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• W3137261796 abstract "HomeRadiologyVol. 299, No. 2 PreviousNext Reviews and CommentaryFree AccessEditorialMore Interventional Oncologic Fire from COLDFIRE-2S. Nahum Goldberg S. Nahum Goldberg Author AffiliationsFrom the Department of Radiology, Hadassah Hebrew University Medical Center, PO Box 19000, Ein Karem, Jerusalem, Israel 9112001.Address correspondence to the author (e-mail: [email protected]).S. Nahum Goldberg Published Online:Mar 16 2021https://doi.org/10.1148/radiol.2021204736MoreSectionsPDF ToolsImage ViewerAdd to favoritesCiteTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinked In See also the article by Meijerink et al in this issue.Professor S. Nahum Goldberg is vice-chairman for research and unit head of image-guided therapy, Department of Radiology at Hadassah Hebrew University Medical Center, Jerusalem, Israel. His primary research interests focus on uncovering methods to improve interventional oncologic techniques, particularly tumor ablation. He is a member of the Israel National Academy of Medicine, a Fulbright Scholar, a Fellow of the Society of Interventional Radiology, and has served on multiple international committees advancing interventional oncology.Download as PowerPointOpen in Image Viewer For the past 2 decades, interventional oncologists have adapted and refined diagnostic guidance devices that use multiple sources of thermal energy, such as radiofrequency and microwave radiation, which can modify or destroy tissue to enable the performance of percutaneous image-guided ablation therapy. These techniques have had a particular impact on the treatment of liver cancers including well-selected primary hepatocellular carcinomas and some populations of intrahepatic metastases including colorectal carcinomas (1,2). Many initial long-term studies in the field have been published in Radiology. Although largely retrospective in nature, these studies note excellent results that rival or even best those with surgery (3–5). To achieve optimal results, the vast majority of these studies emphasize the need for meticulous techniques, which can often prove difficult to replicate, and may have severe limitations in the number and types of patients amenable to successful treatment. These studies also note the challenges of treating not only tumors larger than 3 cm but also those near blood vessels, where perfusion prevents ablative temperatures (3–5). Moreover, the potential of damage to critical adjacent structures such as bile ducts and the colon has led many to avoid the thermal ablation of central hilar tumors and those peripheral and adjacent to the gut. This has propelled the search for other methods to eradicate tumors under imaging guidance.During the past decade, there has been intense study using irreversible electroporation (IRE) for image-guided ablation therapy to address potential extant barriers and to maximize the potential of interventional oncology in the liver and other organs (6). The dominant mechanism of IRE uses a direct electric current to induce the creation of irreversible pores in membranes that alters a cell’s ability to maintain hemostasis, thereby inducing nonthermal cytotoxicity (6). IRE requires great technical skill to place multiple electrodes with precision and requires anesthesia, cardiac monitoring, and neuromuscular blockade. But despite these challenges, IRE offers sufficient potential benefit of tumor destruction while reducing the risk of damaging the integrity of surrounding structures. This makes IRE an appealing choice for several indications. Most notably, IRE is useful for the treatment of pancreas tumors, which are almost always next to critical structures. The benefits of such an approach have been demonstrated in the recent Pancreatic Carcinoma—Safety and Feasibility Study of Irreversible Electroporation, or PANFIRE-2, study (7).In this issue of Radiology, we are treated to another report by the same investigator group who undertook the PANFIRE-2 study. Meijerink et al present the results of a phase II, two-center, single-arm clinical trial using IRE to treat unresectable PET-avid colorectal liver metastases: Colorectal Liver Metastatic Disease: Efficacy of Irreversible Electroporation A Single-Arm Phase II Clinical Trial (COLDFIRE-2) (8). Similar to their prior efforts, this well-designed and superbly executed effort represents a pivotal clinical trial of IRE for the treatment of intrahepatic colorectal metastases unsuitable for partial hepatectomy, thermal ablation, and further systemic treatments. The authors offer hope for achieving successful treatment for a larger population of difficult-to-treat patients—namely those with centrally located tumors and those with tumors between 3 and 5 cm in diameter. More specifically, this prospective study reports the long-term survival of 50 participants with 76 metastases treated over 62 sessions. After 1 year, the primary end point was achieved, as 68% of participants were alive without local recurrence, which exceeded the initial target of 50% survival. The local control rate following repeat procedures was 74% of participants. This latter statistic falls well within the range of studies for tumors in more favorable locations (3–5).The treatment of these tumors in a “high-risk” location was not without morbidity. Twenty-three participants experienced 34 adverse events in 25 of 62 procedures for an overall complication rate of 40%, with a single death for a 2% mortality rate. This represents a lower complication rate than that reported for IRE in the pancreas (58%) (7). Yet, this is substantially higher than most reports of complications for the treatment of intrahepatic tumors in less challenging locations—including the systemic review by the same group of more parenchymal IRE liver ablation with a 16% complication rate (6). It is likely that further refinements in technique will enable further improvements in this complication rate. The investigators provide much-appreciated candor that IRE has a niche indication for difficult-to-reach colorectal liver metastases, but only in the salvage setting. Greater morbidity will exist for procedures performed in some anatomic locations. A more appropriate comparison will need to not only take this into consideration but also compare the complication rate to appropriate alternatives. This may include open surgery, which has greater morbidity. For these and similar patients with central tumors and no other treatment options, a 40% complication rate may be justified. But the decision to treat patients in these high-risk, high-reward situations should only be achieved in concert between the physician and their fully autonomous, informed patients. This must follow full disclosure of the risks and benefits with the appropriate vetting of all the options available. A candid discussion of the results of this study can provide a fuller picture of what can be anticipated—at least in terms of safety.Besides safety, issues of efficacy are also paramount. One of the limitations of the current study is worth highlighting, namely that a 12-month end point is likely too premature to draw full conclusions. The investigators note that “there are no guarantees that the 1-year LTP-free survival [local tumor progression-free survival] reflects a survival benefit similar to that with thermal ablation.” Yet, it is quite understandable as to why the authors chose a manageable goal of 12-month follow-up as their primary end point. Based on historical literature, this represents the time frame for 50% progression-free survival in this heavily pretreated population. Moreover, the need to disseminate the favorable results seen in this poor outcome population is clearly justified and beneficial. Nevertheless, much longer follow-up and additional cohorts will be required to provide a full picture of the true long-term outcome of IRE for treating intrahepatic colorectal cancer. Regardless, the median overall survival was 2.7 years (95% CI: 1.6, 3.8) from the first IRE and 4.8 years (95% CI: 3.1, 6.6) from the date of resection of the primary tumor. These nonsurgical candidates had longer median survival than reported in many surgical series.As noted earlier, one of the key limitations of ablation therapy has been the ability to successfully treat tumors larger than 3 cm in diameter. Nevertheless, the investigators did not find a statistically significant difference in local tumor progression between 3- and 5-cm tumors and those smaller when performing Cox regression analysis. Although the populations were relatively small and will require further confirmation, these data suggest that IRE techniques may enable adequate coverage to expand the range of successfully treated tumors. Some of these benefits may be due to synergistic effects between IRE and the chemotherapy administered in a majority of patients. Combination therapy between thermal ablation and induction chemotherapy—administered systemically or by means of chemoembolization—has demonstrated results that can even outperform surgery (9).Further research and collective experience are warranted if we are to achieve the best clinical results possible. Indeed, when comparing the first five versus the latter 45 participants, the experienced investigators note the eventual local tumor progression rate was 80% versus 33% (P = .06). They rightfully note that IRE has a steep learning curve and is dependent on experience. IRE includes multiple electrical pulse characteristics such as voltage, number of electrical pulses, width, probe spacing, number of electrodes, and exposure, offering the potential for substantial refinement according to tumor type, composition, size, and host organ (10).In conclusion, Meijerink et al report the results of COLDFIRE-2: a pivotal clinical trial of IRE for intrahepatic colorectal carcinoma. This trial has the potential to provide a substantial impact on the treatment of this malady and on interventional oncology as a whole. Despite substantial morbidity (and even mortality), this largest-to-date phase II trial demonstrates the potential for IRE to extend survival, particularly for tumors in the hilum and other areas where traditional thermal ablation is not an ideal minimally invasive option. The general study design is robust, and conclusions of efficacy are sound. As such, the final results of COLDFIRE-2 have been long anticipated and are of great interest to interventional, medical, and surgical oncologists and the patients we serve.Disclosures of Conflicts of Interest: Activities related to the present article: receives a consulting fee or honorarium from Cosman Company. Activities not related to the present article: receives a consulting fee from Cosman Company; institution receives consulting fee from XACT Robotics. Other relationships: disclosed no relevant relationships.References1. Mahnken AH, Pereira PL, de Baère T. Interventional oncologic approaches to liver metastases. Radiology 2013;266(2):407–430. Link, Google Scholar2. Gillams A, Goldberg N, Ahmed M, et al. Thermal ablation of colorectal liver metastases: a position paper by an international panel of ablation experts, The Interventional Oncology Sans Frontières meeting 2013. Eur Radiol 2015;25(12):3438–3454. Crossref, Medline, Google Scholar3. Lencioni R, Cioni D, Crocetti L, et al. Early-stage hepatocellular carcinoma in patients with cirrhosis: long-term results of percutaneous image-guided radiofrequency ablation. Radiology 2005;234(3):961–967. Link, Google Scholar4. Solbiati L, Ahmed M, Cova L, Ierace T, Brioschi M, Goldberg SN. Small liver colorectal metastases treated with percutaneous radiofrequency ablation: local response rate and long-term survival with up to 10-year follow-up. Radiology 2012;265(3):958–968. Link, Google Scholar5. Shady W, Petre EN, Gonen M, et al. Percutaneous Radiofrequency Ablation of Colorectal Cancer Liver Metastases: Factors Affecting Outcomes: A 10-year Experience at a Single Center. Radiology 2016;278(2):601–611. Link, Google Scholar6. Scheffer HJ, Nielsen K, de Jong MC, et al. Irreversible electroporation for nonthermal tumor ablation in the clinical setting: a systematic review of safety and efficacy. J Vasc Interv Radiol 2014;25(7):997–1011; quiz 1011. Crossref, Medline, Google Scholar7. Ruarus AH, Vroomen LGPH, Geboers B, et al. Percutaneous Irreversible Electroporation in Locally Advanced and Recurrent Pancreatic Cancer (PANFIRE-2): A Multicenter, Prospective, Single-Arm, Phase II Study. Radiology 2020;294(1):212–220. Link, Google Scholar8. Meijerink MR, Ruarus AH, Vroomen L, et al. Irreversible electroporation to treat unresectable colorectal liver metastases (COLDFIRE-2): a phase II, two-center, single-arm clinical trial. Radiology 2021. https://doi.org/10.1148/radiol.2021203089. Published online March 16, 2021. Link, Google Scholar9. Lan T, Chang L, Mn R, Wu L, Yuan YF. Comparative Efficacy of Interventional Therapies for Early-stage Hepatocellular Carcinoma: A PRISMA-compliant Systematic Review and Network Meta-analysis. Medicine (Baltimore) 2016;95(15):e3185. Crossref, Medline, Google Scholar10. Appelbaum L, Ben-David E, Faroja M, Nissenbaum Y, Sosna J, Goldberg SN. Irreversible electroporation ablation: creation of large-volume ablation zones in in vivo porcine liver with four-electrode arrays. Radiology 2014;270(2):416–424. Link, Google ScholarArticle HistoryReceived: Jan 3 2021Revision requested: Jan 11 2021Revision received: Jan 12 2021Accepted: Jan 13 2021Published online: Mar 16 2021Published in print: May 2021 FiguresReferencesRelatedDetailsAccompanying This ArticleIrreversible Electroporation to Treat Unresectable Colorectal Liver Metastases (COLDFIRE-2): A Phase II, Two-Center, Single-Arm Clinical TrialMar 16 2021RadiologyRecommended Articles Irreversible Electroporation to Treat Unresectable Colorectal Liver Metastases (COLDFIRE-2): A Phase II, Two-Center, Single-Arm Clinical TrialRadiology2021Volume: 299Issue: 2pp. 470-480The 10-year Survival Analysis of Radiofrequency Ablation for Solitary Hepatocellular Carcinoma 5 cm or Smaller: Primary versus Recurrent HCCRadiology2021Volume: 300Issue: 2pp. 458-469Long-term Therapeutic Outcomes of Radiofrequency Ablation for Subcapsular versus Nonsubcapsular Hepatocellular Carcinoma: A Propensity Score Matched StudyRadiology2016Volume: 280Issue: 1pp. 300-312Outcome of No-Touch Radiofrequency Ablation for Small Hepatocellular Carcinoma: A Multicenter Clinical TrialRadiology2021Volume: 301Issue: 1pp. 229-236A Single-Center Retrospective Analysis of Periprocedural Variables Affecting Local Tumor Progression after Radiofrequency Ablation of Colorectal Cancer Liver MetastasesRadiology2020Volume: 298Issue: 1pp. 212-218See More RSNA Education Exhibits Imaging Roadmap For Colorectal Liver Metastasis Assessment (CRLM)Digital Posters2021Novel Image-Guided Micro-Invasive Percutaneous Treatments of Breast Lesions: Where Do We Stand?Digital Posters2019Irreversible Electroporation in Locally Advanced Pancreatic CancerDigital Posters2022 RSNA Case Collection Radioembolization of Liver Metastasis RSNA Case Collection2020Sigmoid CancerRSNA Case Collection2020Pseudocirrhosis of Hepatic Breast MetastasesRSNA Case Collection2020 Vol. 299, No. 2 Metrics Altmetric Score PDF download" @default.
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