Sorafenib plus hepatic arterial infusion chemotherapy with cisplatin versus sorafenib for advanced hepatocellular carcinoma: randomized phase II trial.

Abstract

BACKGROUND:

Sorafenib (Sor) is acknowledged as a standard therapy for advanced hepatocellular carcinoma (HCC). This trial was conducted to evaluate the effect of addition of hepatic arterial infusion chemotherapy with cisplatin (SorCDDP) to Sor for the treatment of advanced HCC.

PATIENTS AND METHODS:

We conducted a multicenter open-labeled randomized phase II trial in chemo-naïve patients with advanced HCC with Child-Pugh scores of 5-7. Eligible patients were randomly assigned 2:1 to receive SorCDDP (sorafenib: 400 mg bid; cisplatin: 65 mg/m2, day 1, every 4-6 weeks) or Sor (400 mg bid). The primary end point was overall survival.

RESULTS:

A total of 108 patients were randomized (Sor, n = 42; SorCDDP, n = 66). The median survival in the Sor and SorCDDP arms were 8.7 and 10.6 months, respectively [stratified hazard ratio (95% confidence interval), 0.60 (0.38-0.96), P = 0.031]. The median time to progression and the response rate were, respectively, 2.8 months and 7.3% in the Sor arm and 3.1 months and 21.7% in the SorCDDP arm. The adverse events were more frequent in the SorCDDP arm than in the Sor arm, but well-tolerated.

CONCLUSION:

SorCDDP yielded favorable overall survival when compared with Sor in patients with advanced HCC.

CLINICAL TRIAL REGISTRATION:

UMIN-CTR (http://www.umin.ac.jp/ctr/index-j.htm), identification number: UMIN000005703.

• Authors: M Ikeda, S Shimizu, T Sato, M Morimoto, Y Kojima, Y Inaba, A Hagihara, M Kudo, S Nakamori, S Kaneko, R Sugimoto, T Tahara, T Ohmura, K Yasui, K Sato, H Ishii, J Furuse, T Okusaka
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 27 Issue 11 Pg. 2090-2096 (11 2016) ISSN: 1569-8041 [Electronic] England
• PMID: 27573564 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
• Copyright: © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Chemical References

• Phenylurea Compounds
• Niacinamide
• Sorafenib
• Cisplatin

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
• Carcinoma, Hepatocellular (drug therapy, pathology)
• Cisplatin (administration & dosage)
• Disease-Free Survival
• Female
• Humans
• Kaplan-Meier Estimate
• Liver Neoplasms (drug therapy, pathology)
• Male
• Middle Aged
• Neoplasm Staging
• Niacinamide (administration & dosage, analogs & derivatives)
• Phenylurea Compounds (administration & dosage)
• Sorafenib
• Treatment Outcome