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Based on the TOPAZ-1 study, do you now routinely include durvalumab in first line treatment of advanced bile duct cancer?

Is data sufficient to adopt this as the new standard of care? Can you comment on the reported regional and race-based variations in outcomes? Should that data be utilized in determining treatment?
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Do you plan to routinely add durvalumab to gem/cis in first line treatment of advanced bile duct cancer?

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3 Answers
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Medical Oncology · Memorial Sloan Kettering Cancer Center
Answered on

YES! And it is a strong yes. TOPAZ-1 is a very elaborate study with statistically and clinically significant data outcomes. See Do et al., Journal of Clinical Oncology 2022. What is better than holding chemotherapy after 6 months and keeping patients on single agent durvalumab? And avoiding all cumu...

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Mednet Member
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Medical Oncology · Dartmouth Cancer Center, Dartmouth-Hitchcock Medical Center
Answered on · Updated on

**I deleted the initial part of my answer to this question, as the TOPAZ-1 regimen has now been FDA-approved for treatment of metastatic biliary tract cancer.**

It is notable also that much of the separation of survival curves in TOPAZ-1 happened after cessation of active therapy in the control grou...

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Mednet Member
Mednet Member
Medical Oncology · Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Answered on

The TOPAZ-1 study showed that the combination of durvalumab plus gemcitabine/cisplatin prolonged overall survival over gemcitabine/cisplatin alone in advanced biliary tract cancer, and was also well tolerated. Although the survival benefit of durvalumab in this setting is modest, I do think the data...

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