In a prospective study, researchers in Italy found that compensated patients with hepatocellular carcinoma who permanently discontinued therapy with Nexavar had a longer post-treatment survival, according to published findings in Hepatology.
“Treatment with sorafenib of patients with advanced hepatocellular carcinoma is challenged by anticipated discontinuation due to tumor progression, liver decompensation, or adverse effects,” the researchers wrote. “While post-progression survival is clearly determined by the pattern of tumor progression, understanding the factors that drive prognosis in patients who discontinued sorafenib for any reason may help to improve patient management and second-line trial design.”
To investigate this, researcher Massimo Iavarone, MD, 1st Division of Gastroenterology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Italy, and colleagues analyzed data of 260 patients with HCC and cirrhosis consecutively admitted to three referral centers in Italy who were receiving care following permanent discontinuation of Nexavar (sorafenib, Bayer). The primary endpoint was to determine patient survival after permanent discontinuation.
Overall, the median post-sorafenib survival (PSS) rate was 4.1 months (95% CI, 3.3-4.9), which resulted from a survival rate of 4.6 months for 123 patients with tumor progression, survival rate of 7.3 months for 77 patients who experienced adverse events and survival rate of 1.8 months in 60 patients with liver decompensation (P < .001).
Multivariate Cox analysis showed that performance status (PS), prothrombin time, extrahepatic tumor spread, macrovascular invasion and reasons for discontinuation were independent predictors of PSS.
Of all the patients, 200 were potentially eligible for second-line therapy and had a PSS of 5.3 months. This was dependent on reasons of discontinuation (P = .004), PS (P < .001), macrovascular invasion (P < .001) and extrahepatic metastases (P < .002), according to the research. The patients who developed liver decompensation were not eligible for second-line therapy.
The researchers concluded: “Discontinuation due to adverse effects in the absence of macrovascular invasion, extrahepatic metastases and deteriorated PS predicts the best PSS in compensated patients, thereby setting the stage for both improved patient counseling and selection for second-line therapy.” – by Melinda Stevens
Disclosures: Iavarone reports being on the speakers' bureau for Bayer and Gilead Sciences; and has received grants from Bristol-Myers Squibb, Bayer and Gilead Sciences. Please see the full study for all other authors’ relevant financial disclosures.