Clinical Phase I/II Study: Local Disease Control and Survival in Locally Advanced Pancreatic Cancer Treated with Electrochemotherapy.

Francesco Izzo,Antonio Avallone,Secondo Lastoria,Mauro Piccirillo,Vincenza Granata,Valeria D'Alessio,Renato Patrone,Antonella Petrillo,Andrea Belli,Salvatore Tafuto,Vittorio Albino,Raffaele Palaia,Roberta Fusco

doi:10.3390/jcm10061305

Abstract

Objective. To assess local disease control rates (LDCR) and overall survival (OS) in locally advanced pancreatic cancer (LAPC) treated with electrochemotherapy (ECT). Methods. Electrochemotherapy with bleomycin was performed in 25 LAPC patients who underwent baseline Magnetic Resonance Imaging (MRI) and/or Computed Tomography (CT) and Position Emission Tomography (PET) scans before ECT and 1 and 6 months post ECT. LDCR were assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Choi criteria. Needle electrodes with fixed linear (N-30-4B) or fixed hexagonal configurations (N-30-HG or I-40-HG or H-30-ST) or variable geometry (VGD1230 or VGD1240) (IGEA S.p.A., Carpi, Italy) were used to apply electric pulses. Pain evaluation was performed pre-ECT, after 1 month and after 6 months with ECT. Overall survival estimates were calculated by means of a Kaplan-Meier analysis. Results. At 1 month after ECT, 76% of patients were in partial response (PR) and 20% in stable disease (SD). Six months after ECT, 44.0% patients were still in PR and 12.0% in SD. A LDCR of 56.0% was reached six months after ECT: 13 patients treated with fixed geometry had a LDCR of 46.1%, while for the 12 patients treated with variable geometry, the LDCR was 66.7%. The overall survival median value was 11.5 months: for patients treated with fixed geometry the OS was 6 months, while for patients treated with variable geometry it was 12 months. Electrochemotherapy was well-tolerated and abdominal pain was rapidly resolved. Conclusions. Electrochemotherapy obtained good results in terms of LDCR and OS in LAPC. Multiple needle insertion in a variable geometry configuration optimized by pre-treatment planning determined an increase in LDCR and OS compared to a fixed geometry configuration.

Highlights

Because only a limited group of patients responds to chemotherapy, other therapies to be administrated after the end of chemotherapy were explored to obtain tumor debulking or interstitial ablation [6,7] such as irreversible [8,9,10,11] and reversible electroporation [12,13,14,15,16,17,18]
Twenty-five patients with a histological diagnosis of pancreatic adenocarcinoma were treated with ECT: 14/25 (56%) patients with tumors in the head of the pancreas and 11/25 (44%) patients with body/neck pancreatic tumors (Table 1)
A good functional result was obtained without recording of side effects or major complications

Summary

Introduction

Surgical resection is a potentially creativecommons.org/licenses/by/ 4.0/). Curative option but over 80% of patients have unresectable, locally advanced or metastatic pancreatic cancer [1]. The locally advanced pancreatic cancer (LAPC) is defined as non-metastasized but unresectable disease due to involvement of the coeliac trunk or superior mesenteric artery (stage III disease) [2]. Radiotherapy and chemotherapy such as gemcitabine alone or in combination with other chemotherapy agents are the standard therapy [1,2,3,4,5]. Electrochemotherapy with bleomycin has been shown to be very effective in different cutaneous and subcutaneous tumors such as melanoma and chest wall breast cancer recurrence or for the treatment of squamous cell carcinoma of the head and neck when compared with bleomycin therapy alone [19]

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Discussion

Conclusion