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Dual HER2-blockade with pertuzumab and trastuzumab in HER2-positive early breast cancer: a subanalysis of data from the randomized phase III GeparSepto trial.

Identifieur interne : 000054 ( PubMed/Corpus ); précédent : 000053; suivant : 000055

Dual HER2-blockade with pertuzumab and trastuzumab in HER2-positive early breast cancer: a subanalysis of data from the randomized phase III GeparSepto trial.

Auteurs : S. Loibl ; C. Jackisch ; A. Schneeweiss ; S. Schmatloch ; B. Aktas ; C. Denkert ; H. Wiebringhaus ; S. Kümmel ; M. Warm ; S. Paepke ; M. Just ; C. Hanusch ; J. Hackmann ; J-U Blohmer ; M. Clemens ; S Dan Costa ; B. Gerber ; K. Engels ; V. Nekljudova ; G. Von Minckwitz ; M. Untch

Source :

RBID : pubmed:27831502

Abstract

The neoadjuvant phase III GeparSepto study showed that substituting nab-paclitaxel for standard solvent-based paclitaxel significantly improved the pathologic complete response (pCR) rate achieved with a sequential neoadjuvant chemotherapy regimen of paclitaxel, epirubicin and cyclophosphamide for high-risk primary breast cancer. Recent trials demonstrated that in HER2+ breast cancer pCR can be increased by using pertuzumab in addition to trastuzumab and chemotherapy. The present analysis focuses on efficacy and safety data from the subset of patients with HER2+ tumors from the GeparSepto trial (n=396) in comparison to the HER2- cohort.

DOI: 10.1093/annonc/mdw610
PubMed: 27831502

Links to Exploration step

pubmed:27831502

Le document en format XML

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<name sortKey="Wiebringhaus, H" sort="Wiebringhaus, H" uniqKey="Wiebringhaus H" first="H" last="Wiebringhaus">H. Wiebringhaus</name>
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<nlm:affiliation>Gynecology, St. Barbara-Klinik Hamm-Heessen, Hamm, Germany.</nlm:affiliation>
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<name sortKey="Kummel, S" sort="Kummel, S" uniqKey="Kummel S" first="S" last="Kümmel">S. Kümmel</name>
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<nlm:affiliation>Breast Unit, interdisziplinäres Brustzentrum an den Kliniken Essen-Mitte, Essen, Germany.</nlm:affiliation>
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<name sortKey="Warm, M" sort="Warm, M" uniqKey="Warm M" first="M" last="Warm">M. Warm</name>
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<nlm:affiliation>Breast Unit, Brustzentrum im Krankenhaus Köln-Holweide, Köln, Germany.</nlm:affiliation>
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<name sortKey="Hanusch, C" sort="Hanusch, C" uniqKey="Hanusch C" first="C" last="Hanusch">C. Hanusch</name>
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<name sortKey="Hackmann, J" sort="Hackmann, J" uniqKey="Hackmann J" first="J" last="Hackmann">J. Hackmann</name>
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<nlm:affiliation>Breast Unit, Marien Hospital Witten, Witten.</nlm:affiliation>
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<name sortKey="Blohmer, J U" sort="Blohmer, J U" uniqKey="Blohmer J" first="J-U" last="Blohmer">J-U Blohmer</name>
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<nlm:affiliation>Women's Clinic, Klinik für Gynäkologie am Campus Charité Mitte, Berlin, Germany.</nlm:affiliation>
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<name sortKey="Clemens, M" sort="Clemens, M" uniqKey="Clemens M" first="M" last="Clemens">M. Clemens</name>
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<nlm:affiliation>Women's Clinic, Klinikum Mutterhaus der Borromäerinnen, Trier, Germany.</nlm:affiliation>
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<name sortKey="Costa, S Dan" sort="Costa, S Dan" uniqKey="Costa S" first="S Dan" last="Costa">S Dan Costa</name>
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<nlm:affiliation>Gynecology, Universitäts-Frauenklinik, Magdeburg, Germany.</nlm:affiliation>
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<name sortKey="Gerber, B" sort="Gerber, B" uniqKey="Gerber B" first="B" last="Gerber">B. Gerber</name>
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<nlm:affiliation>Women's Clinic, Universitäts-Frauenklinik, Rostock, Germany.</nlm:affiliation>
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<name sortKey="Engels, K" sort="Engels, K" uniqKey="Engels K" first="K" last="Engels">K. Engels</name>
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<nlm:affiliation>Pathology, Zentrum für Pathologie, Zytologie und Molekularpathologie Neuss, Germany.</nlm:affiliation>
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<name sortKey="Nekljudova, V" sort="Nekljudova, V" uniqKey="Nekljudova V" first="V" last="Nekljudova">V. Nekljudova</name>
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<nlm:affiliation>German Breast Group Neu-Isenburg, Germany.</nlm:affiliation>
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<name sortKey="Von Minckwitz, G" sort="Von Minckwitz, G" uniqKey="Von Minckwitz G" first="G" last="Von Minckwitz">G. Von Minckwitz</name>
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<nlm:affiliation>German Breast Group Neu-Isenburg, Germany.</nlm:affiliation>
</affiliation>
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<name sortKey="Untch, M" sort="Untch, M" uniqKey="Untch M" first="M" last="Untch">M. Untch</name>
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<nlm:affiliation>Department of Gynecology and Obstetrics, HELIOS Klinikum Berlin-Buch, Berlin, Germany.</nlm:affiliation>
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<title level="j">Annals of oncology : official journal of the European Society for Medical Oncology</title>
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<div type="abstract" xml:lang="en">The neoadjuvant phase III GeparSepto study showed that substituting nab-paclitaxel for standard solvent-based paclitaxel significantly improved the pathologic complete response (pCR) rate achieved with a sequential neoadjuvant chemotherapy regimen of paclitaxel, epirubicin and cyclophosphamide for high-risk primary breast cancer. Recent trials demonstrated that in HER2+ breast cancer pCR can be increased by using pertuzumab in addition to trastuzumab and chemotherapy. The present analysis focuses on efficacy and safety data from the subset of patients with HER2+ tumors from the GeparSepto trial (n=396) in comparison to the HER2- cohort.</div>
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<DateCreated>
<Year>2016</Year>
<Month>11</Month>
<Day>10</Day>
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<Year>2016</Year>
<Month>11</Month>
<Day>11</Day>
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<Year>2016</Year>
<Month>Nov</Month>
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<Title>Annals of oncology : official journal of the European Society for Medical Oncology</Title>
<ISOAbbreviation>Ann. Oncol.</ISOAbbreviation>
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<ArticleTitle>Dual HER2-blockade with pertuzumab and trastuzumab in HER2-positive early breast cancer: a subanalysis of data from the randomized phase III GeparSepto trial.</ArticleTitle>
<ELocationID EIdType="pii" ValidYN="Y">mdw610</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The neoadjuvant phase III GeparSepto study showed that substituting nab-paclitaxel for standard solvent-based paclitaxel significantly improved the pathologic complete response (pCR) rate achieved with a sequential neoadjuvant chemotherapy regimen of paclitaxel, epirubicin and cyclophosphamide for high-risk primary breast cancer. Recent trials demonstrated that in HER2+ breast cancer pCR can be increased by using pertuzumab in addition to trastuzumab and chemotherapy. The present analysis focuses on efficacy and safety data from the subset of patients with HER2+ tumors from the GeparSepto trial (n=396) in comparison to the HER2- cohort.</AbstractText>
<AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">Patients with histologically confirmed breast cancer (n=1206) received 4 cycles of weekly paclitaxel [either solvent-based (Pac) or nab-paclitaxel (nab-Pac), according to randomization] followed by 4 cycles of epirubicin 90mg/m(2) plus cyclophosphamide 600 mg/m(2) q3w, with concurrent trastuzumab and pertuzumab q3w for those with HER2+ tumors. The primary endpoint was pCR defined as ypT0 ypN0.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Higher rates of pCR were achieved in HER2+ than in HER2- tumors (57.8% vs 22.0%, p<0.0001 ), with the highest rate in the HER2+/HR- cohort (71.0%; 66.7% Pac, 74.6% nab-Pac). In HER2+/HR+ tumors, the pCR rate was 52.9%; (49.7% Pac, 56.4% nab-Pac). Grade ≥3 toxicities were significantly more common in HER2+ than in HER2- patients, with grade 3-4 diarrhea in 7.6% vs 0.9% (p<0.001) and febrile neutropenia in 6.3% vs 3.3% (p=0.023) of patients. LVEF decreases from baseline were uncommon, with 2.0% vs 0.4% of patients showing decreases to <50% along with a ≥10% decrease from baseline.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">In HER2+ early breast cancer, a dual HER2-targeted combination of pertuzumab and trastuzumab, together with taxane-epirubicin-cyclophosphamide neoadjuvant chemotherapy, achieved high rates of pCR.</AbstractText>
<CopyrightInformation>© The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.</CopyrightInformation>
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