New Standard Treatment for Advanced Biliary Tract Cancer: Cisplatin Plus Gemcitabine

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Good news for patients with advanced biliary tract cancer.  Combination of cisplatin and gemcitabine (Gemzar) have been shown to be an effective treatment option for patients with locally advanced or metastatic biliary tract cancer. 

In developed nations, biliary tract cancer is uncommon, but the incidence is increasing.  Most patients, when diagnosed, are already at advanced stage of the disease.  Although advanced biliary tract cancer responds to chemotherapy, there is no standard 1st line palliative regimen.

In the April 8 issue of the New England Journal of Medicine, British researchers reported that cisplatin plus gemcitabine was associated with a significant survival advantage, compared with gemcitabine alone. Toxicity was not substantially increased in patients who received the combination regimen.

The trial was conducted at 37 centers in the United Kingdom. A total of 410 patients with locally advanced or metastatic cholangiocarcinoma, gallbladder cancer, or ampullary cancer were randomized to receive either 1) cisplatin followed by gemcitabine or 2) gemcitabine alone for up to 24 weeks.

Tumor control (complete or partial response or stable disease) was observed in 81.4% of patients in the combination group and 71.8% in the gemcitabine-only group (P = .049). A complete response was observed in 1 patient from each treatment group.                          

Tumor Response for All Evaluable Patients 

All Evaluable Patients Gemcitabine Alone,
n=142 (%)
Cisplatin Plus Gemcitabine,
n=161 (%)
P value
Complete response 1 (0.7) 1 (0.6)  
Partial response 21 (14.8) 41 (25.5)  
Stable disease 80 (56.3) 89 (55.3)  
Tumor control* 102 (71.8) 131 (81.4) 0.049
Progressive disease 40 (28.2) 30 (18.6)


*Complete or partial response or stable disease

 The median overall survival was 11.7 months in the combination group and 8.1 months in the gemcitabine-only group, representing a 36% reduction in mortality. In addition, median progression-free survival was 8.0 months in the combination group and 5.0 months in the gemcitabine-only group (P < .001).

 Similar Adverse Events

Adverse events were similar in the 2 groups. A higher, but not significant, incidence of neutropenia was observed in the combination group and the infection rates were similar between the 2 groups. Patients in the gemcitabine-only group had significantly worse liver function (27.1%) than those in the combination group (16.7%) and the authors speculated the better liver function was a reflection of the better disease control in the combination group.

 N Engl J Med. 2010;362:1273-1281, 1335-1337.

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