Cisplatin plus gemcitabine new treatment option for biliary tract cancer

Patients with locally advanced or metastatic biliary cancer treated with a combination of cisplatin and gemcitabine were 36% less likely to die and 37% less likely to progress than patients assigned gemcitabine alone, according to the published results of the Advanced Biliary Cancer — or ABC — 02 trial.

“The results of the ABC-02 trial indicate that the cisplatin-gemcitabine combination should be considered a standard treatment option for patients with advanced bleary cancer,” according to Brian M. Wolpin, MD, MPH, and Robert J. Mayer, MD, from the Dana-Farber Cancer Institute, Brigham and Women’s Hospital and Harvard Medical School, Boston.

“In addition, it showed that collaboration can permit progress in the treatment of a relatively uncommon group of cancers,” they wrote in an accompanying editorial. “Although this three-month extension in survival among patients with biliary tract cancer is modest, it is a definite step forward.”

In the study, 410 patients with locally advanced or metastatic biliary cancer were randomly assigned cisplatin 25 mg/m² plus gemcitabine 1,000 mg/m² or gemcitabine 1,000 mg/m² alone. The primary endpoint was OS.

Patients were followed for a median of 8.2 months. During this time, 327 (79.8%) deaths occurred. Those patients assigned combination treatment had a median OS of 11.7 months vs. 8.1 months in patients assigned gemcitabine alone (P<.001). This was a 36% reduction in the risk of death (95% CI, 0.52-0.80).

Patients assigned combination treatment also survived longer without disease progression. PFS in these patients was eight months vs. five months in the gemcitabine alone group (P<.001; HR=0.63).

The rate of tumor control among patients assigned cisplatin plus gemcitabine was also higher than among patients on gemcitabine alone (81.4% vs. 71.8%; P=.049).

Patients in the combination group experienced a higher incidence of neutropenia, but overall, the rate of adverse events in the two groups were similar.

When originally presenting the data at the 2009 ASCO Annual Meeting, Juan Valle, MD, senior lecturer and medical oncologist at the University of Manchester, United Kingdom, and the Christie NHS Foundation Trust, said, “We consider cisplatin/gemcitabine to now be the worldwide standard of care and the backbone for further studies in patients with advanced biliary tracts cancers.”

Valle J. N Engl J Med. 362:1273-1281.