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CardioVascular and Interventional Radiology
Published in: CardioVascular and Interventional Radiology 11/2018

01-11-2018 | Clinical Investigation

Transarterial Embolization with Small-Size Particles Loaded with Irinotecan for the Treatment of Colorectal Liver Metastases: Results of the MIRACLE III Study

Authors: Giovanni Mauri, Gianluca Maria Varano, Paolo Della Vigna, Guido Bonomo, Lorenzo Monfardini, Maria Giulia Zampino, Paola Simona Ravenda, Franco Orsi

Published in: CardioVascular and Interventional Radiology | Issue 11/2018

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Abstract

Purpose

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.

Results

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.

Conclusion

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.
Literature
1.
American Cancer Society. Cancer facts and figures 2017. Genes Dev. 2017;21:2525–38.
2.
Manfredi S, Lepage C, Hatem C, Coatmeur O, Faivre J, Bouvier A-M. Epidemiology and management of liver metastases from colorectal cancer. Ann Surg. 2006;244:254–9.CrossRef
3.
Gruber-Rouh T, Naguib NNN, Eichler K, Ackermann H, Zangos S, Trojan J, et al. Transarterial chemoembolization of unresectable systemic chemotherapy-refractory liver metastases from colorectal cancer: long-term results over a 10-year period. Int J Cancer. 2014;134:1225–31.CrossRef
4.
Mattar RE, Al-Alem F, Simoneau E, Hassanain M. Preoperative selection of patients with colorectal cancer liver metastasis for hepatic resection. World J Gastroenterol. 2016;22:567–81.CrossRef
5.
Pedersen IK, Burcharth F, Roikjaer O, Baden H. Resection of liver metastases from colorectal cancer.Indications and results. Dis Colon Rectum. 1994;37:1078–82.CrossRef
6.
Prenen H, Van Cutsem E. Oncological management of unresectable liver metastases. Dig Dis. 2012;30(Suppl 2):137–42.CrossRef
7.
Konopke R, Roth J, Volk A, Pistorius S, Folprecht G, Zöphel K, et al. Colorectal liver metastases: an update on palliative treatment options. J. Gastrointestin. Liver Dis. 2012;21:83–91.PubMed
8.
van Amerongen MJ, van der Stok EP, Fütterer JJ, Jenniskens SFM, Moelker A, Grünhagen DJ, et al. Short term and long term results of patients with colorectal liver metastases undergoing surgery with or without radiofrequency ablation. Eur J Surg Oncol. 2016;42(4):523–30.CrossRef
9.
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;265:958–68.CrossRef
10.
Mauri G, Cova L, De Beni S, Ierace T, Tondolo T, Cerri A, et al. Real-time US-CT/MRI image fusion for guidance of thermal ablation of liver tumors undetectable with US: results in 295 cases. Cardiovasc Intervent Radiol. 2015;38:143–51.CrossRef
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.PubMed
12.
Vogl TJ, Zangos S, Eichler K, Yakoub D, Nabil M. Colorectal liver metastases: regional chemotherapy via transarterial chemoembolization (TACE) and hepatic chemoperfusion: an update. Eur Radiol. 2007;17:1025–34.CrossRef
13.
Vogl TJ, Gruber T, Balzer JO, Eichler K, Hammerstingl R, Zangos S. Repeated transarterial chemoembolization in the treatment of liver metastases of colorectal cancer: prospective study. Radiology. 2009;250:281–9.CrossRef
14.
Narayanan G, Barbery K, Suthar R, Guerrero G, Arora G. Transarterial chemoembolization using DEBIRI for treatment of hepatic metastases from colorectal cancer. Anticancer Res. 2013;33:2077–83.PubMed
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.CrossRef
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.PubMedPubMedCentral
17.
Zampino MG, Magni E, Ravenda PS, Cella CA, Bonomo G, Della Vigna P, et al. Treatments for colorectal liver metastases: a new focus on a familiar concept. Crit Rev Oncol Hematol. 2016;108:154–63.CrossRef
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.PubMed
19.
Liu DM, Thakor AS, Baerlocher M, Alshammari MT, Lim H, Kos S, et al. A review of conventional and drug-eluting chemoembolization in the treatment of colorectal liver metastases: principles and proof. Future Oncol. 2015;11:1421–8.CrossRef
20.
Richardson AJ, Laurence JM, Lam VWT. Transarterial chemoembolization with irinotecan beads in the treatment of colorectal liver metastases: systematic review. J Vasc Interv Radiol. 2013;24:1209–17.CrossRef
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.
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.CrossRef
23.
Akinwande OK, Philips P, Duras P, Pluntke S, Scoggins C, Martin RCG. Small versus large-sized drug-eluting beads (DEBIRI) for the treatment of hepatic colorectal metastases: a propensity score matching analysis. Cardiovasc Intervent Radiol. 2015;38:361–71.CrossRef
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.
25.
Greco G, Cascella T, Facciorusso A, Nani R, Lanocita R, Morosi C, et al. Transarterial chemoembolization using 40 µm drug eluting beads for hepatocellular carcinoma. World J Radiol. 2017;9:245.CrossRef
26.
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.CrossRef
27.
Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013;381:303–12.CrossRef
28.
Van Cutsem E, Nordlinger B, Adam R, Köhne C-H, Pozzo C, Poston G, et al. Towards a pan-European consensus on the treatment of patients with colorectal liver metastases. Eur J Cancer. 2006;42:2212–21.CrossRef
29.
Van Cutsem E, Cervantes A, Adam R, Sobrero A, Van Krieken JH, Aderka D, et al. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016;27:1386–422.CrossRef
30.
Akinwande O, Dendy M, Ludwig JM, Kim HS. Hepatic intra-arterial injection of irinotecan drug eluting beads (DEBIRI) for patients with unresectable colorectal liver metastases: a systematic review. Surg Oncol. 2017;26:268–75.CrossRef
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.CrossRef
32.
Mauri G, Varano GM, Orsi F. TAE for HCC: when the old way is better than the new ones!!! Cardiovasc Intervent Radiol. 2016;39:799–800.CrossRef
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.
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.CrossRef
35.
Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, et al. Randomized Trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015;372:1909–19.CrossRef
Metadata
Title
Transarterial Embolization with Small-Size Particles Loaded with Irinotecan for the Treatment of Colorectal Liver Metastases: Results of the MIRACLE III Study
Authors
Giovanni Mauri
Gianluca Maria Varano
Paolo Della Vigna
Guido Bonomo
Lorenzo Monfardini
Maria Giulia Zampino
Paola Simona Ravenda
Franco Orsi
Publication date
01-11-2018
Publisher
Springer US
Published in
CardioVascular and Interventional Radiology / Issue 11/2018
Print ISSN: 0174-1551
Electronic ISSN: 1432-086X
DOI
https://doi.org/10.1007/s00270-018-2017-x

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