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Regorafenib in previously treated advanced hepatocellular carcinoma: Impact of prior immunotherapy and adverse events
Author(s) -
Yoo Changhoon,
Byeon Seonggyu,
Bang Yeonghak,
Cheon Jaekyung,
Kim Jin W.,
Kim Jee H.,
Chon Hong J.,
Kang Beodeul,
Kang Myoung J.,
Kim Ilhwan,
Hwang JunEul,
Kang Jung H.,
Lee Myung A.,
Hong Jung Y.,
Lim Ho Y.,
Ryoo BaekYeol
Publication year - 2020
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.14496
Subject(s) - regorafenib , sorafenib , medicine , hepatocellular carcinoma , adverse effect , oncology , clinical trial , surgery , cancer , colorectal cancer
Background & Aims Regorafenib demonstrated a clinical benefit for patients with unresectable hepatocellular carcinoma (uHCC) in the phase III RESORCE trial. Considering the heterogeneity of uHCC and discrepancies in its characteristics between prospective trials and daily practice, real‐life evidence is necessary. Methods This multicentre, retrospective analysis was performed by the Korean Cancer Study Group. In total, 440 patients who received regorafenib between January 2017 and November 2019 were identified in nine tertiary referral hospitals in Korea. Results All patients received prior sorafenib, and the median time‐to‐progression (TTP) on sorafenib was 3.9 months (range, 0.2‐71.6). Regorafenib was used as the second, third and fourth to seventh lines of therapy in 305 (69.3%), 115 (26.1%) and 20 (4.5%) patients respectively. According to the RECIST v1.1, the overall response rate was 7.7% (n = 34), and the median progression‐free survival (PFS) and overall survival (OS) were 3.2 (95% CI, 2.8‐3.5) and 12.1 (95% CI, 9.7‐14.5) months respectively. Immune checkpoint inhibitors (ICIs) were given in 115 patients (26.1%) prior to regorafenib. There were no differences in PFS and OS with regorafenib according to the prior use of ICIs (PFS, P = .61; OS, P = .63). The occurrence of hand‐foot skin reaction (HFSR) was associated with a better OS ( P < .001). Conclusions The real‐life clinical outcomes of regorafenib for patients who progressed on prior systemic therapy including ICIs were consistent with the phase III trial results. HFSR was significantly associated with better OS with regorafenib.