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Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma: Japanese subgroup analysis of the REACH trial.
- Source :
- Journal of Gastroenterology; Apr2017, Vol. 52 Issue 4, p494-503, 10p
- Publication Year :
- 2017
-
Abstract
- <bold>Background: </bold>REACH evaluated ramucirumab in the second-line treatment of patients with advanced hepatocellular carcinoma. In the intent-to-treat population (n = 565), a significant improvement in overall survival (OS) was not observed. In patients with an elevated baseline α-fetoprotein (AFP) level (400 ng/mL or greater), an improvement in OS was demonstrated. An analysis of the Japanese patients in REACH was performed.<bold>Methods: </bold>An analysis was performed with the subset of the intent-to-treat population enrolled in Japan (n = 93).<bold>Results: </bold>The median OS was 12.9 months for the ramucirumab arm (n = 45) and 8.0 months for the placebo arm (n = 48) [hazard ratio (HR) 0.621 (95 % confidence interval (CI) 0.391-0.986); P = 0.0416]. The median progression-free survival was 4.1 months for the ramucirumab arm and 1.7 months for the placebo arm [HR 0.449 (95 % CI 0.285-0.706); P = 0.0004]. The objective response rates were 11 % for the ramucirumab arm and 2 % for the placebo arm (P = 0.0817). The grade 3 or higher treatment-emergent adverse events occurring in more than 5 % of patients with a higher incidence for the ramucirumab arm (n = 44) than for the placebo arm (n = 47) were ascites (7% vs 2 %), hypertension (7 % vs 2 %), and cholangitis (7 % vs 0 %). In patients with a baseline AFP level of 400 ng/mL or greater, the median OS was 12.9 months for the ramucirumab arm (n = 20) and 4.3 months for the placebo arm (n = 22) [HR 0.464 (95 % CI 0.232-0.926); P = 0.0263].<bold>Conclusions: </bold>In the Japanese patients in REACH, ramucirumab treatment improved OS, including in patients with a baseline AFP level of 400 ng/mL or greater; improvements in progression-free survival and objective response rate were also demonstrated. The safety profile of ramucirumab was acceptable and well tolerated in Japanese patients. ClinicalTrials.gov identifier NCT01140347. [ABSTRACT FROM AUTHOR]
- Subjects :
- LIVER cancer
DRUG efficacy
PLACEBOS
ASCITES
HYPERTENSION
ALPHA fetoproteins
ANTINEOPLASTIC agents
COMPARATIVE studies
DRUG administration
HEPATOCELLULAR carcinoma
LIVER tumors
RESEARCH methodology
MEDICAL cooperation
MONOCLONAL antibodies
RESEARCH
STATISTICAL sampling
UREA
VITAMIN B complex
EVALUATION research
RANDOMIZED controlled trials
TREATMENT effectiveness
BLIND experiment
KAPLAN-Meier estimator
Subjects
Details
- Language :
- English
- ISSN :
- 09441174
- Volume :
- 52
- Issue :
- 4
- Database :
- Complementary Index
- Journal :
- Journal of Gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 121919342
- Full Text :
- https://doi.org/10.1007/s00535-016-1247-4