Early Experience of Ramucirumab Therapy in Japanese Patients With Unresectable Hepatocellular Carcinoma in Real-World Practice
Abstract BackgroundWe aimed to investigate the efficacy and safety of ramucirumab therapy in Japanese patients with unresectable hepatocellular carcinoma (u-HCC) in real-world practice.MethodsA total of 16 patients with u-HCC were treated with ramucirumab of ≥2 cycles between July 2019 and April 2020. Modified response evaluation criteria in solid tumors (RECIST) and RECIST version 1.1 were used to evaluate radiological responses.ResultsThe patients received ramucirumab as second-line (n = 4), third-line (n = 2), and fourth-line (n = 10). Median observation period was 3.7 months and 3 patients treated as fourth-line died from HCC progression. According to modified RECIST, the objective response rate (ORR) and disease control rate (DCR) were 27.2% and 81.8%, respectively. ORR and DCR by RECIST version 1.1 were 9.1 % and 72.7%, respectively. PFS at 3 months was 68.2%. Drug discontinuation caused by adverse events (AEs) was reported in 7 patients treated as fourth-line and 1 patient as third-line. Pretreatment creatinine (Cr) and estimated glomerular filtration rate (eGFR) were significantly higher in patients with discontinuation owing to AEs (P = 0.01 and P = 0.02). Urine protein-to-creatine ratio after 4 weeks was significantly higher in patients with impaired renal function than patients with preserved renal function (0.93 vs. 0.14; P = 0.017).ConclusionRamucirumab therapy was found to have similar radiological responses between u-HCC patients with single and multiple experiences of TKI therapies. The pretreatment factors would be associated with the incidence of AEs during the therapy.