Asia-Pacific researchers launch trial for combined liver cancer therapy

Medical Tribune August 2008 SFIX
David Brill

An international team of researchers has begun a study into a combination therapy that could prolong the lives of patients with inoperable hepatocellular carcinoma (HCC) – a cancer that is particularly common in Asia.

Thirty one patients will participate in the 2-year phase I/II trial, which aims to combine the oral chemotherapy drug sorafenib (400mg twice daily) with radiation therapy delivered by Selective Internal Radiation (SIR)-Spheres®.

The primary objectives are to assess the tumor response rate and the safety and toxicity of the therapy. Survival, recurrence rates and quality of life are among the secondary outcomes to be investigated.

The study is being carried out by The Asia-Pacific Hepatocellular Carcinoma Trials Group, which is based at the National Cancer Centre Singapore (NCCS). Centers in 12 different countries, including Malaysia, Indonesia and Philippines, have so far been invited to participate.

Professor Soo Khee Chee, director of the NCCS, said that the team was “especially pleased” to announce the trial, adding that he was confident it would produce very strong data.

“This trial is an important milestone for all our researchers and clinician investigators because we will be taking a step forward in our efforts to help our patients combat liver cancer,” said Soo.

The chair of the trial, Associate Professor Pierce Chow, said that HCC is particularly prevalent in Asia owing to high rates of hepatitis B, which is the major cause of the cancer. He said that there was anecdotal evidence to suggest that the combination therapy was promising for HCC patients, but added that it is imperative that scientific data be gathered appropriately from clinical trials.

The high cost of the two treatments is also an important consideration according to Chow, who is a senior consultant surgeon at Singapore General Hospital. Sorafenib costs a patient around S$9,000 per month at NCCS, whereas SIR-Sphere therapy could cost up to S$20,000, he said.

Funding for the trial comes in the form of a S$468,200 grant from Singapore’s National Medical Research Council. Bayer Schering Pharma Singapore, who produce sorafenib, and Sirtex Medical Ltd, who manufacture the SIR-Spheres®, are each providing around S$1.5 million worth of therapeutics.

Sorafenib targets the proliferation of tumor cells and angiogenesis. Data from a Phase III trial, presented in 2007 at the annual meeting of the American Society of Clinical Oncology, showed that the drug extended overall survival in inoperable HCC patients by a median of 3 months but did not induce tumor regression.

SIR-Spheres®, conversely, induce a significant tumor response but trial data have yet to demonstrate an improvement in survival rates Chow said. The therapy involves delivering very high dose radiation directly to the tumor via a catheter, thereby sparing the healthy surrounding tissues.