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Adapted from the NCI Cancer Bulletin, vol. 6/no. 11, June 2, 2009. (See the current issue ⁴.)

The combination of cisplatin ⁵ (Platinol) and gemcitabine ⁶ (Gemzar) helped patients with advanced, inoperable cancers of the biliary tract (gallbladder and bile duct) live several months longer than patients who received gemcitabine alone (11.7 versus 8.2 months), according to findings ⁷ presented at the 2009 annual meeting of the American Society of Clinical Oncology. For patients with these rare but difficult-to-treat cancers, the combination therapy will likely become the new standard treatment, the researchers predicted.

"We consider cisplatin and gemcitabine to now be the worldwide standard of care and the backbone for further studies of patients with advanced biliary tract cancers," lead investigator Juan Valle, M.D., of the University of Manchester in the United Kingdom said in a press briefing before the meeting. At the briefing, ASCO President Dr. Richard Schilsky called the study "definitive" and added: "As one who treats these patients in my own clinic, it's very comforting to have a clear standard of care to offer them."

The final-stage ABC-02 trial ⁸ included 410 patients with advanced biliary tract, gallbladder, or ampullary carcinoma. In addition to improving overall survival, the combination therapy delayed the progression of the disease by 2 months (8.5 versus 6.5 months). In both groups, side effects were similar, although there was a slight increase of neutropenia in patients receiving the combination therapy, the researchers said.

The next steps will involve trying to add some of the newer targeted cancer therapies to the combination and identifying which patients will benefit most from these treatments, noted Dr. Valle. He cautioned that adding another chemotherapy drug could increase toxicity without producing a benefit to patients.

Glossary Terms

A condition in which there is a lower-than-normal number of neutrophils (a type of white blood cell).

The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. The overall survival rate is often stated as a five-year survival rate, which is the percentage of people in a study or treatment group who are alive five years after diagnosis or treatment. Also called survival rate.