Percutaneous Irreversible Electroporation in Locally Advanced and Recurrent Pancreatic Cancer (PANFIRE-2): A Multicenter Prospective Single-arm Phase 2 Study

Monday, February 3, 2020

7:48 AM – 8:00 AM

Location: Galerie 1/2/3, 2nd Floor

Objective: Patients with locally advanced pancreatic cancer (LAPC) have a dismal prognosis, with a median overall survival (OS) of 12-14 months using systemic therapies. Irreversible electroporation (IRE), a non-thermal ablative technique, may prolong survival of LAPC. To investigate the safety and efficacy of percutaneous IRE for LAPC and locally recurring pancreatic cancer in a prospective phase-2 trial.

Methods: Between December 2012 and September 2017, participants with LAPC or post-resection local recurrence were prospectively treated with percutaneous CT-guided IRE (ClinicalTrials.gov Identifier: NCT01939665). Primary endpoint was median OS from diagnosis, with a target median OS of 11.6 months for participants receiving no or gemcitabine-based chemo-induction (group A) and median OS of 14.9 months for participants receiving induction FOLFIRINOX (group B).

Results: Fifty participants (61 years [IQR 56-69]; 25 men, 25 women; 40 LAPC, 10 local recurrence) were included. Median OS using the Kaplan-Meier method was 17 months from LAPC diagnosis (95%-confidence interval [CI], 15-19 months) and 10 months from IRE (95%-CI, 8-11 months). For group A (n=18) as well as group B (n=22) median OS from diagnosis was 17 months (95%-CI, 7-28 and 15-18 months respectively; p=0.26). For recurrences, median OS from diagnosis of recurrence was 16 months (95%-CI, 10.7-22.1 months) and 9 months from IRE (95%-CI, 1.9-16.1 months). After IRE, local recurrence developed in 23/50 participants (46%). Tumor volume ≥37 cm3 (HR 2.9; p=0.02), pre-IRE CA19-9 level ≥2000 U/ml (HR 12.1; p=0.001) and ≤50% CA19-9 decrease three months after IRE (HR 3.1; p=0.01) were predictors of worse survival. Fourteen minor and 21 major complications occurred in 29/50 participants (58%). Two participants died <90 days post-IRE, of which one likely related to IRE treatment.

Conclusions: The target median overall survival for CT-guided percutaneous irreversible electroporation was exceeded both in participants with locally advanced pancreatic cancer (17 months) and with local recurrences (16 months).

Author(s)

AR

Alette Ruarus, MD

Disclosure: Disclosure information not submitted.
LV

Laurien G.P.H. Vroomen, Drs.

MD
Amsterdam UMC - location VUmc

Disclosure: Disclosure information not submitted.

Presenting Author(s)

BG

Bart Geboers, Drs.

MD
Amsterdam UMC - location VUmc

Disclosure: Disclosure information not submitted.

Author(s)

Ev

Eran van Veldhuisen, n/a

BSc
Amsterdam UMC

Disclosure: Disclosure information not submitted.
Robbert S. Puijk, Drs.

MD
Amsterdam UMC - location VUmc

Disclosure: Disclosure information not submitted.
SN

Sanne Nieuwenhuizen, Drs.

MD
Amsterdam UMC - location VUmc

Disclosure: Disclosure information not submitted.
MB

Marc Besselink, n/a

Prof.
Amsterdam UMC

Disclosure: Disclosure information not submitted.
BZ

Babs Zonderhuis, n/a

MD, PhD
Amsterdam UMC

Disclosure: Disclosure information not submitted.
GK

Geert Kazemier, n/a

MD, Phd
Amsterdam UMC

Disclosure: Disclosure information not submitted.
Td

Tanja de Gruijl, n/a

Disclosure: Disclosure information not submitted.
Kv

Krijn van Lienden, n/a

MD, PhD
Amsterdam UMC

Disclosure: Disclosure information not submitted.
Jd

Jan J.J. de Vries, Drs.

MD
Amsterdam UMC - location VUmc

Disclosure: Disclosure information not submitted.
HS

Hester J. Scheffer, Dr.

MD, PhD
Amsterdam UMC - location VUmc

Disclosure: Disclosure information not submitted.
Martijn R. Meijerink, MD, PhD

Interventional Radiologist
Amsterdam UMC

Disclosure: Disclosure information not submitted.