lenvatinib en carcinoma hepatocelular avanzado o irresecable · lenvatinib en carcinoma...
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Lenvatinib en carcinoma hepatocelular avanzado o irresecable
Dr. Teresa MacarullaHospital Vall d´Hebrón
Datos de vida real de Lenvatinib en el Japón
Tsuchiya K et al, presented in 2019 ASCO GI meeting
Datos de vida real de Lenvatinib en el Japón
Tsuchiya K et al, presented in 2019 ASCO GI meeting
Datos de vida real de Lenvatinib en el Japón
Tsuchiya K et al, presented in 2019 ASCO GI meeting
REFLECT trial: CONCLUSIONES
▪ The REFLECT trial is the 1st successful phase 3 trial in the first line setting in uHCC in approximately 10 years.
▪ Lenvatinib met its primary endpoint of OS by statistical confirmation of non-inferiority to Sorafenib (13.6 months vs 12.3 months; HR 0.92; CI 0.79-1.06).
▪ Lenvatinib has achieved statistically significant and clinically meaningful improvement versus sorafenib, assessed by mRECIST, in:
▪ PFS (7.4 months vs 3.7 months; HR 0.66; p<0.0001)▪ TTP (8.9 vs 3.7 months; HR=0.63; p<0.0001)▪ ORR (24% vs 9%, OR=3.13; p<0.0001)
▪ Secondary endpoints of PFS, TTP, and ORR were confirmed by masked IIR.
▪ No new safety signals were found in the lenvatinib arm, and toxicities were managed with dose interruption, modification or discontinuation.
▪ Lenvatinib ESMO- MCBS score is 4.
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