Abstract
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.
Highlights
Cholangiocarcinoma (CCA), which includes intrahepatic, hilar and distal CCA, is a heterogeneous group of rare tumors [1, 2]
The corresponding median Progression free survival (PFS) was 9.9 months (95% confidence interval [Confidence interval (CI)], 7.3– 12.4) in the mFOLFIRINOX group versus 6.4 months in the gemcitabine plus oxaliplatin (Gemox) group
This study was conducted to evaluate the effectiveness and safety of mFOLFIRINOX compared to Gemox for patients with locally advanced or metastatic CCA. Patients This is a retrospective study on consecutive patients with intrahepatic, hilar, or distal CCA at locally advanced or metastatic stage who were treated with either mFOLFIRINOX or Gemox as a first-line therapy from January 2016 to December 2019 at Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Summary
Cholangiocarcinoma (CCA), which includes intrahepatic, hilar and distal CCA, is a heterogeneous group of rare tumors [1, 2]. The prognosis for advanced CCA is less favorable with a median survival of less than 12 months and an overall survival rate (OS) of 5 years of approximately 5% [3]. Gemcitabine plus platinum, as the first-line chemotherapy for CCA, has limited efficacy (OS: 11.7 months) [4]. Gemcitabine plus oxaliplatin (Gemox) has similar efficacy compared with gemcitabine plus cisplatin (weighted median OS: oxaliplatin group vs cisplatin; 9.5 months vs 9.7 months) [5]. The ESMO clinical guidelines recommend cisplatin/gemcitabine chemotherapy regimen or participation in clinical trials for patients with locally advanced or metastatic CCA [8]. Gemcitabine 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
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