TY - JOUR
T1 - Lenvatinib versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma: An inverse probability of treatment weighting analysis.
AU - Casadei-Gardini, Andrea
AU - Scartozzi, Mario
AU - Tada, Toshifumi
AU - Yoo, Changhoon
AU - Shimose, Shigeo
AU - Masi, Gianluca
AU - Lonardi, Sara
AU - Frassineti, Luca Giovanni
AU - Silvestris, Nicola
AU - Piscaglia, Fabio
AU - Kumada, Takashi
AU - Kim, Hyung Don
AU - Koga, Hironori
AU - Vivaldi, Caterina
AU - Soldà, Caterina
AU - Hiraoka, Atsushi
AU - Bang, Yeonghak
AU - Atsukawa, Masanori
AU - Torimura, Takuji
AU - Tsuj, Kunihiko
AU - Itobayashi, Ei
AU - Toyoda, Hidenori
AU - Fukunishi, Shinya
AU - Rimassa, Lorenza
AU - Rimini, Margherita
AU - Cascinu, Stefano
AU - Cucchetti, Alessandro
AU - Arai, Taeang
AU - Nakamura, Shinichiro
AU - Michitaka, Kojiro
AU - Itokawa, Norio
AU - Hayama, Korenobu
AU - Hirooka, Masashi
AU - Koizumi, Yohei
AU - Hiasa, Yoichi
AU - Ishikawa, Toru
AU - Imai, Michitaka
AU - Takaguchi, Koichi
AU - Tsutsui, Akemi
AU - Nagano, Takuya
AU - Kariyama, Kazuya
AU - Nouso, Kazuhiro
AU - Tajiri, Kazuto
AU - Shimada, Noritomo
AU - Shibata, Hiroshi
AU - Ochi, Hironori
AU - Joko, Kouji
AU - Yasuda, Satoshi
AU - Ohama, Hideko
AU - Kawata, Kazuhito
N1 - Funding Information:
LR reports receiving consulting fees from Amgen, ArQule, AstraZeneca, Basilea, Bayer, Celgene, Eisai, Exelixis, Hengrui, Incyte, Ipsen, Lilly, MSD, Nerviano Medical Sciences, Roche, Sanofi; lectures fees from AbbVie, Amgen, Eisai, Gilead, Incyte, Ipsen, Lilly, Roche, Sanofi; travel fees from Ipsen; and institutional research funding from Agios, ARMO BioSciences, AstraZeneca, BeiGene, Eisai, Exelixis, Fibrogen, Incyte, Ipsen, Lilly, MSD, Roche. The authors disclose no conflict of interest.
Publisher Copyright:
© 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/6
Y1 - 2021/6
N2 - Purpose: Data from common clinical practice were used to generate balanced cohorts of patients receiving either sorafenib or lenvatinib, for unresectable hepatocellular carcinoma, with the final aim to investigate their declared equivalence. Methods: Clinical features of lenvatinib and sorafenib patients were balanced through inverse probability of treatment weighting (IPTW) methodology, which weights patients’ characteristics and measured outcomes of each patient in both treatment arms. Overall survival was the primary endpoint and occurrence of adverse events was the secondary. Results: The analysis included 385 patients who received lenvatinib, and 555 patients who received sorafenib. In the unadjusted cohort, lenvatinib did not show a survival advantage over sorafenib (HR: 0.85, 95% CI 0.70-1.02). After IPTW adjustment, lenvatinib still not returned a survival advantage over sorafenib (HR: 0.82, 95% CI: 0.62-1.07) even in presence of balanced baseline characteristics. Lenvatinib provided longer survival than sorafenib in patients previously submitted to TACE (HR: 0.69), with PS of 0 (HR: 0.73) or without extrahepatic disease (HR: 0.69). Conclusion: Present results confirmed randomized controlled trial in the real-life setting, but also suggests that in earlier stages some benefit can be expected.
AB - Purpose: Data from common clinical practice were used to generate balanced cohorts of patients receiving either sorafenib or lenvatinib, for unresectable hepatocellular carcinoma, with the final aim to investigate their declared equivalence. Methods: Clinical features of lenvatinib and sorafenib patients were balanced through inverse probability of treatment weighting (IPTW) methodology, which weights patients’ characteristics and measured outcomes of each patient in both treatment arms. Overall survival was the primary endpoint and occurrence of adverse events was the secondary. Results: The analysis included 385 patients who received lenvatinib, and 555 patients who received sorafenib. In the unadjusted cohort, lenvatinib did not show a survival advantage over sorafenib (HR: 0.85, 95% CI 0.70-1.02). After IPTW adjustment, lenvatinib still not returned a survival advantage over sorafenib (HR: 0.82, 95% CI: 0.62-1.07) even in presence of balanced baseline characteristics. Lenvatinib provided longer survival than sorafenib in patients previously submitted to TACE (HR: 0.69), with PS of 0 (HR: 0.73) or without extrahepatic disease (HR: 0.69). Conclusion: Present results confirmed randomized controlled trial in the real-life setting, but also suggests that in earlier stages some benefit can be expected.
KW - extrahepatic disease
KW - lenvatinib
KW - performance status
KW - sorafenib
KW - survival
KW - trans-arterial chemoembolization
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U2 - 10.1111/liv.14817
DO - 10.1111/liv.14817
M3 - Article
C2 - 33547848
AN - SCOPUS:85101158292
VL - 41
SP - 1389
EP - 1397
JO - Liver International
JF - Liver International
SN - 1478-3223
IS - 6
ER -