▸ Systemic therapies. Historically there have been no safe and effective systemic chemotherapy regimens, but two new agents that have been studied are nolatrexed (Thymitaq) and sorafenib (Nexavar).
A recent phase II trial of nolatrexed in 39 patients with advanced HCC showed one partial response for 7 months (Invest. New Drugs 2007;25:85–94). The median overall survival was 32 weeks. “Unfortunately, this was a huge study that turned out to be less than exciting,” Dr. Hillebrand said.
A more promising drug is sorafenib, which is approved for renal cell carcinoma. A phase II study of 137 patients showed partial response in 2.2%, minor response in 5.8%, and a delay in time to disease progression of 4.2 months.
Recently, a phase III trial of sorafenib in 602 patients was terminated early because improvements in overall survival were seen. Results of the SHARP trial are expected to be released later this year.