Tailoring adjuvant endocrine therapy for premenopausal breast cancer

P. A. Francis, O. Pagani, G. F. Fleming, B. A. Walley, M. Colleoni, I. Láng, H. L. Gómez, C. Tondini, E. Ciruelos, H. J. Burstein, H. R. Bonnefoi, M. Bellet, S. Martino, C. E. Geyer, Matthew Philip Goetz, V. Stearns, G. Pinotti, F. Puglisi, S. Spazzapan, M. A. ClimentL. Pavesi, T. Ruhstaller, N. E. Davidson, R. Coleman, M. Debled, S. Buchholz, J. N. Ingle, E. P. Winer, R. Maibach, M. Rabaglio-Poretti, B. Ruepp, A. Di Leo, A. S. Coates, R. D. Gelber, A. Goldhirsch, M. M. Regan

Research output: Contribution to journalArticle

70 Citations (Scopus)

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 stratif ied 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 tamoxifenalone 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.

Original languageEnglish (US)
Pages (from-to)122-137
Number of pages16
JournalNew England Journal of Medicine
Volume379
Issue number2
DOIs
StatePublished - Jul 12 2018

Fingerprint

exemestane
Tamoxifen
Breast Neoplasms
Therapeutics
Recurrence
Drug Therapy
Disease-Free Survival
Survival Rate

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Francis, P. A., Pagani, O., Fleming, G. F., Walley, B. A., Colleoni, M., Láng, I., ... Regan, M. M. (2018). Tailoring adjuvant endocrine therapy for premenopausal breast cancer. New England Journal of Medicine, 379(2), 122-137. https://doi.org/10.1056/NEJMoa1803164

Tailoring adjuvant endocrine therapy for premenopausal breast cancer. / Francis, P. A.; Pagani, O.; Fleming, G. F.; Walley, B. A.; Colleoni, M.; Láng, I.; Gómez, H. L.; Tondini, C.; Ciruelos, E.; Burstein, H. J.; Bonnefoi, H. R.; Bellet, M.; Martino, S.; Geyer, C. E.; Goetz, Matthew Philip; Stearns, V.; Pinotti, G.; Puglisi, F.; Spazzapan, S.; Climent, M. A.; Pavesi, L.; Ruhstaller, T.; Davidson, N. E.; Coleman, R.; Debled, M.; Buchholz, S.; Ingle, J. N.; Winer, E. P.; Maibach, R.; Rabaglio-Poretti, M.; Ruepp, B.; Di Leo, A.; Coates, A. S.; Gelber, R. D.; Goldhirsch, A.; Regan, M. M.

In: New England Journal of Medicine, Vol. 379, No. 2, 12.07.2018, p. 122-137.

Research output: Contribution to journalArticle

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 2018, 'Tailoring adjuvant endocrine therapy for premenopausal breast cancer', New England Journal of Medicine, vol. 379, no. 2, pp. 122-137. https://doi.org/10.1056/NEJMoa1803164
Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Láng I et al. Tailoring adjuvant endocrine therapy for premenopausal breast cancer. New England Journal of Medicine. 2018 Jul 12;379(2):122-137. https://doi.org/10.1056/NEJMoa1803164
Francis, P. A. ; Pagani, O. ; Fleming, G. F. ; Walley, B. A. ; Colleoni, M. ; Láng, I. ; Gómez, H. L. ; Tondini, C. ; Ciruelos, E. ; Burstein, H. J. ; Bonnefoi, H. R. ; Bellet, M. ; Martino, S. ; Geyer, C. E. ; Goetz, Matthew Philip ; Stearns, V. ; Pinotti, G. ; Puglisi, F. ; Spazzapan, S. ; Climent, M. A. ; Pavesi, L. ; Ruhstaller, T. ; Davidson, N. E. ; Coleman, R. ; Debled, M. ; Buchholz, S. ; Ingle, J. N. ; Winer, E. P. ; Maibach, R. ; Rabaglio-Poretti, M. ; Ruepp, B. ; Di Leo, A. ; Coates, A. S. ; Gelber, R. D. ; Goldhirsch, A. ; Regan, M. M. / Tailoring adjuvant endocrine therapy for premenopausal breast cancer. In: New England Journal of Medicine. 2018 ; Vol. 379, No. 2. pp. 122-137.
@article{21ac302eeff54000b98265157edc7c06,
title = "Tailoring adjuvant endocrine therapy for premenopausal breast cancer",
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 stratif ied 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 tamoxifenalone 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.",
author = "Francis, {P. A.} and O. Pagani and Fleming, {G. F.} and Walley, {B. A.} and M. Colleoni and I. L{\'a}ng and G{\'o}mez, {H. L.} and C. Tondini and E. Ciruelos and Burstein, {H. J.} and Bonnefoi, {H. R.} and M. Bellet and S. Martino and Geyer, {C. E.} and Goetz, {Matthew Philip} and V. Stearns and G. Pinotti and F. Puglisi and S. Spazzapan and Climent, {M. A.} and L. Pavesi and T. Ruhstaller and Davidson, {N. E.} and R. Coleman and M. Debled and S. Buchholz and Ingle, {J. N.} and Winer, {E. P.} and R. Maibach and M. Rabaglio-Poretti and B. Ruepp and {Di Leo}, A. and Coates, {A. S.} and Gelber, {R. D.} and A. Goldhirsch and Regan, {M. M.}",
year = "2018",
month = "7",
day = "12",
doi = "10.1056/NEJMoa1803164",
language = "English (US)",
volume = "379",
pages = "122--137",
journal = "New England Journal of Medicine",
issn = "1533-4406",
publisher = "Massachussetts Medical Society",
number = "2",

}

TY - JOUR

T1 - Tailoring adjuvant endocrine therapy for premenopausal breast cancer

AU - Francis, P. A.

AU - Pagani, O.

AU - Fleming, G. F.

AU - Walley, B. A.

AU - Colleoni, M.

AU - Láng, I.

AU - Gómez, H. L.

AU - Tondini, C.

AU - Ciruelos, E.

AU - Burstein, H. J.

AU - Bonnefoi, H. R.

AU - Bellet, M.

AU - Martino, S.

AU - Geyer, C. E.

AU - Goetz, Matthew Philip

AU - Stearns, V.

AU - Pinotti, G.

AU - Puglisi, F.

AU - Spazzapan, S.

AU - Climent, M. A.

AU - Pavesi, L.

AU - Ruhstaller, T.

AU - Davidson, N. E.

AU - Coleman, R.

AU - Debled, M.

AU - Buchholz, S.

AU - Ingle, J. N.

AU - Winer, E. P.

AU - Maibach, R.

AU - Rabaglio-Poretti, M.

AU - Ruepp, B.

AU - Di Leo, A.

AU - Coates, A. S.

AU - Gelber, R. D.

AU - Goldhirsch, A.

AU - Regan, M. M.

PY - 2018/7/12

Y1 - 2018/7/12

N2 - 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 stratif ied 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 tamoxifenalone 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.

AB - 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 stratif ied 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 tamoxifenalone 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.

UR - http://www.scopus.com/inward/record.url?scp=85050003451&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85050003451&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1803164

DO - 10.1056/NEJMoa1803164

M3 - Article

C2 - 29863451

AN - SCOPUS:85050003451

VL - 379

SP - 122

EP - 137

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 1533-4406

IS - 2

ER -