PMID- 33411209 OWN - NLM STAT- MEDLINE DCOM- 20220214 LR - 20220214 IS - 1573-0646 (Electronic) IS - 0167-6997 (Linking) VI - 39 IP - 3 DP - 2021 Jun TI - Efficacy and safety of modified FOLFIRINOX as salvage therapy for patients with refractory advanced biliary tract cancer: a retrospective study. PG - 836-845 LID - 10.1007/s10637-020-01045-7 [doi] AB - 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/m(2)), leucovorin (400 mg/m(2)), irinotecan (150 mg/m(2)), and continuous infusion of fluorouracil (2400 mg/m(2)) 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. FAU - Ye, Liu-Fang AU - Ye LF AD - 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. AD - Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, 510060, People's Republic of China. AD - Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. FAU - Ren, Chao AU - Ren C AD - 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. AD - Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, 510060, People's Republic of China. AD - Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. FAU - Bai, Long AU - Bai L AD - 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. AD - Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, 510060, People's Republic of China. AD - Department of VIP Region, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. FAU - Liang, Jie-Ying AU - Liang JY AD - 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. AD - Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, 510060, People's Republic of China. AD - Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. FAU - Hu, Ming-Tao AU - Hu MT AD - 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. AD - Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, 510060, People's Republic of China. AD - Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. FAU - Yang, Hui AU - Yang H AD - 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. AD - Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, 510060, People's Republic of China. AD - Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. FAU - Wang, Zhi-Qiang AU - Wang ZQ AD - 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. AD - Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, 510060, People's Republic of China. AD - Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. FAU - Wang, Feng-Hua AU - Wang FH AD - 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. AD - Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, 510060, People's Republic of China. AD - Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. FAU - Xu, Rui-Hua AU - Xu RH AD - 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. AD - Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, 510060, People's Republic of China. AD - Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. FAU - Li, Yu-Hong AU - Li YH AD - 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. AD - Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, 510060, People's Republic of China. AD - Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. FAU - Wang, De-Shen AU - Wang DS AUID- ORCID: 0000-0001-9657-4380 AD - 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. wangdsh@sysucc.org.cn. AD - Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, 510060, People's Republic of China. wangdsh@sysucc.org.cn. AD - Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. wangdsh@sysucc.org.cn. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20210107 PL - United States TA - Invest New Drugs JT - Investigational new drugs JID - 8309330 RN - 0 (Antineoplastic Agents) RN - 0 (folfirinox) RN - 04ZR38536J (Oxaliplatin) RN - 7673326042 (Irinotecan) RN - Q573I9DVLP (Leucovorin) RN - U3P01618RT (Fluorouracil) SB - IM MH - Administration, Intravenous MH - Adult MH - Aged MH - Antineoplastic Agents/adverse effects/*therapeutic use MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Biliary Tract Neoplasms/*drug therapy/mortality MH - Female MH - Fluorouracil/adverse effects/therapeutic use MH - Humans MH - Irinotecan/adverse effects/therapeutic use MH - Kaplan-Meier Estimate MH - Leucovorin/adverse effects/therapeutic use MH - Male MH - Middle Aged MH - Oxaliplatin/adverse effects/therapeutic use MH - Retrospective Studies MH - *Salvage Therapy/adverse effects MH - Treatment Outcome OTO - NOTNLM OT - Advanced biliary tract cancer OT - Dose modification OT - Efficacy OT - FOLFIRINOX OT - Safety OT - Salvage therapy EDAT- 2021/01/08 06:00 MHDA- 2022/02/15 06:00 CRDT- 2021/01/07 12:18 PHST- 2020/11/03 00:00 [received] PHST- 2020/12/04 00:00 [accepted] PHST- 2021/01/08 06:00 [pubmed] PHST- 2022/02/15 06:00 [medline] PHST- 2021/01/07 12:18 [entrez] AID - 10.1007/s10637-020-01045-7 [pii] AID - 10.1007/s10637-020-01045-7 [doi] PST - ppublish SO - Invest New Drugs. 2021 Jun;39(3):836-845. doi: 10.1007/s10637-020-01045-7. Epub 2021 Jan 7.