Life span of inoperable advanced liver cancer patients may be extended by 9 months or more with combined treatment

Singapore, 24th June 2010 – Patients who suffer from hepatocellular carcinoma (HCC) may have a chance to live longer, going by the results of a clinical trial now conducted by the Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group. The result of the study shows that the patients may live up to another nine months longer.

In a recently concluded multi-centre phase II clinical trial, two existing treatment modalities - systemic therapy (Sorafenib) and selective internal radiation therapy (SIR-Spheres) were administered to patients as combination therapy by the Trials Group. The result was they were able to achieve a median overall survival of 11.75 months for the entire group of 35 patients. In the subgroup of patients with no distant spread of disease, a median survival of 18.25 months was achieved. These results were better than those with treatment by either therapy alone.

Professor Soo Khee Chee, Group Chair of the AHCC Trials Group and Director of NCCS remarked: “The trial result is very encouraging as it gives patients a glimmer of hope. This is an excellent example of various centres pooling resources and talents to work together to understand a disease which is prevalent in this part of the world.”

Curative treatment such as surgical resection, transplantation and radiofrequency ablation for patients are not options for patients with advanced HCC. Faced with a poor prognosis, these advanced stage patients generally have a median survival of about 3 months if left untreated.

The encouraging results of the AHCC05 trial were presented at the prestigious American Society of Clinical Oncology (ASCO) conference held in Chicago, USA, on 6th June this year. HCC, a form of liver cancer, is the 5th most common cancer worldwide. Almost 80% of HCC cases are found in the Asia-Pacific region. As the majority of patients with liver cancer do not develop any symptoms, only one in five of them can potentially be cured by surgery when diagnosed. Led by Associate Prof Pierce Chow, Senior Clinician Scientist, Singapore General Hospital and Visiting Consultant at the National Cancer Centre Singapore (NCCS), the investigator-initiated trial, which commenced in June 2008, recruited patients from four countries (Malaysia, Myanmar, Singapore and South Korea) and closed a year after in June 2009.

Supported by the National Medical Research Council, Bayer Schering Pharma Singapore and Sirtex Medical Products, its objective was to evaluate tumour response and overall survival of patients who were given Sorafenib, an oral targeted chemotherapy drug, 11 to 14 days after being administered with SIR-Spheres directly into the tumour through a catheter.

Patients were followed-up monthly at the clinic with a computed tomography (CT) scan for an assessment of their tumour once every three months. Data compiled and analysed by the Singapore Clinical Research Institute showed not only an improvement in the median overall survival but also revealed an overall disease control rate of 79.5%. In fact, one patient responded favourably to the trial and had liver transplant while two others received radiofrequency ablation.

Taken on its own, Sorafenib has proven to be efficacious for patients with advanced HCC as it has an ability to extend patients’ life span by about three months. SIR-Spheres, which works better for advanced cancer confined to the liver (locally advanced), have reported significant tumour regression or shrinkage. However, at present it is unclear which of the two therapies is ideal for patients with locally advanced HCC as they represent the majority of advanced HCC patients.

In view of the success of the AHCC05 trial, the trials group will launch a phase III multi-centre trial, AHCC06, to determine which of these two efficacious therapies would help patients survive longer and be the first line therapy in advanced HCC.

“Patients on this randomised 360-patient phase III trial will be divided into two groups – one group on Sorafenib and patients in the other group on SIR-Spheres, as the primary aim of the trial is to determine a difference, if any, between Sorafenib and SIR-Spheres for locally advanced HCC patients. Upon completion, we hope to conclude which therapy is more beneficial to patients in terms of better survival, tumour shrinkage and quality of life. This therapy will then serve as first line and the other as second line treatment,” said Associate Prof Chow.

More than 20 centres from 13 countries in the Asia Pacific region, including Australia, Republic of Korea, Singapore and Taiwan, are expected to be part of the trial, which is the 6th and largest multicentre trial to be conducted by the AHCC Trials Group.

Patients who are 18-year-old and above with inoperable locally advanced HCC have to be determined suitable for the trial by clinical assessment conducted by the investigator. The public can call +65 6326 6337 if they wish to find out more about the trial.

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