Modified FOLFIRINOX versus gemcitabine plus oxaliplatin as first-line chemotherapy for patients with locally advanced or metastatic cholangiocarcinoma: a retrospective comparative study.
Modified FOLFIRINOX versus gemcitabine plus oxaliplatin as first-line chemotherapy for patients with locally advanced or metastatic cholangiocarcinoma: a retrospective comparative study.
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改良 FOLFIRINOX 与吉西他滨加奥沙利铂作为局部晚期或转移性胆管癌患者的一线化疗：一项回顾性比较研究
DOI：
10.1186/s12885-021-08549-2
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发表时间：
2021-07-16
期刊：
影响因子：
3.8
通讯作者：
Liu Y
中科院分区：
文献类型：
--
作者：
Zou L;Li X;Wu X;Cui J;Cui X;Song X;Ren T;Han X;Zhu Y;Li H;Wu W;Wang X;Gong W;Wang L;Li M;Lau WY;Liu Y
吉西他滨加铂作为胆管细胞癌(CCA)的一线化疗方案疗效有限。本研究的目的是评价改良FOLFIRINOX(MFOLFIRINOX)与吉西他滨加奥沙利铂(Gemox)治疗局部晚期或转移性Cca的疗效。方法从2016年1月至2019年12月，连续接受mFOLFIRINOX或Gemox作为一线化疗方案治疗局部晚期或转移性Cca。主要终点为无进展生存期(PFS)。第二个终点是总生存期(OS)、疾病控制率(DCR)和严重毒性(3-4级)的发生率。在基线和此后每4-6 周评估肿瘤。本研究按照《赫尔辛基宣言》的原则设计和进行，上海交通大学医学院附属新华医院伦理委员会批准(XHEC-D-2020-154)，并在ClinicalTrials.gov注册，编号NCT04305288(注册日期：12/03/2020)。结果49例患者中，FOLFIRINOX组27例，Gemox组22例。两组之间在基线特征上没有显著差异。MFOLFIRINOX组DCR为77.8%，Gemox组为63.5%。相应的中位PFS在mFOLFIRINOX组为9.9 月(95%可信区间，7.3-12.4)，而在吉莫组为6.4 月(95%可信区间，3.6-9.2，p= 0.040)。相应的中位OS为15.7 月(95%CI，12.5~19.0)，12.0 月(95%CI，9.3~14.8，p= 0.099)。MFOLFIRINOX组3~4级呕吐发生率明显高于吉莫司组(7例(25.9%)vs1例(4.5%)，p= 0.044)。结论一线mFOLFIRINOX治疗晚期或转移性颈总动脉疗效较好。
BackgroundGemcitabine plus platinum as the first-line chemotherapy for cholangiocarcinoma (CCA) has limited efficacy. The aim of this study was to evaluate the effectiveness of modified FOLFIRINOX (mFOLFIRINOX) compared to that of gemcitabine plus oxaliplatin (Gemox) for patients with locally advanced or metastatic CCA.MethodsFrom January 2016 to December 2019, consecutive patients who were diagnosed with locally advanced or metastatic CCA were treated with either mFOLFIRINOX or Gemox as a first-line chemotherapy. The main endpoint was Progression free survival (PFS). The second endpoints were Overall survival (OS), Disease control rate (DCR) and incidence of severe toxicity (grade 3–4). Tumors were evaluated at baseline and thence every 4–6 weeks. The study was designed and carried out in accordance with the principles of the declaration of Helsinki, approved by the Ethics Committee of Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine (XHEC-D-2020-154) and registered with ClinicalTrials.gov , number NCT04305288 (registration date: 12/03/2020).ResultsOf 49 patients in this study, 27 were in the FOLFIRINOX regimen group and 22 in the Gemox regimen group. There were no significant differences between groups in baseline characteristics. The DCR was 77.8% in the mFOLFIRINOX group and 63.5% in the Gemox group. The corresponding median PFS was 9.9 months (95% confidence interval [CI], 7.3–12.4) in the mFOLFIRINOX group versus 6.4 months (95% CI,3.6–9.2,p= 0.040) in the Gemox group. The corresponding median OS was 15.7 months (95% CI, 12.5–19.0) versus 12.0 months (95% CI, 9.3–14.8,p= 0.099). Significantly more grade 3–4 vomiting occurred in the mFOLFIRINOX than the Gemox groups (7 (25.9%) vs 1 (4.5%),p= 0.044).ConclusionsFirst-line mFOLFIRINOX offered more promising results in patients with advanced or metastatic CCA.
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影响因子：
2.5
作者：
Bergquist JR;Ivanics T;Storlie CB;Groeschl RT;Tee MC;Habermann EB;Smoot RL;Kendrick ML;Farnell MB;Roberts LR;Gores GJ;Nagorney DM;Truty MJ
通讯作者：
Truty MJ
影响因子：
3.1
作者：
Kang, Myoung Joo;Lee, Jae-Lyun;Kim, Myung-Hwan
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影响因子：
50.5
作者：
Valle, J. W.;Borbath, I.;Arnold, D.
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Arnold, D.
影响因子：
50.5
作者：
Jiang, W.;Zeng, Z. -C.;Chen, Y. -X.
通讯作者：
Chen, Y. -X.
影响因子：
6.1
作者：
Rizzo, Alessandro;Ricci, Angela Dalia;Brandi, Giovanni
通讯作者：
Brandi, Giovanni