Modified FOLFIRINOX versus gemcitabine plus oxaliplatin as first-line chemotherapy for patients with locally advanced or metastatic cholangiocarcinoma: a retrospective comparative study

Lu Zou, Xuechuan Li, Xiangsong Wu, Jiujie Cui, Xuya Cui, Xiaoling Song, Tai Ren, Xusheng Han, Yidi Zhu, Huaifeng Li, Wenguang Wu, Xu'an Wang, Wei Gong, Liwei Wang, Maolan Li, Wan Yee Lau, Yingbin Liu, Lu Zou, Xuechuan Li, Xiangsong Wu, Jiujie Cui, Xuya Cui, Xiaoling Song, Tai Ren, Xusheng Han, Yidi Zhu, Huaifeng Li, Wenguang Wu, Xu'an Wang, Wei Gong, Liwei Wang, Maolan Li, Wan Yee Lau, Yingbin Liu

Abstract

Background: 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.

Methods: From 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).

Results: Of 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).

Conclusions: First-line mFOLFIRINOX offered more promising results in patients with advanced or metastatic CCA.

Keywords: mFOLFIRINOX chemotherapy gemcitabine cholangiocarcinoma.

Conflict of interest statement

All authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Progression-free survival (A) and overall survival (B) in patients receiving mFOLFIRINOX (n = 27) and Gemox (n = 22)

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