Single-Center phase II trial of transarterial chemoembolization with drug-eluting beads for patients with unresectable hepatocellular carcinoma

Initial experience in the United States

Diane K. Reyes, Josephina A. Vossen, Ihab R. Kamel, Nilofer S. Azad, Tamara A. Wahlin, Michael S. Torbenson, Michael A. Choti, Jean Francois H Geschwind

Research output: Contribution to journalArticle

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Abstract

Purpose: This prospective phase II pilot study evaluated safety and efficacy of transarterial chemoembolization (TACE) with drug-eluting beads (DEBs) loaded with doxorubicin in patients with unresectable hepatocellular carcinoma (HCC). Methods: Twenty patients with unresectable HCC (75% Child's A, 95% Eastern Cooperative Oncology Group performance status 0 to 1, 60% Barcelona Clinic Liver Cancer C, tumor size 6.9 cm) underwent 34 DEB-TACE sessions. Primary endpoints were tumor response, assessed by contrast-enhanced magnetic resonance imaging at 1 month after treatment, using size (response evaluation criteria in solid tumors [RECIST]), contrast-enhancement (European Association for the Study of the Liver) and apparent diffusion coefficient values, and safety assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Secondary endpoints included feasibility, progression-free survival, and overall survival. Results: DEB-TACE was successfully performed in 34 sessions and demonstrated a favorable safety profile. On initial (1 month) postprocedural magnetic resonance imaging, treated lesions had a mean decrease in size of 4% (P = 0.1129). Using RECIST, partial response was achieved in 2 patients (10%), and 18 patients (90%) had stable disease. Treated tumors demonstrated a mean decrease in contrast enhancement of 64% (P < 0.0001). By European Association for the Study of the Liver criteria, 12 patients (60%) had objective tumor response, and 8 (40%) had stable disease. No patients had progression of a treated lesion while undergoing treatment. At 6 months, the disease control rate was 95% using RECIST. Overall survival rates at 1 and 2 years were 65% and 55%, respectively; median overall survival was 26 months. Discussion: DEB-TACE is safe and effective in achieving local tumor control in patients with unresectable HCC.

Original languageEnglish (US)
Pages (from-to)526-532
Number of pages7
JournalCancer Journal
Volume15
Issue number6
DOIs
StatePublished - Nov 2009

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Hepatocellular Carcinoma
Pharmaceutical Preparations
Neoplasms
Safety
Magnetic Resonance Imaging
Survival
National Cancer Institute (U.S.)
Liver Neoplasms
Terminology
Doxorubicin
Disease-Free Survival
Survival Rate
Therapeutics
Response Evaluation Criteria in Solid Tumors

Keywords

  • Doxorubicin
  • Drug delivery systems
  • Hepatocellular carcinoma
  • Intra-arterial injection

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Single-Center phase II trial of transarterial chemoembolization with drug-eluting beads for patients with unresectable hepatocellular carcinoma : Initial experience in the United States. / Reyes, Diane K.; Vossen, Josephina A.; Kamel, Ihab R.; Azad, Nilofer S.; Wahlin, Tamara A.; Torbenson, Michael S.; Choti, Michael A.; Geschwind, Jean Francois H.

In: Cancer Journal, Vol. 15, No. 6, 11.2009, p. 526-532.

Research output: Contribution to journalArticle

Reyes, Diane K. ; Vossen, Josephina A. ; Kamel, Ihab R. ; Azad, Nilofer S. ; Wahlin, Tamara A. ; Torbenson, Michael S. ; Choti, Michael A. ; Geschwind, Jean Francois H. / Single-Center phase II trial of transarterial chemoembolization with drug-eluting beads for patients with unresectable hepatocellular carcinoma : Initial experience in the United States. In: Cancer Journal. 2009 ; Vol. 15, No. 6. pp. 526-532.
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abstract = "Purpose: This prospective phase II pilot study evaluated safety and efficacy of transarterial chemoembolization (TACE) with drug-eluting beads (DEBs) loaded with doxorubicin in patients with unresectable hepatocellular carcinoma (HCC). Methods: Twenty patients with unresectable HCC (75{\%} Child's A, 95{\%} Eastern Cooperative Oncology Group performance status 0 to 1, 60{\%} Barcelona Clinic Liver Cancer C, tumor size 6.9 cm) underwent 34 DEB-TACE sessions. Primary endpoints were tumor response, assessed by contrast-enhanced magnetic resonance imaging at 1 month after treatment, using size (response evaluation criteria in solid tumors [RECIST]), contrast-enhancement (European Association for the Study of the Liver) and apparent diffusion coefficient values, and safety assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Secondary endpoints included feasibility, progression-free survival, and overall survival. Results: DEB-TACE was successfully performed in 34 sessions and demonstrated a favorable safety profile. On initial (1 month) postprocedural magnetic resonance imaging, treated lesions had a mean decrease in size of 4{\%} (P = 0.1129). Using RECIST, partial response was achieved in 2 patients (10{\%}), and 18 patients (90{\%}) had stable disease. Treated tumors demonstrated a mean decrease in contrast enhancement of 64{\%} (P < 0.0001). By European Association for the Study of the Liver criteria, 12 patients (60{\%}) had objective tumor response, and 8 (40{\%}) had stable disease. No patients had progression of a treated lesion while undergoing treatment. At 6 months, the disease control rate was 95{\%} using RECIST. Overall survival rates at 1 and 2 years were 65{\%} and 55{\%}, respectively; median overall survival was 26 months. Discussion: DEB-TACE is safe and effective in achieving local tumor control in patients with unresectable HCC.",
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AU - Vossen, Josephina A.

AU - Kamel, Ihab R.

AU - Azad, Nilofer S.

AU - Wahlin, Tamara A.

AU - Torbenson, Michael S.

AU - Choti, Michael A.

AU - Geschwind, Jean Francois H

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