Cockrum Paul, Dennen Syvart, Brown Audrey, Briggs Jonathon, Paluri Ravi
Medical Affairs, Ipsen Biopharmaceuticals Inc, Cambridge, MA, USA.
Genesis Research Group, Hoboken, NJ, USA.
Future Oncol. 2025 Jan;21(2):241-260. doi: 10.1080/14796694.2024.2435253. Epub 2024 Dec 8.
This systematic review summarizes real-world clinical outcomes and economic burden of first-line FOLFIRINOX (FFX)/modified FFX (mFFX) and nab-paclitaxel plus gemcitabine (GnP) in metastatic pancreatic ductal adenocarcinoma in the US.
Embase and MEDLINE were searched for materials published since 2014; citations were reviewed in a two-step process. Included studies were qualitatively synthesized.
Searches yielded 2,528 citations; 29 were included (17 clinical studies/12 economic studies). In 9/17 clinical studies, median overall survival (mOS) ranged from 4.7 months to 11.4 months for FFX/mFFX, with the unweighted median of the estimates within this range being 9.2 months; for GnP mOS ranged from 3.6 to 9.8 months, and the unweighted median of the estimates was 6.9 months. In 8/17 studies, grade 3/4 anemia, neutropenia, and thrombocytopenia were the most commonly reported adverse events. Across economic burden studies, total costs were similar between the 2 groups. Outpatient, supportive care, and granulocyte colony-stimulating factor costs were higher for the FFX generic regimen, and chemotherapy costs were higher for the GnP branded regimen.
Real-world OS in FFX- and GnP-treated populations was shorter than that in clinical trials, and total costs of FFX and GnP were similar, but with differences in cost components.
本系统评价总结了美国一线应用FOLFIRINOX(FFX)/改良FOLFIRINOX(mFFX)和白蛋白结合型紫杉醇联合吉西他滨(GnP)治疗转移性胰腺导管腺癌的真实世界临床结局和经济负担。
检索Embase和MEDLINE中自2014年以来发表的资料;通过两步流程对文献进行综述。对纳入的研究进行定性综合分析。
检索得到2528篇文献;纳入29篇(17项临床研究/12项经济研究)。在17项临床研究中的9项中,FFX/mFFX组的中位总生存期(mOS)为4.7个月至11.4个月,该范围内估计值的未加权中位数为9.2个月;GnP组的mOS为3.6至9.8个月,估计值的未加权中位数为6.9个月。在17项研究中的8项中,3/4级贫血、中性粒细胞减少和血小板减少是最常报告的不良事件。在各项经济负担研究中,两组的总成本相似。FFX通用方案的门诊、支持治疗和粒细胞集落刺激因子成本较高,GnP品牌方案的化疗成本较高。
FFX和GnP治疗人群的真实世界总生存期短于临床试验,FFX和GnP的总成本相似,但成本构成有所不同。