To assess the safety, tolerability, and efficacy of small drug-eluting embolic (DEE) agents (70-150 μm) for chemoembolization of hepatocellular carcinoma (HCC). MATERIALS AND METHODS: This single-center, single-arm, retrospective study involved 421 patients (mean age, 66.1 y ± 9.8 [standard deviation]) with Barcelona Clinic Liver Cancer (BCLC) stage A (n = 88), B (n = 140), or C (n = 193) HCC and Child-Pugh class A (n = 233) or B (n = 188) cirrhosis. Patients had a mean of 7.2 lesions ± 4.8 (range, 1-21; mean diameter of target lesion, 21.4 cm ± 8.1; unilobar, n = 132; bilobar, n = 289; portal vein involvement, n = 193). One (n = 320) or 2 (n = 101) vials of small DEEs loaded with doxorubicin 50 mg per vial were delivered selectively (ie, segmentally) or superselectively (ie, directly into the tumor-feeding vessel) until complete delivery or stasis/near-stasis. Treatment was repeated in patients with partial response or stable disease at 1- or 3-month follow-up (mean, 2.0 cycles ± 0.9). Adverse events within 30 days of chemoembolization, response per modified Response Evaluation Criteria In Solid Tumors (mRECIST), and survival were assessed. RESULTS: Within 30 days after treatment, no deaths or bleeding events occurred, but all patients had at least 1 episode of postembolization syndrome (pain, fever, and/or nausea/vomiting; 27.1% grade 3/4 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0) and increased bilirubin and liver aminotransferase levels (0.2% and 5.9% grade 3/4, respectively). Overall response rates were 94.5% at 3 months and 99.5% at 6 months. Median overall survival was 42.0 months (95% confidence interval, 38.0-43.0 mo). CONCLUSIONS: Chemoembolization with small DEE agents is well tolerated and an effective treatment for a broad range of patients with liver-confined HCC.

Transarterial Chemoembolization with Small Drug-Eluting Beads in Patients with Hepatocellular Carcinoma: Experience from a Cohort of 421 Patients at an Italian Center

Carandina, Riccardo;Lonardi, Sara;Vitale, Alessandro;Gringeri, Enrico;Zanus, Giacomo;Cillo, Umberto
2017

Abstract

To assess the safety, tolerability, and efficacy of small drug-eluting embolic (DEE) agents (70-150 μm) for chemoembolization of hepatocellular carcinoma (HCC). MATERIALS AND METHODS: This single-center, single-arm, retrospective study involved 421 patients (mean age, 66.1 y ± 9.8 [standard deviation]) with Barcelona Clinic Liver Cancer (BCLC) stage A (n = 88), B (n = 140), or C (n = 193) HCC and Child-Pugh class A (n = 233) or B (n = 188) cirrhosis. Patients had a mean of 7.2 lesions ± 4.8 (range, 1-21; mean diameter of target lesion, 21.4 cm ± 8.1; unilobar, n = 132; bilobar, n = 289; portal vein involvement, n = 193). One (n = 320) or 2 (n = 101) vials of small DEEs loaded with doxorubicin 50 mg per vial were delivered selectively (ie, segmentally) or superselectively (ie, directly into the tumor-feeding vessel) until complete delivery or stasis/near-stasis. Treatment was repeated in patients with partial response or stable disease at 1- or 3-month follow-up (mean, 2.0 cycles ± 0.9). Adverse events within 30 days of chemoembolization, response per modified Response Evaluation Criteria In Solid Tumors (mRECIST), and survival were assessed. RESULTS: Within 30 days after treatment, no deaths or bleeding events occurred, but all patients had at least 1 episode of postembolization syndrome (pain, fever, and/or nausea/vomiting; 27.1% grade 3/4 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0) and increased bilirubin and liver aminotransferase levels (0.2% and 5.9% grade 3/4, respectively). Overall response rates were 94.5% at 3 months and 99.5% at 6 months. Median overall survival was 42.0 months (95% confidence interval, 38.0-43.0 mo). CONCLUSIONS: Chemoembolization with small DEE agents is well tolerated and an effective treatment for a broad range of patients with liver-confined HCC.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11577/3252464
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