Modified FOLFIRINOX for unresectable locally advanced or metastatic gallbladder cancer, a comparison with GEMOX regimen

Xu-Ya Cui; Xue-Chuan Li; Jiu-Jie Cui; Xiang-Song Wu; Lu Zou; Xiao-Ling Song; Tai Ren; Yi-Di Zhu; Huai-Feng Li; Yang Yang; Ke Liu; Xu-Sheng Han; Zi-Yao Jia; Wen-Guang Wu; Xu-An Wang; Wei Gong; Li-Wei Wang; Mao-Lan Li; Ying-Bin Liu

doi:10.21037/hbsn-20-846

Modified FOLFIRINOX for unresectable locally advanced or metastatic gallbladder cancer, a comparison with GEMOX regimen

Hepatobiliary Surg Nutr. 2021 Aug;10(4):498-506. doi: 10.21037/hbsn-20-846.

Authors

Xu-Ya Cui^{1

2

3

4

5

6}, Xue-Chuan Li^{2

3

4

5

6}, Jiu-Jie Cui^{4

6

7}, Xiang-Song Wu^{1

3

5}, Lu Zou^{2

3

4

5

6}, Xiao-Ling Song^{1

3

5}, Tai Ren^{1

3

5}, Yi-Di Zhu^{1

3

5}, Huai-Feng Li^{1

3

5}, Yang Yang^{2

3

4

5

6}, Ke Liu^{2

3

4

5

6}, Xu-Sheng Han^{1

3

5}, Zi-Yao Jia^{1

3

5}, Wen-Guang Wu^{2

3

4

5

6}, Xu-An Wang^{2

3

4

5

6}, Wei Gong^{1

3

5}, Li-Wei Wang^{4

6

7}, Mao-Lan Li^{1

3

5}, Ying-Bin Liu^{2

3

4

5

6}

Affiliations

¹ Department of General Surgery, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
² Department of Biliary-Pancreatic Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
³ Shanghai Key Laboratory of Biliary Tract Disease Research, Shanghai, China.
⁴ State Key Laboratory of Oncogenes and Related Genes, Shanghai, China.
⁵ Shanghai Research Center of Biliary Tract Disease, Shanghai, China.
⁶ Shanghai Cancer Institute, Shanghai, China.
⁷ Department of Medical Oncology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.

Abstract

Background: The first-line chemotherapy regimen for advanced gallbladder cancer (GBC) is gemcitabine plus platinum (GP), despite its efficacy is limited. The current investigation is a retrospective study to compare the safety and efficacy between the modified FOLFIRINOX (mFOLFIRINOX) and gemcitabine plus oxaliplatin (GEMOX) as the first-line chemotherapy for unresectable locally advanced or metastatic GBC.

Methods: The data of patients with unresectable locally advanced or metastatic GBC, who were treated with mFOLFIRINOX or GEMOX as the first-line therapy between April 2014 and April 2018 at Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, were retrieved. This retrospective study evaluated the clinical characteristics, survival outcomes and adverse events.

Results: A total of 44 patients (n=25 in mFOLFIRINOX, n=19 in GEMOX) were included. There were no significant differences between groups in baseline characteristics. The median progression free survival (mPFS) was 5.0 months in the mFOLFIRINOX group and 2.5 months in the GEMOX group [P=0.021; hazard ratio (HR), 0.499; 95% CI, 0.266 to 0.937]. The median overall survival (mOS) was 9.5 months in the mFOLFIRINOX group and 7.0 months in the GEMOX group (P=0.019; HR, 0.471; 95% CI, 0.239 to 0.929). Disease control rate (DCR) was 76.0% in the mFOLFIRINOX group and 47.4% in the GEMOX group (P=0.051). The rate of grade 3-4 adverse events was 48% in the mFOLFIRINOX group and 36.8% in the GEMOX group (P=0.459). The incidence of grade 3-4 neutropenia and diarrhea were more common in the mFOLFIRINOX group, while the incidence of grade 3-4 thrombocytopenia and peripheral neuropathy were more common in the GEMOX group.

Conclusions: mFOLFIRINOX might improve the poor prognosis of unresectable locally advanced or metastatic GBC, and the results need to be further verified by prospective clinical studies.

Keywords: Gallbladder cancer (GBC); chemotherapy; gemcitabine plus oxaliplatin (GEMOX); modified FOLFIRINOX (mFOLFIRINOX).