The American Society of Clinical Oncology (ASCO) said results of the Phase III BILCAP clinical trial for biliary tract cancer found that adding capecitabine to the patient treatment plan after surgery extended the survival rate by a median of 15 months.
The added oral chemotherapy treatment was compared to a control group that had surgery alone, the ASVO release said.
The 447 patients in the study were randomly assigned after surgery to either six months of treatment with capecitabine or observation alone. Those in the observation group lived for a median of 36 months, while those who received capecitabine lived a median of 51 months.
“Biliary tract cancer is a disease of decidedly unmet need as until recently there has been little research on treating the disease,” Dr. John Primrose, professor of surgery at the University of Southampton, United Kingdom and lead study author, xaid in the release. “Our trial is the first to enroll a sufficient number of patients to show that chemotherapy after surgery can have a significant improvement in survival, with modest side effects.”
Biliary cancer affects the bile ducts inside and outside of the gallbladder and liver. Only 20 percent of these cancers can be removed, and even with successful surgery, the five-year survival rate is only 10 percent.
“This study helps resolve long-standing questions about adjuvant treatment for biliary tract cancer, for which there has been no standard of care,” ASCO President Daniel Hayes said in the release. “This oral chemotherapy is widely available and can offer patients the chance to live more than a year longer.”