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

J Clin Lab Anal. 2019 Oct;33(8):e22975. doi: 10.1002/jcla.22975. Epub 2019 Jul 22.

Abstract

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.

Keywords: drug-eluting beads-transarterial chemoembolization; hepatocellular carcinoma; predictive factor; safety; treatment response.

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Carcinoma, Hepatocellular / mortality*
  • Carcinoma, Hepatocellular / pathology
  • Carcinoma, Hepatocellular / therapy
  • Chemoembolization, Therapeutic / methods*
  • Drug Delivery Systems / methods*
  • Female
  • Follow-Up Studies
  • Humans
  • Liver Neoplasms / mortality*
  • Liver Neoplasms / pathology
  • Liver Neoplasms / therapy
  • Male
  • Microspheres*
  • Middle Aged
  • Neoplasm Recurrence, Local / mortality*
  • Neoplasm Recurrence, Local / pathology
  • Neoplasm Recurrence, Local / therapy
  • Prognosis
  • Prospective Studies
  • Survival Rate