Colorectal liver metastatic disease: Efficacy of irreversible electroporation-a single-arm phase II clinical trial (COLDFIRE-2 trial)

BMC Cancer

Volumn 15, Issue 1, 2015, Pages

  Scheffer, Hester J ^a   Vroomen, Laurien G P H ^a   Nielsen, Karin ^a   van Tilborg, Aukje A J M ^a   Comans, Emile F I ^a   van Kuijk, Cornelis ^a   van der Meijs, Bram B ^a   van den Bergh, Janneke ^a   van den Tol, Petrousjka M P ^a   Meijerink, Martijn R ^a  

^a VU UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Colorectal liver metastases; FDG PET; Irreversible electroporation (IRE); Liver neoplasms secondary; Local; Neoplasm recurrence; PET CT; Tumor ablation

Indexed keywords

ANTINEOPLASTIC AGENT; FLUORODEOXYGLUCOSE F 18; TUMOR MARKER;

ARTICLE; CLINICAL ARTICLE; COLORECTAL CANCER; COMPUTER ASSISTED TOMOGRAPHY; CONTRAST ENHANCEMENT; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; ELECTROPORATION; HISTOPATHOLOGY; HUMAN; LIVER METASTASIS; MULTICENTER STUDY; NUCLEAR MAGNETIC RESONANCE IMAGING; PALLIATIVE THERAPY; PHASE 2 CLINICAL TRIAL; POSITRON EMISSION TOMOGRAPHY; PROSPECTIVE STUDY; SCORING SYSTEM; TUMOR ABLATION; TUMOR GROWTH; ABLATION THERAPY; AGED; CLINICAL TRIAL; COLORECTAL TUMOR; FEMALE; LIVER NEOPLASMS; MALE; MIDDLE AGED; PATHOLOGY; PROCEDURES; SECONDARY; SURVIVAL ANALYSIS; X-RAY COMPUTED TOMOGRAPHY;

ABLATION TECHNIQUES; AGED; COLORECTAL NEOPLASMS; ELECTROPORATION; FEMALE; FLUORODEOXYGLUCOSE F18; HUMANS; LIVER NEOPLASMS; MALE; MIDDLE AGED; SURVIVAL ANALYSIS; TOMOGRAPHY, X-RAY COMPUTED;

EID: 84945124865     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/s12885-015-1736-5     Document Type: Article

References (39)

1. Rempp H, Boss A, Helmberger T, Pereira P. The current role of minimally invasive therapies in the management of liver tumors. Abdom Imaging. 2011;36:635-47.
2. Abdalla EK, Vauthey J-N, Ellis LM, Ellis V, Pollock R, Broglio KR, et al. Recurrence and outcomes following hepatic resection, radiofrequency ablation, and combined resection/ablation for colorectal liver metastases. Ann Surg Oncol. 2004;239:818-25. discussions 825-7.
3. Gleisner A, Choti MA, Assumpcao L, Nathan H, Schulick R, Pawlik T. Recurrence and survival following hepatic resection, radiofrequency ablation, and combined resection-radiofrequency ablation. Arch Surg. 2014;143:1204-12.
4. De Baere T, Elias D, Dromain C, Gamal El Din M, Kuoch V, Ducreux M, et al. Hepatic Metastases with a Mean Follow-Up of More Than 1 Year. AJR Am J Roentgenol. 2000;175(December):1619-25.
5. Cannon R, Ellis S, Hayes D, Narayanan G, Martin RCG. Safety and early efficacy of irreversible electroporation for hepatic tumors in proximity to vital structures. J Surg Oncol. 2012;107(October):544-9.
6. Vogl TJ, Farshid P, Naguib NNN, Darvishi A, Bazrafshan B, Mbalisike E, et al. Thermal ablation of liver metastases from colorectal cancer: radiofrequency, microwave and laser ablation therapies. Radiol Med. 2014;119:451-61.
7. Van Tilborg AAJM, Meijerink MR, Sietses C, Van Waesberghe JHTM, Mackintosh MO, Meijer S, et al. Long-term results of radiofrequency ablation for unresectable colorectal liver metastases: a potentially curative intervention. Br J Radiol. 2011;84:556-65.
8. Lu DSK, Yu NC, Raman SS, Limanond P, Lassman C, Murray K, et al. Radiofrequency Ablation of Hepatocellular Carcinoma: Treatment Success as Defined by Histologic Examination of the Explanted Liver. Radiology. 2005;234:954-60.
9. Van den Bos W, Muller BG, de la Rosette JJCMH. A randomized controlled trial on focal therapy for localized prostate carcinoma: hemiablation versus complete ablation with irreversible electroporation. J Endourol. 2013;27:262-4.
10. Davalos RV, Mir LM, Rubinsky B. Tissue Ablation with Irreversible Electroporation. Ann Biomed Eng. 2005;33:223-31.
11. Maor E, Ivorra A, Mitchell JJ, Rubinsky B. Vascular smooth muscle cells ablation with endovascular nonthermal irreversible electroporation. J Vasc Interv Radiol. 2010;21:1708-15.
12. Narayanan G, Arora G, Quintana D, Mukkamalla U, Barbery KJ, Hosein P, et al. Vessel patency post irreversible electroporation (IRE) ablation: a 15month follow-up. J Vasc Interv Radiol. 2012;23:S53.
13. Silk MT, Wimmer T, Lee KS, Srimathveeravalli G, Brown KT, Kingham PT, et al. Percutaneous Ablation of Peribiliary Tumors with Irreversible Electroporation. J Vasc Interv Radiol. 2014;25:112-8.
14. Faroja M, Ahmed M, Appelbaum L, Ben-David E, Moussa M, Sosna J, et al. Irreversible Electroporation Ablation: Is All the Damage Nonthermal? Radiology. 2012;266:462-70.
15. Neal II RE, Cheung W, Kavnoudias H, Thomson KR. Spectrum of imaging and characteristics for liver tumors treated with irreversible electroporation. J Biomed Sci Engin. 2012;2012:11-5.
16. Scheffer HJ, Nielsen K, van Tilborg AA, Vieveen JM, Bouwman RA, Kazemier G, et al. Ablation of colorectal liver metastases by irreversible electroporation: results of the COLDFIRE-I ablate-and-resect study. Eur Radiol. 2014;24:2467-75.
17. Scheffer HJ, Nielsen K, de Jong MC, van Tilborg AAJM, Vieveen JM, Bouwman AR, et al. Irreversible Electroporation for Nonthermal Tumor Ablation in the Clinical Setting: A Systematic Review of Safety and Efficacy. J Vasc Interv Radiol. 2014;25:997-1011.
18. Dutton SJ, Kenealy N, Love SB, Wasan HS, Sharma RA. FOXFIRE protocol: an open-label, randomised, phase III trial of 5-fluorouracil, oxaliplatin and folinic acid (OxMdG) with or without interventional Selective Internal Radiation Therapy (SIRT) as first-line treatment for patients with unresectable liver-on. BMC Cancer. 2014;14:497.
19. Van Tilborg AAJM, Scheffer HJ, Nielsen K, van Waesberghe JHTM, Comans EF, van Kuijk C, et al. Transcatheter CT Arterial Portography and CT Hepatic Arteriography for Liver Tumor Visualization during Percutaneous Ablation. J Vasc Interv Radiol. 2014;25:1101-11.
20. Knavel EM, Brace CL. Tumor ablation: common modalities and general practices. Tech Vasc Interv Radiol. 2013;16:192-200.
21. Boellaard R, O'Doherty MJ, Weber WA, Mottaghy FM, Lonsdale MN, Stroobants SG, et al. FDG PET and PET/CT: EANM procedure guidelines for tumour PET imaging: version 1.0. Eur J Nucl Med Mol Imaging. 2010;37:181-200.
22. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45:228-47.
23. Wahl RL, Jacene H, Kasamon Y, Lodge MA. Response Criteria in Solid Tumors. J Nucl Med. 2009;50 Suppl 1:122-50.
24. Nielsen K, van Tilborg AAJM, Scheffer HJ, Meijerink MR, Klerk ESMDL-D, Meijer S, et al. PET-CT after radiofrequency ablation of colorectal liver metastases: Suggestions for timing and image interpretation. Eur J Radiol. 2013;82(12):2169-75.
25. Nielsen K, Scheffer HJ, Pieters IC, van Tilborg AAJM, van Waesberghe J-HTM, Oprea-Lager DE, et al. The use of PET-MRI in the follow-up after radiofrequency-and microwave ablation of colorectal liver metastases. BMC Med Imaging. 2014;14:27.
26. Ahmed M. Image-guided Tumor Ablation: Standardization of Terminology and Reporting Criteria -A 10-Year Update. Radiology. 2014;273:241-60.
27. Parmar M, Machin D. Survival Analysis: A Practical Approach. Chichester: John Wiley & Sons; 1996.
28. Hosein PJ, Echenique A, Loaiza-Bonilla A, Froud T, Barbery K, Rocha Lima CM, et al. Percutaneous Irreversible Electroporation for the Treatment of Colorectal Cancer Liver Metastases with a Proposal for a New Response Evaluation System. J Vasc Interv Radiol. 2014;25:1233-9.
29. Common Terminology criteria for Adverse Events version 4.0. U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute. [ http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference:5x7.pdf ]. Accessed 14 June 2010.
30. Kingham TP, Karkar AM, D'Angelica MI, Allen PJ, Dematteo RP, Getrajdman GI, et al. Ablation of Perivascular Hepatic Malignant Tumors with Irreversible Electroporation. J Am Coll Surg. 2012;215:379-87.
31. Fleiss JL, Levin B, Paik MC. Statistical Methods for Rates and Proportions. Thirdth ed. New York: John Wiley & Sons; 2003.
32. Newcombe RG. Two sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998;17:857-72.
33. Tanis E, Nordlinger B, Mauer M, Sorbye H, van Coevorden F, Gruenberger T, et al. Local recurrence rates after radiofrequency ablation or resection of colorectal liver metastases. Analysis of the European Organisation for Research and Treatment of Cancer #40004 and #40983. Eur J Cancer. 2014;50:912-9.
34. Appelbaum L, Mahgerefteh SY, Sosna J, Goldberg SN. Image-guided fusion and navigation: applications in tumor ablation. Tech Vasc Interv Radiol. 2013;16:287-95.
35. Lee EW, Chen C, Prieto VE, Dry SM, Loh CT, Kee ST. Advanced hepatic ablation technique for creating complete cell death: irreversible electroporation. Radiology. 2010;255:426-33.
36. Appelbaum L, Ben-David E, Sosna J, Nissenbaum Y, Goldberg SN. US Findings after Irreversible Electroporation Ablation: radiologic-pathologic correlation. Radiology. 2012;262:117-25.
37. Lee YJ, Lu DSK, Osuagwu F, Lassman C. Irreversible electroporation in porcine liver: acute computed tomography appearance of ablation zone with histopathologic correlation. J Comput Assist Tomogr. 2013;37:154-8.
38. Lee EW, Wong D, Tafti BA, Prieto V, Totonchy M, Hilton J, et al. Irreversible electroporation in eradication of rabbit VX2 liver tumor. J Vasc Interv Radiol. 2012;23:833-40.
39. Kuehl H, Antoch G, Stergar H, Veit-Haibach P, Rosenbaum-Krumme S, Vogt F, et al. Comparison of FDG-PET, PET/CT and MRI for follow-up of colorectal liver metastases treated with radiofrequency ablation: initial results. Eur J Radiol. 2008;67:362-71.