NEJM EvidenceDurvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer

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The phase 3 TOPAZ-1 trial evaluated durvalumab plus gemcitabine and cisplatin as first-line treatment for advanced biliary tract cancer. This double-blind, placebo-controlled study randomized 685 patients to receive either durvalumab or placebo in combination with chemotherapy. The trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival for patients receiving durvalumab plus chemotherapy compared to placebo plus chemotherapy, with similar safety profiles between the two groups.

Key Points:

• Durvalumab plus chemotherapy significantly improved overall survival compared to placebo plus chemotherapy (hazard ratio 0.80; 95% CI, 0.66 to 0.97; P=0.021).
• Median overall survival was 12.8 months (95% CI, 11.1 to 14.0) in the durvalumab group versus 11.5 months (95% CI, 10.1 to 12.5) in the placebo group.
• The 24-month overall survival rate was 24.9% (95% CI, 17.9 to 32.5) for durvalumab and 10.4% (95% CI, 4.7 to 18.8) for placebo.
• Progression-free survival was also improved with durvalumab (hazard ratio 0.75; 95% CI, 0.63 to 0.89; P=0.001).
• Objective response rates were 26.7% with durvalumab and 18.7% with placebo.
• Grade 3 or 4 adverse events occurred in 75.7% of patients in the durvalumab group and 77.8% in the placebo group.
• The addition of durvalumab to chemotherapy did not significantly increase toxicity compared to chemotherapy alone.

About 8,000 people in the United States are diagnosed with bile duct cancer in the US each year. This includes both intrahepatic (inside the liver) and extrahepatic (outside the liver) bile duct cancers. (American Cancer Society)

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