A retrospective study of patient-tailored FOLFIRINOX as a first-line chemotherapy for patients with advanced biliary tract cancer

Abstract

Background: FOLFIRINOX is a pillar first-line regimen in the treatment of pancreatic cancer. Historically, biliary tract cancer (BTC) and pancreatic cancer have been treated similarly with gemcitabine alone or combined with a platinum compound. With growing evidence supporting the role of fluoropyrimidines in the treatment of BTC, we aimed at assessing the outcomes of patients (pts) with BTC on frontline FOLFIRINOX. Methods: We retrospectively analyzed data of all our consecutive patients with locally advanced (LA) or metastatic (M) BTC who were registered to receive FOLFIRINOX as a first-line therapy between 12/2013 and 11/2017 at Paul Brousse university hospital. The main endpoints were Overall Survival (OS), Time-to-Progression (TTP), best Objective Response Rate (ORR), Disease Control rate (DCR), secondary macroscopically-complete resection (res) and incidence of severe (grade 3-4) toxicity (tox). Results: There were 17 male (40%) and 25 female (60%) pts. aged 36 to 84 years (median: 67). They had PS of 0 (55%) or 1 (45%), and intrahepatic cholangiocarcinoma (CCA) (21 pts., 50%), gallbladder carcinoma (8 pts., 19%), perihilar CCA (7 pts., 17%), distal CCA (4 pts., 10%) and ampulloma (2 pts., 5%). BTC was LA or M in 10 (24%) and 32 pts. (76%) respectively. Biliary stent was placed in 14 pts. (33%). A median of 10 courses was given with median treatment duration of 6 months. There were no untoward toxicity issues, with no febrile neutropenia, emergency admission for toxicity or toxic death. We observed 12 partial responses (29%) and 19 disease stabilisations (45%). Six patients (14%) underwent secondary R0-R1 resection. Median TTP was 8 months [95%CL, 6-10] and median OS was 15 months [13-17]. Patients undergoing secondary resection displayed a 3-y disease-free rate of 83%. Conclusions: First-line FOLFIRINOX offers promising results in patients with LA and M-BTC. It deserves prospective evaluation to further improve outcomes for advanced BTC.

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

“…Previous studies showed that when compared with gemcitabine, FOLFIRINOX prolonged survival for patients with metastatic pancreatic cancer [ 9 , 17 ]. For advanced biliary tract cancer, a retrospective study showed median OS of patients with first-line FOLFIRINOX was as long as 15 months [ 11 ]. In addition, several studies have demonstrated the efficacy and safety of FOLFIRINOX or mFOLFOX as a second-line treatment for advanced CCA [ 12 , 18 , 19 ].…”

“…As therapeutic similarities in sensitivity to fluorouracil, platinum and gemcitabine exist between CCA and pancreatic cancer [ 10 ], mFOLFIRINOX might show better efficacy than Gemox in treating patients with CCA. Ulusakarya et al [ 11 ] had reported that the median OS of patients with advanced biliary tract cancer treated with first-line FOLFIRINOX was as long as 15 months. Recently, Angela et al [ 12 ] reported mFOLFOX (folinic acid, fluorouracil, and oxaliplatin) improved the prognosis of patients with advanced biliary tract cancer after progression on cisplatin and gemcitabine.…”

Current options and future directions of systemic therapy for advanced biliary tract cancer

“…This regimen is being evaluated against cisplatin and gemcitabine in the ongoing Phase III SWOG 1815 trial (NCT03768414). The use of 5-fluorouracil (5-FU)/leucovorin/irinotecan/oxaliplatin (FOLFIRINOX) as first-line treatment has led to a disease control rate (DCR) of 75% and OS of 15 months in small retrospective series [24,25].…”

Outcomes in patients receiving palliative chemotherapy for advanced biliary tract cancer

“…After failure of GemCis, recent studies recommend the use of FOLFOX as second line treatment of ABTC [2,15]. In addition, various triple therapies [16] such as FOLFIRINOX [17][18][19] or irinotecan / fluorouracil / leucovorin [20], checkpoint inhibitors alone or in combination with chemotherapy [21], and molecular targeted therapies such as the inhibition of fibroblast growth factor receptor (FGFR) 1-4 [22][23][24][25][26] or isocitrate dehydrogenase (IDH) 1 [27] are currently being investigated in clinical trials (reviewed in [21,28]).…”