Charlottesville, Va., April 15, 2008 - By combining the use of stents and photodynamic therapy, also called SpyGlass, physicians at the University of Virginia have been able to significantly increase survival rates for patients suffering from advanced cholangiocarcinoma, cancer of the liver bile duct.
"Most patients who develop this type of cancer cannot have surgery as it is diagnosed at such a late stage, so there was not much we could do except offer them palliative care," said University of Virginia Gastroenterologist Michel Kahaleh, M.D., lead investigator of the study. "By combining therapies, we saw an improved survival rate from just more than 7 months to more than 16 months."
In the study, recently published in the March 2008 issue of Clinical Gastroenterology and Hepatology, 48 patients were treated with advanced cholangiocarcinoma over a five year period. Twenty-nine patients were treated with biliary stents, with the remaining 19 being treated with the stents and photodynamic therapy (PDT). The stents decompress the bile ducts, maintaining liver function. The combined therapy group received treatment every three months, at which time all stents were replaced.
The combined therapy group had survival rates of 16.2 months compared to the stent-only group's 7.4 months. Mortality rates in the group that received PDT was 0, 16, and 56 percent at three, six, and 12 months respectively. Mortality rates in the stent-only group were 28, 52, and 82 percent respectively. Kahaleh said the number of stent-replacement procedures and PDT sessions were the only factors which significantly impacted survival.
Photodynamic Therapy treatment uses a photosensitizing agent (porfimer sodium in this study) which is activated using light of a specific wavelength, which then kills the targeted cells. PDT has been used for more than a decade to destroy cancer cells and reduce tumor size.
Cancer of the liver bile ducts is the second most common liver cancer and has significant mortality and mortality. Of the approximately 2,000 cases diagnosed each year, the vast majority of patients survive up to three months without intervention or four to six months with decompression treatment.
"Stents alone do not destroy or shrink the tumors or cancer cells. We were not surprised that the combined therapy offers a significant benefit to the patient, as this is accepted treatment in Europe," said Kahaleh. "However the FDA (Food and Drug Administration) wants to see more data so we have completed what we believe is the first published comparative American study on the treatment."
Kahaleh hopes to begin a multi-center trial within six months.