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Nexavar beneficial in liver cancer regardless of prognostic factors

Nexavar treatment consistently showed benefit in hepatocellular carcinoma regardless of prognostic factors, according to results of a recently published study.

“Although analyses of potential predictive factors for sorafenib benefit have been attempted with data from single-arm, observational studies, the lack of a placebo arm in these trials has prevented proper differentiation between prognostic and predictive markers,” Jordi Bruix, MD, from the BLCL Hospital Clinic Barcelona, Spain, and colleagues wrote. “Our analysis showed a consistent OS benefit with sorafenib treatment compared with placebo irrespective of patient baseline characteristics, subgroup or prognostic factors for survival.”

Researchers also found that the presence of macroscopic vascular invasion, high alpha fetoprotein and high neutrophil-to-lymphocyte ratio were linked to poorer overall survival, while a lack of extrahepatic spread, hepatitis C and lower neutrophil-to-lymphocyte ratio predicted greater overall survival.

The retrospective analysis included 826 patients with unresectable HCC from both the SHARP and AP randomized, double blind phase 3 clinical studies. Patients received either Nexavar (sorafenib, Onyx Pharmaceuticals) 400 mg or placebo twice daily.

On multivariate analysis, the factors associated with poorer OS among the sorafenib patients included macroscopic vascular invasion (HR = 1.369; P = .0412), alpha fetoprotein over 200 ng/mL (HR = 1.552; P = .0018) and high neutrophil-to-lymphocyte ratio (HR = 2.133; P = .0024). These factors were similarly significant among the placebo group.

In the sorafenib group only, additional factors associated with poorer OS included Eastern Cooperative Oncology Group performance status 1 or 2 (HR = 1.552; P = .0028), presence of tumor burden (HR = 1.895; P = .0013), more than three baseline target lesions (HR = 1.728; P = .0014), maximum baseline target lesion size of 6 cm or larger (HR = 1.514; P = .0041), high bilirubin (HR = 1.563; P = .0041) and low albumin (HR = 1.496; P = .0458).

Compared with the placebo group, sorafenib showed a greater survival benefit across all patient subgroups (HR 0.85) and was significantly greater among patients with an absence of extrahepatic spread (HR = 0.55; P = .015) and HCV (HR = 0.81; P = .045), and in those with low neutrophil-to-lymphocyte ratio (HR = 0.46; P = .0497).

“This study demonstrated that sorafenib treatment provides a survival benefit across all categories of patients but also shows that the magnitude of benefit is significantly more intense in patients with disease confined to the liver (without [extrahepatic spread]), with HCV, or a low [neutrophil-to-lymphocyte ratio],” the researchers concluded. “These results should help inform the prognosis of patients receiving sorafenib therapy and provide further refinements for the design of trials testing new agents versus sorafenib.” – by Talitha Bennett

Disclosure: Bruix reports he has received research support from Bayer HealthCare Pharmaceuticals; honoraria from Bayer HealthCare Pharmaceuticals, ArQule, BTG, Bristol-Myers Squibb, Terumo and Kowa; and consulted for Daichi, ArQule, Bayer HealthCare Pharmaceuticals, BTG, Sirtex, AbbVie, Terumo, Bristol-Myers Squibb, Novartis, Eisai, Kowa and Roche. Please see the full study for the other researchers’ relevant financial disclosures.