# TOPAZ-1: durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer

Source: https://onco.cc/key-papers/paper-topaz-1-nejm-evidence-2022/  
OnCo record `paper-topaz-1-nejm-evidence-2022` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding durvalumab to gemcitabine-cisplatin lengthened survival in advanced bile duct and gallbladder cancer, the first improvement on chemotherapy alone in more than a decade, with about a quarter of patients alive at two years.

## Summary

Phase 3 placebo-controlled trial of 685 patients with previously untreated unresectable or metastatic biliary tract cancer randomised to durvalumab or placebo with gemcitabine and cisplatin for up to eight cycles followed by durvalumab or placebo maintenance.

Median overall survival was 12.8 versus 11.5 months (hazard ratio 0.80) with 24-month survival 24.9 versus 10.4 percent, progression-free survival 7.2 versus 5.7 months, and no meaningful increase in toxicity.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: NEJM Evidence
- Year: 2022
- DOI: 10.1056/EVIDoa2200015
- Authors: Oh DY, Ruth He A, Qin S, et al.
- Findings: Median overall survival 12.8 vs 11.5 months; hazard ratio 0.80.; 24-month overall survival 24.9 percent vs 10.4 percent.
- What it means: Durvalumab with gemcitabine-cisplatin is a first-line standard for advanced biliary tract cancer, with pembrolizumab (KEYNOTE-966) as the alternative.
- Caveats: Modest median gain; benefit concentrated in a minority of long-term survivors.; No validated biomarker to select patients.

## Sources

- NEJM Evid 2022: https://doi.org/10.1056/EVIDoa2200015
- PubMed: https://pubmed.ncbi.nlm.nih.gov/38319896/

## Connected records

- cancers: [Extrahepatic cholangiocarcinoma (perihilar and distal)](https://onco.cc/cancers/extrahepatic-cholangiocarcinoma/), [Intrahepatic cholangiocarcinoma](https://onco.cc/cancers/intrahepatic-cholangiocarcinoma/)
- drugs: [Cisplatin](https://onco.cc/drugs/cisplatin/), [Durvalumab](https://onco.cc/drugs/durvalumab/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/)
- trials: [TOPAZ-1](https://onco.cc/trials/topaz-1/)
- journals: [NEJM Evidence](https://onco.cc/journals/nejm-evidence/)

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