Researchers from the United Kingdom have reported that 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. The details of this Phase III clinical trial will be presented at the 2009 annual meeting of the American Society of Clinical Oncology (ASCO), May 29-June 2, in Orlando Florida.  

Approximately 7,200 new patients are diagnosed with cancer of the biliary tract each year in the United States, and 3,600 patients will die of biliary tract cancer, which makes up approximately 1% of all deaths from cancer. Biliary tract cancers are notoriously challenging to treat, especially after failure of surgery, which is the only curative therapy. On the basis of a review of the literature, researchers from Germany concluded in 2007 that Gemzar plus a platinum compound is the current standard of care for patients with advanced biliary tract carcinoma.

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 occurred slightly more often in patients treated with Gemzar plus cisplatin than in patients treated with Gemzar alone (22.6% versus 17.9%).

Comments: These data confirm that Gemzar and a platinum compound is the standard of care for patients with advanced biliary cancer. 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: 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). Journal of Clinical Oncology 2009;27:15s, Abstract #4503.