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Combination Gemcitabine-Capecitabine Used to Treat Advanced Biliary Cancers: Presented at ECCO

By Cameron Johnston

COPENHAGEN, DENMARK -- September 23, 2003 -- The combination of gemcitabine and capecitabine has been shown to be effective in stabilising patients with gallbladder cancer, prolonging survival somewhat, and with minimal toxicities, according to a study conducted in Toronto, Canada.

Cancer of the gallbladder is an extremely aggressive form of cancer, with survival times rarely exceeding 6 months. This form of cancer is also known to respond poorly, if at all, to traditional chemotherapy regimens.

The results of the study were presented here September 22^nd at ECCO 12: The European Cancer Conference.

According to the investigators, lead by Dr. J.J. Knox, Princess Margaret Hospital/University Health Network, Toronto, Canada, patients in the study were treated with 1000 mg/m² of gemcitabine on days 1 and 8 of a 21-day cycle, and with twice daily oral capecitabine 650 mg/m² on days 1 to 14.

Thirteen patients in the study had cancer of the gallbladder and 12 had cholangiocarcinoma, all of which were inoperable.

These patients were all chemotherapy naïve at enrolment, but after 4.2 months of follow-up and a mean of 3 treatment cycles, there were 6 partial responses, and 9 patients with stable disease. Median time to disease progression was 6.3 months and overall survival was 9.6 months.

There were no cases of grade 4 toxicity reported, but 20 patients had grade 3 neutropaenia, 12 had grade 3 thrombocytopaenia and 16 had grade 3 hand and foot syndrome.

The objective response rate seen in this study was equal to or better than what has been seen in other studies to date, but this study also showed disease stabilisation, an "encouraging" median survival, and a relatively mild toxicity profile, according to the researchers.

They are undertaking a phase III study to investigate this treatment regimen further, Dr. Knox said.


[Study title: Phase II Trial of Gemcitabine and Capecitabine (Gemcap) in Patients with Advanced Biliary Cancer. Abstract 191]

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