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dc.contributor.authorFrancis, PA
dc.contributor.authorPagani, O
dc.contributor.authorFleming, GF
dc.contributor.authorWalley, BA
dc.contributor.authorColleoni, M
dc.contributor.authorLáng, I
dc.contributor.authorGómez, HL
dc.contributor.authorTondini, C
dc.contributor.authorCiruelos, E
dc.contributor.authorBurstein, HJ
dc.contributor.authorBonnefoi, HR
dc.contributor.authorBellet, M
dc.contributor.authorMartino, S
dc.contributor.authorGeyer, CE
dc.contributor.authorGoetz, MP
dc.contributor.authorStearns, V
dc.contributor.authorPinotti, G
dc.contributor.authorPuglisi, F
dc.contributor.authorSpazzapan, S
dc.contributor.authorCliment, MA
dc.contributor.authorPavesi, L
dc.contributor.authorRuhstaller, T
dc.contributor.authorDavidson, NE
dc.contributor.authorColeman, R
dc.contributor.authorDebled, M
dc.contributor.authorBuchholz, S
dc.contributor.authorIngle, JN
dc.contributor.authorWiner, EP
dc.contributor.authorMaibach, R
dc.contributor.authorRabaglio-Poretti, M
dc.contributor.authorRuepp, B
dc.contributor.authorDi Leo, A
dc.contributor.authorCoates, AS
dc.contributor.authorGelber, RD
dc.contributor.authorGoldhirsch, A
dc.contributor.authorRegan, MM
dc.contributor.authorSOFT and TEXT Investigators and the International Breast Cancer Study Group
dc.date.accessioned2021-07-02T10:58:16Z
dc.date.available2021-07-02T10:58:16Z
dc.identifier.citationThe New England journal of medicine, 2018, 379 (2), pp. 122 - 137en_US
dc.identifier.issn0028-4793
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/4664
dc.identifier.eissn1533-4406en_US
dc.identifier.eissn1533-4406
dc.identifier.doi10.1056/nejmoa1803164en_US
dc.identifier.doi10.1056/nejmoa1803164
dc.description.abstract<h4>Background</h4>In the Suppression of Ovarian Function Trial (SOFT) and the Tamoxifen and Exemestane Trial (TEXT), the 5-year rates of recurrence of breast cancer were significantly lower among premenopausal women who received the aromatase inhibitor exemestane plus ovarian suppression than among those who received tamoxifen plus ovarian suppression. The addition of ovarian suppression to tamoxifen did not result in significantly lower recurrence rates than those with tamoxifen alone. Here, we report the updated results from the two trials.<h4>Methods</h4>Premenopausal women were randomly assigned to receive 5 years of tamoxifen, tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression in SOFT and to receive tamoxifen plus ovarian suppression or exemestane plus ovarian suppression in TEXT. Randomization was stratified according to the receipt of chemotherapy.<h4>Results</h4>In SOFT, the 8-year disease-free survival rate was 78.9% with tamoxifen alone, 83.2% with tamoxifen plus ovarian suppression, and 85.9% with exemestane plus ovarian suppression (P=0.009 for tamoxifen alone vs. tamoxifen plus ovarian suppression). The 8-year rate of overall survival was 91.5% with tamoxifen alone, 93.3% with tamoxifen plus ovarian suppression, and 92.1% with exemestane plus ovarian suppression (P=0.01 for tamoxifen alone vs. tamoxifen plus ovarian suppression); among the women who remained premenopausal after chemotherapy, the rates were 85.1%, 89.4%, and 87.2%, respectively. Among the women with cancers that were negative for HER2 who received chemotherapy, the 8-year rate of distant recurrence with exemestane plus ovarian suppression was lower than the rate with tamoxifen plus ovarian suppression (by 7.0 percentage points in SOFT and by 5.0 percentage points in TEXT). Grade 3 or higher adverse events were reported in 24.6% of the tamoxifen-alone group, 31.0% of the tamoxifen-ovarian suppression group, and 32.3% of the exemestane-ovarian suppression group.<h4>Conclusions</h4>Among premenopausal women with breast cancer, the addition of ovarian suppression to tamoxifen resulted in significantly higher 8-year rates of both disease-free and overall survival than tamoxifen alone. The use of exemestane plus ovarian suppression resulted in even higher rates of freedom from recurrence. The frequency of adverse events was higher in the two groups that received ovarian suppression than in the tamoxifen-alone group. (Funded by Pfizer and others; SOFT and TEXT ClinicalTrials.gov numbers, NCT00066690 and NCT00066703 , respectively.).en_US
dc.formatPrint-Electronicen_US
dc.format.extent122 - 137en_US
dc.languageengen_US
dc.language.isoengen_US
dc.rights.urihttp://www.rioxx.net/licenses/all-rights-reserveden_US
dc.subjectSOFT and TEXT Investigators and the International Breast Cancer Study Groupen_US
dc.subjectHumansen_US
dc.subjectBreast Neoplasmsen_US
dc.subjectNeoplasm Recurrence, Localen_US
dc.subjectTamoxifenen_US
dc.subjectAndrostadienesen_US
dc.subjectReceptor, erbB-2en_US
dc.subjectAntineoplastic Agents, Hormonalen_US
dc.subjectAromatase Inhibitorsen_US
dc.subjectDisease-Free Survivalen_US
dc.subjectChemotherapy, Adjuvanten_US
dc.subjectFollow-Up Studiesen_US
dc.subjectPremenopauseen_US
dc.subjectAdulten_US
dc.subjectMiddle Ageden_US
dc.subjectFemaleen_US
dc.subjectYoung Adulten_US
dc.subjectKaplan-Meier Estimateen_US
dc.titleTailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer.en_US
dc.typeJournal Article
dcterms.dateAccepted2018-06-01
rioxxterms.versionVoRen_US
rioxxterms.versionofrecord10.1056/nejmoa1803164en_US
dc.relation.isPartOfThe New England journal of medicineen_US
pubs.issue2en_US
pubs.notesNot knownen_US
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.publication-statusPublisheden_US
pubs.volume379en_US
pubs.embargo.termsNot knownen_US
icr.researchteamClinical Trials & Statistics Unit
dc.contributor.icrauthorBliss, Judithen_US


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