{"entity":{"id":"paper-toga-trastuzumab-gastric-lancet-2010","kind":"paper","name":"ToGA (Bang 2010): trastuzumab with chemotherapy for HER2-positive advanced gastric cancer","aka":[],"tldr":"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.","asOf":"2026-09-08","links":[{"label":"Full text (DOI)","url":"https://doi.org/10.1016/S0140-6736(10)61121-X"},{"label":"ClinicalTrials.gov NCT01041404","url":"https://clinicaltrials.gov/study/NCT01041404"}],"tags":[],"related":["paper-slamon-trastuzumab-nejm-2001"],"cancers":["gastric"],"sections":[],"technologies":[],"targets":["her2"],"drugs":["trastuzumab","cisplatin","capecitabine","fluorouracil"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["her2-positive","ihc","os"],"trials":["toga"],"people":["bang-yung-jue"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"The Lancet","year":2010,"doi":"10.1016/S0140-6736(10)61121-X","authors":"Bang YJ, Van Cutsem E, Feyereislova A, et al.","paperType":"rct","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."],"whatItMeans":"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."],"changedPractice":true,"participants":594},"route":"/key-papers/paper-toga-trastuzumab-gastric-lancet-2010/","neighbours":{"paper":[{"id":"paper-slamon-trastuzumab-nejm-2001","kind":"paper","name":"Slamon 2001: adding trastuzumab to chemotherapy for HER2-positive metastatic breast cancer","route":"/key-papers/paper-slamon-trastuzumab-nejm-2001/"}],"cancer":[{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"gastric-her2-positive","kind":"cancer","name":"HER2-positive gastric cancer","route":"/cancers/gastric-her2-positive/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"term":[{"id":"her2-positive","kind":"term","name":"HER2-positive (IHC 3+ or ISH-amplified)","route":"/terms/her2-positive/"},{"id":"ihc","kind":"term","name":"Immunohistochemistry (IHC)","route":"/terms/ihc/"},{"id":"os","kind":"term","name":"Overall survival (OS)","route":"/terms/os/"}],"trial":[{"id":"toga","kind":"trial","name":"ToGA","route":"/trials/toga/"}],"person":[{"id":"bang-yung-jue","kind":"person","name":"Yung-Jue Bang","route":"/people/bang-yung-jue/"}]}}