Evidence map›Paper›PMID 31157583›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Neoadjuvant Trastuzumab Emtansine and Pertuzumab in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Three-Year Outcomes From the Phase III KRISTINE Study.

Sara A Hurvitz, Miguel Martin, Kyung Hae Jung, Chiun-Sheng Huang, Nadia Harbeck, Vicente Valero, Daniil Stroyakovskiy, Hans Wildiers, Mario Campone, Jean-François Boileau and 11 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 155 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
155citing papers in PubMed, 8 pooled it
11.8field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

155 citing papers in PubMed, 8 syntheses or guidelines pooled it, 242 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Dual neoadjuvant blockade plus chemotherapy versus monotherapy for the treatment of women with non-metastatic HER2-positive breast cancer: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Pooled it
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  7. Guideline
  8. Pooled it
  9. Trial
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95 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 13 institutions in 8 countries.

Sara A HurvitzUniversity of California, Los Angeles, Los Angeles, CA.
Miguel MartinUniversidad Complutense, CUBERONC, GEICAM, Madrid, Spain.
Kyung Hae JungAsan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Chiun-Sheng HuangNational Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Republic of China.
Nadia HarbeckUniversity of Munich, Munich, Germany.
Vicente ValeroThe University of Texas MD Anderson Cancer Center, Houston, TX.
Daniil StroyakovskiyMoscow City Oncology Hospital 62, Moscow, Russia.
Hans WildiersUniversity Hospitals Leuven, Leuven, Belgium.
Mario CamponeCentre René Gauducheau, Saint-Herblain, France.
Jean-François BoileauMcGill University, Jewish General Hospital Segal Cancer Centre, Montréal, Québec, Canada.
Peter A FaschingUniversity Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.
Karen AfenjarTranslational Research in Oncology, Paris, France.
Gonzalo SperaTranslational Research in Oncology, Montevideo, Uruguay.
Vanesa Lopez-ValverdePAREXEL International GmbH, Berlin, Germany.
Chunyan SongGenentech, South San Francisco, CA.
Peter TraskGenentech, South San Francisco, CA.
Thomas BouletPAREXEL International GmbH, Berlin, Germany.
Joseph A SparanoMontefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY.
W Fraser SymmansThe University of Texas MD Anderson Cancer Center, Houston, TX.
Alastair M ThompsonBaylor College of Medicine, Houston, TX.
Dennis SlamonUniversity of California, Los Angeles, Los Angeles, CA.
The University of Texas MD Anderson Cancer Center · USUniversity of California, Los Angeles · USAlbert Einstein College of Medicine · USAsan Medical Center · KRBaylor College of Medicine · USGEICAM – Spanish Breast Cancer Group · ESInstitut Génétique Nantes Atlantique · FRJewish General Hospital · CALudwig-Maximilians-Universität München · DEMoscow City Oncology Hospital №62 · RUNational Taiwan University Hospital · TWTranslational Research in Oncology · FRUniversitätsklinikum Erlangen · DE

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeThe KRISTINE study compared neoadjuvant trastuzumab emtansine plus pertuzumab (T-DM1+P) with docetaxel, carboplatin, trastuzumab plus P (TCH+P) for the treatment human epidermal growth factor receptor 2-positive stage II to III breast cancer. T-DM1+P led to a lower pathologic complete response rate (44.4%

methodsPatients were randomly assigned to neoadjuvant T-DM1+P or TCH+P every 3 weeks for six cycles. Patients who received T-DM1+P continued adjuvant T-DM1+P, and patients who received TCH+P received adjuvant trastuzumab plus pertuzumab. Secondary end points included event-free survival (EFS), overall survival, patient-reported outcomes (measured from random assignment), and invasive disease-free survival (IDFS; measured from surgery).

resultsOf patients, 444 were randomly assigned (T-DM1+P, n = 223; TCH+P, n = 221). Median follow-up was 37 months. Risk of an EFS event was higher with TDM-1+P (hazard ratio [HR], 2.61 [95% CI, 1.36 to 4.98]) with more locoregional progression events before surgery (15 [6.7%]

conclusionCompared with TCH+P, T-DM1+P resulted in a higher risk of an EFS event owing to locoregional progression events before surgery, a similar risk of an IDFS event, fewer grade 3 or greater AEs during neoadjuvant treatment, and more AEs leading to treatment discontinuation during adjuvant treatment.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarboplatinChemotherapy, AdjuvantDisease-Free SurvivalDocetaxelErb-b2 Receptor Tyrosine KinasesFemaleHumansKaplan-Meier EstimateMiddle AgedNeoadjuvant TherapyTrastuzumabAntibodies, Monoclonal, HumanizedCarboplatinDocetaxelERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespertuzumabTrastuzumab

Identifiers

PMID31157583
PMCPMC6774816
OpenAlexW2948405934

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.