Duration of Adjuvant Aromatase-Inhibitor Therapy in Postmenopausal Breast Cancer.

Administration, Oral Aged Anastrozole / administration & dosage Antineoplastic Agents, Hormonal / administration & dosage Aromatase Inhibitors / administration & dosage Breast Neoplasms / drug therapy Chemotherapy, Adjuvant Disease-Free Survival Fractures, Bone / epidemiology Humans Kaplan-Meier Estimate Middle Aged Neoplasm Recurrence, Local / prevention & control Postmenopause Prospective Studies Receptors, Estrogen Receptors, Progesterone Tamoxifen / therapeutic use

Journal

The New England journal of medicine

ISSN: 1533-4406

Titre abrégé: N Engl J Med

Pays: United States

ID NLM: 0255562

Informations de publication

Date de publication:
29 07 2021

Historique:

entrez: 28 7 2021

pubmed: 29 7 2021

medline: 19 8 2021

Statut: ppublish

Résumé

For postmenopausal women with hormone-receptor-positive breast cancer, the most effective duration for adjuvant therapy with an aromatase inhibitor remains unclear. In this prospective, phase 3 trial, we randomly assigned postmenopausal women with hormone-receptor-positive breast cancer who had received 5 years of adjuvant endocrine therapy to receive the aromatase inhibitor anastrozole for an additional 2 years (2-year group, receiving a total of 7 years) or an additional 5 years (5-year group, receiving a total of 10 years). The primary end point was disease-free survival. The primary analysis included all the patients who were still participating in the trial and who had no recurrence 2 years after randomization (i.e., when treatment in the 2-year group had ended). Secondary end points were overall survival, contralateral breast cancer, second primary cancer, and clinical bone fracture. Among the 3484 women who were enrolled in the trial, 3208 remained in the trial without disease progression after the first 2 years of extended anastrozole treatment following randomization. Among these women, disease progression or death occurred in 335 women in each treatment group in the primary-analysis set at 8 years (hazard ratio, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P = 0.90). No between-group differences occurred in most secondary end points, and subgroup analyses did not indicate differences in any particular subgroup. The risk of clinical bone fracture was higher in the 5-year group than in the 2-year group (hazard ratio, 1.35; 95% CI, 1.00 to 1.84). In postmenopausal women with hormone-receptor-positive breast cancer who had received 5 years of adjuvant endocrine therapy, extending hormone therapy by 5 years provided no benefit over a 2-year extension but was associated with a greater risk of bone fracture. (Funded by AstraZeneca and the Austrian Breast and Colorectal Cancer Study Group; ABCSG-16/SALSA ClinicalTrials.gov number, NCT00295620.).

Sections du résumé

BACKGROUND

For postmenopausal women with hormone-receptor-positive breast cancer, the most effective duration for adjuvant therapy with an aromatase inhibitor remains unclear.

METHODS

In this prospective, phase 3 trial, we randomly assigned postmenopausal women with hormone-receptor-positive breast cancer who had received 5 years of adjuvant endocrine therapy to receive the aromatase inhibitor anastrozole for an additional 2 years (2-year group, receiving a total of 7 years) or an additional 5 years (5-year group, receiving a total of 10 years). The primary end point was disease-free survival. The primary analysis included all the patients who were still participating in the trial and who had no recurrence 2 years after randomization (i.e., when treatment in the 2-year group had ended). Secondary end points were overall survival, contralateral breast cancer, second primary cancer, and clinical bone fracture.

RESULTS

Among the 3484 women who were enrolled in the trial, 3208 remained in the trial without disease progression after the first 2 years of extended anastrozole treatment following randomization. Among these women, disease progression or death occurred in 335 women in each treatment group in the primary-analysis set at 8 years (hazard ratio, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P = 0.90). No between-group differences occurred in most secondary end points, and subgroup analyses did not indicate differences in any particular subgroup. The risk of clinical bone fracture was higher in the 5-year group than in the 2-year group (hazard ratio, 1.35; 95% CI, 1.00 to 1.84).

CONCLUSIONS

In postmenopausal women with hormone-receptor-positive breast cancer who had received 5 years of adjuvant endocrine therapy, extending hormone therapy by 5 years provided no benefit over a 2-year extension but was associated with a greater risk of bone fracture. (Funded by AstraZeneca and the Austrian Breast and Colorectal Cancer Study Group; ABCSG-16/SALSA ClinicalTrials.gov number, NCT00295620.).

Identifiants

DOI: 10.1056/NEJMoa2104162 PMID: 34320285

pubmed: 34320285

doi: 10.1056/NEJMoa2104162

doi:

Substances chimiques

Antineoplastic Agents, Hormonal 0

Aromatase Inhibitors 0

Receptors, Estrogen 0

Receptors, Progesterone 0

Tamoxifen 094ZI81Y45

Anastrozole 2Z07MYW1AZ

Banques de données

ClinicalTrials.gov

['NCT00295620']

Types de publication

Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

395-405

Investigateurs

Z Bago-Horvath (Z)

R Bartsch (R)

M Bolliger (M)

Y Devyatko (Y)

P Dubsky (P)

R Exner (R)

F Fitzal (F)

H Forstner (H)

N Frank (N)

T Fuereder (T)

M Gnant (M)

T Helbich (T)

Z Hola (Z)

D Hussian (D)

R Jakesz (R)

D Kandioler (D)

A Koennyue (A)

S Konrad (S)

B Korkmaz (B)

D Kauer-Dorner (D)

U Pluschnig (U)

F A Poglitsch (FA)

M Rudas (M)

H Schoen-Andres (H)

G G Steger (GG)

S Kacerovsky-Strobl (S)

M Urak (M)

J Widder (J)

K Wimmer (K)

A Galid (A)

V Riegler (V)

K Schliegl (K)

U Wieder (U)

P Aiginger (P)

M Blum (M)

L Öhler (L)

T D Papala (TD)

K Schlemmer (K)

U Schmidbauer (U)

A Bruns (A)

U Denison (U)

B Dixer (B)

I Duduleanu (I)

P Hnizdo (P)

M Janauer (M)

S Lazar (S)

T Modarressy-Onghaie (T)

M Mossig (M)

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