Compared with starting patients with hepatocellular carcinoma on a standard dose of sorafenib, reducing the starting dose was associated with reduced treatment costs, yet did not reduce overall survival, a large retrospective analysis showed.

“Our data suggest that the initiation of sorafenib at a reduced dosage may be a safe and reasonable strategy for some patients with HCC,” researchers led by Kim A. Reiss, MD , wrote in the Journal of Oncology.

Dr. Reiss, of the Philadelphia-based Perelman Center for Advanced Medicine, and her associates analyzed data from 4,903 patients with HCC who were prescribed sorafenib at 128 Veterans Health Administration hospitals between January 2006 and April 2015. They used Cox regression analysis to examine the impact of the drug’s starting dose on patient outcomes and cost. The primary endpoint was overall survival of patients who were prescribed a standard starting dose of sorafenib at 800 mg/d, compared with a starting dose of less than 800 mg/d.

The mean age of patients was 62 years, 99% were male, and 61% where white. In an unmatched and unadjusted analysis, the researchers found that compared with patients who received a standard starting dose of sorafenib, those who received a reduced starting dose had more Barcelona Clinic Liver Cancer stage D disease (P less than .001), higher Model for End-Stage Liver Disease Sodium scores (P less than .001), higher Child-Turcotte-Pugh scores (P less than .001), higher Cirrhosis Comorbidity Index scores (P=.01), and a lower overall survival (a median of 200 vs. 233 days, respectively; HR 1.10). However, after propensity score matching and adjustment for potential confounders, the difference in overall survival between the two treatment groups dropped below the noninferiority margin (P less than .001), the investigators reported (J Clin Oncol. 2017 Sept 5 ).

In addition, patients who received a reduced starting dose of sorafenib had a significantly lower total cost of the medication ($5,636 vs. $8,661; P less than .001) and were less likely to stop taking sorafenib because of GI effects (8.7% vs. 10.8%; P = .047).

The study was supported by unrestricted research funds from Bayer HealthCare Pharmaceuticals and the VA HIV, Hepatitis, and Related Conditions Programs in the Office of Specialty Care Services. One of the authors, Ronac Mamtani, MD, is supported by National Institutes of Health/National Cancer Institute grant K23CA18718.


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