# ToGA (Bang 2010): trastuzumab with chemotherapy for HER2-positive advanced gastric cancer

Source: https://onco.cc/key-papers/paper-toga-trastuzumab-gastric-lancet-2010/  
OnCo record `paper-toga-trastuzumab-gastric-lancet-2010` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The trial that brought HER2 testing and trastuzumab to stomach cancer: adding the antibody to chemotherapy prolonged survival in patients whose gastric or junction cancers overexpressed HER2, about a fifth of those screened.

## Summary

ToGA screened 3,665 patients with advanced gastric or gastro-oesophageal junction cancer and found HER2 positivity in 22.1%. It randomised 594 HER2-positive patients to trastuzumab plus cisplatin and a fluoropyrimidine or to chemotherapy alone. Trastuzumab improved overall survival, progression-free survival and response rate, with the largest benefit in tumours with high HER2 expression (immunohistochemistry 3+ or 2+ with amplification), which became the definition of HER2 positivity used for gastric cancer.

## Fields

- Kind: Key paper
- Last checked: 2026-09-08
- Journal: The Lancet
- Year: 2010
- DOI: 10.1016/S0140-6736(10)61121-X
- Authors: Bang YJ, Van Cutsem E, Feyereislova A, et al.
- Findings: HER2 positivity in 22.1% of 3,665 screened patients; 594 randomised to trastuzumab plus chemotherapy or chemotherapy alone.; Median overall survival 13.8 vs 11.1 months, hazard ratio 0.74.; In tumours with IHC 3+ or IHC 2+ and FISH-positive HER2: median overall survival 16.0 vs 11.8 months.; Response rate 47% vs 35%; no increase in cardiac events of note.
- What it means: ToGA made gastric cancer the second disease treated by HER2 status and introduced gastric-specific HER2 scoring. It is the base on which trastuzumab deruxtecan and pembrolizumab combinations in HER2-positive gastric cancer have built.
- Caveats: Open-label design.; Benefit was concentrated in high HER2 expressers; IHC 2+ FISH-negative and IHC 0 or 1+ FISH-positive tumours gained little.; Chemotherapy backbone was cisplatin with capecitabine or fluorouracil.

## Sources

- Full text (DOI): https://doi.org/10.1016/S0140-6736(10)61121-X
- ClinicalTrials.gov NCT01041404: https://clinicaltrials.gov/study/NCT01041404

## Connected records

- key papers: [Slamon 2001: adding trastuzumab to chemotherapy for HER2-positive metastatic breast cancer](https://onco.cc/key-papers/paper-slamon-trastuzumab-nejm-2001/)
- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [HER2-positive gastric cancer](https://onco.cc/cancers/gastric-her2-positive/)
- targets: [HER2](https://onco.cc/targets/her2/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- terms: [HER2-positive (IHC 3+ or ISH-amplified)](https://onco.cc/terms/her2-positive/), [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/), [Overall survival (OS)](https://onco.cc/terms/os/)
- trials: [ToGA](https://onco.cc/trials/toga/)
- people: [Yung-Jue Bang](https://onco.cc/people/bang-yung-jue/)

---
JSON: https://onco.cc/api/v1/entities/paper-toga-trastuzumab-gastric-lancet-2010.json