At the beginning of 2020, the Galician Scientific and Technical Advice Unit (Unidad de Asesoramiento Científico-técnico, Avalia-T) released a health technology assessment on irreversible electroporation (IRE) for the treatment of liver and pancreatic cancer that aimed to analyze its safety, effectiveness, considerations for use, and the economic, organizational, social, ethical, or legal aspects.
Avalia-T conducted a literature search in the main medical databases, including Medline, Embase, Centre for Research and Dissemination, Web of Science up until January 2019. The main features and results of the studies that were included were summarized in evidence tables. A synthesis of the evidence was carried out using the GRADE system. In order to evaluate the bias risk of the studies, specific tools were used depending on the type of study. The quality of evidence was assessed using the GRADE system. Study selection, data extraction, and evaluation of evidence were performed independently by two members of the authoring team.
The results obtained by Avalia-T are outlined below:
- The systematic literature search retrieved 15 observational studies that met eligibility criteria, eight for pancreatic cancer, and seven for liver cancer. No randomized controlled trials were found:
- The non-randomized controlled trial for pancreatic cancer included 21 patients receiving the intervention. The 32 patients of the control group received some type of non-curative surgery
- The remaining seven prospective single-arm observational studies enrolled 226 patients treated with IRE
- According to the only comparative study, the median overall survival of patients after IRE did not differ significantly between the treatment and the control group (10.03 versus 9.3 months; p = 0.053)
- The median survival after IRE ranged from 4.3 to 12 months in four of the included single-arm trials
- One study accounted for the survival of 22.6 months
- The median overall survival after diagnosis varied from 12.5 to 17.5 months
- Regarding safety, none of the studies reported deaths during the intervention. In total, 44 out of 226 treated patients (19.5%) experienced major adverse events although at least 16 were not considered procedure-related by the authors
- The overall procedure-related mortality (grade V adverse events) was 16 % (4/247 patients) among all studies. The frequency of grade III or IV IRE-procedure related complications was 10.6% (range 0-44 %)
- For liver cancer, seven single-arm studies were included, which enrolled 151 patients:
- The mean overall survival after IRE in the only study with data to calculate it was 37.92 months (95 % CI 30.28, 45.57)
- None of the studies reported intervention specific deaths (during the intervention)
- The frequency of major adverse events was 8.70% (12/138), varying this frequency from 0 % to 28.6 % among included studies
- Major adverse events were hemothorax, hemoperitoneum, hemorrhage and portal vein, and bile duct stenosis.
Avalia-T provided the following conclusions:
- The efficacy evidence of IRE in achieving complete ablation is insufficient. It is also unclear whether IRE would be effective in improving the overall survival of patients with pancreatic and liver cancer compared to standard treatment
- The evidence is also insufficient to establish whether IRE is safer, or at least as safe, as the standard treatment for both pancreatic cancer and liver cancer. In addition, the studies raise some concerns regarding the occurrence of serious adverse events when IRE is used for the treatment of these tumors.
See the full report in Spanish here.
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