Abstract
According to the National Cancer Registry, 3486 people (1744 men and 1742 women) were diagnosed with pancreatic adenocarcinoma in Poland in 2018, resulting in 4908 deaths (2396 men and 2512 women). The only chance of successful treatment is through surgical resection, which is possible in only 20-30% of patients (stage I, II and some stage III cases).The remaining 70-80% of patients are those with stage III and IV disease, for whom resection is not possible. Mean survival in these patients is approx. 10.4 months (stage III). In the recent decade, an innovative method called electroporation, which involves destabilization of the cell membrane, has been established. This process can be reversible (RE) or irreversible (IRE), and leads to cell death. The ability to change membrane permeability has led to the development of novel methods involving electrochemotherapy (ECT) and calcium electroporation (CaEP) to treat solid tumors. In this study, both ECT and CaEP will be used to treat pancreatic cancer patients with poor prognosis. For each patient, the best "therapeutic moment" for the procedure will be selected based on the therapeutic protocol. Patients will receive reversible and irreversible electroporation (control arm-group A), CaEP (active arm-group B), or ECT with intravenous and intratumoral administration of bleomycin (active arm-group C) randomized 1:1:1. The primary endpoints will be progression-free survival (PFS) and patients' quality of life (QOL) assessed using the EORTC-PAN 26 scale. Secondary endpoints will be patient overall survival (OS), body weight, pain level, and levels of biomarkers such as Ca 19-9. The Irreversible Electroporation, ELectrochemotherapy and Calcium electroporation (IREC) study is necessary to examine the safety and efficiency of irreversible electroporation, electrochemotherapy and calcium electroporation in pancreatic cancer treatment.
Highlights
Pancreatic cancer is a global problem with increasing incidence, high mortality-to-incidence ratio, lack of screening tools, and few effective forms of treatment.[1,2,3] The fiveyear survival rate does not exceed than 7–8% and most patients are diagnosed at stage III or above, which means the tumor cannot be resected.[1]
The only chance of successful treatment is through surgical resection, which is possible in only 20–30% of patients.The remaining 70–80% of patients are those with stage III and IV disease, for whom resection is not possible
The ability to change membrane permeability has led to the development of novel methods involving electrochemotherapy (ECT) and calcium electroporation (CaEP) to treat solid tumors
Summary
Received on July 1, 2021 Accepted on July 5, 2021 Published online on July 27, 2021. Rudno-Rudzińska J, Kielan W, Guziński M, Kulbacka J. Electrochemotherapy, and irreversible electroporation on quality of life and progression-free survival in patients with pancreatic cancer: IREC clinical study.
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