Hepatic arterial infusion chemotherapy followed by sorafenib in patients with advanced hepatocellular carcinoma (HICS 55): an open label, non-comparative, phase II trial

• Main Authors: Masahiro Hatooka, Tomokazu Kawaoka, Hiroshi Aikata, Yuki Inagaki, Kei Morio, Takashi Nakahara, Eisuke Murakami, Masataka Tsuge, Akira Hiramatsu, Michio Imamura, Yoshiiku Kawakami, Kazuo Awai, Keiichi Masaki, Koji Waki, Hirotaka Kohno, Hiroshi Kohno, Takashi Moriya, Yuko Nagaoki, Toru Tamura, Hajime Amano, Yoshio Katamura, Kazuaki Chayama
• Format: Article
• Language: English
• Published: BMC 2018-06-01
• Series: BMC Cancer
• Subjects: HCC; HAIC; Sorafenib; Tumor marker; RECIST
• Online Access: http://link.springer.com/article/10.1186/s12885-018-4519-y

Abstract Background In patients with advanced hepatocellular carcinoma (HCC), evidence is unclear as to whether hepatic arterial infusion chemotherapy (HAIC) or sorafenib is superior. We performed a prospective, open-label, non-comparative phase II study to assess survival with HAIC or HAIC converted to sorafenib. Methods Fifty-five patients were prospectively enrolled. Patients received HAIC as a second course if they had complete response, partial response, or stable disease (SD) with an alpha fetoprotein (AFP) ratio < 1 or a des-γ-carboxy prothrombin (DCP) ratio < 1. Patients were switched to sorafenib if they had SD with an AFP ratio > 1 and a DCP ratio > 1 or disease progression. The primary endpoint was the 1-year survival rate. Secondary endpoints were the 2-year survival rate, HAIC response, survival rate among HAIC responders, progression-free survival, and adverse events. Results Of the 55 patients in the intent-to-treat population, the 1-year and 2-year survival rates were 64.0 and 48.3%, respectively. After the first course of HAIC, one (1.8%) patient showed complete response, 13 (23.6%) showed partial response, 30 (54.5%) had SD, and 10 (18.1%) patients had progressive disease. Twenty-three patients (41.8%) had SD with AFP ratios < 1 or DCP ratios < 1, and 7 (12.7%) had SD with AFP ratios > 1 and DCP ratios > 1. Thirty-seven patients (68.5%) were responders and 17 (30.9%) were non-responders to HAIC. In responders, the 1-year and 2-year survival rates were 78 and 62%, respectively. Conclusion Given the results of this study, this protocol deserves consideration for patients with advanced HCC. This trial was registered prospectively from December 12. 2012 to September 1. 2016.