A recent Phase III clinical trial has found that a triplet chemotherapy regimen, combining gemcitabine, cisplatin, and albumin-bound paclitaxel, does not improve overall survival for patients with advanced, inoperable biliary tract cancers. The study, led by researchers at the University of Arizona Health Sciences and published in the Journal of Clinical Oncology, challenges the hypothesis that intensifying chemotherapy would lead to better outcomes for these patients.
The trial, which included 441 participants newly diagnosed with inoperable or metastatic biliary tract cancers, compared the triplet regimen to the standard two-drug combination of gemcitabine and cisplatin. Participants were randomly assigned to either treatment arm.
No Survival Advantage
"Comparing results from the two regimens showed no significant difference in the average length of time the patient survived after diagnosis with advanced, inoperable biliary tract cancer," said Dr. Rachna Shroff, the associate director of clinical investigations at the U of A Cancer Center and leader of the clinical trial. "Our research also indicates that the three-drug regimen may increase the toxicity of the treatment."
Biliary Tract Cancer and Current Treatment Landscape
Biliary tract cancer, while relatively rare, is aggressive and often spreads rapidly. The two-drug regimen of gemcitabine and cisplatin has been the standard of care for over a decade, but its effectiveness is limited. While newer precision treatments exist, they only benefit a small subset of patients, highlighting the need for more effective options.
Potential Subgroup Benefits
Despite the overall negative results, Dr. Shroff noted that the three-drug regimen might still be a viable option for patients with specific types of biliary tract cancers, such as gallbladder cancer, or for those whose cancer has not metastasized. In these subgroups, response rates and survival outcomes were higher.
Future Research Directions
Ongoing analyses will focus on identifying subsets of biliary cancer patients who may benefit from the three-drug regimen. The trial also resulted in the creation of the largest repository of biliary cancer specimens in the United States, which will be used for future research efforts. "Our accrual of more than 450 patients in a little more than two years really shows there is a need for new ways to help people with biliary tract cancer," said Dr. Shroff.
The research was supported in part by the National Cancer Institute, a division of the National Institutes of Health.
