Transarterial Embolization with Small-Size Particles Loaded with Irinotecan for the Treatment of Colorectal Liver Metastases: Results of the MIRACLE III Study
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This pilot study was performed to investigate safety and local tumor control following transarterial embolization with small-size particles loaded with irinotecan (DEB-IRI) in patients with colorectal liver metastases (CRLM).
Materials and Methods
Patients with pretreated CRLM with mono- or bilobar lesions involving less than 60% of the liver parenchyma and Eastern Cooperative Oncology Group performance status 0 or 1 underwent superselective DEB-IRI embolization with 40 µm diameter embolic microspheres.
Eighteen patients (11 males, 7 females, median age 61 years) underwent 80 embolization procedures (mean 4.4, range 2–12 per patient). No serious adverse events were reported within 30 days. A total of 39 treatment-related AEs occurred across all embolization procedures. No G4 or G5 treatment-related AEs occurred. Local tumor control, defined as complete response, partial response, or stable disease, was achieved in 16/18 (88.9%), 7/17 (41.2%), and 3/17 (17.6%) patients at 3, 6, and 12 months, respectively. Median liver progression-free survival was 5.9 months (range 27–409 days), and median overall survival was 13.5 months.
In this small series, DEB-IRI embolization with small beads was demonstrated a safe procedure in the treatment of patients with CRLM. The promising results in terms of liver-specific progression-free survival and overall survival reported deserve further confirmation in larger prospective trials.
Level of Evidence
Level 4, case series.
KeywordsColorectal liver metastases Transarterial chemoembolization Particles Survival Irinotecan
Elizabeth J. Davis, Ph.D., (Boston Scientific, Maple Grove, MN) provided medical writing assistance.
The study was funded by CeloNova BioSciences (San Antonio, TX) and Boston Scientific (Marlborough, MA).
Compliance with Ethical Standards
Conflict of interest
GM received consultancy fee from Elesta SrL, speaker honorarium from Guerbet, and travel support by RGG; FO received travel support by RGG, CeloNova and Boston Scientific; all other authors declare they have no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
It was obtained from all individual participants included in the study.
- 1.American Cancer Society. Cancer facts and figures 2017. Genes Dev. 2017;21:2525–38.Google Scholar
- 11.Fiorentini G, Aliberti C, Tilli M, Mulazzani L, Graziano F, Giordani P, et al. Intra-arterial infusion of irinotecan-loaded drug-eluting beads (DEBIRI) versus intravenous therapy (FOLFIRI) for hepatic metastases from colorectal cancer: final results of a phase III study. Anticancer Res. 2012;32:1387–95.PubMedGoogle Scholar
- 15.Maleux G, Deroose C, Laenen A, Verslype C, Heye S, Haustermans K, et al. Yttrium-90 radioembolization for the treatment of chemorefractory colorectal liver metastases: technical results, clinical outcome and factors potentially influencing survival. Acta Oncol. 2016;55(4):486–95.CrossRefGoogle Scholar
- 16.Kennedy AS, Ball D, Cohen SJ, Cohn M, Coldwell DM, Drooz A, et al. Multicenter evaluation of the safety and efficacy of radioembolization in patients with unresectable colorectal liver metastases selected as candidates for (90)Y resin microspheres. J. Gastrointest Oncol. 2015;6:134–42.PubMedPubMedCentralGoogle Scholar
- 18.Aliberti C, Fiorentini G, Muzzio PC, Pomerri F, Tilli M, Dallara S, et al. Trans-arterial chemoembolization of metastatic colorectal carcinoma to the liver adopting DC Bead(R), drug-eluting bead loaded with irinotecan: results of a phase II clinical study. Anticancer Res. 2011;31:4581–7.PubMedGoogle Scholar
- 21.Dreher MR, Sharma KV, Woods DL, Reddy G, Tang Y, Pritchard WF, et al. Radiopaque drug-eluting beads for transcatheter embolotherapy: experimental study of drug penetration and coverage in swine. J Vasc Interv Radiol. 2012;23(257–64):e4.Google Scholar
- 22.Lee K-H, Liapi E, Vossen JA, Buijs M, Ventura VP, Georgiades C, et al. Distribution of iron oxide-containing Embosphere particles after transcatheter arterial embolization in an animal model of liver cancer: evaluation with MR imaging and implication for therapy. J Vasc Interv Radiol. 2008;19:1490–6.CrossRefGoogle Scholar
- 24.Tanaka T, Nishiofuku H, Hukuoka Y, Sato T, Masada T, Takano M, et al. Pharmacokinetics and antitumor efficacy of chemoembolization using 40 µm irinotecan-loaded microspheres in a rabbit liver tumor model. J Vasc Interv Radiol. 2014;25(1037–1044):e2.Google Scholar
- 31.Bonomo G, Pedicini V, Monfardini L, Della Vigna P, Poretti D, Orgera G, et al. Bland embolization in patients with unresectable hepatocellular carcinoma using precise, tightly size-calibrated, anti-inflammatory microparticles: first clinical experience and one-year follow-up. Cardiovasc Intervent Radiol. 2010;33:552–9.CrossRefGoogle Scholar
- 33.Brown KT, Do RK, Gonen M, Covey AM, Getrajdman GI, Sofocleous CT, et al. Randomized trial of hepatic artery embolization for hepatocellular carcinoma using doxorubicin-eluting microspheres compared with embolization with microspheres alone. Oncol: J. Clin; 2016.Google Scholar
- 34.Iezzi R, Marsico VA, Guerra A, Cerchiaro E, Cassano A, Basso M, et al. Trans-Arterial chemoembolization with irinotecan-loaded drug-eluting beads (DEBIRI) and capecitabine in refractory liver prevalent colorectal metastases: a phase II single-center study. Cardiovasc Intervent Radiol. 2015;38:1523–31.CrossRefGoogle Scholar