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Invest New Drugs. 2019 Jun 6. doi: 10.1007/s10637-019-00801-8. [Epub ahead of print]

Sequential therapy with sorafenib and regorafenib for advanced hepatocellular carcinoma: a multicenter retrospective study in Japan.

Author information

1
Department of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba, 260-8670, Japan. ogasawaras@chiba-u.jp.
2
Translational Research and Development Center, Chiba University Hospital, Chiba, Japan. ogasawaras@chiba-u.jp.
3
Department of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba, 260-8670, Japan.
4
Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Chiba, Japan.
5
Department of Gastroenterology, Asahi General Hospital, Asahi, Japan.
6
Department of Gastroenterology, Matsudo City General Hospital, Matsudo, Japan.
7
Department of Gastroenterology, Funabashi Municipal Medical Center, Funabashi, Japan.
8
Department of Gastroenterology, National Hospital Organization Chiba Medical Center, Chiba, Japan.
9
Department of Gastroenterology, Kimitsu Chuo Hospital, Kisarazu, Japan.
10
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan.
11
Translational Research and Development Center, Chiba University Hospital, Chiba, Japan.
12
Department of Medical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
13
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
14
Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan.

Abstract

Background Conversion from sorafenib to regorafenib is primarily an evidence-based treatment strategy in patients with advanced hepatocellular carcinoma (HCC). This study aimed to assess the safety and efficacy of sequential therapy with sorafenib and regorafenib in patients with advanced HCC by analysis of outcomes in clinical practice with the aim to complement phase III findings. Methods The medical records of patients with advanced HCC receiving regorafenib were retrieved to collect data on sorafenib administration at seven Japanese institutions. Radiological responses and adverse events were evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1 and the Common Terminology Criteria for Adverse Events version 4.0, respectively. Results Before March 2018, 44 patients were administered regorafenib for advanced HCC. The median sorafenib treatment duration was 8.4 months. The most common adverse events were similar to those reported by the RESORCE trial. The median overall survival (OS) was 17.3 months (95% confidence interval [CI] 11.4-22.9), and 17 of 37 patients (45.9%) discontinued regorafenib and received sequential systemic therapy after regorafenib. These patients had significantly longer OS than those who were treated by the best supportive care or sub-optimal therapy (not reached versus 8.7 months [95% CI 5.8-11.7]; P < 0.001). Conclusion The results based on Japanese clinical practices verified the tolerability of regorafenib in advanced HCC. Major regorafenib-associated adverse events were similar to those related to sorafenib. OS was significantly longer than expected, which might be associated with the sequential systemic therapies after regorafenib, mainly lenvatinib.

KEYWORDS:

Hepatocellular carcinoma; Lenvatinib; RESORCE; Regorafenib; Second-line; Sorafenib

PMID:
31172442
DOI:
10.1007/s10637-019-00801-8

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