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. 2021 Dec 24:13:9379-9389.
doi: 10.2147/CMAR.S330195. eCollection 2021.

Real-Life Clinical Data of Lenvatinib versus Sorafenib for Unresectable Hepatocellular Carcinoma in Italy

Valentina Burgio  1 , Massimo Iavarone  2 , Giovanni Giuseppe Di Costanzo  3 , Fabio Marra  4 , Sara Lonardi  5   6 , Emiliano Tamburini  7 , Fabio Piscaglia  8 , Gianluca Masi  9   10 , Ciro Celsa  11 , Francesco Giuseppe Foschi  12 , Marianna Silletta  13 , Daniela Caterina Amoruso  14 , Margherita Rimini  15 , Mariangela Bruccoleri  2 , Raffaella Tortora  3 , Claudia Campani  4 , Caterina Soldà  6 , Massimo Giuseppe Viola  16 , Antonella Forgione  8 , Fabio Conti  12 , Francesca Salani  9   10 , Silvia Catanese  9   10 , Carmelo Marco Giacchetto  17 , Claudia Fulgenzi  13 , Carmine Coppola  14 , Pietro Lampertico  18 , Antonio Pellino  6   19 , Gabriele Rancatore  17 , Giuseppe Cabibbo  17 , Francesca Ratti  20 , Federica Pedica  21 , Angelo Della Corte  22 , Massimo Colombo  18 , Francesco De Cobelli  23 , Luca Aldrighetti  20 , Stefano Cascinu  1   23 , Andrea Casadei-Gardini  1   23
Affiliations

Real-Life Clinical Data of Lenvatinib versus Sorafenib for Unresectable Hepatocellular Carcinoma in Italy

Valentina Burgio et al. Cancer Manag Res. .

Abstract

Background: Lenvatinib has been approved in Italy since October 2019 as a first-line therapy for advanced hepatocellular carcinoma (HCC) and to date data on effectiveness and safety of lenvatinib are not available in our region. To fill this gap, we performed a multicentric analysis of the real-world treatment outcomes with the propensity score matching in a cohort of Italian patients with unresectable HCC who were treated with either sorafenib or lenvatinib.

Aims and methods: To evaluate the effectiveness of sorafenib and lenvatinib as primary treatment of advanced HCC in clinical practice we performed a multicentric analysis of the treatment outcomes of 288 such patients recruited in 11 centers in Italy. A propensity score was used to mitigate confounding due to referral biases in the assessment of mortality and progression-free survival.

Results: Over a follow-up period of 11 months the Cox regression model showed 48% reduction of death risk for patients treated with lenvatinib (95% CI: 0.34-0.81; p = 0.0034), compared with those treated with sorafenib. The median PFS was 9.0 and 4.9 months for lenvatinib and sorafenib arm, respectively. Patients treated with lenvatinib showed a higher percentage of response rate (29.4% vs 2.8%; p < 0.00001) compared with patients treated with sorafenib. Sorafenib was shown to be correlated with more HFSR, diarrhea and fatigue, while lenvatinib with more hypertension and fatigue.

Conclusion: Our study highlighted for the first time the efficacy and safety of lenvatinib in an Italian cohort of patients.

Keywords: hepatocarcinoma; lenvatinib; sorafenib.

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Conflict of interest statement

ACG: Speaking/teaching, consultant and advisory board for Bayer, AstraZeneca, BMS, Ipsen, MSD, EISAI. MI: Speaking/teaching, consultant and advisory board for Bayer, Gilead Sciences, BMS, Janssen, Ipsen, MSD, BTG-Boston Scientific, AbbVie, Guerbet, EISAI, Shionogi. FM: Consultant for and travel grants from Bayer, consultant for EISAI/Merck and Ipsen, during the conduct of the study; consultant for Menarini, Novo Nordisk, Astra Zeneca, Allergan, and Novartis, travel grants from AbbVie. MI: personal fees from IPSEN, during the conduct of the study. FP: advisory board, consultant/lectures from Bracco, Bayer, Astra Zeneca, IPSEN, Roche, Eisai, MSD, Esaote, GE, Samsung, Exact Sciences, Tiziana Life Sciences. CC: personal fees from Eisai, Ipsen. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
CONSORT diagram of the study.
Figure 2
Figure 2
Kaplan-Meier curves for OS in sorafenib and lenvatinib cohorts (A), and Kaplan-Meier curves for PFS in sorafenib and lenvatinib cohorts (B).
Figure 3
Figure 3
Different response rates between sorafenib and lenvatinib.
Figure 4
Figure 4
Forest plot for overall survival (A) and progression free survival (B).
See this image and copyright information in PMC

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