TY - JOUR
T1 - Phase II study of chemoembolization with drug-eluting beads in patients with hepatic neuroendocrine metastases
T2 - High incidence of biliary injury
AU - Bhagat, Nikhil
AU - Reyes, Diane K.
AU - Lin, Mingde
AU - Kamel, Ihab
AU - Pawlik, Timothy M.
AU - Frangakis, Constantine
AU - Geschwind, J. F.
N1 - Funding Information:
This study was partially funded by National Institutes of Health Grant No. R01 CA160771-2 and BioCompatibles UK Ltd. Clinical Trials.gov trial no. NCT00730483. Previous presentations include the following: (1) American Society of Clinical Oncology, Gastrointestinal Cancers Symposium, San Francisco, CA, January 20 to 22, 2011; (2) Cardiovascular and Interventional Radiological Society of Europe, 2011, Sept 10–14, and (3) Society of Interventional Radiology, 36th Annual Scientific Meeting, Chicago, IL, 2011.
Funding Information:
Nikhil Bhagat, Mingde Lin, and Jean-Francois Geschwind were partially funded by National Institutes of Health Grant No. R01 CA 160771-2. Jean-Francois Geschwind was partially funded by Biocompatibles UK Ltd.
PY - 2013/4
Y1 - 2013/4
N2 - 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 (<4 cm) lesions. Subsequently, four underwent percutaneous drainage, three for abscess formation and one for symptoms related to mass effect. Conclusions: Although biloma and liver abscess are known risks after TACE, the high incidence in our study population was unexpected and forced interruption of the trial. Although this occurred in a small group of patients, we have changed our technique and patient selection as a result of these findings, thus allowing resumption of the trial.
AB - 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 (<4 cm) lesions. Subsequently, four underwent percutaneous drainage, three for abscess formation and one for symptoms related to mass effect. Conclusions: Although biloma and liver abscess are known risks after TACE, the high incidence in our study population was unexpected and forced interruption of the trial. Although this occurred in a small group of patients, we have changed our technique and patient selection as a result of these findings, thus allowing resumption of the trial.
KW - Biliary injury
KW - Chemoembolization
KW - Drug-eluting beads
KW - Neuroendocrine metastases
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U2 - 10.1007/s00270-012-0424-y
DO - 10.1007/s00270-012-0424-y
M3 - Review article
C2 - 22722717
AN - SCOPUS:84875223168
VL - 36
SP - 449
EP - 459
JO - Cardiovascular Radiology
JF - Cardiovascular Radiology
SN - 7415-5101
IS - 2
ER -