Scientific Abstracts: Liver Metastases and Pancreas
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).