Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer

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Background: The recurrence score based on the 21-gene breast cancer assay predicts chemotherapy benefit if it is high and a low risk of recurrence in the absence of chemotherapy if it is low; however, there is uncertainty about the benefit of chemotherapy for most patients, who have a midrange score...

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Autores: Sparano, JA, Gray, RJ, Makower, DF, Pritchard, KI, Albain, KS, Hayes, DF, Geyer, CE Jr, Dees, EC, Goetz, MP, Olson, JA Jr, Lively, T, Badve, SS, Saphner, TJ, Wagner, LI, Whelan, TJ, Ellis, MJ, Paik, S, Wood, WC, Ravdin, PM, Keane, MM, Gomez Moreno, HL, Reddy, PS, Goggins, TF, Mayer, IA, Brufsky, AM, Toppmeyer, DL, Kaklamani, VG, Berenberg, JL, Abrams, J, Sledge, GW Jr
Formato: artículo
Fecha de Publicación:2018
Institución:Instituto Nacional de Enfermedades Neoplásicas
Repositorio:INEN-Institucional
Lenguaje:inglés
OAI Identifier:oai:repositorio.inen.sld.pe:inen/136
Enlace del recurso:https://repositorio.inen.sld.pe/handle/inen/136
Nivel de acceso:acceso abierto
Materia:https://purl.org/pe-repo/ocde/ford#3.02.21
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spelling Sparano, JAGray, RJMakower, DFPritchard, KIAlbain, KSHayes, DFGeyer, CE JrDees, ECGoetz, MPOlson, JA JrLively, TBadve, SSSaphner, TJWagner, LIWhelan, TJEllis, MJPaik, SWood, WCRavdin, PMKeane, MMGomez Moreno, HLReddy, PSGoggins, TFMayer, IABrufsky, AMToppmeyer, DLKaklamani, VGBerenberg, JLAbrams, JSledge, GW Jr2024-07-01T16:28:56Z2024-07-01T16:28:56Z2018Background: The recurrence score based on the 21-gene breast cancer assay predicts chemotherapy benefit if it is high and a low risk of recurrence in the absence of chemotherapy if it is low; however, there is uncertainty about the benefit of chemotherapy for most patients, who have a midrange score. Methods: We performed a prospective trial involving 10,273 women with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, axillary node-negative breast cancer. Of the 9719 eligible patients with follow-up information, 6711 (69%) had a midrange recurrence score of 11 to 25 and were randomly assigned to receive either chemoendocrine therapy or endocrine therapy alone. The trial was designed to show noninferiority of endocrine therapy alone for invasive disease-free survival (defined as freedom from invasive disease recurrence, second primary cancer, or death). Results: Endocrine therapy was noninferior to chemoendocrine therapy in the analysis of invasive disease-free survival (hazard ratio for invasive disease recurrence, second primary cancer, or death [endocrine vs. chemoendocrine therapy], 1.08; 95% confidence interval, 0.94 to 1.24; P=0.26). At 9 years, the two treatment groups had similar rates of invasive disease-free survival (83.3% in the endocrine-therapy group and 84.3% in the chemoendocrine-therapy group), freedom from disease recurrence at a distant site (94.5% and 95.0%) or at a distant or local-regional site (92.2% and 92.9%), and overall survival (93.9% and 93.8%). The chemotherapy benefit for invasive disease-free survival varied with the combination of recurrence score and age (P=0.004), with some benefit of chemotherapy found in women 50 years of age or younger with a recurrence score of 16 to 25. Conclusions: Adjuvant endocrine therapy and chemoendocrine therapy had similar efficacy in women with hormone-receptor-positive, HER2-negative, axillary node-negative breast cancer who had a midrange 21-gene recurrence score, although some benefit of chemotherapy was found in some women 50 years of age or younger. (Funded by the National Cancer Institute and others; TAILORx ClinicalTrials.gov number, NCT00310180 .).application/pdf10.1056/NEJMoa1804710https://repositorio.inen.sld.pe/handle/inen/136engN Engl J MedUSMassachussetts Medical Societyinfo:eu-repo/semantics/openAccessdc.rights.uri: https//creativecomons.org/licenses/by/4.0/https://purl.org/pe-repo/ocde/ford#3.02.21Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancerinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionreponame:INEN-Institucionalinstname:Instituto Nacional de Enfermedades Neoplásicasinstacron:INENPublicationORIGINAL2018_Sparano, gray.pdfapplication/pdf348210https://repositorio.inen.sld.pe/bitstreams/5dfbadda-c976-483b-9561-c738a8cdd2e6/download3247011b66552405b101ac32127c9475MD51TEXT2018_Sparano, gray.pdf.txt2018_Sparano, gray.pdf.txtExtracted texttext/plain53216https://repositorio.inen.sld.pe/bitstreams/1e95400c-04f9-4306-9daa-c892c4a5acef/download5f4e28c4ee455e94d44859ee355f4c95MD52THUMBNAIL2018_Sparano, gray.pdf.jpg2018_Sparano, gray.pdf.jpgGenerated Thumbnailimage/jpeg5941https://repositorio.inen.sld.pe/bitstreams/5755e758-c5b4-41cb-86b1-750b3e925a71/download71c7959b3ceae48e567ae81bcdf57e8fMD53inen/136oai:repositorio.inen.sld.pe:inen/1362024-10-23 17:24:04.76dc.rights.uri: https//creativecomons.org/licenses/by/4.0/info:eu-repo/semantics/openAccesshttps://repositorio.inen.sld.peRepositorio INENrepositorioinendspace@gmail.com
dc.title.none.fl_str_mv Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer
title Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer
spellingShingle Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer
Sparano, JA
https://purl.org/pe-repo/ocde/ford#3.02.21
title_short Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer
title_full Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer
title_fullStr Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer
title_full_unstemmed Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer
title_sort Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer
author Sparano, JA
author_facet Sparano, JA
Gray, RJ
Makower, DF
Pritchard, KI
Albain, KS
Hayes, DF
Geyer, CE Jr
Dees, EC
Goetz, MP
Olson, JA Jr
Lively, T
Badve, SS
Saphner, TJ
Wagner, LI
Whelan, TJ
Ellis, MJ
Paik, S
Wood, WC
Ravdin, PM
Keane, MM
Gomez Moreno, HL
Reddy, PS
Goggins, TF
Mayer, IA
Brufsky, AM
Toppmeyer, DL
Kaklamani, VG
Berenberg, JL
Abrams, J
Sledge, GW Jr
author_role author
author2 Gray, RJ
Makower, DF
Pritchard, KI
Albain, KS
Hayes, DF
Geyer, CE Jr
Dees, EC
Goetz, MP
Olson, JA Jr
Lively, T
Badve, SS
Saphner, TJ
Wagner, LI
Whelan, TJ
Ellis, MJ
Paik, S
Wood, WC
Ravdin, PM
Keane, MM
Gomez Moreno, HL
Reddy, PS
Goggins, TF
Mayer, IA
Brufsky, AM
Toppmeyer, DL
Kaklamani, VG
Berenberg, JL
Abrams, J
Sledge, GW Jr
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Sparano, JA
Gray, RJ
Makower, DF
Pritchard, KI
Albain, KS
Hayes, DF
Geyer, CE Jr
Dees, EC
Goetz, MP
Olson, JA Jr
Lively, T
Badve, SS
Saphner, TJ
Wagner, LI
Whelan, TJ
Ellis, MJ
Paik, S
Wood, WC
Ravdin, PM
Keane, MM
Gomez Moreno, HL
Reddy, PS
Goggins, TF
Mayer, IA
Brufsky, AM
Toppmeyer, DL
Kaklamani, VG
Berenberg, JL
Abrams, J
Sledge, GW Jr
dc.subject.ocde.none.fl_str_mv https://purl.org/pe-repo/ocde/ford#3.02.21
topic https://purl.org/pe-repo/ocde/ford#3.02.21
description Background: The recurrence score based on the 21-gene breast cancer assay predicts chemotherapy benefit if it is high and a low risk of recurrence in the absence of chemotherapy if it is low; however, there is uncertainty about the benefit of chemotherapy for most patients, who have a midrange score. Methods: We performed a prospective trial involving 10,273 women with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, axillary node-negative breast cancer. Of the 9719 eligible patients with follow-up information, 6711 (69%) had a midrange recurrence score of 11 to 25 and were randomly assigned to receive either chemoendocrine therapy or endocrine therapy alone. The trial was designed to show noninferiority of endocrine therapy alone for invasive disease-free survival (defined as freedom from invasive disease recurrence, second primary cancer, or death). Results: Endocrine therapy was noninferior to chemoendocrine therapy in the analysis of invasive disease-free survival (hazard ratio for invasive disease recurrence, second primary cancer, or death [endocrine vs. chemoendocrine therapy], 1.08; 95% confidence interval, 0.94 to 1.24; P=0.26). At 9 years, the two treatment groups had similar rates of invasive disease-free survival (83.3% in the endocrine-therapy group and 84.3% in the chemoendocrine-therapy group), freedom from disease recurrence at a distant site (94.5% and 95.0%) or at a distant or local-regional site (92.2% and 92.9%), and overall survival (93.9% and 93.8%). The chemotherapy benefit for invasive disease-free survival varied with the combination of recurrence score and age (P=0.004), with some benefit of chemotherapy found in women 50 years of age or younger with a recurrence score of 16 to 25. Conclusions: Adjuvant endocrine therapy and chemoendocrine therapy had similar efficacy in women with hormone-receptor-positive, HER2-negative, axillary node-negative breast cancer who had a midrange 21-gene recurrence score, although some benefit of chemotherapy was found in some women 50 years of age or younger. (Funded by the National Cancer Institute and others; TAILORx ClinicalTrials.gov number, NCT00310180 .).
publishDate 2018
dc.date.accessioned.none.fl_str_mv 2024-07-01T16:28:56Z
dc.date.available.none.fl_str_mv 2024-07-01T16:28:56Z
dc.date.issued.fl_str_mv 2018
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