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Sorafenib did not extend time to progression in advanced HCC after transarterial chemoembolization
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2010 Gastrointestinal Cancers Symposium
Results of a study presented Saturday during the 2010 Gastrointestinal Cancers Symposium showed that addition of sorafenib, a synthetic compound targeting growth signaling and angiogenesis, after transarterial chemoembolization did not significantly extend time to progression for patients with advanced hepatocellular carcinoma.
Kiwamu Okita, MD, professor in the department of gastroenterology and hepatology with Shimonoseki Kohsei Hospital in Shimonoseki, Japan, presented the results of the late-breaking abstract and said further analysis leads investigators to believe sorafenib (Nexavar, Bayer) may yet have a role to play in the treatment of these patients.
“Exploratory analysis suggested a positive impact associated with sorafenib treatment,” he said. Several factors may influence time to progression in these patients including age, number of lesions and response to treatment with transarterial chemoembolization (TACE), according to Okita.
Researchers enrolled patients from Japan and South Korea with unresectable hepatocellular carcinoma and Child-Pugh A disease with ≥25% tumor necrosis/shrinkage at one to three months following treatment with TACE. They were randomly assigned 400 mg sorafenib (n=229) or placebo (n=229). Patients with fewer than 10 lesions or lesions smaller than 70 mm prior to TACE were excluded. The primary endpoint was time to progression.
Median duration of treatment was 17 weeks in the sorafenib group and 20 weeks in the placebo group. Treatment continued until the occurrence of radiologically confirmed disease progression/recurrence or intolerable toxicity occurred.
Median time to progression was 5.4 months in the sorafenib group compared with 3.7 months in the placebo group (HR=0.87; 95% CI, 0.70-1.09). Okita said an exploratory analysis by investigator assessment showed a median time to progression of 7.2 months in the sorafenib group vs. 5.3 months in the placebo group (HR=0.79; 95% CI, 0.63-1.00).
In the sorafenib group, 41% of patients discontinued treatment due to adverse events. Compared with the placebo group, the sorafenib group experienced far greater rates for grade-3/grade-4 hand-foot-skin reaction (35% vs. 0%), hypertension (16% vs. 2%) and diarrhea (6% vs. 2%). – by Jason Harris
For more information:
- Okita K. # LBA128. Presented at: the 2010 Gastrointestinal Cancers Symposium; Jan 22-24, 2010; Orlando, Fla.
The rationale for this study is very sound because it aims to combine an effective locoregional therapy with a survival benefit, TACE, with the only approved systemic therapy, sorafenib. The latter has been shown to have antiangiogenic properties as well. The hypothesis, based on the study design, is that sorafenib, after completion of TACE, would serve as maintenance or even "adjuvant" therapy to prolong time to progression. The study did not meet its primary endpoint as there was no statistically significant difference between sorafenib and placebo in regards to time to progression based on central review.
– Anthony B. El-Khoueiry, MD
Assistant
Professor of Medicine, University of Southern California
