Author information
1Department of Oncology, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute Hospital, Milan, Italy. margherita.rimini@gmail.com.
2Department of Oncology, IRCCS San Raffaele Hospital, Milan, Italy. margherita.rimini@gmail.com.
3Medical Oncology, University and University Hospital of Cagliari, Cagliari, Italy.
4Department of Internal Medicine, Japanese Red Cross Himeji Hospital, Himeji, Japan.
5Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-Ku, Sapporo, Hokkaido, 060-8638, Japan.
6Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, 830-0011, Japan.
7Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan.
8Department of Medical Oncology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea.
9Department of Internal Medicine 1, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany.
10Department of Medicine, School of Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea.
11Unidade de Hepatologia, CHTMAD, Vila Real, Portugal.
12Unit of Medical Oncology 2, University Hospital of Pisa, Pisa, Italy.
13Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
14Oncology Unit 1, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.
15Division of Internal Medicine, Hepatobiliary and Immunoallergic Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
16Department of Nursing, Gifu Kyoritsu University, Ogaki, Japan.
17Medical Oncology Unit, Department of Oncology and Hematology, Central Hospital of Belcolle, Strada Sammartinese Snc, 01100, Viterbo, Italy.
18Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan.
19Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Ehime, Japan.
20Department of Gastroenterology, Okayama City Hospital, Okayama, Japan.
21Department of Gastroenterology and Hepatology, Kagawa University, Kagawa, Japan.
22Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan.
23Department of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan.
24Department of Gastroenterology, Asahi General Hospital, Asahi, Japan.
25Department of Gastroenterology, Osaka Medical and Pharmaceutical University, Osaka, Japan.
26Center of Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan.
27Department of Gastroenterology, Saiseikai Niigata Hospital, Niigata, Japan.
28Department of Gastroenterology, Toyama University Hospital, Toyama, Japan.
29Hepato-Biliary Center, Japanese Red Cross Matsuyama Hospital, Matsuyama, Japan.
30Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan.
31Department of Gastroenterology, Japanese Red Cross Takamatsu Hospital, Takamatsu, Japan.
32Department of Internal Medicine, Division of Gastroenterology and Hepatology, Hyogo Medical University, Nishinomiya, Japan.
33Department of Gastroenterology, Gunma Saiseikai Maebashi Hospital, Maebashi, Japan.
34Department of Clinical Research, National Hospital Organization Takasaki General Medical Center, Takasaki, Japan.
35Division of Gastroenterology and Hepatology, Otakanomori Hospital, Kashiwa, Japan.
36Department of Hepatology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
37Department of Surgery, Kansai Medical University, Osaka, Japan.
38Department of Gastroenterology, National Hospital Organization Takasaki General Medical Center, Takasaki, Japan.
39Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, 20072, Milan, Italy.
40Department of Oncology, IRCCS San Raffaele Hospital, Milan, Italy.
41Department of Oncology, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute Hospital, Milan, Italy.
Abstract
Introduction: The best first-line treatment for patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh (CP) class B remains unknown. The aim of the present study was to perform a real-world analysis on a large sample of patients with unresectable HCC with CP B treated with atezolizumab plus bevacizumab Vs Lenvatinib.
Methods: The study population included patients affected by advanced (BCLC-C) or intermediate (BCLC-B) HCC patients not suitable for locoregional therapies from both the Western and Eastern world (Italy, Germany, Republic of Korea and Japan), who received atezolizumab plus bevacizumab or Lenvatinib as first-line treatment. All the study population presented a CP class of B. The primary endpoint of the study was the overall survival (OS) of CP B patients treated with Lenvatinib compared to atezolizumab plus bevacizumab. Survival curves were estimated using the product-limit method of Kaplan-Meier. The role of stratification factors was analyzed with log-rank tests. Finally, an interaction test was performed for the main baseline clinical characteristics.
Results: 217 CP B HCC patients were enrolled in the study: 65 (30%) received atezolizumab plus bevacizumab, and 152 (70%) received lenvatinib. The mOS for patients receiving Lenvatinib was 13.8 months (95% CI: 11.6-16.0), compared to 8.2 months (95% CI 6.3-10.2) for patients receiving atezolizumab plus bevacizumab as first-line treatment (atezolizumab plus bevacizumab Vs Lenvatinib: HR 1.9, 95% CI 1.2-3.0, p = 0.0050). No statistically significant differences were highlighted in terms of mPFS. The multivariate analysis confirmed that patients receiving Lenvatinib as first-line treatment have a significantly longer OS compared to patients receiving atezolizumab plus bevacizumab (HR 2.01; 95% CI 1.29-3.25, p = 0.0023). By evaluating the cohort of patients who received atezolizumab plus bevacizumab, we found that Child B patients with ECOG PS 0, or BCLC B stage or ALBI grade 1 were those who had benefited from the treatment thus showing survival outcomes no significantly different compared to those receiving Lenvatinib.
Conclusion: The present study suggests for the first time a major benefit from Lenvatinib compared to atezolizumab plus bevacizumab in a large cohort of patients with CP B class HCC.