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Background Health-related quality of life (HRQoL) is an important outcome measure and prognostic indicator in hepatocellular carcinoma (HCC). KEYNOTE-240 (NCT02702401) assessed the efficacy and safety of pembrolizumab plus best supportive care (BSC) versus placebo plus BSC in patients with HCC who previously received sorafenib. This study presents the results of a prespecified exploratory analysis of patient-reported outcomes. Methods Patients completed the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and its HCC supplement (EORTC QLQ-HCC18) electronically at baseline; at weeks 2, 3, 4, 6, 9, 12, and 18; and then every 9 weeks until 1 year or end of treatment, and at the 30-day safety follow-up visit. Results The HRQoL population included 271 and 127 patients randomly assigned to pembrolizumab and placebo, respectively. From baseline to week 12, changes in both scores were similar between pembrolizumab and placebo; global health status/QoL scores were stable. The proportions of patients who improved, remained stable, or deteriorated across all functional domain and symptom scores were generally similar between pembrolizumab and placebo. Time to deterioration was similar between the 2 arms based on the prespecified analysis of EORTC QLQ-HCC18 domains of abdominal swelling, fatigue, and pain. Conclusion Pembrolizumab preserved HRQoL during treatment for advanced HCC. Combined with efficacy and safety results from KEYNOTE-240, these findings support a positive benefit/risk profile for pembrolizumab in a second-line treatment setting for patients with HCC who previously received sorafenib.

BACKGROUND: Patients with hepatocellular carcinoma (HCC) have a poor prognosis if their tumors are not diagnosed early. The authors investigated factors associated with the receipt of liver transplant among patients with HCC and evaluated the effects of these differences on survival. METHODS: The authors reviewed records from consecutive patients diagnosed with HCC at Columbia University Medical Center from January 1, 2002 to September 1, 2008. We compared patient clinical and demographic characteristics, developed a multivariable logistic regression model of predictors of transplant, and used a Cox model to analyze predictors of mortality. RESULTS: Of 462 HCC patients, 175 (38%) received a transplant. Black patients were much less likely than whites to receive a transplant (odds ratio [OR], 0.03; 95% confidence interval [CI], 0.0-0.37). Hispanics and Asians were also less likely to undergo transplantation, but the differences were not statistically significant. Patients with private insurance were more likely to receive a transplant than those with Medicaid (odds ratio [OR], 22.07; 95% confidence interval [CI], 2.67-182.34). Black and Hispanic patients, and Medicaid recipients, presented with more advanced disease than whites and privately insured patients, and had poorer survival. In a Cox model, those who did not receive a transplant were 3 times as likely as transplant recipients to die, but race and insurance were not independently predictive of mortality. CONCLUSIONS: Race and insurance status were strongly associated with receipt of transplantation and with more advanced disease at diagnosis, but transplantation was the most important determinant of survival. Improved access to care for nonwhite and Medicaid patients may allow more patients to benefit from transplant. Cancer 2010. © 2010 American Cancer Society.

Hepatocellular carcinoma (HCC) is the most rapidly increasing cause of cancer death in the United States. Although many risk factors for HCC are well defined, including hepatitis B virus (HBV), hepatitis C virus (HCV), and alcohol, most series have indicated that 5% to 30% of patients with HCC lack a readily identifiable risk factor for their cancer. The majority of "cryptogenic" HCC in the United States is attributed to nonalcoholic fatty liver disease (NAFLD), a hepatic manifestation of the metabolic syndrome. The metabolic syndrome is a constellation of problems that includes insulin resistance, obesity, hypertension, and hyperlipidemia. Increasingly, components of the metabolic syndrome are being linked to various forms of cancer with respect to both increased risk of disease and worsened outcome. In this review, the authors focused on the relation between metabolic syndrome and HCC. They investigated the increased risks of HCC among individuals with features of metabolic syndrome, potentially worsened cancer outcomes in these patients, possible pathogenic mechanisms to explain these relations, and treatment options for those with NAFLD and its progressive counterpart, nonalcoholic steatohepatitis. It is predicted that metabolic syndrome will lead to large increases in the incidence of HCC over the next decades. A better understanding of the relation between these 2 diseases ultimately should lead to improved screening and treatment options for patients with HCC.