Evidence map›Paper›PMID 35512402›Full record

Trial reportJournal of the National Cancer Institute2022

Impact of Age on Clinical Outcomes and Efficacy of Adjuvant Dual Anti-HER2 Targeted Therapy.

Matteo Lambertini, Shona Fielding, Sibylle Loibl, Wolfgang Janni, Emma Clark, Maria Alice Franzoi, Debora Fumagalli, Carmela Caballero, Luca Arecco, Sharon Salomoni and 12 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of the National Cancer Institute, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01358877 (A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 38% 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.

NCT01358877 phase3completednot on this map

A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

TypeinterventionalSponsorHoffmann-La RocheRan2011 to 2024Enrolled4,804ConditionsBreast CancerArms5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
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

22 authors at 15 institutions in 10 countries.

Matteo LambertiniDepartment of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Genova, Italy.ORCID 0000-0003-1797-5296
Shona FieldingFrontier Science Scotland, Kincraig, UK.
Sibylle LoiblGerman Breast Cancer Group (GBG), Germany.
Wolfgang JanniDepartment of Obstetrics and Gynecology, Universitaetsklinikum, Ulm, Germany.
Emma ClarkRoche Products Ltd, Welwyn Garden City, UK.
Maria Alice FranzoiInstitute Gustave Roussy, Villjuif, France.
Debora FumagalliBreast International Group (BIG), Brussels, Belgium.
Carmela CaballeroBreast International Group (BIG), Brussels, Belgium.
Luca AreccoDepartment of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Genova, Italy.ORCID 0000-0002-3818-0364
Sharon SalomoniDepartment of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Genova, Italy.
Noam F PondeIQVIA Biotech, Morrisville, NC, USA.
Francesca PoggioDepartment of Medical Oncology, U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
Hee Jeong KimDivision of Breast, Department of Surgery, College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Korea.
Cynthia Villarreal-GarzaBreast Cancer Center, Hospital Zambrano Hellion, Tecnologico de Monterrey, San Pedro Garza Garcia, Nuevo Leon, Mexico.
Olivia PaganiGeneva University Hospitals, Lugano University and Swiss Group for Clinical Cancer Research (SAKK), Geneva, Switzerland.
Shani Paluch-ShimonSharett Institute of Oncology, Hadassah University Hospital & Faculty of Medicine Hebrew University, Jerusalem, Israel.
Alberto BallestreroDepartment of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Genova, Italy.
Lucia Del MastroDepartment of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of Genova, Genova, Italy.ORCID 0000-0002-9546-5841
Martine PiccartDepartment of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium.
Jose BinesNational Cancer Institute (INCA), Rio de Janeiro, Brazil.
Ann H PartridgeDepartment of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Evandro de AzambujaDepartment of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium.ORCID 0000-0001-9501-4509
Ospedale Policlinico San Martino · ITBreast International Group · BEUniversité Libre de Bruxelles · BEAsan Medical Center · KRFrontier Agriculture (United Kingdom) · GBGerman Breast group · DEHarvard University · USHospital Zambrano Hellion · MXInstitut Gustave Roussy · FRInstituto Nacional de Câncer - INCA · BRIQVIA (United States) · USRoche (United Kingdom) · GBSwiss Group For Clinical Cancer Research · CHUniversity Hospital Ulm · DEUniversity of Genoa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundYoung age at breast cancer (BC) diagnosis has historically been a rationale for overtreatment. Limited data with short follow-up exist on the prognostic value of age at diagnosis in HER2-positive BC and the benefit of anti-HER2 therapy in young patients.

methodsAPHINITY (NCT01358877) is an international, placebo-controlled, double-blind randomized phase III trial in HER2-positive early BC patients investigating the addition of pertuzumab to adjuvant chemotherapy plus trastuzumab. The prognostic and predictive value of age on invasive disease-free survival (IDFS) as continuous and dichotomous variable (aged 40 years or younger and older than 40 years) was assessed. A subpopulation treatment effect pattern plot analysis was conducted to illustrate possible treatment-effect heterogeneity based on age as a continuous factor.

resultsOf 4804 included patients, 768 (16.0%) were aged 40 years or younger at enrollment. Median follow-up was 74 (interquartile range = 62-75) months. Young age was not prognostic either as dichotomous (hazard ratio [HR] = 1.06, 95% confidence interval [CI] = 0.84 to 1.33) or continuous (HR = 1.00, 95% CI = 1.00 to 1.01) variable. Lack of prognostic effect of age was observed irrespective of hormone receptor status and treatment arm. No statistically significant interaction was observed between age and pertuzumab effect (Pinteraction = 0.61). Adding pertuzumab improved IDFS for patients in the young (HR = 0.86, 95% CI = 0.56 to 1.32) and older (HR = 0.75, 95% CI = 0.62 to 0.92) cohorts. Similar results were observed irrespective of hormone receptor status. Subpopulation treatment effect pattern plot analysis confirmed the benefit of pertuzumab in 6-year IDFS across age subpopulations.

conclusionsIn patients with HER2-positive early BC treated with modern anticancer therapies, young age did not demonstrate either prognostic or predictive value, irrespective of hormone receptor status.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesAntineoplastic Combined Chemotherapy ProtocolsChemotherapy, AdjuvantFemaleHormonesHumansTrastuzumabTreatment OutcomeErb-b2 Receptor Tyrosine KinasesHormonesTrastuzumab

Identifiers

PMID35512402
PMCPMC9360461
OpenAlexW4229032102

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LicenceCC BY-NC-ND
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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.