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OS comparable between Dovitinib, Nexavar for advanced HCC

The overall survival and safety rates were similar between patients with advanced hepatocellular carcinoma treated with Dovitinib vs. Nexavar, according to published findings.

“In this randomized phase 2 study, Dovitinib activity was not greater than that of sorafenib as frontline therapy in Asian-Pacific patients with advanced [hepatocellular carcinoma],” Ann-Lii Cheng, MD, PhD, of the National Taiwan University Hospital and National Taiwan University Cancer Center, and colleagues wrote.

The researchers randomly assigned 82 patients to a regimen of 500 mg per day of Dovitinib (TKI258, Novartis) for 5 days on and 2 off, and 83 patients to a regimen of 400 mg per day of Nexavar (sorafenib, Bayer) twice daily. All patients were ineligible for surgical and/or locoregional therapies or experienced disease progression after previous use of sorafenib. Primary and secondary endpoints were overall survival (OS) and time to tumor progression.

“Although sorafenib has shown to improve overall survival and radiological time-to-tumor progression in Asian-Pacific patients with advanced HCC (median OS, 6.5 months; median time to tumor progression, 2.8 months), better systemic therapy remains an unmet need for patients with HCC in the Asia-Pacific region,” the researchers wrote.

Results showed patients treated with TKI258 and sorafenib had similar OS rates (8 vs. 8.4 months). The median time-to-progression per assessment was 4.1 months (95% CI, 2.8-4.2) for patients treated with TKI258 and 4.1 months (95% CI, 2.8-4.3) for patients treated with sorafenib.

All patients experienced at least one adverse event, regardless of which treatment they received. The most common adverse events in the TKI258-treated group were diarrhea (62%), decreased appetite (43%), nausea (41%), vomiting (41%), fatigue (35%), rash (34%) and pyrexia (30%). Common adverse events for sorafenib-treated patients included palmar-plantar erythrodysesthesia syndrome (66%) and decreased appetite (31%).

All patients discontinued treatment due to disease progression (52% in the TKI258 group, 73% in the sorafenib group) or an adverse event (29% in the TKI258 group, 14% in the sorafenib group).

In a subgroup analysis, patients treated with TKI258 with baseline plasma soluble vascular endothelial growth factor receptor (sVEGFR1) and hepatocyte growth factor (HGF) below median levels had higher median OS compared with patients who had soluble VEGFR1 and HGF above the median levels (11.2 vs. 5.7 months for sVEGFR1; 11.2 vs. 5.9 months for HGF; P = .0002 for both).

The researchers concluded: “Dovitinib was well-tolerated, but activity was not greater than sorafenib as a frontline systemic therapy for HCC. Based on these data, no subsequent phase 3 study has been planned.” – by Melinda Stevens

Disclosure: Cheng reports consulting for Bayer, Eisai, Merck Serono, Merck Sharp & Dohme and Novartis. Please see the study for all other researchers’ relevant financial disclosures.