Entry Detail
| General information | |
| Database: | DB00105 |
| Objective: | To compare the clinical outcomes of sorafenib plus either erlotinib or placebo in patients with advanced hepatocellular carcinoma (hepatocellular carcinoma) in a multicenter, multinational, randomized, phase III trial. |
| Authors: | Zhu AX, et al |
| Title: | SEARCH: a phase III, randomized, doubleblind, placebocontrolled trial of sorafenib plus erlotinib in patients with advanced hepatocellular carcinoma. |
| Journal: | J Clin Oncol. |
| Year: | 2015 |
| PMID: | 25547503 |
| Trial Design | |
| Clinical Trial Id: | NCT0901901 |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | sorafenib+erlotinib |
| Study Type: | a multicenter, multinational, randomized, phase III trial. |
| Key Patients Feature: | Patients with advanced hepatocellular carcinoma and underlying ChildPugh class A cirrhosis, who were naive to systemic treatment |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | sorafenib+placebo |
| Treatment Info: | patients were randomly assigned to sorafenib plus either erlotinib (n = 362) or placebo (n = 358). |
| Primary End Point: | overall survival (OS). |
| Secondary End Point: | NA |
| Patients Number: | 720 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 6.6% v 3.9%; P = .102 |
| Disease Control Rate: | 43.9% v 52.5%; P = .021 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | median TTP:3.2 v 4.0; HR, 1.135; P = .18 |
| Median OS A vs. C: | 9.5 v 8.5;[HR], 0.929; P = .408 |
| Adverse Event(agent arm): | In the sorafenib/erlotinib and sorafenib/placebo arms, the rates of treatmentemergent serious AEs (58.0% v 54.6%) and drugrelated serious AEs (21.0% v 22.8%) were similar. AEs matched the known safety profiles of both agents, but rates of rash/desquamation, anorexia, and diarrhea were higher in the sorafenib/erlotinib arm, whereas rates of alopecia and handfoot skin reaction were higher in the sorafenib/placebo arm. Withdrawal rates for AEs during cycles 1 to 3 were higher in the sorafenib/erlotinib arm. |
| Conclusions: | Adding erlotinib to sorafenib did not improve survival in patients with advanced hepatocellular carcinoma. |