According to a recent article, researchers have found that adding durvalumab to chemotherapy treatments results in prolonged survival rates in patients with advanced biliary tract cancer.
Biliary tract cancer, also called cholangiocarcinoma, is a rare cancer that affects the tubes that carry bile from the liver to the small intestine. There are multiple subtypes, all of which are based on the location of the tumor is the biliary tract.
Symptoms often do not present until the later stages of the cancer, and they include:
- Loss of appetite and weight
- Pale bowel movements
- Dark urine
- Pain on the right side of the abdomen
Durvalumab, also known as Imfinzi, is an anti-cancer drug that is classified as an Anti-PD-L1 monoclonal antibody. It is typically used to treat urothelial cancers and unresectable stage III non-small cell lung cancer.
Phase 3 Study
Researchers came to their conclusions through the results of a phase 3 randomized TOPAZ-1 trial. The study tested the combining of durvalumab and chemotherapy to see if it would increase the overall survival (OS) in patients diagnosed with biliary tract cancer.
The trial was an international, double-blind (both the patient and the researcher do not know if the patient received the treatment that is being tested) phase 3 trial. In total, there were 685 patients involved, all of whom had untreated, unresectable, locally advanced biliary tract cancer.
Each patient either received equal amounts of gemcitabine and cisplatin along with 1,500 mg of durvalumab every three weeks, or they received the chemotherapy drugs along with a placebo. This continued on unless there was disease progression or an unacceptable toxicity.
Results of the Study
The results of the study proved that adding durvalumab to chemotherapy did improve the overall survival rates and progress free survival of patients with biliary tract cancer significantly. The median time for these patients were 12.8 months compared to 11.5 months for those who received the placebo.
A year and a half portion of the trial showed 35.1% of patients on durvalumab survived in comparison to 25.6% of patients who received the placebo. In addition, the durvalumab group had higher rates of overall survival and overall response rate after the year and a half.
The study proved that adding durvalumab to chemotherapy results in increased survival without creating any serious adverse events.
Next, the researchers in the study are looking at the immunotherapy agents and biomarkers in biliary tract cancer. This is a hopeful step for the creation of new research and drugs.