P-153 Safety and effectiveness of sorafenib in elderly patients diagnosed with advanced hepatocellular carcinoma in a monographic oncologic center

Sorafenib has been the standard of care for patients with advanced hepatocellular carcinoma (HCC) for 13 years, but safety data and outcomes in older patients are inconclusive. We aimed to evaluate the impact of age, comorbidities and initial low-dose therapy on sorafenib effectiveness and safety in elderly patients. We performed a retrospective analysis including all HCC patients treated with first-line sorafenib at our institution since the use of electronic health records (2009). Our endpoints were overall survival (OS), progression-free survival (PFS), response rate (RR), and the incidence of grade 2-5 adverse events (AEs). Variables were compared between young (< 75 years) and elderly (≥ 75) using Mann-Whitney U test for continuous variables and chi-2 test or Fisher’s exact test for categorical variables. The survival function by age and potential prognostic factors was plotted using Kaplan–Meier curves with differences between these groups compared using log-rank test. Before conducting Cox regression analyses, the proportional hazards assumption was checked with log-likelihood ratio tests of each predictor. Logistic regression and multivariable logistic regression were performed to evaluate the impact of potential prognostic factors on the incidence of AEs and discontinuation of treatment. Two hundred and two patients were studied; 157 (77.72%) were aged < 75 and 45 (22.28%) were ≥ 75. The elderly patients were more likely to have arterial hypertension (44.87 vs 66.22%, p 0.04), VHC-related aetiology (44.59 vs 62.22%, p 0.037), previous treatment with ≥ 2 transarterial chemoembolization (25.64 vs 43.18%, p 0.024) amb low initial dose (< 800mg/d [9%] vs 800mg/d [31%], p 0.001). No difference in the OS of those aged < 75 and ≥ 75 was observed (15.31 vs 13.93 months, p 0.58) or neither impact of low-dose therapy (p 0.38); only previous locoregional treatment (HR 0.63 [IC95% 0.44-0.90], p 0.01) and dose reduction (HR 0.46, [IC95% 0.32-0.66], p < 0.001) showed impact on OS in multivariable model. Neither statistical impact on PFS of age (8.77 vs 5.85 months, p.0.57) nor initial low-dose therapy (p 0.68) was observed. The older patients did not experience a higher incidence of AEs compared to younger patients (88.9 vs 91.1%, p 0.66) and it was not related with low-dose therapy (p 0.304). No statistical difference in the discontinuation of sorafenib due to toxicity was observed between aged < 75 and ≥ 75 (30.4 vs 42.2%, p 0.14). The initial complete-dose therapy, BCLC stage and polypharmacy were related with a higher incidence of AEs (78.1 vs 21.9% [p 0.04], 35.9 vs 64.1% [p 0.03], and 29.5 vs 70.29% [p 0.03] respectively) but only BLCL stage maintained the statistical significance in the multivariate model (OR 0.24 [IC95% 0.10-0.56], p 0.01). No statistical difference in RR was observed in elderly patients compared to younger patients (p 0.30). Elderly patients with advanced HCC, when treated with sorafenib, have equivalent clinical outcomes with similar toxicity rates as the younger patients. Age alone should not be a discriminating factor in the management of advanced HCC. Low-dose therapy was not significantly related to a lower incidence of AEs.