Publications Repository

Publications Repository

View item 
  •   Home
  • ICR Divisions
  • Clinical Studies
  • View item
  • Home
  • ICR Divisions
  • Clinical Studies
  • View item
JavaScript is disabled for your browser. Some features of this site may not work without it.

Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer.

Thumbnail
View/Open
Published version (606.7Kb)
ICR Author
Bliss, Judith
Author
Francis, PA
Pagani, O
Fleming, GF
Walley, BA
Colleoni, M
Láng, I
Gómez, HL
Tondini, C
Ciruelos, E
Burstein, HJ
Bonnefoi, HR
Bellet, M
Martino, S
Geyer, CE
Goetz, MP
Stearns, V
Pinotti, G
Puglisi, F
Spazzapan, S
Climent, MA
Pavesi, L
Ruhstaller, T
Davidson, NE
Coleman, R
Debled, M
Buchholz, S
Ingle, JN
Winer, EP
Maibach, R
Rabaglio-Poretti, M
Ruepp, B
Di Leo, A
Coates, AS
Gelber, RD
Goldhirsch, A
Regan, MM
SOFT and TEXT Investigators and the International Breast Cancer Study Group
Show allShow less
Type
Journal Article
Metadata
Show full item record
Abstract
Background 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.Methods 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.Results 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.Conclusions 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.).
URI
https://repository.icr.ac.uk/handle/internal/4664
DOI
https://doi.org/10.1056/nejmoa1803164
Collections
  • Clinical Studies
Subject
SOFT and TEXT Investigators and the International Breast Cancer Study Group
Humans
Breast Neoplasms
Neoplasm Recurrence, Local
Tamoxifen
Androstadienes
Receptor, erbB-2
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Disease-Free Survival
Chemotherapy, Adjuvant
Follow-Up Studies
Premenopause
Adult
Middle Aged
Female
Young Adult
Kaplan-Meier Estimate
Research team
Clinical Trials & Statistics Unit
Clinical Trials & Statistics Unit
Language
eng
Date accepted
2018-06-01
Citation
The New England journal of medicine, 2018, 379 (2), pp. 122 - 137

Browse

All of ICR repositoryICR DivisionsBy issue dateAuthorsTitlesPublication TypesThis collectionBy issue dateAuthorsTitlesPublication Types
  • Login
  • Registered office: The Institute of Cancer Research, 123 Old Brompton Road, London, SW7 3RP
    A Charity, Not for Profit. Company Limited by Guarantee.
    Registered in England No. 534147. VAT Registration No. GB 849 0581 02.