Antonio D'Alessio1,2, Claudia Angela Maria Fulgenzi1,3, Naoshi Nishida4, Martin Schönlein5, Johann von Felden6, Kornelius Schulze6, Henning Wege6, Vincent E Gaillard7, Anwaar Saeed8, Brooke Wietharn8, Hannah Hildebrand8, Linda Wu9, Celina Ang9, Thomas U Marron9, Arndt Weinmann10, Peter R Galle10, Dominik Bettinger11, Bertram Bengsch11,12,13, Arndt Vogel14, Lorenz Balcar15, Bernhard Scheiner15, Pei-Chang Lee16, Yi-Hsiang Huang16,17, Suneetha Amara18, Mahvish Muzaffar18, Abdul Rafeh Naqash18,19, Antonella Cammarota2,20, Nicola Personeni2,20, Tiziana Pressiani20, Rohini Sharma1, Matthias Pinter15, Alessio Cortellini1, Masatoshi Kudo4, Lorenza Rimassa2,20, David J Pinato1,21. 1. Department of Surgery & Cancer, Imperial College London, Hammersmith Hospital, London, UK. 2. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy. 3. Division of Medical Oncology, Policlinico Universitario Campus Bio-Medico, Rome, Italy. 4. Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan. 5. Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 6. Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 7. F. Hoffmann-La Roche Ltd., Basel, Switzerland. 8. Division of Medical Oncology, Department of Medicine, Kansas University Cancer Center, Kansas City, Kansas, USA. 9. Division of Hematology/Oncology, Department of Medicine, Tisch Cancer Institute, Mount Sinai Hospital, New York, New York, USA. 10. University Medical Center Mainz, Mainz, Germany. 11. Department of Medicine II (Gastroenterology, Hepatology, Endocrinology and Infectious Diseases), Faculty of Medicine, Freiburg University Medical Center, University of Freiburg, Freiburg, Germany. 12. University of Freiburg, Signalling Research Centres BIOSS and CIBSS, Freiburg, Germany. 13. German Cancer Consortium (DKTK), partner site, Freiburg, Germany. 14. Hannover Medical School, Hannover, Germany. 15. Division of Gastroenterology & Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria. 16. Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. 17. Institute of Clinical Medicine, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. 18. Division of Hematology/Oncology, East Carolina University, Greenville, North Carolina, USA. 19. Medical Oncology/TSET Phase 1 Program, Stephenson Cancer Center, University of Oklahoma, Norman, Oklahoma, USA. 20. Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy. 21. Division of Oncology, Department of Translational Medicine, University of Piemonte Orientale, Novara, Italy.
Abstract
BACKGROUND AND AIMS: Atezolizumab plus bevacizumab (AtezoBev) is the standard of care for first-line treatment of unresectable HCC. No evidence exists as to its use in routine clinical practice in patients with impaired liver function. APPROACH AND RESULTS: In 216 patients with HCC who were consecutively treated with AtezoBev across 11 tertiary centers, we retrospectively evaluated treatment-related adverse events (trAEs) graded (G) according to Common Terminology Criteria for Adverse Events v5.0, including in the analysis all patients treated according to label (n = 202, 94%). We also assessed overall survival (OS), progression-free survival (PFS), overall response (ORR), and disease control rates (DCR) defined by Response Evaluation Criteria in Solid Tumors v1.1. Disease was mostly secondary to viral hepatitis, namely hepatitis C (n = 72; 36%) and hepatitis B infection (n = 35, 17%). Liver function was graded as Child-Pugh (CP)-A in 154 patients (76%) and CP-B in 48 (24%). Any grade trAEs were reported by 143 patients (71%), of which 53 (26%) were G3 and 3 (2%) G4. Compared with CP-A, patients with CP-B showed comparable rates of trAEs. Presence and grade of varices at pretreatment esophagogastroduodenoscopy did not correlate with bleeding events. After a median follow-up of 9.0 months (95% CI, 7.8-10.1), median OS was 14.9 months (95% CI, 13.6-16.3), whereas median PFS was 6.8 months (95% CI, 5.2-8.5). ORR and DCR were respectively 25% and 73%, with no difference across CP classes. CONCLUSIONS: This study confirms reproducible safety and efficacy of AtezoBev in routine practice. Patients with CP-B reported similar tolerability compared with CP-A, warranting prospective evaluation of AtezoBev in this treatment-deprived population.
BACKGROUND AND AIMS: Atezolizumab plus bevacizumab (AtezoBev) is the standard of care for first-line treatment of unresectable HCC. No evidence exists as to its use in routine clinical practice in patients with impaired liver function. APPROACH AND RESULTS: In 216 patients with HCC who were consecutively treated with AtezoBev across 11 tertiary centers, we retrospectively evaluated treatment-related adverse events (trAEs) graded (G) according to Common Terminology Criteria for Adverse Events v5.0, including in the analysis all patients treated according to label (n = 202, 94%). We also assessed overall survival (OS), progression-free survival (PFS), overall response (ORR), and disease control rates (DCR) defined by Response Evaluation Criteria in Solid Tumors v1.1. Disease was mostly secondary to viral hepatitis, namely hepatitis C (n = 72; 36%) and hepatitis B infection (n = 35, 17%). Liver function was graded as Child-Pugh (CP)-A in 154 patients (76%) and CP-B in 48 (24%). Any grade trAEs were reported by 143 patients (71%), of which 53 (26%) were G3 and 3 (2%) G4. Compared with CP-A, patients with CP-B showed comparable rates of trAEs. Presence and grade of varices at pretreatment esophagogastroduodenoscopy did not correlate with bleeding events. After a median follow-up of 9.0 months (95% CI, 7.8-10.1), median OS was 14.9 months (95% CI, 13.6-16.3), whereas median PFS was 6.8 months (95% CI, 5.2-8.5). ORR and DCR were respectively 25% and 73%, with no difference across CP classes. CONCLUSIONS: This study confirms reproducible safety and efficacy of AtezoBev in routine practice. Patients with CP-B reported similar tolerability compared with CP-A, warranting prospective evaluation of AtezoBev in this treatment-deprived population.