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Clinical Trial
. 2018 Mar;117(3):354-362.
doi: 10.1002/jso.24872. Epub 2017 Oct 16.

Primary systemic therapy in resectable pancreatic ductal adenocarcinoma using mFOLFIRINOX: A pilot study

Robert de W Marsh  1 , Mark S Talamonti  2 , Marshall S Baker  2 , Mitchell Posner  3 , Kevin Roggin  3 , Jeffrey Matthews  3 , Daniel Catenacci  4 , Mark Kozloff  4 , Blase Polite  4 , Michele Britto  1 , Chi Wang  2 , Hedy Kindler  4
Affiliations
Clinical Trial

Primary systemic therapy in resectable pancreatic ductal adenocarcinoma using mFOLFIRINOX: A pilot study

Robert de W Marsh et al. J Surg Oncol. 2018 Mar.

Abstract

Background and objectives: Surgery followed by gemcitabine and/or a fluoropyrimidine is standard therapy for resectable PDAC. mFOLFIRINOX (oxaliplatin 85 mg/m2 , irinotecan 180 mg/m2 , leucovorin 400 mg/m2 Day 1, 5-FU 2400 mg/m2 × 48 h IV, peg-filgrastim 6 mg SQ day 3, every 14 days) has substantial activity in metastatic PDAC. We wished to determine the tolerability/efficacy of peri-operative mFOLFIRINOX in resectable PDAC.

Methods: Patients with resectable PDAC (ECOG PS 0/1) received four cycles of mFOLFIRINOX pre- and post-surgery. The primary endpoint was completion of preoperative chemotherapy plus resection. Secondary endpoints included completion of all therapy, R0 resection, treatment related toxicity, PFS, and OS.

Results: Twenty-one patients enrolled: median age 62 (47-78); 20/21 (95%) completed four cycles of preoperative mFOLFIRINOX; response by RECIST was 1 CR, 3 PR, 16 SD; 17/21 (81%) completed resection, 16/21 (76%) R0; 14/21 (66%) completed four cycles of postoperative mFOLFIRINOX. Grade 3 and 4 toxicity occurred in 23% and 14% patients pre-operatively, 26% and 6.0% post-operatively. Nine patients are alive with median follow-up of 27.7 (3.1-47.1) months.

Conclusions: PST using mFOLFIRINOX in resectable PDAC is feasible and tolerable. R0 resection rate is high and survival promising, requiring longer follow-up and larger studies for definitive assessment.

Keywords: FOLFIRINOX; cancer; chemotherapy; pancreatic; resectable.

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Figures

FIGURE 1
FIGURE 1
CONSORT diagram
FIGURE 2
FIGURE 2
Kaplan-Meier survival curves. OS, overall survival; PFS, progression free survival
See this image and copyright information in PMC

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