2012 Gastrointestinal Cancers Symposium
SAN FRANCISCO — Sorafenib improved time to progression without increasing toxicity when added to transarterial chemoembolization and doxorubicin-eluting beads for patients with intermediate-stage hepatocellular carcinoma, according to Phase 2 results from the double blind, randomized SPACE trial.
Median time-to-progression was 169 days (95% CI, 166 -219) vs. 166 days (95% CI, 113 -168) for patients assigned to placebo (HR=0.797; 95% CI, 0.588-1.080).
“The median [time-to-progression] was almost identical between the two arms at 5.5 months, but the curve of the sorafenib patients is clearly delayed for progression,” said Riccardo Lencioni, MD, PhD, director of the division of diagnostic imaging and intervention in the department of hepatology and liver transplantation at Pisa University Hospital in Italy. “This is captured in the hazard ratio of 0.79, which is significant given the predefined alpha of 0.15.”
In the trial, patients with asymptomatic, unresectable, multinodular tumors without vascular invasion or extrahepatic spread were randomly assigned to 400 mg daily sorafenib (Nexavar, Bayer Healthcare) or placebo continuously until progression. All patients received transarterial chemoembolization and doxorubicin-eluting beads.
There were 154 patients in the sorafenib group and 153 assigned to placebo. Median treatment duration was 4.8 months in the sorafenib group and 6.3 months in the placebo group. The objective response rate (35.7% vs. 28.1%) and rate of progressive disease (13% vs. 23.5%) both favored the sorafenib arm.
Researchers did not observe any new safety findings that would discourage the use of sorafenib in this combination, Lencioni said.
“The combination of sorafenib plus [transarterial chemoembolization] and [doxorubicin-eluting beads] was technically feasible and well tolerated, with the expected overall safety profile,” he said. “These positive signals need to be confirmed in ongoing phase 3 trials in this patient population.”
For more information:
- Lencioni R. Abstract #LBA154. Presented at: ASCO Gastrointestinal Cancers Symposium; Jan. 19-21, 2012; San Francisco.
Disclosure: Dr. Lencioni reports serving as a consultant for Bayer and Onyx Pharmaceuticals, and receiving honoraria and research funding from Bayer.