Patients with Slowly Proliferative Early Breast Cancer Have Low Five-Year Recurrence Rates in a Phase III Adjuvant Trial of Capecitabine.
Clin Cancer Res
; 21(19): 4305-11, 2015 Oct 01.
Article
em En
| MEDLINE
| ID: mdl-26041745
ABSTRACT
PURPOSE:
We conducted a randomized phase III study to determine whether patients with early breast cancer would benefit from the addition of capecitabine (X) to a standard regimen of doxorubicin (A) plus cyclophosphamide (C) followed by docetaxel (T). EXPERIMENTALDESIGN:
Treatment comprised eight cycles of ACâT (T dose 100 mg/m(2) on day 1) or ACâXT (X dose 825 mg/m(2) twice daily, days 1-14; T dose 75 mg/m(2) on day 1). The primary endpoint was 5-year disease-free survival (DFS).RESULTS:
Of 2,611 women, 1,304 were randomly assigned to receive ACâT and 1,307 to receive ACâXT. After a median follow-up of 5 years, the study failed to meet its primary endpoint [HR, 0.84; 95% confidence interval (CI), 0.67-1.05; P = 0.125]. A significant improvement in overall survival, a secondary endpoint, was seen with ACâXT versus ACâT (HR, 0.68; 95% CI, 0.51-0.92; P = 0.011). There were no unexpected adverse events. Of patients with estrogen receptor (ER)-positive/HER2-negative disease, 70% of whom were node-positive, 26% and 59% had tumors with a centrally assessed Ki-67 score of <10% or <20%, respectively, and only 17 (2%) and 53 (6%) DFS events, respectively, occurred in these groups at 7 years.CONCLUSIONS:
The very low event rate in patients with ER-positive, low Ki-67 cancers, regardless of nodal status, strongly suggests that these patients should not be enrolled in adjuvant trials that assess 5-year DFS rates and that central Ki-67 analyses can identify these patients.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Mama
/
Capecitabina
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Antimetabólitos Antineoplásicos
Tipo de estudo:
Clinical_trials
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Adult
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Aged
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Female
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Humans
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Middle aged
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article