Hyung-Don Kim1, Yeonghak Bang1, Myung Ah Lee2, Jin Won Kim3, Jee Hyun Kim3, Hong Jae Chon4, Beodeul Kang4, Myoung Joo Kang5, Ilhwan Kim5, Jaekyung Cheon6, Jun-Eul Hwang7, Jung Hun Kang8, Seonggyu Byeon9, Jung Yong Hong9, Baek-Yeol Ryoo1, Ho Yeong Lim9, Changhoon Yoo1. 1. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 2. Division of Hematology-Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea. 3. Division of Hematology-Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. 4. Division of Hematology-Oncology, Department of Internal Medicine, Bundang CHA Hospital, Seongnam, Korea. 5. Division of Oncology, Department of Internal Medicine, Inje University College of Medicine, Haeundae Paik Hospital, Busan, Korea. 6. Division of Hematology-Oncology, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea. 7. Division of Hematology-Oncology, Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea. 8. Division of Hematology-Oncology, Department of Internal Medicine, Gyeongsang National University, Jinju, Korea. 9. Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Abstract
INTRODUCTION: Regorafenib is an approved agent in patients with advanced hepatocellular carcinoma (HCC) who progressed on sorafenib, but little is known about its clinical outcomes in Child-Pugh B patients. We aimed to investigate the safety and effectiveness of regorafenib in Child-Pugh B HCC patients. METHODS: This multicentre retrospective study included 59 patients with Child-Pugh B HCC who received regorafenib. Comparative analyses were performed with an independent cohort of Child-Pugh class A patients from the same registry (n = 440). RESULTS: The median age was 58 years (range, 19-83). All patients had progression on prior sorafenib. Regorafenib was given as 2nd line, and 3rd-4th line systemic therapy in 37 (62.7%) and 22 (37.3%) patients respectively. Compared to Child-Pugh A cohort, grade 3-4 AEs were more common in the Child-Pugh B cohort (27.1% vs 14.1%, P = .017). The median progression-free survival (PFS) and overall survival (OS) were 1.8 and 4.6 months, respectively, and these were significantly poorer than the Child-Pugh A cohort (P = .008 and P < .001 respectively). Child-Pugh B patients with albumin-bilirubin (ALBI) grade 3 had a significantly higher frequency of increased bilirubin (P = .01 for any grade and P = .01 for grade 3-4) and showed significantly poorer OS (P = .021), compared to those with ALBI grade 1 or 2. CONCLUSION: Regorafenib's poor clinical outcomes and increased frequency of severe adverse events lead us to discourage its use in the Child-Pugh B population. In particular, regorafenib should not be used in Child-Pugh B patients with ALBI grade 3.
INTRODUCTION:Regorafenib is an approved agent in patients with advanced hepatocellular carcinoma (HCC) who progressed on sorafenib, but little is known about its clinical outcomes in Child-Pugh B patients. We aimed to investigate the safety and effectiveness of regorafenib in Child-Pugh B HCC patients. METHODS: This multicentre retrospective study included 59 patients with Child-Pugh B HCC who received regorafenib. Comparative analyses were performed with an independent cohort of Child-Pugh class A patients from the same registry (n = 440). RESULTS: The median age was 58 years (range, 19-83). All patients had progression on prior sorafenib. Regorafenib was given as 2nd line, and 3rd-4th line systemic therapy in 37 (62.7%) and 22 (37.3%) patients respectively. Compared to Child-Pugh A cohort, grade 3-4 AEs were more common in the Child-Pugh B cohort (27.1% vs 14.1%, P = .017). The median progression-free survival (PFS) and overall survival (OS) were 1.8 and 4.6 months, respectively, and these were significantly poorer than the Child-Pugh A cohort (P = .008 and P < .001 respectively). Child-Pugh B patients with albumin-bilirubin (ALBI) grade 3 had a significantly higher frequency of increased bilirubin (P = .01 for any grade and P = .01 for grade 3-4) and showed significantly poorer OS (P = .021), compared to those with ALBI grade 1 or 2. CONCLUSION:Regorafenib's poor clinical outcomes and increased frequency of severe adverse events lead us to discourage its use in the Child-Pugh B population. In particular, regorafenib should not be used in Child-Pugh B patients with ALBI grade 3.
Authors: Gauri Mishra; Ammar Majeed; Anouk Dev; Guy D Eslick; David J Pinato; Hirofumi Izumoto; Atsushi Hiraoka; Teh-Ia Huo; Po-Hong Liu; Philip J Johnson; Stuart K Roberts Journal: J Gastrointest Cancer Date: 2022-05-30
Authors: Josep M Llovet; Roser Pinyol; Robin K Kelley; Anthony El-Khoueiry; Helen L Reeves; Xin Wei Wang; Gregory J Gores; Augusto Villanueva Journal: Nat Cancer Date: 2022-04-28
Authors: Catherine Leyh; Ursula Ehmer; Daniel Roessler; Alexander B Philipp; Florian P Reiter; Petia Jeliazkova; Leonie S Jochheim; Matthias Jeschke; Janina Hammig; Johannes M Ludwig; Jens M Theysohn; Andreas Geier; Christian M Lange Journal: Cancers (Basel) Date: 2022-04-13 Impact factor: 6.575