The Absolute Effect / Oncology Evidence / Evidence Index
REFLECT
In first-line unresectable hepatocellular carcinoma with preserved liver function, is lenvatinib non-inferior to sorafenib for overall survival?
Registry: NCT01761266 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.
Phase III randomized non-inferiority; n=954.Primary-source evidence summaryStudy design, population and eligibility
Phase III randomized non-inferiority; n=954.
Unresectable HCC, Child-Pugh A, ECOG 0–1; major portal vein invasion/high liver occupation excluded.
Treatment and comparator
Intervention: Lenvatinib weight-based daily dosing.
Comparator: Sorafenib 400 mg twice daily.
Endpoints
OS non-inferiority primary.
Key efficacy and clinical outcomes
Median OS 13.6 vs 12.3 mo (HR 0.92; 95% CI 0.79–1.06): non-inferior, not superior. ORR 18.8% vs 6.5% by RECIST 1.1.
Source-reported outcome visualization
Values are reproduced from the cited report; bars are scaled within this figure. First-line unresectable HCC · Child-Pugh A
Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.
Toxicity and treatment burden
Hypertension, proteinuria, weight loss, hypothyroidism; sorafenib hand-foot skin reaction/diarrhoea.
Absolute effect and NNT/NNH
Non-inferiority only; exclusions limit generalizability. ORR varies by mRECIST vs RECIST.
NNT/NNH is not calculated unless a directly reported, comparable fixed-time risk difference supports it. Median survival and hazard ratios alone do not provide an NNT.
Critical interpretation and limitations
Non-inferiority only; exclusions limit generalizability. ORR varies by mRECIST vs RECIST.
This page is an evidence summary, not a substitute for multidisciplinary assessment or patient-specific decision-making.
Current-practice context
Review date: 9 November 2026. Primary publication and selected follow-up sources were reviewed. Full disease-specific guideline, regulatory-label and sequencing audit remains pending; verify current local recommendations and biomarker eligibility before clinical application.