An investigation of efficacy, safety, and prognostic factors of drug‐eluting beads‐transarterial chemoembolization operation with CalliSpheres(®) Microspheres in treating Chinese hepatocellular carcinoma patients

BACKGROUND: We aimed to investigate treatment response, survival profiles, safety profiles, and predictive factors of drug‐eluting beads‐transarterial chemoembolization (DEB‐TACE) with CalliSpheres(®) Microspheres (CSM) in treating Chinese hepatocellular carcinoma (HCC) patients. METHODS: A total of 66 HCC patients about to receive DEB‐TACE with CSM therapy were consecutively enrolled in this prospective cohort study. Treatment response was recorded. Besides, progression‐free survival (PFS) and overall survival (OS) were also recorded. All adverse events including pain, nausea, vomiting, fever, and liver function damage were recorded during hospitalization. RESULTS: 37.9% of patients achieved complete response (CR) and 81.8% of patients achieved an objective response rate (ORR). For survival, mean PFS and OS were 13.7 (11.7‐15.8) months and 18.8 (95% CI: 16.3‐21.2) months, respectively. Multivariate logistic regression analysis revealed that a number of nodules ≥2 was an independent factor for worse CR; moreover, multivariate Cox's regression analysis disclosed that largest sample size ≥5 cm was an independent factor for shorter PFS, and Child‐Pugh B and BCLC stage B/C were independent predictive factors for unfavorable OS. As to AEs, numbers of patients suffered liver function damage, pain, nausea, vomiting, and fever were 29 (43.9%), 27 (40.9%), 22 (33.3%), 13 (19.7%), and 37 (56.1%), respectively. CONCLUSION: Drug‐eluting beads‐transarterial chemoembolization with CSM is an effective and tolerated treatment for Chinese HCC patients, and number of nodules ≥2, largest nodule size ≥5 cm, Child‐Pugh stage B, and BCLC stage B/C correlates with unfavorable prognosis.