Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
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.

PubMed Disclaimer

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

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Siegel R, Miller K, Jemal A. Cancer statistics, 2017. CA Cancer J Clin. 2017;67:7–30. - PubMed
    1. Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review, 1975–2013. Bethesda, MD: National Cancer Institute;
    1. Ahmed SI, Bochkarev V, Oleynikov D, Sasson AR. Patients with pancreatic adenocarcinoma benefit from staging laparoscopy. J Laparoendosc Adv Surg Tech A. 2006;16:458–463. - PubMed
    1. Shah D, Fisher WE, Hodges SE, et al. Preoperative prediction of complete resection in pancreatic cancer. J Surg Res. 2008;147:216–220. - PubMed
    1. Croome KP, Jayaraman S, Schlachta CM. Preoperative staging of cancer of the pancreatic head: is there room for improvement? Can J Surg. 2010;53:171–174. - PMC - PubMed

MeSH terms