Back to Search
Start Over
REFLECT-a phase 3 trial comparing efficacy and safety of lenvatinib to sorafenib for the treatment of unresectable hepatocellular carcinoma: an analysis of Japanese subset.
- Source :
- Journal of Gastroenterology; Jan2020, Vol. 55 Issue 1, p113-122, 10p, 1 Diagram, 3 Charts, 2 Graphs
- Publication Year :
- 2020
-
Abstract
- <bold>Background: </bold>A phase 3, multinational, randomized, non-inferiority trial (REFLECT) compared the efficacy and safety of lenvatinib (LEN) and sorafenib (SOR) in patients with unresectable hepatocellular carcinoma (uHCC). LEN had an effect on overall survival (OS) compared to SOR, statistically confirmed by non-inferiority [OS: median = 13.6 months vs. 12.3 months; hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.79-1.06], and demonstrated statistically significant improvements in progression-free survival (PFS) and the objective response rate (ORR) in the overall population. The results of a subset analysis that evaluated the efficacy and safety of LEN and SOR in the Japanese population are reported.<bold>Methods: </bold>The intent-to-treat population enrolled in Japan was analyzed.<bold>Results: </bold>Of 954 patients in the overall population, 168 Japanese patients were assigned to the LEN arm (N = 81) or the SOR arm (N = 87). Median OS was 17.6 months for LEN vs. 17.8 months for SOR (HR 0.90; 95% CI 0.62-1.29). LEN showed statistically significant improvements over SOR in PFS (7.2 months vs. 4.6 months) and ORR (29.6% vs. 6.9%). The relative dose intensity of LEN and SOR in the Japanese population was lower than in the overall population. Frequently observed, related adverse events included palmar-plantar erythrodysaesthesia syndrome (PPES), hypertension, decreased appetite, and proteinuria in the LEN arm, and PPES, hypertension, diarrhea, and alopecia in the SOR arm.<bold>Conclusions: </bold>The efficacy and safety of LEN in the Japanese population were similar to those in the overall population of REFLECT. With manageable adverse events, LEN is a new treatment option for Japanese patients with uHCC.<bold>Trial Registration Id: </bold>ClinicalTrials.gov. No. NCT01761266. [ABSTRACT FROM AUTHOR]
- Subjects :
- HEPATOCELLULAR carcinoma
PROGRESSION-free survival
JAPANESE people
ADVERSE health care events
CONFIDENCE intervals
THERAPEUTIC use of antineoplastic agents
QUINOLINE
RESEARCH
UREA
LIVER tumors
RESEARCH methodology
MEDICAL cooperation
EVALUATION research
TREATMENT effectiveness
COMPARATIVE studies
RANDOMIZED controlled trials
SURVIVAL analysis (Biometry)
STATISTICAL sampling
Subjects
Details
- Language :
- English
- ISSN :
- 09441174
- Volume :
- 55
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- Journal of Gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 141049226
- Full Text :
- https://doi.org/10.1007/s00535-019-01642-1