Evidence map›Paper›PMID 26951122›Full record

Observational studyInternational journal of clinical pharmacy2016

Trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel in the neoadjuvant setting of HER-2 positive breast cancer.

Moisés Uriarte-Pinto, Ángel Escolano-Pueyo, Vicente Gimeno-Ballester, Oihana Pascual-Martínez, María Reyes Abad-Sazatornil, María José Agustín-Ferrández

Registry-linked trialAbstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in International journal of clinical pharmacy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03123770 (The Efficacy and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Followed by Docetaxel in Breast Cancer Patients), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.4field-weighted citation impact, top 17% 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.

NCT03123770 phase4unknown statusnot on this map

The Efficacy and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Followed by Docetaxel in Breast Cancer Patients: A Multicentric, Open-label, Non-randomized Concurrent Control, Non-inferiority Trial

TypeinterventionalSponsorZhejiang UniversityRan2016 to 2021Enrolled384ConditionsBreast CancerArmsPegylated liposomal doxorubicin, Cyclophosphamide, Epirubicin, Docetaxel
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 16 citations in OpenAlex.

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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

6 authors at 1 institution in 1 country.

Moisés Uriarte-PintoPharmacy Department, Miguel Servet University Hospital, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain. muriarte215@gmail.com.
Ángel Escolano-PueyoPharmacy Department, Miguel Servet University Hospital, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
Vicente Gimeno-BallesterPharmacy Department, Miguel Servet University Hospital, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
Oihana Pascual-MartínezPharmacy Department, Miguel Servet University Hospital, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
María Reyes Abad-SazatornilPharmacy Department, Miguel Servet University Hospital, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
María José Agustín-FerrándezPharmacy Department, Miguel Servet University Hospital, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
Hospital Universitario Miguel Servet · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroudNeoadjuvant treatment based on the combination of trastuzumab plus chemotherapy is the standard of care in patients with HER2-positive early or locally advanced breast cancer. The concurrent use of trastuzumab, anthracyclines and taxanes is frequently used in this setting despite the potential cardiotoxicity of both anthracyclines and trastuzumab. However, not much information is available about this chemotherapy scheme.

objectiveWe wanted to evaluate the efficacy and safety profile of the combination of trastuzumab, liposome-encapsulated doxorubicin and paclitaxel as neoadjuvant scheme. We also tried to establish predictive factors of pathologic complete response.

settingThe study was carried out in a tertiary University Hospital of Spain.

methodThis is a descriptive study of the clinical practice performed in our hospital.

main outcome measureEfficacy was measured in terms of pathologic complete response, which was defined as the absence of invasive cancer cells in the breast and the axilla after neoadjuvant treatment.

resultsThirty patients were included, the median age was 48. Seventeen (56.7 %) were hormonal receptor (HR) positive, 14 (46.6 %) had IIIa-b clinical stage and one of them had inflammatory breast cancer. 12 patients (40 %) achieved pCR. Patients with HR-negative BC achieved a higher pCR rate than those ones with HR-positive BC (61.5 % and 23.5 %, respectively; p value = 0.035). 21 patients (70 %) underwent breast conservative surgery. The treatment was in general well tolerated, most frequent grade 3-4 adverse events were neutropenia (20 %), asthenia and liver enzyme alteration (10 %) and febrile neutropenia (6.7 %). No patient developed heart failure, but one (3.3 %) presented a 10 % asymptomatic absolute reduction in left ventricular fraction ejection.

conclusionsThe studied treatment for the neoadjuvant setting of HER2 positive breast cancer seems to be an effective therapeutic option. Despite the expected high rate of cardiotoxicity of this regimen, the study results shows that this treatment regimen appears to be safe. The combination of trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel should be considered for the treatment of HER2-overexpressing breast cancer.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDoxorubicinErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesHumansLiposomesMiddle AgedPaclitaxelTrastuzumabDoxorubicinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLiposomesPaclitaxelTrastuzumabCardiotoxicityDocetaxelHER2-breast cancerLiposomal doxorubicinTrastuzumab

Identifiers

PMID26951122
OpenAlexW2301809082

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.