New International Colorectal Cancer Study Using Targeted Radiotherapy Offers Hope To The 1 In 3 Patients Whose Disease Has Metastasised To Their Liver

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology;  Liver Disease / Hepatitis
Article Date: 19 Oct 2007 - 1:00 PDT

email to a friend   printer friendly   opinions  

Doctors anticipate a new international research study into advanced colorectal cancer will determine the best first-line treatment to prolong and improve the lives of patients with disease that has spread to their liver, and may change standard colorectal cancer treatment practices worldwide.

The largest of its kind in the world, the SIRFLOX study has now started in twelve Australian hospitals and will compare two of the latest treatments for secondary liver cancer: an innovative Australian-developed radiation therapy that targets liver tumours, and three systemic chemotherapy drugs.

The randomised controlled trial will involve hospitals in Australia, New Zealand, the US and Europe, with patients accepted into the study until December 2008. It will involve 320 patients, with progression-free survival as the primary end-point.

The study will be led in Australia by medical oncologists Dr Guy van Hazel from Mount Hospital, Perth, and Associate Professor Peter Gibbs from Royal Melbourne Hospital, who announced the study in Melbourne today at the annual AGITG Scientific Meeting. (The Australasian Gastro Intestinal Trials Group (AGITG) is an independent trials group committed to addressing unanswered clinical questions through clinical trials research.) In this instance, the SIRFLOX study will be sponsored and conducted independently by biotechnology company Sirtex Medical Limited (Sirtex).

Dr van Hazel said the SIRFLOX study was vital because more than 30 per cent of patients diagnosed with colorectal cancer each year develop liver metastases1,2, which are usually inoperable and difficult to treat.

"We're hoping the study will provide definitive evidence of the best first-line treatment to control patients' liver tumours and prolong patients' lives by months or even years without compromising their quality of life," Dr van Hazel said.

"The study is designed to discover whether selective internal radiation therapy (SIRT) in combination with gold-standard FOLFOX chemotherapy is more effective than chemotherapy alone for the one in three colorectal cancer patients who have inoperable liver tumours."

Assoc Prof Gibbs said the study could have a major impact worldwide on the treatment of advanced colorectal cancer if the results demonstrate a significant survival benefit when patients receive SIRT plus FOLFOX chemotherapy as their first directed therapy.

1 McLoughlin J et al, Resection of Colorectal Liver Metastases: Current Perspectives. Cancer Control 2006; 13(1):32-41

2 Australian Institute of Health & Welfare, Australian Association of Cancer Research; Cancer in Australia 2003 and Cancer in NSW: Incidence and Mortality 2003.

  "The first treatment a patient receives often determines his or her long term prognosis because tumours can grow quickly and become resistant over time, particularly with an aggressive disease like liver cancer," Assoc Prof Gibbs said.

"The results of this Australian-led study could see a big leap forward in the treatment of colorectal cancer that spreads to the liver, and offer new hope to thousands of people.

"Australia is leading the way in developing an effective targeted treatment for secondary liver cancer, which is the ultimate cause of death for one in three of all cancer patients, particularly those with colorectal cancer."

Assoc Prof Gibbs said only 10-20 per cent of patients are able to have surgery or ablation because of the number, size or location of their liver tumours, however, it is hoped that more patients will be able to undergo potentially curative surgery after their tumours are reduced in size following SIRT treatment.

All patients in the study will receive a chemotherapy regimen called FOLFOX (folinic acid, fluorouracil and oxaliplatin), which is the gold-standard treatment of choice for secondary liver cancer from primary colorectal cancer.

Half the patients will also receive selective internal radiation therapy or SIRT, which is a targeted internal form of radiotherapy designed to destroy liver tumours that cannot be removed by surgery.

Microscopic radioactive particles are injected into the bloodstream of the liver, where they target tumours with a single, high dose of radiation while sparing healthy tissue.

Using SIRT enables doctors to deliver up to 40 times more radiation to the liver tumours than conventional radiotherapy, which can only be applied in small doses to limited areas of the body and may adversely affect nearby tissues.

The twelve Australian hospitals currently involved include:

Victoria: Royal Melbourne Hospital, Western Hospital, Monash Medical Centre, Peninsula Oncology Centre; WA: Mount Hospital, Sir Charles Gairdner Hospital; NSW: Sydney Adventist Hospital, St George Hospital, Royal North Shore Hospital, Nepean Hospital; Qld: Wesley Hospital; SA: Ashford Cancer Centre.

Prospective Australian patients can find out more about the SIRFLOX Study by visiting the website at http://www.sirtex.com.

• Additional
• References
• Citations