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

• Published in: Investigational new drugs 2020-02, Vol.38 (1), p.172-180
• Main Authors: Ogasawara, Sadahisa, Ooka, Yoshihiko, Itokawa, Norio, Inoue, Masanori, Okabe, Shinichiro, Seki, Atsuyoshi, Haga, Yuki, Obu, Masamichi, Atsukawa, Masanori, Itobayashi, Ei, Mizumoto, Hideaki, Sugiura, Nobuyuki, Azemoto, Ryosaku, Kanayama, Kengo, Kanzaki, Hiroaki, Maruta, Susumu, Maeda, Takahiro, Kusakabe, Yuko, Yokoyama, Masayuki, Kobayashi, Kazufumi, Kiyono, Soichiro, Nakamura, Masato, Saito, Tomoko, Suzuki, Eiichiro, Nakamoto, Shingo, Yasui, Shin, Tawada, Akinobu, Chiba, Tetsuhiro, Arai, Makoto, Kanda, Tatsuo, Maruyama, Hitoshi, Kato, Naoya
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carcinoma, Hepatocellular - drug therapy; Carcinoma, Hepatocellular - pathology; Confidence intervals; Female; Follow-Up Studies; Hepatocellular carcinoma; Humans; Inhibitor drugs; Liver cancer; Liver Neoplasms - drug therapy; Liver Neoplasms - pathology; Male; Medical records; Medicine; Medicine & Public Health; Middle Aged; Oncology; Patients; Pharmacology/Toxicology; Phenylurea Compounds - administration & dosage; Prognosis; Pyridines - administration & dosage; Response Evaluation Criteria in Solid Tumors; Retrospective Studies; Short Report; Solid tumors; Sorafenib - administration & dosage; Studies; Survival Rate; Targeted cancer therapy; Therapy; Tumors
• ISSN: 0167-6997; 1573-0646
• DOI: 10.1007/s10637-019-00801-8

Summary 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