Evidence map›Paper›PMID 24457911›Full record

Trial reportBritish journal of cancer2014

Trastuzumab or lapatinib with standard chemotherapy for HER2-positive breast cancer: results from the GEICAM/2006-14 trial.

E Alba, J Albanell, J de la Haba, A Barnadas, L Calvo, P Sánchez-Rovira, M Ramos, F Rojo, O Burgués, E Carrasco and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00841828 (A Multicentre, Randomised Phase II to Compare Epirubicin), which is not on this map. Cited by 35 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 6 pooled it
5.4field-weighted citation impact, top 3% 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.

NCT00841828 phase2completednot on this map

A Multicentre, Randomised Phase II to Compare Epirubicin (E) & Cyclophosphamide (C) Treatment Plus Docetaxel (D) & Trastuzumab vs. E & C Treatment Plus D & Lapatinib in Women With Primary Resectable or Locally Advanced HER2+ Breast Cancer

TypeinterventionalSponsorSpanish Breast Cancer Research GroupRan2009 to 2013Enrolled102ConditionsBreast CancerArmsEpirubicin, Cyclophosphamide, Docetaxel, Lapatinib, Trastuzumab
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 6 syntheses or guidelines pooled it, 83 citations in OpenAlex.

  1. Pooled it
  2. 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
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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

15 authors at 10 institutions in 1 country.

E AlbaDepartment of Medical Oncology, Hospital Universitario Virgen de la Victoria, Málaga 29010, Spain.
J AlbanellHospital Parc de Salut Mar, 8003 Barcelona, Spain.
J de la HabaHospital Universitario Reina Sofía, 14004 Córdoba, Spain.
A BarnadasHospital Santa Creu i Sant Pau, Universidad Autónoma de Barcelona, 8041 Barcelona, Spain.
L CalvoComplejo Hospitalario Universitario de A Coruña, 15006A Coruña, Spain.
P Sánchez-RoviraHospital General de Jaén, 23007 Jaén, Spain.
M RamosCentro Oncológico de Galicia, 15009A Coruña, Spain.
F Rojo1] Hospital Parc de Salut Mar, 8003 Barcelona, Spain [2] Department of Pathology, Fundación Jiménez Díaz, 28040 Madrid, Spain.
O BurguésDepartment of Pathology and Oncology, Hospital Clínico Universitario de Valencia, 46010 Valencia, Spain.
E CarrascoGEICAM (Spanish Breast Cancer Research Group), 28703 Madrid, Spain.
R CaballeroGEICAM (Spanish Breast Cancer Research Group), 28703 Madrid, Spain.
I PorrasHospital Universitario Reina Sofía, 14004 Córdoba, Spain.
A TibauHospital Santa Creu i Sant Pau, Universidad Autónoma de Barcelona, 8041 Barcelona, Spain.
M C CámaraGEICAM (Spanish Breast Cancer Research Group), 28703 Madrid, Spain.
A LluchDepartment of Pathology and Oncology, Hospital Clínico Universitario de Valencia, 46010 Valencia, Spain.
GEICAM – Spanish Breast Cancer Group · ESHospital Clínico Universitario de Valencia · ESHospital Universitario Reina Sofía · ESUniversitat Autònoma de Barcelona · ESCentro Oncológico de Galicia · ESComplejo Hospitalario de Jaén · ESComplexo Hospitalario Universitario A Coruña · ESHospital Clínico Universitario Virgen de la Victoria · ESHospital Universitario Fundación Jiménez Díaz · ESParc de Salut · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe addition of trastuzumab (T) and lapatinib (L) to neoadjuvant chemotherapy increases the pathological complete response (pCR) rate in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We investigated the efficacy of T or L with neoadjuvant chemotherapy and specific efficacy biomarkers.

methodsPatients with stages I-III (including inflammatory) HER2-positive breast cancer were randomised to receive epirubicin (E) plus cyclophosphamide (C) × 4 cycles followed by docetaxel (D) plus either T (EC-DT) or L (EC-DL). End points included pCR (primary), clinical response, toxicity, and pCR-predictive biomarkers.

resultsWe randomised 102 patients to EC-DT (50) and EC-DL (52). Median age was 48, 56% were premenopausal and 58% had oestrogen receptor (ER)-positive tumours. Pathological complete response in breast was 52.1% (95% CI:38.0-66.2%) for EC-DT and 25.5% (95% CI:13.5-37.5%) for EC-DL (P=0.0065). Pathological complete response in breast and axilla was 47.9% for EC-DT and 23.5% for EC-DL (P=0.011). Grade 3-4 toxicity did not differ across treatments, except for diarrhoea (2% in EC-DT vs 13.5% in EC-DL, P=0.030). Multivariate analyses showed that treatment (P=0.036) and ER (P=0.014) were the only predictors of pCR in both groups.

conclusionEC-DT exhibited higher efficacy and lower toxicity than EC-DL. Of the different biomarkers studied, only the absence of ER expression was associated with increased pCR.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCyclophosphamideDocetaxelEpirubicinErb-b2 Receptor Tyrosine KinasesFemaleHumansLapatinibMiddle AgedNeoadjuvant TherapyQuinazolinesAntibodies, Monoclonal, HumanizedBiomarkers, TumorCyclophosphamideDocetaxelEpirubicinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLapatinibQuinazolinesTaxoidsTrastuzumab

Identifiers

PMID24457911
PMCPMC3950860
OpenAlexW2046958698

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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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.