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Efficacy and safety of modified FOLFIRINOX as salvage therapy for patients with refractory advanced biliary tract cancer: a retrospective study

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Summary

Background Gemcitabine plus cisplatin is regarded as the standard first-line therapy for patients with advanced biliary tract cancer (BTC); however, no standard chemotherapy has yet been recommended after treatment failure. Modified FOLFIRINOX (mFOLFIRINOX) appears to be a better-tolerated regimen, which leads to improved survival in metastatic pancreatic cancer that has histological and molecular similarities with BTC. We assessed the efficacy and safety of mFOLFIRINOX as salvage therapy in advanced BTC patients who were refractory to previous chemotherapy. Methods A total of 15 consecutive patients with documented unresectable locally advanced or metastatic BCT who received the mFOLFIRINOX regimen were included in the study. Patients were intravenously administrated with oxaliplatin (65 mg/m2), leucovorin (400 mg/m2), irinotecan (150 mg/m2), and continuous infusion of fluorouracil (2400 mg/m2) over 46 h. The objective response rates (ORR), disease control rates (DCR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were recorded. Results At least three cycles of mFOLFIRINOX regimen were delivered to 15 patients with a median number of 6.0 cycles (IQR 5.5–11.0). The median duration of treatment was 3.8 months (IQR 2.9–8.5). Four patients (26.7%) achieved an ORR, and 12 patients (80.0%) had a DCR. The median PFS and OS were 6.7 months (95%CI 2.3–11.1) and 13.2 months (95%CI 7.3–19.1), respectively. Five patients (33.3%) had treatment-related grade 3/4 AEs. The most common grade 3/4 AE was neutropenia (n = 3, 20.0%), while there was no occurrence of febrile neutropenia. Conclusion Treatment with mFOLFIRINOX has promising efficacy and favorable tolerance as salvage therapy in patients with refractory advanced BCT.

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Data availability

The data in the current study are not publicly available to protect patient privacy, but the data in favor of these findings are available from the corresponding author if any reasonable request.

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Acknowledgements

We gratefully thank all the patients of this study, and the National Natural Science Foundation of China supporting this work.

Funding

This work was supported by the National Natural Science Foundation of China (No.82073302, 81602070).

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Author notes

  1. Liu-Fang Ye, Chao Ren, and Long Bai contributed equally to this study.

Authors and Affiliations

  1. State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, 510060, People’s Republic of China

    Liu-Fang Ye, Chao Ren, Long Bai, Jie-Ying Liang, Ming-Tao Hu, Hui Yang, Zhi-Qiang Wang, Feng-Hua Wang, Rui-Hua Xu, Yu-Hong Li & De-Shen Wang

  2. Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, 510060, People’s Republic of China

    Liu-Fang Ye, Chao Ren, Long Bai, Jie-Ying Liang, Ming-Tao Hu, Hui Yang, Zhi-Qiang Wang, Feng-Hua Wang, Rui-Hua Xu, Yu-Hong Li & De-Shen Wang

  3. Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of China

    Liu-Fang Ye, Chao Ren, Jie-Ying Liang, Ming-Tao Hu, Hui Yang, Zhi-Qiang Wang, Feng-Hua Wang, Rui-Hua Xu, Yu-Hong Li & De-Shen Wang

  4. Department of VIP Region, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of China

    Long Bai

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Contributions

Conception and design: Liu-Fang Ye, Chao Ren, Long Bai, De-Shen Wang. Material preparation and data collection: Liu-Fang Ye, Chao Ren, Long Bai, Jie-Ying Liang, Ming-Tao Hu, Hui Yang, Zhi-Qiang Wang, Feng-Hua Wang, Rui-Hua Xu, Yu-Hong Li, De-Shen Wang. Data analysis and interpretation: Liu-Fang Ye, Chao Ren, Long Bai, Yu-Hong Li, De-Shen Wang. Manuscript writing: all authors. Final approval of manuscript: all authors.

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Correspondence to De-Shen Wang.

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This study performed in line with the principles of the Declaration of Helsinki. Approval was granted by the ethical committee of Sun Yat-sen University Cancer Center.

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Ye, LF., Ren, C., Bai, L. et al. Efficacy and safety of modified FOLFIRINOX as salvage therapy for patients with refractory advanced biliary tract cancer: a retrospective study. Invest New Drugs 39, 836–845 (2021). https://doi.org/10.1007/s10637-020-01045-7

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