Reduced initial sorafenib doses in patients with hepatocellular carcinoma (HCC) may decrease cost of therapy, pill burden, rates of discontinuation due to treatment-related adverse events (AEs), and have a noninferior overall survival (OS) rate compared with the standard dose, according to a study published in The Journal of Clinical Oncology.
For this study, investigators retrospectively assessed 4903 patients with hepatocellular carcinoma who received sorafenib. Sixty-three percent (3094) received the standard starting dose of 800 mg daily and 37% (1809) received reduced doses.
Median overall survival was lower in patients who received sorafenib at a reduced initial dose compared with those who received the standard dose (200 days vs 233 days; hazard ratio [HR], 1.10). However, after propensity score matching and adjusting for potential confounders, no significant difference in OS was observed (adjusted HR, 0.92; 95% CI, 0.83-1.01), which was significantly below the noninferiority margin (P <.001).
The reduced-dose arm was prescribed fewer tablets (median, 180 tablets) compared with the standard-dose arm (276 tablets; P <.001), and had much lower costs ($5636 vs $8661; P <.001).
Patients were also less likely to discontinue treatment due to gastrointestinal AEs (8.7% vs 10.8%; P =.047).
The study authors conclude by saying that the findings “suggest that the initiation of sorafenib at a reduced dosage may be a safe and reasonable strategy for some patients with HCC.”
1. Reiss KA, Yu S, Mamtani R, et al. Starting dose of sorafenib for the treatment of hepatocellular carcinoma: a retrospective, multi-institutional study [published online September 5, 2017]. J Clin Oncol. doi: 10.1200/JCO.2017.73.8245