Durvalumab Combined with Chemotherapy in Advanced Biliary Tract and Gallbladder Cancer
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Reviewed & Translated by Dat Tien Nguyen, B.A, ScM.
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Posted on July 8th, 2024
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The combination of gemcitabine and cisplatin is commonly used to treat advanced biliary tract and gallbladder cancer, but the median survival rate with this regimen is less than 12 months. Durvalumab, a monoclonal antibody, enhances the immune system's antitumor activity by disrupting the immunosuppressive interaction between PD-1 and PD-1L. AstraZeneca sponsored a study to evaluate the effectiveness of Durvalumab in treating advanced biliary tract and gallbladder cancer.
The phase 3 clinical study included 685 patients with a median age of 64 years. Over half had intrahepatic cholangiocarcinoma, around 20% had extrahepatic primary tumors, and approximately one-quarter had gallbladder cancer. More than 80% had metastatic disease, primarily to the lymph nodes and liver, with about 30% metastasizing to the respiratory tract and peritoneum. Patients were randomly assigned to receive either 1500 mg of durvalumab or a placebo intravenously. Both treatments were given on day 1 of every 3-week cycle, alongside gemcitabine (1000 mg/m²) and cisplatin (25 mg/m²) on days 1 and 8 of each cycle. After eight cycles of concurrent immunotherapy and chemotherapy, gemcitabine-cisplatin was discontinued. Durvalumab or placebo administration continued on a 4-week cycle. After nearly 2 years of follow-up, the 24-month survival rate was 23.6% for those treated with durvalumab in conjunction with gemcitabine and cisplatin and 11.5% for those given the placebo with the chemotherapy combination. There was no significant difference in the incidence of moderate-to-severe adverse events between the durvalumab and placebo groups.
The phase 3 clinical study included 685 patients with a median age of 64 years. Over half had intrahepatic cholangiocarcinoma, around 20% had extrahepatic primary tumors, and approximately one-quarter had gallbladder cancer. More than 80% had metastatic disease, primarily to the lymph nodes and liver, with about 30% metastasizing to the respiratory tract and peritoneum. Patients were randomly assigned to receive either 1500 mg of durvalumab or a placebo intravenously. Both treatments were given on day 1 of every 3-week cycle, alongside gemcitabine (1000 mg/m²) and cisplatin (25 mg/m²) on days 1 and 8 of each cycle. After eight cycles of concurrent immunotherapy and chemotherapy, gemcitabine-cisplatin was discontinued. Durvalumab or placebo administration continued on a 4-week cycle. After nearly 2 years of follow-up, the 24-month survival rate was 23.6% for those treated with durvalumab in conjunction with gemcitabine and cisplatin and 11.5% for those given the placebo with the chemotherapy combination. There was no significant difference in the incidence of moderate-to-severe adverse events between the durvalumab and placebo groups.