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Five-Years Outcome Analysis of 142 Consecutive Hepatocellular Carcinoma Patients Treated with Doxorubicin Eluting Microspheres 30–60 μm: Results from a Single-Centre Prospective Phase II Trial

  • Clinical Investigation
  • Interventional Oncology
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Abstract

Purpose

To assess prospectively long-term results of doxorubicin-loaded HepaSphere 30–60 μm in consecutive patients with hepatocellular carcinoma (HCC) not amenable to curative treatments.

Patients and Methods

Single-center study from June 2011 to December 2015 in 151 patients treated with 75 mg of doxorubicin per HepaSphere vial. Baseline: Barcelona Clinic Liver Cancer BCLC A/B was 49.3%/50.7%, and median diameter 6.1 cm (mean 6.7 ± 2.0). Liver function, local response (mRECIST), liver time to progression (LTTP), progression-free survival (PFS), overall survival (OS) and adverse events (AEs) were recorded.

Results

Final analysis included 142 patients with median follow-up of 46.8 months (range 4–72) without grade 4/5 AEs, and 30-day mortality was 0%. Mean number of scheduled treatments was 2.6 (range 1–3) and on demand 3 (range 1–8). Complete response for single tumor ≤ 5 cm was 75.0% and 66.7% for Child A and Child B, while for > 5 cm was 28.6% and 11.8%, respectively. OS was 31.0 months (mean 33.3 ± 15.2; range 8–69), notably for BCLC A 41 months (mean 41.1 ± 15.3; range 13–69) and for BCLC B 26.0 (mean 26.0 ± 10.5; range 8–51). OS at 1, 3 and 5 years: 95.8%, 75.7% and 21.4% for BCLC A, and 94.4%, 36.1% and 2.7% for BCLC B. Median LTTP for BCLC A was 11 months (mean 11.9 ± 4.7; range 3–24) and 7.5 for BCLC B (mean 7.9 ± 2.9). Local response was significant for OS and LTTP (p < 0.0001), while size and lesion number affected LPFS and OS (p < 0.001).

Conclusions

HepaSphere 30–60 μm loaded with doxorubicin provides a safe and effective treatment option for patients with HCC.

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Abbreviations

DEM:

Drug-eluting microsphere

DEM-TACE:

Drug-eluting microsphere transarterial chemoembolization

HCC:

Hepatocellular carcinoma

BCLC classification:

Barcelona Clinic Liver Cancer

mRECIST:

Local response

LTTP:

Time to progression in the liver

PFS:

Progression-free survival

OS:

Overall survival

AEs:

Adverse events

NACT:

HCC not amenable to curative treatments

OS:

Overall survival

CR:

Complete response

PR:

Partial response

SD:

Stable disease

PD:

Progressive disease

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Authors and Affiliations

  1. 2nd Department of Radiology, Medical School, National and Kapodistrian University of Athens, 19 Monis Kyccou, 15669, Papagou, Athens, Greece

    K. Malagari, Th. Kiakidis, A. Kelekis, D. Filipiadis, E. Emmanouil & N. Kelekis

  2. Attikon Hospital, Chaidari, Greece

    K. Malagari, A. Kelekis, D. Filipiadis & N. Kelekis

  3. Evgenidion Hospital, Athens, Greece

    K. Malagari, Th. Kiakidis, A. Kelekis, E. Emmanouil, A. Chatziioannou & N. Kelekis

  4. Radiology Department of Tzanion General Hospital, Athens, Greece

    H. Moschouris

  5. University of Massachusets Medical School, Worcester, MA, USA

    S. Harward

  6. Tzanion Hospital, Athens, Greece

    S. Vrakas

  7. 2nd Clinic of Medicine and Hepatology Medical School, National and Kapodistrian University of Athens, Athens, Greece

    D. Koundouras, J. Koskinas & S. Dourakis

  8. 2nd Clinic of Internal Medicine University of Athens Hippokration Hospital, Athens, Greece

    D. Koundouras, J. Koskinas & S. Dourakis

  9. Department of Surgery, University Hospital of Ioannina (UOI), Ioannina, Greece

    G. Glantzounis

  10. 1st Department of Radiology, Medical School, National and Kapodistrian University of Athens, Athens, Greece

    A. Chatziioannou

  11. Radiology Department of Laikon University Hospital, Athens, Greece

    V. Vergadis

  12. Department of Internal Medicine and Hepatology Unit, Agioi Anargyroi General and Oncology Hospital of Kifissia Hospital Timiou Stavrou and Noufaron, Kalyftaki, Athens, Greece

    I. Elefsiniotis

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  1. K. Malagari
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Malagari, K., Moschouris, H., Kiakidis, T. et al. Five-Years Outcome Analysis of 142 Consecutive Hepatocellular Carcinoma Patients Treated with Doxorubicin Eluting Microspheres 30–60 μm: Results from a Single-Centre Prospective Phase II Trial. Cardiovasc Intervent Radiol 42, 1551–1562 (2019). https://doi.org/10.1007/s00270-019-02260-3

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