CHICAGO — In a randomized phase 2 trial, treatment with Nexavar plus hepatic arterial infusion chemotherapy with cisplatin yielded better results vs. treatment with Nexavar alone for patients with advanced hepatocellular carcinoma, according to a poster presented at the ASCO Annual Meeting.
“Sorafenib has been acknowledged as a standard therapy for advanced hepatocellular carcinoma and is available worldwide,” Masafumi Ikeda, MD, chief of the department of hepatobiliary and pancreatic oncology, National Cancer Center Hospital East, Kashiwa, Japan, told Healio.com/Hepatology. “Hepatic arterial infusion chemotherapy with cisplatin is still often undertaken in Japan, because a favorable tumor-shrinking effect and long-term survival of the patients are sometimes observed even in patients with highly advanced HCC. Because no randomized controlled trials have demonstrated any survival advantage of (hepatic arterial infusion chemotherapy], no consensus has been reached on its establishment as standard treatment for advanced HCC.”
From June 2011 to December 2013, Ikeda and colleagues randomly assigned 108 patients with no prior chemotherapy to treatment with Nexavar (sorafenib, Bayer Healthcare) alone (n = 42; 800 mg, twice daily) or sorafenib plus hepatic arterial infusion chemotherapy (HAIC) with cisplatin (SP; n=66; sorafenib: 800 mg twice daily; cisplatin at 65 mg/m2, day 1, every 4 to 6 weeks up to a maximum of 6 cycles), to evaluate the efficacy and safety of the two treatments for advanced HCC. Patients were followed until December 2014 and the primary endpoint was overall survival.
Patients treated with SP had a greater overall median survival compared with patients treated with sorafenib alone (10.6 and 8.7 months), respectively. The median time to progression was 3.1 and 2.8 months in the SP and sorafenib arms (HR = 0.78; 95% CI, 0.52-1.16) and stratified HR was 0.78 (95% CI, 0.59-1.21), according to the research.
Common, more frequent adverse events seen in the patients treated with SP compared with sorafenib alone were neutropenia (60 vs. 43.9%), leukocytopenia (75.4 vs. 43.9%), hemoglobin, (89.2 vs. 73.2%), thrombocytopenia (89.2 vs. 80.5%), hyponatremia (81.5 vs. 53.7%), nausea (41.4 vs. 19.5%) and hiccups (9.2 vs. 0%), respectively.
“We concluded SP yielded favorable overall survival as compared to [sorafenib] in patients with advanced HCC,” Ikeda said. – by Melinda Stevens
Disclosure: Ikeda reports consulting for NanoCarrier and being on the speaker’s bureau for Abbott Diagnostics, Bayer Yakuhin, Bristol-Myers Squibb, Dainippon Sumitomo Pharma, Guerbet, Kyowa Hakko Kirin, Merck Serono, Novartis, Takeda and Yakult. Ikeda reports his institution receives research funding from AstraZeneca, Bayer Yakuhin, Boston Biomedical, Chugai Pharma, Dainippon Sumitomo Pharma, Eisai, GlaxoSmithKline, Kowa, Kyowa Hakko Kirin, Lilly Japan, Merck Serono, Novartis, OncoTherapy Science, Inc., Ono Pharmaceutical, Otsuka, Pfizer, Taiho Pharmaceutical, Yakult and Zeria Pharmaceutical. Please see the full study for all other authors’ relevant financial disclosures.