Abstract 1343
Background
FOLFIRINOX is a first-line regimen in the treatment of pancreatic cancer. Historically, BTC and pancreatic cancers were treated similarly with gemcitabine alone or combined with a platinum compound. A growing body of evidence supports the role of fluoropyrimidines in the treatment of BTC.
Methods
We retrospectively analyzed data of all our pts with locally advanced (LA) or metastatic (M) BTC who received FOLFIRINOX as a first-line therapy from 12/2013 to 11/2017 at Paul Brousse university hospital. The main endpoints were OS, TTP, ORR, DC, secondary resection and toxicity.
Results
There were 42 pts: 17 male (40%) and 25 female (60%) pts aged 36 to 84 years (median: 67). Pts had PS of 0 (55%) and 1 (45%). They had intrahepatic cholangiocarcinoma (iCCA) (21 pts, 50%), gallbladder carcinoma (8 pts, 19%), perihilar CCA (7 pts, 17%), distal CCA (4 pts, 10%) and ampulloma (2 pts, 5%). No biopsy could be obtained in 2 pts. BTC was LA or M in 9 (21%) and 33 pts (79%) respectively. Biliary stent was placed in 14 pts (33%). A median (m) of 10 courses was given with m treatment duration of 6 months (mo). At the cutoff on 01/01/2018, regimen was ongoing in 7 pts (18%). Dose intensity (m) was 74, 34 and 1150 mg/m2/w for irinotecan, oxaliplatin and 5FU respectively. The most common nonhematological toxicity was sensory neuropathy: grade 1/2 in 15 pts (36%), no grade 3/4. We observed 15 PR (36%), 16 SD (38%), and 10 PD (24%); 1 pt has not been evaluated for efficacy. Fifteen pts (36%) were alive, 24 pts (57%) died, 3 pts (7%) were lost to follow-up. Four out of 5 pts who underwent resection were alive without disease. At a median follow-up time of 12 mo (1 to 26), mTTP was 9 mo [95%CL, 5 – 12] and mOS was 15 mo [14 – 16]. mTTP was better for LA (not reached) than M-BTC (8 mo), p = 0.05; OS was statistically similar. mTTP was worse in pts with iCCA than other primaries (7 mo [4 – 10] vs 14 mo [9 – 19], p = 0.005); OS was not significantly different. ORR and DC were associated with both better TTP and OS. ORR: mTTP (16 vs 5 mo, p < 0.001), mOS (19 vs 11 mo, p = 0.01); DC: mTTP (10 vs 2 mo, p < 0.001), mOS (18 vs 7 mo, p = 0.002).
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.
Clinical trial identification
Legal entity responsible for the study
Department of Oncology, Hôpital Paul Brousse.
Funding
Has not received any funding.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
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