# KEYNOTE-590: pembrolizumab plus chemotherapy for first-line treatment of advanced oesophageal cancer

Source: https://onco.cc/key-papers/paper-keynote-590-lancet-2021/  
OnCo record `paper-keynote-590-lancet-2021` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding pembrolizumab to cisplatin-fluorouracil lengthened survival in advanced oesophageal cancer of both histologies, most clearly in squamous cell carcinoma and in tumours with high PD-L1, establishing chemo-immunotherapy as the first-line standard.

## Summary

Phase 3 placebo-controlled trial of 749 patients with untreated advanced oesophageal or Siewert type 1 junctional cancer (73 percent squamous) randomised to pembrolizumab or placebo with cisplatin and fluorouracil.

Median overall survival was 12.4 versus 9.8 months overall (hazard ratio 0.73), 13.9 versus 8.8 months in squamous cell carcinoma with combined positive score of 10 or more (hazard ratio 0.57), and progression-free survival was improved in all groups.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: The Lancet
- Year: 2021
- DOI: 10.1016/S0140-6736(21)01234-4
- Authors: Sun JM, Shen L, Shah MA, et al.
- Findings: Median overall survival 12.4 vs 9.8 months overall; hazard ratio 0.73.; Squamous with combined positive score 10 or more: 13.9 vs 8.8 months; hazard ratio 0.57.
- What it means: Pembrolizumab plus chemotherapy is a first-line standard for advanced oesophageal cancer, with the strongest recommendation for PD-L1-expressing tumours.
- Caveats: Benefit in adenocarcinoma and in low PD-L1 tumours was smaller.; Cisplatin-fluorouracil backbone is less used in some regions.

## Sources

- Lancet 2021: https://doi.org/10.1016/S0140-6736(21)01234-4
- PubMed: https://pubmed.ncbi.nlm.nih.gov/34454674/

## Connected records

- cancers: [Oesophageal and junctional adenocarcinoma](https://onco.cc/cancers/oesophageal-adenocarcinoma/), [Oesophageal squamous cell carcinoma](https://onco.cc/cancers/oesophageal-squamous-cell-carcinoma/)
- drugs: [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- trials: [KEYNOTE-590](https://onco.cc/trials/keynote-590/)
- journals: [The Lancet](https://onco.cc/journals/lancet/)

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