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.
Real-Life Clinical Data of Lenvatinib versus Sorafenib for Unresectable Hepatocellular Carcinoma in Italy / Valentina Burgio; Massimo Iavarone; Giovan Giuseppe Di Costanzo; Fabio Marra; Sara Lonardi; Emiliano Tamburini; Fabio Piscaglia; Gianluca Masi; Ciro Celsa; Francesco Giuseppe Foschi; Marianna Silletta; Daniela Caterina Amoruso; Margherita Rimini; Mariangela Bruccoleri; Raffaella Tortora; Claudia Campani; Caterina Soldà; Massimo Giuseppe Viola; Antonella Forgione; Fabio Conti; Francesca Salani; Silvia Catanese; Carmelo Marco Giacchetto; Claudia Angela Maria Fulgenzi; Carmine Coppola; Pietro Lampertico; Antonio Pellino; Gabriele Rancatore; Giuseppe Cabibbo; Francesca Ratti; Federica Pedica; Angelo Della Corte; Massimo Colombo; Francesco De Cobelli; Luca Aldrighetti; Stefano Cascinu; Andrea Casadei-Gardini. - In: CANCER MANAGEMENT AND RESEARCH. - ISSN 1179-1322. - ELETTRONICO. - Volume 13:(2021), pp. 9379-9389. [10.2147/CMAR.S330195]
Real-Life Clinical Data of Lenvatinib versus Sorafenib for Unresectable Hepatocellular Carcinoma in Italy
Fabio Piscaglia;Antonella Forgione;
2021
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.File | Dimensione | Formato | |
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