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Atezolizumab plus bevacizumab versus lenvatinib or sorafenib in non-viral unresectable hepatocellular carcinoma: an international propensity score matching analysis |
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ESMO Open. 2022 Oct 5;7(6):100591. doi: 10.1016/j.esmoop.2022.100591. Online ahead of print.
M Rimini 1, L Rimassa 2, K Ueshima 3, V Burgio 1, S Shigeo 4, T Tada 5, G Suda 6, C Yoo 7, J Cheon 8, D J Pinato 9, S Lonardi 10, M Scartozzi 11, M Iavarone 12, G G Di Costanzo 13, F Marra 14, C Soldà 15, E Tamburini 16, F Piscaglia 17, G Masi 18, G Cabibbo 19, F G Foschi 20, M Silletta 21, T Pressiani 22, N Nishida 3, H Iwamoto 4, N Sakamoto 6, B-Y Ryoo 7, H J Chon 8, F Claudia 9, T Niizeki 4, T Sho 6, B Kang 8, A D'Alessio 9, T Kumada 23, A Hiraoka 24, M Hirooka 25, K Kariyama 26, J Tani 27, M Atsukawa 28, K Takaguchi 29, E Itobayashi 30, S Fukunishi 31, K Tsuji 32, T Ishikawa 33, K Tajiri 34, H Ochi 35, S Yasuda 36, H Toyoda 36, C Ogawa 37, T Nishimur 38, T Hatanaka 39, S Kakizaki 40, N Shimada 41, K Kawata 42, T Tanaka 24, H Ohama 31, K Nouso 26, A Morishita 27, A Tsutsui 29, T Nagano 29, N Itokawa 28, T Okubo 28, T Arai 28, M Imai 33, A Naganuma 43, Y Koizumi 25, S Nakamura 5, K Joko 35, H Iijima 38, Y Hiasa 25, F Pedica 44, F De Cobelli 45, F Ratti 46, L Alrighetti 46, M Kudo 3, S Cascinu 47, A Casadei-Gardini 48
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Author information
- 1IRCCS San Raffaele Scientific Institute Hospital, Department of Oncology, Vita-Salute San Raffaele University, Milan, Italy.
- 2Department of Biomedical Sciences, Humanitas University, Milan, Italy; Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Milan, Italy.
- 3Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Higashi-Osaka, Japan.
- 4Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.
- 5Department of Internal Medicine, Japanese Red Cross Himeji Hospital, Himeji, Japan.
- 6Department of Gastroenterology and Hepatology, Hokkaido, Japan; University Graduate School of Medicine, Sapporo, Japan.
- 7Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
- 8Department of Medical Oncology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea.
- 9Department of Surgery & Cancer, Imperial College London, Hammersmith Hospital, London, UK; Department of Translational Medicine, Università degli Studi del Piemonte Orientale, Novara, Italy.
- 10Oncology Unit 3, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.
- 11Medical Oncology, University and University Hospital of Cagliari, Cagliari, Italy.
- 12Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy.
- 13Department of Hepatology, Naples, Italy.
- 14Dipartimento di Medicina Sperimentale e Clinica, Università di Firenze, Firenze, Italy.
- 15Oncology Unit 1, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.
- 16Department of Oncology and Palliative Care, Cardinale Hospital, Naples, Italy.
- 17Division of Internal Medicine, Hepatobiliary and Immunoallergic Disease, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
- 18Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy; Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
- 19Section of Gastroenterology & Hepatology, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, Palermo, Italy.
- 20Internal Medicine, Infermi Hospital, Faenza (AUSL ROMAGNA), Ravenna, Italy.
- 21Division of Medical Oncology, Policlinico Universitario Campus Bio-Medico, Rome, Italy.
- 22Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Milan, Italy.
- 23Department of Nursing, Gifu Kyoritsu University, Ogaki, Japan.
- 24Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan.
- 25Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Ehime, Japan.
- 26Department of Gastroenterology, Okayama City Hospital, Okayama, Japan.
- 27Department of Gastroenterology and Hepatology, Kagawa University, Kagawa, Japan.
- 28Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan.
- 29Department of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan.
- 30Department of Gastroenterology, Asahi General Hospital, Asahi, Japan.
- 31Premier Departmental Research of Medicine, Osaka Medical and Pharmaceutical University, Shinya Fukunishi, Osaka, Japan.
- 32Center of Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan.
- 33Department of Gastroenterology, Saiseikai Niigata Hospital, Niigata, Japan.
- 34Department of Gastroenterology, Toyama University Hospital, Toyama, Japan.
- 35Hepato-biliary Center, Japanese Red Cross Matsuyama Hospital, Matsuyama, Japan.
- 36Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan.
- 37Department of Gastroenterology, Japanese Red Cross Takamatsu Hospital, Takamatsu, Japan.
- 38Department of Internal medicine, Division of Gastroenterology and Hepatology, Hyogo College of Medicine, Nishinomiya, Japan.
- 39Department of Gastroenterology, Gunma Saiseikai Maebashi Hospital, Maebashi, Japan.
- 40Department of Clinical Research, National Hospital Organization Takasaki General Medical Center, Takasaki, Japan.
- 41Division of Gastroenterology and Hepatology, Otakanomori Hospital, Kashiwa, Japan.
- 42Department of Hepatology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
- 43Department of Gastroenterology, National Hospital Organization Takasaki General Medical Center, Takasaki, Japan.
- 44Department of Experimental Oncology, Pathology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
- 45School of Medicine, Vita-Salute San Raffaele University, Milan, Italy.
- 46Hepatobiliary Surgery Division, Liver Center, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy.
- 47Department of Oncology, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute Hospital, Milan, Italy.
- 48Department of Oncology, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute Hospital, Milan, Italy. Electronic address: casadeigardini@gmail.com.
Abstract
Background: A growing body of evidence suggests that non-viral hepatocellular carcinoma (HCC) might benefit less from immunotherapy.
Materials and methods: We carried out a retrospective analysis of prospectively collected data from consecutive patients with non-viral advanced HCC, treated with atezolizumab plus bevacizumab, lenvatinib, or sorafenib, in 36 centers in 4 countries (Italy, Japan, Republic of Korea, and UK). The primary endpoint was overall survival (OS) with atezolizumab plus bevacizumab versus lenvatinib. Secondary endpoints were progression-free survival (PFS) with atezolizumab plus bevacizumab versus lenvatinib, and OS and PFS with atezolizumab plus bevacizumab versus sorafenib. For the primary and secondary endpoints, we carried out the analysis on the whole population first, and then we divided the cohort into two groups: non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH) population and non-NAFLD/NASH population.
Results: One hundred and ninety patients received atezolizumab plus bevacizumab, 569 patients received lenvatinib, and 210 patients received sorafenib. In the whole population, multivariate analysis showed that treatment with lenvatinib was associated with a longer OS [hazard ratio (HR) 0.65; 95% confidence interval (CI) 0.44-0.95; P = 0.0268] and PFS (HR 0.67; 95% CI 0.51-0.86; P = 0.002) compared to atezolizumab plus bevacizumab. In the NAFLD/NASH population, multivariate analysis confirmed that lenvatinib treatment was associated with a longer OS (HR 0.46; 95% CI 0.26-0.84; P = 0.0110) and PFS (HR 0.55; 95% CI 0.38-0.82; P = 0.031) compared to atezolizumab plus bevacizumab. In the subgroup of non-NAFLD/NASH patients, no difference in OS or PFS was observed between patients treated with lenvatinib and those treated with atezolizumab plus bevacizumab. All these results were confirmed following propensity score matching analysis. By comparing patients receiving atezolizumab plus bevacizumab versus sorafenib, no statistically significant difference in survival was observed.
Conclusions: The present analysis conducted on a large number of advanced non-viral HCC patients showed for the first time that treatment with lenvatinib is associated with a significant survival benefit compared to atezolizumab plus bevacizumab, in particular in patients with NAFLD/NASH-related HCC.
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