HCC is the second leading cause of cancer-related deaths worldwide. Sorafenib (SFN) has been the backbone of advanced HCC treatment over the past decade. Since the mean age of HCC presentation is between 50 and 60 years, data on SFN use in the elderly patients (pts) remain scarce due to underrepresentation of this population in pivotal clinical trials. Thus, the treatment of elderly HCC pts represents a clinical challenge given the concomitance of advanced age with chronic hepatopathy, raising concerns about clinical benefit and increased toxicity in this subgroup. We analyzed a cohort of HCC pts with the aim of evaluating the efficacy and safety of SFN in this specific population.
A cohort of pts with advanced HCC treated with SFN was retrospectively evaluated. Pts were divided into 2 groups: (A) those younger than 70 years-old (y-o) and (B) those who were 70 y-o or older at the time of SFN initiation. Survival (OS) was calculated from the first day of SFN to death or last data record. Time to treatment failure (TTF) due to disease progression or toxicity was calculated from the first to the last day on SFN. TTF and OS were estimated using Kaplan-Meier and curves were compared by log-rank test.
We analyzed 226 HCC pts treated with SFN from Oct-2007 to Jan-2017. Group B was comprised of 37 (16.4%) pts, median age 73.5 years (70-85), 75.7% male, 29.7% had HCV, 86.5% Child-Pugh A, 37.8% had extrahepatic spread. Reduced starting dose SFN (< 800 mg/d) was more common in Group B than in Group A (27% vs 11.8%, p = 0.026). No statistically significant differences in OS (7.9 vs 9.8 months, p = 0.534) or TTF (3.5 vs 4.3 months, p = 0.962) were detected between Groups A and B. The incidence of dermatologic adverse events (38.6% vs 34.1%, p = 0.596) and hypertension (7% vs 5%, p = 0.641) did not differ significantly between Groups A and B, respectively. Intolerance leading to SFN discontinuation occurred in 11% and 9.5% of pts in Groups A and B, respectively (p = 0.780).
Our findings suggest that the efficacy and the incidence of adverse events were similar in elderly HCC pts treated with SFN when compared to younger pts. Thus, age alone should not be used to determine the therapy of pts with advanced HCC being considered for SFN.
Clinical trial identification
Legal entity responsible for the study
Instituto do Câncer do Estado de São Paulo.
Has not received any funding.
G. Nader Marta: Travel expenses: Bayer. M.I. Braghiroli: Honoraria: MSD; Research funding: Bayer. J. Sabbaga: Consulting or advisory role: Bayer, MSD; Speaker\'s bureau: Roche, Bayer, MSD; Travel expenses: Bayer. All other authors have declared no conflicts of interest.