 268 名患者的数据与 PRODIGE 试验中 FFX 臂纳入的 171 名患者的数据进行了比较。两种治疗方法的生存结果没有差异。两种治疗的总生存期均为 11.1 个月(FFX 的危险比(HR)为 1.10,95%置信区间(CI)为 0.81-1.49;= 0.527)。无进展生存期 GN 组为 6.0 个月,FFX 组为 6.4 个月(FFX 的 HR 为 1.11,95% CI 为 0.82-1.50;= 0.520)。另一方面,我们观察到毒性特征存在差异:GN 组更常见 3/4 级贫血,而 FFX 组报告的 3/4 级呕吐和腹泻发生率更高。FFX 和 GN 在转移性胰腺癌的一线治疗中显示出等效的疗效,但安全性特征不同。建议寻找可靠的预测生物标志物,以改善转移性 PC 的治疗策略。