A retrospective analysis of a cohort comprised predominantly of Hispanic patients with advanced hepatocellular carcinoma (HCC) showed no significant difference in median overall survival (OS) for older compared with younger patients. These study findings were published in the Journal of Geriatric Oncology.
The incidence of HCC has been shown to increase with increasing age across different populations with a peak age of 70 years, and rates of HCC among US Hispanic patients are second only to those observed in Asian patients. However, older patients and those of Hispanic ethnicity have not been well represented in cancer clinical trials.
Although the kinase inhibitor, sorafenib, received approval from the US Food and Drug Administration (FDA) in 2007 for the treatment of unresectable HCC on the basis of results from 2 pivotal cancer trials, detailed subgroup analyses focusing on the older patients enrolled in these studies have not yet been performed. Furthermore, most retrospective analyses that have been undertaken included patients from Asia or Europe.
The aim of this analysis was to compare the efficacy and safety of sorafenib in older and younger age groups of a predominantly Hispanic cohort of adults receiving treatment at a National Cancer Institute-designated cancer center in south Texas during the period from 2008 to 2013. Study inclusion criteria included Child-Pugh class A or B and an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or below.
Among the 118 patients included in the analysis, 87 patients were classified as younger (younger than 65; median age, 55) and 31 were classified as older (65 and older; median age, 70). More than 70% of patients in each age group were classified as Hispanic, with the majority of the remaining patients classified as non-Hispanic white. Patients in the older group were more likely to be scored as Child-Pugh class A (71.0%) compared with those in the younger group (51.2%), and to have received prior local therapy (90.3% vs 65.5%).
Although differences in efficacy outcomes for the 2 age groups were not statistically significant, median progression-free survival was 4.6 months and 6.2 months (P =.71), and median overall survival (OS) was 10.2 months and 13.5 months (P =.15) in the younger and older groups, respectively.
In addition, median OS was 11.2 months for Hispanic patients vs 8.7 months (P =.53) for non-Hispanic whites.
Regarding the safety of sorafenib, older patients were more likely than younger patients to have experienced grade 2/3 hand-foot syndrome (25.8% vs 10.3%) and fatigue (42% vs 31%), whereas grade 2/3 nausea (6.5% vs 10.3%) and diarrhea (3.2% vs 8.0%) were more common in the younger patients. No grade 4 or 5 adverse events were reported in either age group.
The study authors noted that this patient cohort “had a small sample size, but the trend toward higher survival in older patients may be a selection bias based on the liver function (more Child-Pugh A cirrhosis), etiology of cirrhosis (rising incidence of fatty liver), genetics (majority Hispanic), and/or aging hepatitis C viral-infected population in older adults that is unique from younger patients.”
“Having more Child-Pugh A cirrhosis, likely allowed for better tolerability of sorafenib, and therefore, a trend toward a better survival.
“As newer treatments are in development for HCC, future studies should incorporate geriatric assessments, so we can identify the ideal older adult who would benefit from treatment, and therefore, avoid overtreatment or undertreatment,” the study authors concluded.
Arora SP, Ananth S, Ketchem N, Gelfond J, Michalek J, Mahalingam D. The efficacy and safety of sorafenib in older adults with advanced hepatocellular carcinoma: an analysis of a majority Hispanic cohort [published online April 6, 2020]. J Geriatr Oncol. doi: 10.1016/j.jgo.2020.03.018