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Modified FOLFIRINOX as neoadjuvant treatment in patients with borderline resectable and locally advanced pancreatic adenocarcinoma: A single-center study
Background
FOLFIRINOX represents the standard neoadjuvant chemotherapy regimen for patients with pancreatic ductal adenocarcinoma (PDAC). However, it is associated with significant toxicity. Thus, the less toxic modified FOLFIRINOX (mFOLFIRINOX) is increasingly being used. The aim of this study is to present the results of neoadjuvant mFOLFIRINOX in patients (pts) with borderline resectable (BR) and locally advanced (LA) PDAC.
Methods
The study included pts with BR PDAC, according to the international consensus criteria published on 2017 (Isaji et al. Pancreatology 2018; 18:2-11) and pts with locally advanced PDAC who were deemed potential candidates for radical surgery in case of significant response to chemotherapy. mFOLFIRINOX included oxaliplatin 85mg/m2, irinotecan 150mg/m2, leucovorin 350mg and 5-fluorouracil 2400mg/m2 as 48h infusion, repeated every 14 days. Demographic, clinical, treatment and efficacy data were collected from pt files. Efficacy endpoints were radiological response, R0 surgery, pathological response, progression-free survival and overall survival.
Results
In total 20 pts were analyzed, 11 (55%) with BR and 9 (45%) with LA unresectable tumors. Seven (35%) were males, 9 (45%) had PS ECOG 0 and 11 (55%) had PS 1. Median age was 64.5 years (range, 44-75). The site of the tumor was in the head of the pancreas in 14 pts (70%), in the body in 5 (25%) and in the tail in 1 (5%). Eight pts (40%) had biliary stent. The median maximum diameter of the tumor was 31.5mm (range, 20-59), for BR tumors 29mm (range, 20-45) and for LA 44mm (range, 26-59), Mann-Whitney p= 0.067. Median CA19-9 serum levels were 78.5 IU/L (range, 1-4452), for pts with BR tumors they were 58 IU/L (range, 1-1910) and for LA 158 IU/L (range, 2-4452), Mann-Whitney p= 0.603. Tumor diameter was not correlated with CA19-9 serum levels (p=0.795). A median of 8 cycles (range, 2-12) of neoadjuvant chemotherapy were administered. Eleven pts (55%) had radiological partial response, 8 pts (40%) stable disease and only one pt had disease progression as best response to neoadjuvant chemotherapy. Of pts with BR tumors 8 (73%) achieved a partial response, whereas only 3 pts (33%) with LA tumors responded (p= 0.175). In total, 12 pts (60%) underwent R0 radical surgery (11 Whipple procedure, 1 peripheral pancreatectomy). All but one pts with BR tumors (N=10, 91%) underwent radical surgery, while only 2 pts (22%) with LA tumors did so (p=0.005). Pts who underwent radical surgery, received a median of 7 cycles (range, 2-12) of neoadjuvant chemotherapy, while pts who did not achieve a radical operation, received a median of 10 cycles (range, 8-12), Mann-Whitney p=0.001). One patient (8%) with LA tumor achieved a pathological complete response. After a median follow-up of 15.5 months (range, 4.9-38), 3 operated pts relapsed and 4 inoperable pts progressed, while 5 pts with BR and 3 with LA tumors died. More mature survival data will be presented in the congress.
Conclusions
mFOLFIRINX has significant activity as neoadjuvant treatment in PDAC.
Legal entity responsible for the study
The author.
Funding
Has not received any funding.
Disclosures
All authors have declared no conflicts of interest.
