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Statements

Subject Item
n2:RIV%2F00843989%3A_____%2F11%3A00103150%21RIV13-MZ0-00843989
rdf:type
skos:Concept n16:Vysledek
dcterms:description
Trastuzumab improves survival in the adjuvant treatment of HER-positive breast cancer, although combined therapy with anthracycline-based regimens has been associated with cardiac toxicity. We wanted to evaluate the efficacy and safety of a new nonanthracycline regimen with trastuzumab. We randomly assigned 3222 women with HER2-positive early-stage breast cancer to receive doxorubicin and cyclophosphamide followed by docetaxel every 3 weeks (AC-T), the same regimen plus 52 weeks of trastuzumab (AC-T plus trastuzumab), or docetaxel and carboplatin plus 52 weeks of trastuzumab (TCH). The primary study end point was disease-free survival. Secondary end points were overall survival and safety. At a median follow-up of 65 months, 656 events triggered this protocol-specified analysis. The estimated disease-free survival rates at 5 years were 75% among patients receiving AC-T, 84% among those receiving AC-T plus trastuzumab, and 81% among those receiving TCH. Estimated rates of overall survival were 87%, 92%, and 91%, respectively. No significant differences in efficacy (disease-free or overall survival) were found between the two trastuzumab regimens, whereas both were superior to AC-T. The rates of congestive heart failure and cardiac dysfunction were significantly higher in the group receiving AC-T plus trastuzumab than in the TCH group (P<0.001). Eight cases of acute leukemia were reported: seven in the groups receiving the anthracycline-based regimens and one in the TCH group subsequent to receiving an anthracycline outside the study. The addition of 1 year of adjuvant trastuzumab significantly improved disease-free and overall survival among women with HER2-positive breast cancer. The risk-benefit ratio favored the nonanthracycline TCH regimen over AC-T plus trastuzumab, given its similar efficacy, fewer acute toxic effects, and lower risks of cardiotoxicity and leukemia. (Funded by Sanofi-Aventis and Genentech; BCIRG-006 ClinicalTrials.gov number, NCT00021255.) Trastuzumab improves survival in the adjuvant treatment of HER-positive breast cancer, although combined therapy with anthracycline-based regimens has been associated with cardiac toxicity. We wanted to evaluate the efficacy and safety of a new nonanthracycline regimen with trastuzumab. We randomly assigned 3222 women with HER2-positive early-stage breast cancer to receive doxorubicin and cyclophosphamide followed by docetaxel every 3 weeks (AC-T), the same regimen plus 52 weeks of trastuzumab (AC-T plus trastuzumab), or docetaxel and carboplatin plus 52 weeks of trastuzumab (TCH). The primary study end point was disease-free survival. Secondary end points were overall survival and safety. At a median follow-up of 65 months, 656 events triggered this protocol-specified analysis. The estimated disease-free survival rates at 5 years were 75% among patients receiving AC-T, 84% among those receiving AC-T plus trastuzumab, and 81% among those receiving TCH. Estimated rates of overall survival were 87%, 92%, and 91%, respectively. No significant differences in efficacy (disease-free or overall survival) were found between the two trastuzumab regimens, whereas both were superior to AC-T. The rates of congestive heart failure and cardiac dysfunction were significantly higher in the group receiving AC-T plus trastuzumab than in the TCH group (P<0.001). Eight cases of acute leukemia were reported: seven in the groups receiving the anthracycline-based regimens and one in the TCH group subsequent to receiving an anthracycline outside the study. The addition of 1 year of adjuvant trastuzumab significantly improved disease-free and overall survival among women with HER2-positive breast cancer. The risk-benefit ratio favored the nonanthracycline TCH regimen over AC-T plus trastuzumab, given its similar efficacy, fewer acute toxic effects, and lower risks of cardiotoxicity and leukemia. (Funded by Sanofi-Aventis and Genentech; BCIRG-006 ClinicalTrials.gov number, NCT00021255.)
dcterms:title
Adjuvant trastuzumab in HER2-positive breast cancer Adjuvant trastuzumab in HER2-positive breast cancer
skos:prefLabel
Adjuvant trastuzumab in HER2-positive breast cancer Adjuvant trastuzumab in HER2-positive breast cancer
skos:notation
RIV/00843989:_____/11:00103150!RIV13-MZ0-00843989
n16:predkladatel
n17:ico%3A00843989
n3:aktivita
n15:N
n3:aktivity
N
n3:cisloPeriodika
14
n3:dodaniDat
n12:2013
n3:domaciTvurceVysledku
n10:8002495 n10:3530523
n3:druhVysledku
n14:J
n3:duvernostUdaju
n4:S
n3:entitaPredkladatele
n6:predkladatel
n3:idSjednocenehoVysledku
184663
n3:idVysledku
RIV/00843989:_____/11:00103150
n3:jazykVysledku
n13:eng
n3:klicovaSlova
monoclonal antibody; ovarian cancer; randomized trials; tumor cells; HER2 status; chemotherapy; receptor; therapy; doxorubicin
n3:klicoveSlovo
n5:monoclonal%20antibody n5:tumor%20cells n5:HER2%20status n5:doxorubicin n5:ovarian%20cancer n5:chemotherapy n5:receptor n5:randomized%20trials n5:therapy
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[1D36EBA4A170]
n3:nazevZdroje
New England Journal of Medicine
n3:obor
n18:FD
n3:pocetDomacichTvurcuVysledku
2
n3:pocetTvurcuVysledku
423
n3:rokUplatneniVysledku
n12:2011
n3:svazekPeriodika
365
n3:tvurceVysledku
Chan, A. Slamon, D. Pawlicki, M. Mackey, J. Eiermann, W. Valero, V. Štefánek, Ivan Glaspy, J. Pinter, T. Robert, N. Vodvářka, Pavel Martin, M. Press, M. Pienkowski, T.
n3:wos
000295578700004
s:issn
0028-4793
s:numberOfPages
11
n11:doi
10.1056/NEJMoa0910383