Transarterial chemoembolization with pirarubicin-eluting microspheres in patients with unresectable hepatocellular carcinoma: Preliminary results

Abstract

Purpose: To present the early results of pirarubicin-eluting microsphere transarterial chemoembolization (PE-TACE) for patients with unresectable hepatocellular carcinoma (HCC).

Materials and methods: We retrospectively analyzed 55 consecutive patients with HCC who received PE-TACE between April 1, 2015 and August 30, 2016. The complication rate, tumor response rate, progression-free survival (PFS), and overall survival (OS) were analyzed.

Results: Adverse events were generally mild and included abdominal pain and fever, although a major complication was reported in 1 patient (1.8%). During a median follow-up of 10.0 months (range, 3.0-24.0 months), 14 patients (25.5%) achieved a complete tumor response, 25 (45.5%) had a partial response, 9 (16.4%) showed stable disease, and 7 (12.7%) had disease progression. The 1-month overall response rate was 70.9%, and the local tumor response rate was 89.0%. The 1-month tumor response rate was 100% for Barcelona Clinic Liver Cancer (BCLC) stage A or B disease and 62.8% for BCLC stage C disease. The median PFS was 6.1 months (95% confidence interval [95%CI], 3.4-8.8 months; range, 1.0-24.0 months). The median OS was 11.0 months (95%CI, 7.1-14.9 months; range, 2.0-24.0 months). Kaplan-Meier analysis (log-rank test) found significant differences in OS between patients grouped by tumor number (P = 0.006), tumor size (P = 0.035), and Eastern Cooperative Oncology Group (ECOG) score (P = 0.005). The tumor number (1 vs. ≥2) was the only factor independently associated with OS (hazard ratio [HR], 2.867; 95%CI, 1.330-6.181; P = 0.007).

Conclusions: PE-TACE for unresectable HCC may be safe, with favorable tumor response rates and survival time, especially in patients with a single large tumor. Longer follow-up using a larger series is necessary to confirm these preliminary results.

Keywords: Drug-eluting chemoembolization; Hepatocellular carcinoma; Microspheres; Therapeutic chemoembolization; Treatment outcome.

Fig. 1

Pirarubicin-eluting HepaSphere microspheres. (a) Angiography showed hepatocellular carcinoma in the right liver. (b) Stasis was observed after embolization. (c) Repeat angiography performed 5 min later showed recanalization of the tumor-feeding arteries. (d) Repeat angiography performed 5 min after additional embolization showed stasis of the tumor arteries. (e) Repeat angiography confirmed stasis of the tumor arteries. (f–g) Pirarubicin-eluting HepaSphere beads. The diameter of the beads used in this study was 120–240 μm.

Fig. 2

Enrolment of the study participants. HCC:Hepatocellular carcinoma, PE-TACE:Pirarubicin-eluting microsphere transcatheter arterial chemoembolization, TACE:Transcatheter arterial chemoembolization.

Fig. 3

Imaging data from a patient showing a complete tumor response. (a) Contrast-enhanced computed tomography (CT) image showing hepatocellular carcinoma in the right liver. (b–h) Follow-up CT images at different time points (1.5, 4.5, 6, 8, 11, 14, and 25 months, respectively) indicated a complete tumor response to therapy.

Fig. 4

Kaplan-Meier curves illustrating overall survival and progression-free survival in the 55 patients treated by pirarubicin-eluting microsphere transcatheter arterial chemoembolization. (a) The median overall survival was 11.0 months (95% confidence interval, 7.1–14.9 months; range, 2.0–24.0 months). The 6-month and 1-year survival rates were 75.0% and 53.1%, respectively. (b) The median progression-free survival was 6.1 months (95% confidence interval, 3.4–8.8 months; range, 1.0–24.0 months).

Fig. 5

Kaplan-Meier analysis of factors affecting overall survival (OS). (a) Log-rank analysis of OS stratified according to tumor number (single vs. multiple, P = 0.006). (b) Log-rank analysis of OS stratified according to tumor size (<5 cm vs. 5–10 cm vs. ≥10 cm, P = 0.035). (c) Log-rank analysis of OS stratified according to ECOG score (0 vs. 1 vs. 2, P = 0.005). (d) Log-rank analysis of OS stratified according to BCLC stage (A/B vs. C, P = 0.080). (e) Log-rank analysis of OS stratified according to Child-Pugh class (A vs. B, P = 0.196). (f) Log-rank analysis of OS stratified according to macroscopic vascular invasion (absent vs. present, P = 0.062).