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Prospective Series of Transarterial Chemoembolization of Metastatic Colorectal Cancer to the Liver with 30–60 μm Microspheres Loaded with Irinotecan

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Abstract

Purpose

To describe safety and clinical outcomes among patients with metastatic colorectal cancer (mCRC) to the liver treated with transarterial chemoembolization with HepaSphere™ Microspheres 30–60 μm loaded with irinotecan (ΙRI-HEP-TACE).

Material and methods

In this prospective study (NCT04866290), 100 adults with confirmed mCRC to the liver who were ineligible for resection were enrolled and followed up to 24 months or death. Study outcomes among Salvage (patients not tolerating more cycles of chemotherapy) and Non-salvage patients included overall survival (OS), progression-free survival (PFS), objective response (OR), objective response rate (ORR), best tumor response (BTR), adverse events (AEs), and pharmacokinetics of irinotecan and its active metabolite, 7-ethyl-10-hydroxy-camptothecin (SN38).

Results

The median age was 66 years (range: 31–89). Median OS was 15.08 months (95% confidence interval [CI]: 12.33–17.25). PFS was 8.52 months (95% CI: 6.0–9.0; p < 0.001). ORR was 42.2% (95% CI: 31.57–53.50) and 35.9% (95% CI: 25.57–47.62) based on modified RECIST (Response Evaluation Criteria in Solid Tumors) and RECIST 1.1 criteria. BTR was not significantly different between mRECIST and RECIST (p = 0.745). The Non-salvage group had a statistically significant difference in median OS relative to the Salvage group (15.3 vs. 3 months; p < 0.001). Pharmacokinetic analyses demonstrated no correlation of OS with plasma concentration of irinotecan and SN38 (all p > 0.05). Most AEs were Grade 2 (257/279), the most common AE was right upper abdominal pain (180/279). One major AE (tumor rupture) was reported.

Conclusion

IRI-HEP-TACE is an alternative treatment for patients with Non-salvage mCRC to the liver.

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Abbreviations

AEs:

Adverse events

BTR:

Best tumor response

CI:

Confidence interval

CR:

Complete response

IRI-HEP-TACE:

Transarterial chemoembolization with HepaSphere Microspheres 30–60 μm loaded with irinotecan

mCRC:

Metastatic colorectal cancer

(m)RECIST:

(modified) Response Evaluation Criteria in Solid Tumors

OR:

Objective response

ORR:

Objective response rate

OS:

Overall survival

PD:

Progressive disease

PFS:

Progression-free survival

PR:

Partial response

RR:

Response rate

SD:

Stable disease

SN38:

7-Ethyl-10-hydroxy-camptothecin

TACE:

Transarterial chemoembolization

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Acknowledgements

The authors wish to thank Jerry Bounsanga, MSTAT, an employee of Merit Medical Systems, Inc. for additional analytical support. Editorial assistance in the preparation of this article was provided Gloria DeWalt, PhD, MWC, an employee of Merit Medical Systems, Inc. The authors wish to thank also Eleni Prokaki BAMSc for the coordination of the study prokaki.elena@gmail.com.

Funding

This study was funded by Merit Medical Systems, Inc. and was registered at www.clinicaltrials.gov (NCT04866290).

Author information

Authors and Affiliations

  1. Department of Radiology, Medical School, National and Kapodistrian University of Athens, 19 Monis Kyccou, 15 669 Papagou, Athens, Greece

    K. Malagari, Th Kiakidis, A. Charokopakis, D. K. Filippiadis & N. Kelekis

  2. Evgenidion and Attikon University Hospitals, Chaidari, Greece

    K. Malagari, Th Kiakidis, A. Charokopakis, D. K. Filippiadis & N. Kelekis

  3. Interventional Radiology Department, Tzanion General Hospital, Piraeus, Athens, Greece

    H. Moschouris

  4. Laikon General Hospital, Athens, Greece

    C. Vergadis

  5. Evangelismos Hospital, Athens, Greece

    N. Alevisopoulos

  6. Department of Interventional Radiology, Agios Savvas Anticancer Hospital, Athens, Greece

    V. Kartsouni

  7. Department of Internal Medicine, Agios Savvas Anticancer Hospital, Αthens, Greece

    Ir Panagiotou

  8. Interventional Radiology, Université de Paris-Citè, PARCC, INSERM, 75006, Service de Radiologie Interventionnelle Assistance Publique - Hôpitaux de Paris Hôpital Européen Georges Pompidou, Paris, France

    O. Pellerin

  9. Ioannina University Hospital, Ioannina, Greece

    G. Glantzounis

  10. Department of Radiology, Amalia Fleming Hospital, Athens, Greece

    E. Emmanouil

  11. Laikon Hospital, Athens, Greece

    N. Tsavaris

  12. ASTAT-Statistics in Clinical Research, 166 75, Athens, Greece

    G. Psarros & E. Delicha

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  1. K. Malagari
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Malagari, K., Kiakidis, T., Moschouris, H. et al. Prospective Series of Transarterial Chemoembolization of Metastatic Colorectal Cancer to the Liver with 30–60 μm Microspheres Loaded with Irinotecan. Cardiovasc Intervent Radiol 46, 880–890 (2023). https://doi.org/10.1007/s00270-023-03446-6

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