Single-center phase II trial of transarterial chemoembolization with drug-eluting beads for patients with unresectable hepatocellular carcinoma: initial experience in the United States

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.

Figures

FIGURE 1

Changes in size, enhancement, and ADC value after DEBTACE. (A) Baseline gadolinium-enhanced MRI of the abdomen of a 55-year-old man with hepatitis C virus and a hypervascular lesion of 6.0 cm in his right liver lobe. (B) Corresponding baseline diffusion-weighted image shows a lesion with an ADC value of 0.996 × 10−3 mm2/s. (C) Gadolinium-enhanced MRI 1 month after DEBTACE shows almost complete necrosis, associated with a small reduction in size (5.7 cm). (D) Corresponding diffusion-weighted after DEB-TACE shows a lesion with an ADC value of 1.785 × 10−3 mm2/s. (E) Six-month posttreatment MRI shows a significant smaller lesion (4.2 cm).

FIGURE 2

Histologic findings associated with tumor response. (A) Pre-treatment MRI showing a hypervascular lesion in segments 5 to 6. (B) Posttreatment MRI illustrating 85% to 90% tumor necrosis. (C) Gross specimen after resection. (D) Histo-pathology from the tumor documenting extensive necrosis and no viable tumor cells. DEB is noted within the necrotic tumor.

FIGURE 3

Kaplan-Meier survival curve. Kaplan-Meier estimates of overall survival and progression-free survival (N = 20). OS indicates overall survival; PFS, progression-free survival.