Phase II study of chemoembolization with drug-eluting beads in patients with hepatic neuroendocrine metastases: High incidence of biliary injury

Nikhil Bhagat, Diane K. Reyes, Mingde Lin, Ihab R Kamel, Timothy M. Pawlik, Constantine Frangakis, J. F. Geschwind

Research output: Contribution to journalArticle

Abstract

Purpose: To evaluate safety in an interim analysis of transarterial chemoembolization (TACE) with doxorubicin-eluting beads (DEB) in 13 patients with hepatic metastases from neuroendocrine tumors (NETs) as part of a phase II trial. Methods: Institutional Review Board approval and informed consent were obtained. Thirteen patients completed preliminary safety analysis. Their mean age was 65 years, Eastern Cooperative Oncology Group status was 0/1, tumor burden range was 4-75 %, and mean targeted tumor size was 5.9 cm. Up to four DEB-TACE sessions (100-300 μm beads loaded with ≤100 mg doxorubicin) within 6 months were allowed. Tumor response was assessed by magnetic resonance imaging 1 month after treatment using contrast-enhancement [European Association for the Study of the Liver (EASL) and size Response Evaluation Criteria in Solid Tumors (RECIST)] criteria. Safety was assessed by National Cancer Institute Common Terminology Criteria. Results:: DEB-TACE was successfully performed in all 13 patients. At 1 month follow-up, there was a mean 12 % decrease in tumor size (p <0.0003) and a 56 % decrease in tumor enhancement (p <0.0001). By EASL criteria, the targeted lesion objective response rate was 78 %. Grade 3 to 4 toxicities were fatigue (23 %), increased alanine amino transferase (15 %), hyperglycemia (15 %), and abdominal pain (8 %). Seven patients developed bilomas (54 %); all of these patients had multiple small (

Original languageEnglish (US)
Pages (from-to)449-459
Number of pages11
JournalCardioVascular and Interventional Radiology
Volume36
Issue number2
DOIs
StatePublished - Apr 2013

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Doxorubicin
Neoplasm Metastasis
Liver
Incidence
Wounds and Injuries
Pharmaceutical Preparations
Safety
Neoplasms
Neuroendocrine Tumors
National Cancer Institute (U.S.)
Research Ethics Committees
Transferases
Tumor Burden
Informed Consent
Terminology
Hyperglycemia
Alanine
Abdominal Pain
Fatigue
Magnetic Resonance Imaging

Keywords

  • Biliary injury
  • Chemoembolization
  • Drug-eluting beads
  • Neuroendocrine metastases

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Phase II study of chemoembolization with drug-eluting beads in patients with hepatic neuroendocrine metastases : High incidence of biliary injury. / Bhagat, Nikhil; Reyes, Diane K.; Lin, Mingde; Kamel, Ihab R; Pawlik, Timothy M.; Frangakis, Constantine; Geschwind, J. F.

In: CardioVascular and Interventional Radiology, Vol. 36, No. 2, 04.2013, p. 449-459.

Research output: Contribution to journalArticle

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abstract = "Purpose: To evaluate safety in an interim analysis of transarterial chemoembolization (TACE) with doxorubicin-eluting beads (DEB) in 13 patients with hepatic metastases from neuroendocrine tumors (NETs) as part of a phase II trial. Methods: Institutional Review Board approval and informed consent were obtained. Thirteen patients completed preliminary safety analysis. Their mean age was 65 years, Eastern Cooperative Oncology Group status was 0/1, tumor burden range was 4-75 {\%}, and mean targeted tumor size was 5.9 cm. Up to four DEB-TACE sessions (100-300 μm beads loaded with ≤100 mg doxorubicin) within 6 months were allowed. Tumor response was assessed by magnetic resonance imaging 1 month after treatment using contrast-enhancement [European Association for the Study of the Liver (EASL) and size Response Evaluation Criteria in Solid Tumors (RECIST)] criteria. Safety was assessed by National Cancer Institute Common Terminology Criteria. Results:: DEB-TACE was successfully performed in all 13 patients. At 1 month follow-up, there was a mean 12 {\%} decrease in tumor size (p <0.0003) and a 56 {\%} decrease in tumor enhancement (p <0.0001). By EASL criteria, the targeted lesion objective response rate was 78 {\%}. Grade 3 to 4 toxicities were fatigue (23 {\%}), increased alanine amino transferase (15 {\%}), hyperglycemia (15 {\%}), and abdominal pain (8 {\%}). Seven patients developed bilomas (54 {\%}); all of these patients had multiple small (",
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AU - Geschwind, J. F.

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