According to the results of a Phase III clinical trial that will be presented at the 2009 annual meeting of the American Society of Clinical Oncology (ASCO), treatment of gallbladder or bile duct cancer with a combination of Gemzar® (gemcitabine) and cisplatin results in better survival and a lower risk of cancer progression than treatment with Gemzar alone.

Biliary tract cancer includes cancers of the gallbladder and bile ducts. These cancers are relatively rare and tend to be diagnosed at an advanced stage.

Patients diagnosed with advanced biliary tract cancer often have poor survival, and the optimal approach to treatment remains uncertain. Patients may be treated with chemotherapy, enrolled in a clinical trial, or given best supportive care (management of symptoms).

To evaluate a combination of chemotherapy drugs for the treatment of biliary tract cancer, researchers conducted a Phase III clinical trial among 324 patients with inoperable, advanced biliary tract cancer. Study participants were assigned to receive chemotherapy with Gemzar alone or Gemzar plus cisplatin. Information from the Phase III trial was combined with information from a prior Phase II trial, bringing the total number of study participants to 410.

  • Overall survival was 11.7 months among patients treated with Gemzar plus cisplatin compared with 8.3 months among patients treated with Gemzar alone.
  • Survival without cancer progression was 8.5 months among patients treated with Gemzar plus cisplatin compared with 6.5 months among patients treated with Gemzar alone.
  • Neutropenia (low white blood cell count) occurred slightly more often in patients treated with Gemzar plus cisplatin than in patients treated with Gemzar alone (22.6% versus 17.9%).

In a prepared statement, the lead researcher noted: “Based on these findings, we can now establish the first-ever standard of care for advanced biliary tract cancers. We found that adding cisplatin to [Gemzar] therapy significantly slowed cancer progression and extended survival for these rare but hard-to-treat cancers.”

Reference: 2009 ASCO Annual Meeting May 14 Presscast. Valle JW et al. Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC): Results of a multicenter, randomized phase III trial (the UK ABC-02 trial). Abstract #4503.

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