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Gemcitabine plus cisplatin effective in treating advanced biliary tract cancer
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2009 ASCO Annual Meeting
The combination use of gemcitabine plus cisplatin to treat patients with advanced or metastatic biliary tract cancer reduced the risk of death by 32% and the risk of progression by 30% compared with treatment with gemcitabine alone.
The data from the phase-3 trial were presented ahead of the 2009 ASCO Annual Meeting.
“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,” said Juan Valle, MD, senior lecturer and medical
oncologist at the University of Manchester, United Kingdom, and the Christie
NHS Foundation Trust. 
Click
here to listen to a clip from Dr. Valle's presentation.
Researchers enrolled 410 patients aged older than 18 into the trial. Patients were randomly assigned to either cisplatin 25 mg/m2 followed by gemcitabine (Gemzar, Lilly) 1,000 mg/m2 (n=206) or to 1,000 mg/m2 gemcitabine alone (n=204).
PFS was longer in patients assigned to combination treatment vs. gemcitabine alone (8.5 months vs. 6.5 months).
OS was 11.7 months in those patients assigned combination treatment compared with 8.3 months for patients on gemcitabine alone (HR=0.70; 95% CI, 0.54-0.89).
The combination of gemcitabine and cisplatin was generally well tolerated. The most common adverse effect was moderate neutropenia.
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