TY - JOUR
T1 - Real Life Study of Lenvatinib Therapy for Hepatocellular Carcinoma
T2 - RELEVANT Study
AU - Casadei-Gardini, Andrea
AU - Rimini, Margherita
AU - Kudo, Masatoshi
AU - Shimose, Shigeo
AU - Tada, Toshifumi
AU - Suda, Goki
AU - Goh, Myung Ji
AU - Jefremow, Andre
AU - Scartozzi, Mario
AU - Cabibbo, Giuseppe
AU - Campani, Claudia
AU - Tamburini, Emiliano
AU - Tovoli, Francesco
AU - Ueshima, Kazuomi
AU - Aoki, Tomoko
AU - Iwamoto, Hideki
AU - Torimura, Takuji
AU - Kumada, Takashi
AU - Hiraoka, Atsushi
AU - Atsukawa, Masanori
AU - Itobayashi, Ei
AU - Toyoda, Hidenori
AU - Sakamoto, Naoya
AU - Sho, Takuya
AU - Kang, Wonseok
AU - Siebler, Jürgen
AU - Neurath, Markus Friedrich
AU - Burgio, Valentina
AU - Cascinu, Stefano
N1 - Publisher Copyright:
© 2022
PY - 2022/12/11
Y1 - 2022/12/11
N2 - Introduction: In the REFLECT trial, lenvatinib was found to be noninferior compared to sorafenib in terms of overall survival. Here, we analyze the effects of lenvatinib in the real-life experience of several centers across the world and identify clinical factors that could be significantly associated with survival outcomes. Methods: The study population was derived from retrospectively collected data of HCC patients treated with lenvatinib. The overall cohort included western and eastern populations from 23 center in five countries. Results: We included 1,325 patients with HCC and treated with lenvatinib in our analysis. Median OS was 16.1 months. Overall response rate was 38.5%. Multivariate analysis for OS highlighted that HBsAg positive, NLR >3, and AST >38 were independently associated with poor prognosis in all models. Conversely, NAFLD/NASH-related etiology was independently associated with good prognosis. Median progression-free survival was 6.3 months. Multivariate analysis for progression-free survival revealed that NAFLD/NASH, BCLC, NLR, and AST were independent prognostic factors for progression-free survival. A proportion of 75.2% of patients suffered from at least one adverse effect during the study period. Multivariate analysis exhibited the appearance of decreased appetite grade ≥2 versus grade 0-1 as an independent prognostic factor for worse progression-free survival. 924 patients of 1,325 progressed during lenvatinib (69.7%), and 827 of them had a follow-up over 2 months from the beginning of second-line treatment. From first-line therapy, the longest median OS was obtained with the sequence lenvatinib and immunotherapy (47.0 months), followed by TACE (24.7 months), ramucirumab (21.2 months), sorafenib (15.7 months), regorafenib (12.7 months), and best supportive care (10.8 months). Conclusions: Our study confirms in a large and global population of patients with advanced HCC, not candidates for locoregional treatment the OS reported in the registration study and a high response rate with lenvatinib.
AB - Introduction: In the REFLECT trial, lenvatinib was found to be noninferior compared to sorafenib in terms of overall survival. Here, we analyze the effects of lenvatinib in the real-life experience of several centers across the world and identify clinical factors that could be significantly associated with survival outcomes. Methods: The study population was derived from retrospectively collected data of HCC patients treated with lenvatinib. The overall cohort included western and eastern populations from 23 center in five countries. Results: We included 1,325 patients with HCC and treated with lenvatinib in our analysis. Median OS was 16.1 months. Overall response rate was 38.5%. Multivariate analysis for OS highlighted that HBsAg positive, NLR >3, and AST >38 were independently associated with poor prognosis in all models. Conversely, NAFLD/NASH-related etiology was independently associated with good prognosis. Median progression-free survival was 6.3 months. Multivariate analysis for progression-free survival revealed that NAFLD/NASH, BCLC, NLR, and AST were independent prognostic factors for progression-free survival. A proportion of 75.2% of patients suffered from at least one adverse effect during the study period. Multivariate analysis exhibited the appearance of decreased appetite grade ≥2 versus grade 0-1 as an independent prognostic factor for worse progression-free survival. 924 patients of 1,325 progressed during lenvatinib (69.7%), and 827 of them had a follow-up over 2 months from the beginning of second-line treatment. From first-line therapy, the longest median OS was obtained with the sequence lenvatinib and immunotherapy (47.0 months), followed by TACE (24.7 months), ramucirumab (21.2 months), sorafenib (15.7 months), regorafenib (12.7 months), and best supportive care (10.8 months). Conclusions: Our study confirms in a large and global population of patients with advanced HCC, not candidates for locoregional treatment the OS reported in the registration study and a high response rate with lenvatinib.
KW - ALBI
KW - Hepatocellular carcinoma
KW - Lenvatinib
KW - Neutrophils to lymphocyte ratio
KW - Nonalcoholic fatty liver disease
KW - Nonalcoholic steatohepatitis
KW - Outcome
KW - Second line
KW - Tyrosine kinase inhibitors
UR - https://www.scopus.com/pages/publications/85139330643
U2 - 10.1159/000525145
DO - 10.1159/000525145
M3 - Article
AN - SCOPUS:85139330643
SN - 2235-1795
VL - 11
SP - 527
EP - 539
JO - Liver Cancer
JF - Liver Cancer
IS - 6
ER -
