Reproducible safety and efficacy of atezolizumab plus bevacizumab for HCC in clinical practice : Results of the AB-real study
Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved..
BACKGROUND: IMbrave150 has established the superiority of atezolizumab plus bevacizumab over sorafenib in patients with unresectable hepatocellular carcinoma (HCC).
METHODS: We generated a prospectively maintained database including patients treated with atezolizumab plus bevacizumab for unresectable HCC across Europe, Asia and USA. Clinico-pathologic characteristics were assessed for their prognostic influence on overall survival (OS) and progression-free survival (PFS) in univariable and multivariate analyses. Overall response rate by RECIST v1.1 and treatment-related adverse events (TRAEs) per CTCAE v.5.0 were reported.
RESULTS: Out of 433 patients, 296 Child-Pugh A and ECOG performance status01 patients received atezolizumab plus bevacizumab in first line and were included. Patients were mostly male (82.7%), cirrhotic (75%) with history of viral hepatitis (65.9%). Overall, 68.9% had Barcelona Clinic Liver Cancer C-stage HCC with portal vein tumour thrombosis (PVTT, 35%) and extrahepatic spread (EHS, 51.7%). After a median follow-up of 10.0 months (95% confidence interval (CI): 9.4-10.4), median OS and PFS were 15.7 (95% CI: 14.5-NE) and 6.9 months (95% CI: 6.1-8.3), respectively. In the response-evaluable patients (n = 273), overall response rate was 30.8%. Overall, 221 patients (74.6%) developed TRAEs, with 70 (23.6%) reporting grade 3 or higher TRAEs; 25 (8.4%) patients had bleeding events. OS was independently associated with baseline Albumin-bilirubin (ALBI) grade and PVTT. Shorter PFS was associated with AFP≥ 400 ng/ml, worse ALBI and presence of EHS.
CONCLUSION: This global observational study confirms the reproducible safety and efficacy of atezolizumab plus bevacizumab in routine clinical practice. Within Child-Pugh-A criteria, the presence of PVTT and higher ALBI grade identify patients with poorer survival.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:175 |
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| Enthalten in: |
European journal of cancer (Oxford, England : 1990) - 175(2022) vom: 01. Nov., Seite 204-213 |
| Sprache: |
Englisch |
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| Links: |
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| Anmerkungen: |
Date Completed 18.10.2022 Date Revised 08.11.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.ejca.2022.08.024 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM346651107 |
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| 024 | 7 | |a 10.1016/j.ejca.2022.08.024 |2 doi | |
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| 041 | |a eng | ||
| 100 | 1 | |a Fulgenzi, Claudia Angela Maria |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Reproducible safety and efficacy of atezolizumab plus bevacizumab for HCC in clinical practice |b Results of the AB-real study |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 18.10.2022 | ||
| 500 | |a Date Revised 08.11.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved. | ||
| 520 | |a BACKGROUND: IMbrave150 has established the superiority of atezolizumab plus bevacizumab over sorafenib in patients with unresectable hepatocellular carcinoma (HCC) | ||
| 520 | |a METHODS: We generated a prospectively maintained database including patients treated with atezolizumab plus bevacizumab for unresectable HCC across Europe, Asia and USA. Clinico-pathologic characteristics were assessed for their prognostic influence on overall survival (OS) and progression-free survival (PFS) in univariable and multivariate analyses. Overall response rate by RECIST v1.1 and treatment-related adverse events (TRAEs) per CTCAE v.5.0 were reported | ||
| 520 | |a RESULTS: Out of 433 patients, 296 Child-Pugh A and ECOG performance status01 patients received atezolizumab plus bevacizumab in first line and were included. Patients were mostly male (82.7%), cirrhotic (75%) with history of viral hepatitis (65.9%). Overall, 68.9% had Barcelona Clinic Liver Cancer C-stage HCC with portal vein tumour thrombosis (PVTT, 35%) and extrahepatic spread (EHS, 51.7%). After a median follow-up of 10.0 months (95% confidence interval (CI): 9.4-10.4), median OS and PFS were 15.7 (95% CI: 14.5-NE) and 6.9 months (95% CI: 6.1-8.3), respectively. In the response-evaluable patients (n = 273), overall response rate was 30.8%. Overall, 221 patients (74.6%) developed TRAEs, with 70 (23.6%) reporting grade 3 or higher TRAEs; 25 (8.4%) patients had bleeding events. OS was independently associated with baseline Albumin-bilirubin (ALBI) grade and PVTT. Shorter PFS was associated with AFP≥ 400 ng/ml, worse ALBI and presence of EHS | ||
| 520 | |a CONCLUSION: This global observational study confirms the reproducible safety and efficacy of atezolizumab plus bevacizumab in routine clinical practice. Within Child-Pugh-A criteria, the presence of PVTT and higher ALBI grade identify patients with poorer survival | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Advanced HCC | |
| 650 | 4 | |a Atezolizumab | |
| 650 | 4 | |a Bevacizumab | |
| 650 | 4 | |a First line | |
| 650 | 4 | |a Systemic treatment | |
| 650 | 7 | |a Albumins |2 NLM | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 650 | 7 | |a Antineoplastic Agents |2 NLM | |
| 650 | 7 | |a alpha-Fetoproteins |2 NLM | |
| 650 | 7 | |a Bevacizumab |2 NLM | |
| 650 | 7 | |a 2S9ZZM9Q9V |2 NLM | |
| 650 | 7 | |a atezolizumab |2 NLM | |
| 650 | 7 | |a 52CMI0WC3Y |2 NLM | |
| 650 | 7 | |a Sorafenib |2 NLM | |
| 650 | 7 | |a 9ZOQ3TZI87 |2 NLM | |
| 650 | 7 | |a Bilirubin |2 NLM | |
| 650 | 7 | |a RFM9X3LJ49 |2 NLM | |
| 700 | 1 | |a Cheon, Jaekyung |e verfasserin |4 aut | |
| 700 | 1 | |a D'Alessio, Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a Nishida, Naoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Ang, Celina |e verfasserin |4 aut | |
| 700 | 1 | |a Marron, Thomas U |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Linda |e verfasserin |4 aut | |
| 700 | 1 | |a Saeed, Anwaar |e verfasserin |4 aut | |
| 700 | 1 | |a Wietharn, Brooke |e verfasserin |4 aut | |
| 700 | 1 | |a Cammarota, Antonella |e verfasserin |4 aut | |
| 700 | 1 | |a Pressiani, Tiziana |e verfasserin |4 aut | |
| 700 | 1 | |a Personeni, Nicola |e verfasserin |4 aut | |
| 700 | 1 | |a Pinter, Matthias |e verfasserin |4 aut | |
| 700 | 1 | |a Scheiner, Bernhard |e verfasserin |4 aut | |
| 700 | 1 | |a Balcar, Lorenz |e verfasserin |4 aut | |
| 700 | 1 | |a Napolitano, Andrea |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Yi-Hsiang |e verfasserin |4 aut | |
| 700 | 1 | |a Phen, Samuel |e verfasserin |4 aut | |
| 700 | 1 | |a Naqash, Abdul Rafeh |e verfasserin |4 aut | |
| 700 | 1 | |a Vivaldi, Caterina |e verfasserin |4 aut | |
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| 700 | 1 | |a Masi, Gianluca |e verfasserin |4 aut | |
| 700 | 1 | |a Bettinger, Dominik |e verfasserin |4 aut | |
| 700 | 1 | |a Vogel, Arndt |e verfasserin |4 aut | |
| 700 | 1 | |a Schönlein, Martin |e verfasserin |4 aut | |
| 700 | 1 | |a von Felden, Johann |e verfasserin |4 aut | |
| 700 | 1 | |a Schulze, Kornelius |e verfasserin |4 aut | |
| 700 | 1 | |a Wege, Henning |e verfasserin |4 aut | |
| 700 | 1 | |a Galle, Peter R |e verfasserin |4 aut | |
| 700 | 1 | |a Kudo, Masatoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Rimassa, Lorenza |e verfasserin |4 aut | |
| 700 | 1 | |a Singal, Amit G |e verfasserin |4 aut | |
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| 700 | 1 | |a Cortellini, Alessio |e verfasserin |4 aut | |
| 700 | 1 | |a Gaillard, Vincent E |e verfasserin |4 aut | |
| 700 | 1 | |a Chon, Hong Jae |e verfasserin |4 aut | |
| 700 | 1 | |a Pinato, David James |e verfasserin |4 aut | |
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