Irreversible Electroporation to Treat Unresectable Colorectal Liver Metastases (COLDFIRE-2): A Phase II, Two-Center, Single-Arm Clinical Trial

Meijerink, Martijn R.; Ruarus, Alette H.; Vroomen, Laurien G. P. H.; Puijk, Robbert S.; Geboers, Bart; Nieuwenhuizen, Sanne; Bemd, Bente A. T. van den; Nielsen, Karin; Vries, Jan J. J. de; Lienden, Krijn P. van; Lissenberg‐Witte, Birgit I.; Tol, M. Petrousjka van den; Scheffer, Hester J.

doi:10.1148/radiol.2021203089

Cited by 39 publications

(25 citation statements)

References 29 publications

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“…Another study of 24 patients with unresectable CLM showed 3-and 5-year overall survival rates of 25% and 8.3%, respectively [62]. Recently, a phase II, single-arm clinical trial of unresectable CLM near critical structures reported a local control rate after 1 year following repeat IRE of 74%, and the overall complication rate was 40% [72]. Although this complication rate was substantially higher than most reports for the thermal ablation of CLM in less challenging locations, the authors inferred that most of the procedures having been performed simultaneously with surgery might be the cause of the high complication rate and not all of the reported adverse events were directly related to the IRE.…”

Section: Irreversible Electroporationmentioning

confidence: 99%

Image-Guided Ablation for Colorectal Liver Metastasis: Principles, Current Evidence, and the Path Forward

Lin

Paolucci

Brock

et al. 2021

Cancers

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Image-guided ablation can provide effective local tumor control in selected patients with CLM. A randomized controlled trial suggested that radiofrequency ablation combined with systemic chemotherapy resulted in a survival benefit for patients with unresectable CLM, compared to systemic chemotherapy alone. For small tumors, ablation with adequate margins can be considered as an alternative to resection. The improvement of ablation technologies can allow the treatment of tumors close to major vascular structures or bile ducts, on which the applicability of thermal ablation modalities is challenging. Several factors affect the outcomes of ablation, including but not limited to tumor size, number, location, minimal ablation margin, RAS mutation status, prior hepatectomy, and extrahepatic disease. Further understanding of the impact of tumor biology and advanced imaging guidance on overall patient outcomes might help to tailor its application, and improve outcomes of image-guided ablation.

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Section: Irreversible Electroporationmentioning

confidence: 99%

Image-Guided Ablation for Colorectal Liver Metastasis: Principles, Current Evidence, and the Path Forward

Lin

Paolucci

Brock

et al. 2021

Cancers

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“…Although there are some differences in the 1-year LTP rate, the midterm results of our study with a 2-year LTP-free rate of almost 23% and a 3-year LTP-free rate of almost 20% are comparable with a previous study (2-year progression-free survival 18% [16]). To further evaluate and classify the advantages of IRE in the We can further conclude that heterogeneity in target tumor size, origin and overall tumor biology, patient population, especially regarding prior liver surgery, and operator experience, have all been identified as potential confounders and are all potential causes for the reported high variability of local efficacy rates [32,33].…”

Section: Discussionmentioning

confidence: 99%

Recurrent Colorectal Liver Metastases in the Liver Remnant After Major Liver Surgery—IRE as a Salvage Local Treatment When Resection and Thermal Ablation are Unsuitable

Hitpaß

Distelmaier

Neumann

et al. 2021

Cardiovasc Intervent Radiol

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Purpose To examine the safety and short-term oncologic outcomes of computer-tomography-guided (CT-guided) irreversible electroporation (IRE) of recurrent, irresectable colorectal liver metastases (CRLM) after major hepatectomy deemed unsuitable for thermal ablation. Patients and Methods Twenty-three patients undergoing CT-guided IRE of recurrent CRLM after major hepatectomy were included in this study. All tumors were located adjacent to sole remaining intrahepatic blood vessels and bile ducts, precluding thermal ablation. Patients underwent systematic clinical and imaging follow-up, including magnetic resonance imaging of the liver at 1-month and 3-month intervals thereafter. Time to local and intrahepatic tumor progression within 12 and 36 months and associated risk factors were assessed using Kaplan Meier and Cox regression analysis, respectively. Results Complete ablation with a safety margin of at least 0.5 cm was achieved in 22/23 (95.6%) patients. No vessel injury or thrombosis occurred. Five patients developed moderate biliary stenosis after a median of 4 weeks, without requiring treatment. Local tumor-progression-free rates within 12/36 months were 64%/57.4%, respectively. Intrahepatic-progression-free rate within 12/36 months was 36.4%/19.5%, respectively. Five (23%) patients were tumor-free at the end of follow-up. Multivariate Cox regression analysis did not show any association between local tumor-progression-free rates and patient age, target tumor size, primary tumor side or synchronicity of liver metastases. Conclusion In this highly selected patient population with local recurrences of CRLM after major surgery, IRE was shown to be a safe salvage treatment option when thermal ablation is unsuitable.

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“…IRE is optimal for managing tumors smaller than 5 cm [ 55 ], indeed an important limitation is the incapability to completely ablate lesions larger than 5 cm without repeated attempts or repositioning of the electrodes [ 56 ]. A recent phase II study supports the potentiality of this technology in the CLM setting [ 57 ]. Due to the limitations of RFA and MWA on hilar tumors [ 58 ], despite a non-neglectable complication rate of IRE itself in this hard-to-reach CLM 57], the most likely future potential application of this technique will be as a niche indication in this setting.…”

Section: Interventional Treatment Options For Omd Crcmentioning

confidence: 92%

Optimizing Loco Regional Management of Oligometastatic Colorectal Cancer: Technical Aspects and Biomarkers, Two Sides of the Same Coin

Mauri

Monfardini

Garnero

et al. 2021

Cancers

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Colorectal cancer (CRC) is the third most common cancer worldwide and has a high rate of metastatic disease which is the main cause of CRC-related death. Oligometastatic disease is a clinical condition recently included in ESMO guidelines that can benefit from a more aggressive locoregional approach. This review focuses the attention on colorectal liver metastases (CRLM) and highlights recommendations and therapeutic locoregional strategies drawn from the current literature and consensus conferences. The different percutaneous therapies (radiofrequency ablation, microwave ablation, irreversible electroporation) as well as trans-arterial approaches (chemoembolization and radioembolization) are discussed. Ablation margins, the choice of the imaging guidance as well as characteristics of the different ablation techniques and other technical aspects are analyzed. A specific attention is then paid to the increasing role of biomarkers (in particular molecular profiling) and their role in the selection of the proper treatment for the right patient. In conclusion, in this review an up-to-date state of the art of the application of locoregional treatments on CRLM is provided, highlighting both technical aspects and the role of biomarkers, two sides of the same coin.

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Irreversible Electroporation to Treat Unresectable Colorectal Liver Metastases (COLDFIRE-2): A Phase II, Two-Center, Single-Arm Clinical Trial

Cited by 39 publications

References 29 publications

Image-Guided Ablation for Colorectal Liver Metastasis: Principles, Current Evidence, and the Path Forward

Image-Guided Ablation for Colorectal Liver Metastasis: Principles, Current Evidence, and the Path Forward

Recurrent Colorectal Liver Metastases in the Liver Remnant After Major Liver Surgery—IRE as a Salvage Local Treatment When Resection and Thermal Ablation are Unsuitable

Optimizing Loco Regional Management of Oligometastatic Colorectal Cancer: Technical Aspects and Biomarkers, Two Sides of the Same Coin

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