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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 [J Gastroenterol] 2017 Apr; Vol. 52 (4), pp. 494-503. Date of Electronic Publication: 2016 Aug 22. - Publication Year :
- 2017
-
Abstract
- Background: 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.<br />Methods: An analysis was performed with the subset of the intent-to-treat population enrolled in Japan (n = 93).<br />Results: 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].<br />Conclusions: 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.
- Subjects :
- Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols adverse effects
Carcinoma, Hepatocellular blood
Double-Blind Method
Drug Administration Schedule
Female
Humans
Kaplan-Meier Estimate
Liver Neoplasms blood
Male
Middle Aged
Niacinamide administration & dosage
Niacinamide adverse effects
Niacinamide analogs & derivatives
Phenylurea Compounds administration & dosage
Phenylurea Compounds adverse effects
Sorafenib
Treatment Outcome
alpha-Fetoproteins analysis
Ramucirumab
Antibodies, Monoclonal administration & dosage
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Carcinoma, Hepatocellular drug therapy
Liver Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1435-5922
- Volume :
- 52
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Journal of gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 27549242
- Full Text :
- https://doi.org/10.1007/s00535-016-1247-4