Ramucirumab for HCC patients who experienced two or more systemic therapy: A multicenter study.

Abstract

395 Background: Ramucirumab has been approved for hepatocellular carcinoma (HCC) patients whose α-fetoprotein was≥400 ng/mL as a second-line agent after sorafenib. The present study aimed to clarify the efficacy and safety of ramucirumab including patients who experienced two or more systemic treatments or whose hepatic reserve was deteriorated. Methods: We enrolled 76 unresectable HCC patients from 14 institutes. The data, regarding survival, radiological response, and adverse events were retrospectively collected. This cohort included 35 patients who received more than two molecular targeted agents and 29 Child-Pugh B or C patients. The radiological response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Results: Median overall survival (OS) in the total cohort was 7.5 months (m), whereas it was 7.5 m, 9.8 m, and 6.8 m in patients who were administered ramucirumab as the second-, third-, and fourth-line therapies, respectively. The overall survival of Child-Pugh A patients (n = 47) was significantly longer than that of Child-Pugh B/C patients (n = 29) (OS 10.3 m vs. 6.7m, p = 0.04). Progression-free survival in the second-, third-, and fourth-line therapies was 3.7, 2.2, and 3.4 m, respectively. The best response identified by RECIST version 1.1 was partial response (PR) in one patient and stable disease (SD) in 25 patients, and the disease control rate (DCR) in the study was 49.1%. There were no statistically significant differences in DCR between the treatment courses. Regarding adverse events, there was no difference between the treatment courses. However, peripheral edema, the development of ascites that required the administration of diuretics (Grade ≥ 2), and diarrhea were significantly more frequent in Child-Pugh B/C patients than in Child-Pugh A patients (peripheral edema; 65.5% vs . 31.9%, p = 0.005, ascites; 62.0% vs . 19.1%, p < 0.001, diarrhea; 27.6% vs . 8.5%, p = 0.05). Conclusions: Ramucirumab was useful as a second-line therapy and feasible as a third- or fourth-line treatment for HCC.