Erlotinib for advanced hepatocellular carcinoma. A systematic review of phase II/III clinical trials

• Published in: Saudi medical journal 2016-11, Vol.37 (11), p.1184-1190
• Main Authors: Zhang, Jing, Zong, Yuan, Xu, Gang-Zhu, Xing, Ke
• Format: Article
• Language: English
• Subjects: Antineoplastic Agents - therapeutic use; Carcinoma, Hepatocellular - drug therapy; Carcinoma, Hepatocellular - mortality; Carcinoma, Hepatocellular - pathology; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Erlotinib Hydrochloride - therapeutic use; Evidence-Based Medicine; Humans; Liver Neoplasms - drug therapy; Liver Neoplasms - mortality; Liver Neoplasms - pathology; Neoplasm Staging; Survival Analysis; Systematic Review; Treatment Outcome
• ISSN: 0379-5284; 1658-3175
• DOI: 10.15537/smj.2016.11.16267

To evaluate the efficacy and safety of erlotinib for the treatment of advanced hepatocellular carcinoma (HCC). A systematic literature search was undertaken in June 2015. Phase II/III trials of erlotinib for the treatment of advanced HCC were included. A descriptive analysis was applied. The study was conducted in College of Medicine, Honghui Hospital, Xi'an Jiaotong University, Xi'an, China, between June 2015 and January 2016. Ten trials, comprising 9 phase II and one phase III trial, were included in the systematic review. The tumor response rate was 0% in 4 of the phase II trials, less than 10% in 3 of the phase II trials and the phase III trial, and greater than 20% in 2 of the phase II trials. The disease control rate was 42.5-79.6% in most studies. Three studies reported a median progression-free survival (PFS) of 6.5-9.0 months, although PFS was less than 3.5 months in most studies. Most trials reported a median overall survival of 6.25-15.65 months. The most frequent grade 3/4 toxicities were fatigue (11.9%), diarrhea (10%), increased alanine and aspartate transaminases (7.3%), and rash/desquamation (6.9%). Conclusion: Erlotinib provides efficacious and well-tolerated treatment for advanced HCC. However, more detailed investigations of HCC pathogenesis and evaluation of sensitive patient subsets are needed to improve outcomes of patients with advanced HCC. Additional well-designed, randomized, controlled trials are needed to evaluate the efficacy and safety of erlotinib as monotherapy or combination with other drugs for advanced HCC.