Evidence map›Paper›PMID 30706247›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2019

Biomarker analysis of the GATSBY study of trastuzumab emtansine versus a taxane in previously treated HER2-positive advanced gastric/gastroesophageal junction cancer.

Manish A Shah, Yoon-Koo Kang, Peter C Thuss-Patience, Atsushi Ohtsu, Jaffer A Ajani, Eric Van Cutsem, Silke Hoersch, Marie-Laurence Harle-Yge, Sanne Lysbet de Haas

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIComparative Study
PubMed Publisher
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01641939 (A Randomized, Multicenter, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine), which is not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01641939 phase2 / phase3terminatednot on this map

A Randomized, Multicenter, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine (T-DM1) Versus Taxane (Docetaxel Or Paclitaxel) In Patients With Previously Treated Locally Advanced Or Metastatic HER2-Positive Gastric Cancer, Including Adenocarcinoma Of The Gastroesophageal Junction

TypeinterventionalSponsorHoffmann-La RocheRan2012 to 2016Enrolled415ConditionsGastric CancerArmsTaxane, trastuzumab emtansine
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
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  5. Antibody-Drug Conjugates in the Treatment of Esophageal Cancer.Current treatment options in oncology · 2026
    Review
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  7. Advances in Targeting HER2 across Cancer Subtypes: A Pan-Tumor Approach.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Review
  8. Review
  9. Article
  10. Review
  11. Article
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  13. Antibody-drug conjugates in gastric cancer: from molecular landscape to clinical strategies.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2024
    Review
  14. Review
  15. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 6 countries.

Manish A ShahDivision of Hematology and Medical Oncology, Meyer Cancer Center of Weill Cornell Medical College, New York, NY, USA. mas9313@med.cornell.edu.ORCID 0000-0002-6913-9655
Yoon-Koo KangDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Peter C Thuss-PatienceDepartment of Hematology, Oncology and Tumor Immunology, Charité - University Medicine Berlin, Berlin, Germany.
Atsushi OhtsuDepartment of GI Oncology/Gastroenterology, National Cancer Center Hospital East, Kashiwa, Japan.
Jaffer A AjaniDepartment of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Eric Van CutsemDigestive Oncology, University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.
Silke HoerschStatistics Department, KOEHLER eClinical GmbH, Freiburg, Germany.
Marie-Laurence Harle-YgePharmaceutical Development Clinical Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Sanne Lysbet de HaasDepartment of Oncology Biomarker Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Roche (Switzerland) · CHCharité - Universitätsmedizin Berlin · DEKU Leuven · BENational Cancer Center Hospital East · JPNewYork–Presbyterian Hospital · USThe University of Texas MD Anderson Cancer Center · USUlsan College · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrespecified exploratory biomarker analyses of the phase II/III GATSBY study (NCT01641939) assessed whether patient subgroups experienced a survival benefit from trastuzumab emtansine (T-DM1) versus taxane therapy, and to advance understanding of HER2-positive advanced gastric/gastroesophageal junction cancer (AGC) disease biology.

methodsAdults with HER2-positive AGC whose disease progressed during/after first-line therapy were enrolled and randomized to receive T-DM1 [Stage 1: 3.6 mg/kg q3w, 2.4 mg/kg qw, or taxane (docetaxel/paclitaxel); Stage 2: 2.4 mg/kg qw or taxane]. Primary efficacy endpoint was overall survival (OS). Prespecified exploratory biomarkers included HER2, HER3, PTEN, PIK3CA mutation status, FcγR, and cMET. Tumor samples from patients who received 2.4 mg/kg T-DM1 (n = 228) or taxane (n = 117) were included.

resultsMedian OS was longer in subgroups with HER2 immunohistochemistry (IHC) 3+ [9.5 versus 8.3 months for T-DM1 versus taxane; hazard ratio (HR) 0.99 (95% CI 0.68-1.43)] versus HER2 IHC 2+/in situ hybridization-positive [5.2 versus 9.2 months for T-DM1 versus taxane; HR 1.53 (95% CI 0.94-2.50)] tumors. Trends towards increased median OS were also observed in subgroups with > versus ≤ median HER2 mRNA expression, higher versus lower HER2 gene copy number, HER2 gene ratio and H score, and homogenous or nonfocal HER2 IHC staining. T-DM1 was not associated with superior OS versus taxane in any subgroup.

conclusionsPatients with previously treated HER2-positive AGC with higher HER2 expression experienced a better treatment effect from T-DM1 than those with lower HER2 expression and may derive comparable survival benefits from T-DM1 and taxane therapy. CLINICAL TRIALS REGISTRATION: NCT01641939 ( https://clinicaltrials.gov/ct2/show/NCT01641939 ).

Indexed as

Polymorphism, GeneticAdolescentAdo-Trastuzumab EmtansineAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDocetaxelErb-b2 Receptor Tyrosine KinasesEsophagogastric JunctionFemaleFollow-Up StudiesHumansMaleMiddle AgedAdo-Trastuzumab EmtansineBiomarkers, TumorDocetaxelERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesPaclitaxelBiomarkersGastric cancerGastroesophageal junctionTrastuzumab emtansine

Identifiers

PMID30706247
OpenAlexW2914092341

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.