TY - JOUR
T1 - Reproducible safety and efficacy of atezolizumab plus bevacizumab for HCC in clinical practice
T2 - Results of the AB-real study
AU - Fulgenzi, Claudia Angela Maria
AU - Cheon, Jaekyung
AU - D'Alessio, Antonio
AU - Nishida, Naoshi
AU - Ang, Celina
AU - Marron, Thomas U.
AU - Wu, Linda
AU - Saeed, Anwaar
AU - Wietharn, Brooke
AU - Cammarota, Antonella
AU - Pressiani, Tiziana
AU - Personeni, Nicola
AU - Pinter, Matthias
AU - Scheiner, Bernhard
AU - Balcar, Lorenz
AU - Napolitano, Andrea
AU - Huang, Yi Hsiang
AU - Phen, Samuel
AU - Naqash, Abdul Rafeh
AU - Vivaldi, Caterina
AU - Salani, Francesca
AU - Masi, Gianluca
AU - Bettinger, Dominik
AU - Vogel, Arndt
AU - Schönlein, Martin
AU - von Felden, Johann
AU - Schulze, Kornelius
AU - Wege, Henning
AU - Galle, Peter R.
AU - Kudo, Masatoshi
AU - Rimassa, Lorenza
AU - Singal, Amit G.
AU - Sharma, Rohini
AU - Cortellini, Alessio
AU - Gaillard, Vincent E.
AU - Chon, Hong Jae
AU - Pinato, David James
N1 - Publisher Copyright:
© 2022 The Author(s)
PY - 2022/11
Y1 - 2022/11
N2 - 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.
AB - 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.
KW - Advanced HCC
KW - Atezolizumab
KW - Bevacizumab
KW - First line
KW - Systemic treatment
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U2 - 10.1016/j.ejca.2022.08.024
DO - 10.1016/j.ejca.2022.08.024
M3 - Article
C2 - 36148739
AN - SCOPUS:85140144076
SN - 0959-8049
VL - 175
SP - 204
EP - 213
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -