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Combo Treatment Beneficial in Biliary-Tract Cancer Study

MONDAY Nov. 23, 2009 -- A new combination drug therapy shows promise in treating patients with advanced biliary-tract cancers, researchers say.

The study from the Massachusetts General Hospital Cancer Center in Boston found that survival and tumor response in patients treated with bevacizumab (Avastin), an angiogenesis inhibitor that has helped slow the growth of other cancers, in addition to the chemotherapy regimen of gemcitabine and oxaliplatin -- a combined treatment called GEMOX-B -- was comparable to findings in previous studies in which patients were treated with gemcitabine and oxaliplatin alone.

In the new phase 2 trial, 35 biliary-tract cancer patients were given all three drugs intravenously (bevacizumab at 10 milligrams per kilogram, followed by gemcitabine at 1,000 milligrams per square meter, and oxaliplatin at 85 milligrams per square meter) on days 1 and 15, every 28 days. Whole-body PET scans were used to assess patients at the start of the study and at the end of the second cycle of treatment.

The researchers found that the overall tumor response rate was 40 percent (14 patients with confirmed partial responses) and stable disease was noted in another 10 patients (29 percent). The overall survival was found to be 12.7 months, with a median progression-free survival of seven months. However, progression-free survival at six months was below the targeted rate at 63 percent, they noted.

The most common negative side effects of GEMOX-B therapy were fatigue, an abnormally low number of white blood cells, peripheral neuropathy, high blood pressure and gastrointestinal problems, but the therapy was generally well-tolerated, the study authors pointed out.

The findings add to increasing evidence "supporting the combination of molecularly targeted agents with chemotherapy to further improve treatment outcomes in patients with biliary-tract cancers," the researchers wrote.

The findings are published in the Nov. 22 online edition of The Lancet Oncology.

Posted: November 2009


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