Unknown

Dataset Information

0

Adjuvant exemestane with ovarian suppression in premenopausal breast cancer.


ABSTRACT: BACKGROUND:Adjuvant therapy with an aromatase inhibitor improves outcomes, as compared with tamoxifen, in postmenopausal women with hormone-receptor-positive breast cancer. METHODS:In two phase 3 trials, we randomly assigned premenopausal women with hormone-receptor-positive early breast cancer to the aromatase inhibitor exemestane plus ovarian suppression or tamoxifen plus ovarian suppression for a period of 5 years. Suppression of ovarian estrogen production was achieved with the use of the gonadotropin-releasing-hormone agonist triptorelin, oophorectomy, or ovarian irradiation. The primary analysis combined data from 4690 patients in the two trials. RESULTS:After a median follow-up of 68 months, disease-free survival at 5 years was 91.1% in the exemestane-ovarian suppression group and 87.3% in the tamoxifen-ovarian suppression group (hazard ratio for disease recurrence, second invasive cancer, or death, 0.72; 95% confidence interval [CI], 0.60 to 0.85; P<0.001). The rate of freedom from breast cancer at 5 years was 92.8% in the exemestane-ovarian suppression group, as compared with 88.8% in the tamoxifen-ovarian suppression group (hazard ratio for recurrence, 0.66; 95% CI, 0.55 to 0.80; P<0.001). With 194 deaths (4.1% of the patients), overall survival did not differ significantly between the two groups (hazard ratio for death in the exemestane-ovarian suppression group, 1.14; 95% CI, 0.86 to 1.51; P=0.37). Selected adverse events of grade 3 or 4 were reported for 30.6% of the patients in the exemestane-ovarian suppression group and 29.4% of those in the tamoxifen-ovarian suppression group, with profiles similar to those for postmenopausal women. CONCLUSIONS:In premenopausal women with hormone-receptor-positive early breast cancer, adjuvant treatment with exemestane plus ovarian suppression, as compared with tamoxifen plus ovarian suppression, significantly reduced recurrence. (Funded by Pfizer and others; TEXT and SOFT ClinicalTrials.gov numbers, NCT00066703 and NCT00066690, respectively.).

SUBMITTER: Pagani O 

PROVIDER: S-EPMC4175521 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

altmetric image

Publications

Adjuvant exemestane with ovarian suppression in premenopausal breast cancer.

Pagani Olivia O   Regan Meredith M MM   Walley Barbara A BA   Fleming Gini F GF   Colleoni Marco M   Láng István I   Gomez Henry L HL   Tondini Carlo C   Burstein Harold J HJ   Perez Edith A EA   Ciruelos Eva E   Stearns Vered V   Bonnefoi Hervé R HR   Martino Silvana S   Geyer Charles E CE   Pinotti Graziella G   Puglisi Fabio F   Crivellari Diana D   Ruhstaller Thomas T   Winer Eric P EP   Rabaglio-Poretti Manuela M   Maibach Rudolf R   Ruepp Barbara B   Giobbie-Hurder Anita A   Price Karen N KN   Bernhard Jürg J   Luo Weixiu W   Ribi Karin K   Viale Giuseppe G   Coates Alan S AS   Gelber Richard D RD   Goldhirsch Aron A   Francis Prudence A PA  

The New England journal of medicine 20140601 2


<h4>Background</h4>Adjuvant therapy with an aromatase inhibitor improves outcomes, as compared with tamoxifen, in postmenopausal women with hormone-receptor-positive breast cancer.<h4>Methods</h4>In two phase 3 trials, we randomly assigned premenopausal women with hormone-receptor-positive early breast cancer to the aromatase inhibitor exemestane plus ovarian suppression or tamoxifen plus ovarian suppression for a period of 5 years. Suppression of ovarian estrogen production was achieved with th  ...[more]

Similar Datasets

| S-EPMC4341825 | biostudies-literature
| S-EPMC10419413 | biostudies-literature
| S-EPMC8376312 | biostudies-literature
| S-EPMC8409154 | biostudies-literature
| S-EPMC4562429 | biostudies-literature
| S-EPMC4872316 | biostudies-literature
| S-EPMC4872319 | biostudies-literature
| S-EPMC6193457 | biostudies-literature
| S-EPMC8902441 | biostudies-literature
| S-EPMC7059882 | biostudies-literature