Patients with advanced biliary cancer treated with cisplatin plus gemcitabine experience a significant survival advantage without added toxicity, according to a study published in The New England Journal of Medicine (2010;362(14):1273-1281).

For the study, John Bridgewater, MD, PhD, of the University College London Cancer Institute , and colleagues randomly assigned 410 patients with locally advanced or metastatic biliary tract cancer to receive either cisplatin followed by gemcitabine or gemcitabine alone for up to 24 weeks.

Results revealed that the chemotherapy combination improved survival by 3.6 months compared with gemcitabine alone in locally advanced or metastatic cases (11.7 versus 8.1 months). After a median 8.2 months of follow-up, the primary overall survival advantage of combination chemotherapy was accompanied by improved tumor control or by partial response or stable disease. Moreover, progression-free survival showed the advantage of cisplatin plus gemcitabine over gemcitabine alone.

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Researchers reported that the only disadvantage in adverse events with the chemotherapy combination was trend for excess neutropenia.

“We believe that it should become the standard for patients with biliary tract cancer and become the basis for further investigations,” Dr. Bridgewater stated. “While median overall survival had never formally been determined for biliary cancer, this study sets the standard benchmark at nearly 12 months for combination treatment, which contrasts with survival of not greater than six months in pancreatic cancer with any kind of treatment.”