WEDNESDAY, April 7 (HealthDay News) -- Adding a second chemotherapy drug to the treatment regimen of people with biliary tract cancer improves their survival odds considerably, according to new research.
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This type of cancer -- which occurs in the bile duct and gall bladder -- is notoriously difficult to treat and often fatal.
"These are uncommon cancers, and the lack of any definitive data to support a regimen has meant that patients have had rather a raw deal, treated with an assortment of regimens and not given the option of clinical trials, as is the case for other, more common cancers," said Dr. John Bridgewater, senior author of a paper appearing in the April 8 issue of the New England Journal of Medicine.
The treatment verified in the study is already "what many would consider a standard treatment, and we know from informal communications with many colleagues that many across the world, not just in the U.S. or U.K., are already using this as a standard regimen," added Bridgewater, who is a senior lecturer in medical oncology at the Cancer Institute at the University College London.
Medical professionals have not been sure whether biliary tract cancers responded to chemotherapy at all.
"This establishes that chemotherapy works in this disease and that the combination of two drugs, which are standard, is actually superior to the one drug and, more likely than not, superior to doing nothing," said Dr. Tanios Bekaii-Saab, medical director of the gastrointestinal oncology division at the Ohio State University Comprehensive Cancer Center.
Although still relatively rare, the incidence of this type of cancer is on the rise, perhaps due to increases in gallstone disease and hepatitis C, the study and an accompanying editorial stated. According to information in the report on the study, about 9,000 new cases of biliary tract cancer are diagnosed in the United States each year.
Because it's so rare, Bekaii-Saab said, "there really are not a lot of options." For advanced cancer, it's different chemotherapy drugs and combinations. Early stage cancer can be removed surgically, he said.
The study involved 410 men and women with locally advanced or metastatic biliary tract cancer -- either gallbladder cancer, ampullary cancer (in a part of the intestine into which the pancreatic and bile ducts flow) or cholangiocarcinoma (in the bile ducts).
It took researchers at 37 institutions six years to amass that number of patients, the researchers said.
"Frankly, there's never been a study like this, meaning a phase 3 study of 400-plus patients looked at in a randomized way," Bekaii-Saab said.
Participants were randomized to receive either the chemotherapy agent cisplatin followed by gemcitabine or just gemcitabine. All were treated as outpatients.
Up till now, gemcitabine alone has been the mainstay of treatment, according to the editorial.
People in the combination therapy group lived an average of 11.7 months, compared with 8.1 months for those in the gemcitabine-alone group, a difference of 3.6 months.
Recurrences were delayed in the combination group compared with the single-therapy group, and tumor control was also better.
Side effects were about the same in both groups.
"Although, it may seem modest, 3.6 months is a significant benefit," Bridgewater said. "Many standard regimens have been established with improvements in survival of less than this, and the critical point is that this was achieved without increased toxicity."
Bekaii-Saab added that, without treatment, people with this type cancer face an average survival of three to four months. "This is tripling the chances of patients surviving this cancer in a stage 4 setting," he said. "Your life span goes from an average of a short four months to about a year. Also, when the tumor shrinks, you're feeling better."
Also, he said, about half will survive a year, and 20% up to two years.
"Without any treatment, zero percent will ever survive the two years," Bekaii-Saab said. "This is a significant improvement."
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SOURCES: John Bridgewater, M.D., Ph.D., senior lecturer, medical oncology, University College London Cancer Institute, London; Tanios Bekaii-Saab, M.D., medical director, division of gastrointestinal oncology, Ohio State University Comprehensive Cancer Center, Columbus, Ohio; April 8, 2010, New England Journal of Medicine