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Patients with Slowly Proliferative Early Breast Cancer Have Low Five-Year Recurrence Rates in a Phase III Adjuvant Trial of Capecitabine.
- Source :
-
Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2015 Oct 01; Vol. 21 (19), pp. 4305-11. Date of Electronic Publication: 2015 Jun 03. - Publication Year :
- 2015
-
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).<br />Experimental Design: Treatment comprised eight cycles of AC→T (T dose: 100 mg/m(2) on day 1) or AC→XT (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).<br />Results: Of 2,611 women, 1,304 were randomly assigned to receive AC→T and 1,307 to receive AC→XT. 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 AC→XT versus AC→T (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.<br />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.<br /> (©2015 American Association for Cancer Research.)
- Subjects :
- Adult
Aged
Antimetabolites, Antineoplastic administration & dosage
Antimetabolites, Antineoplastic adverse effects
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Biomarkers, Tumor
Breast Neoplasms mortality
Capecitabine administration & dosage
Capecitabine adverse effects
Chemotherapy, Adjuvant
Docetaxel
Female
Follow-Up Studies
Humans
Kaplan-Meier Estimate
Ki-67 Antigen metabolism
Middle Aged
Neoplasm Grading
Neoplasm Recurrence, Local
Neoplasm Staging
Taxoids administration & dosage
Treatment Outcome
Antimetabolites, Antineoplastic therapeutic use
Breast Neoplasms drug therapy
Breast Neoplasms pathology
Capecitabine therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1557-3265
- Volume :
- 21
- Issue :
- 19
- Database :
- MEDLINE
- Journal :
- Clinical cancer research : an official journal of the American Association for Cancer Research
- Publication Type :
- Academic Journal
- Accession number :
- 26041745
- Full Text :
- https://doi.org/10.1158/1078-0432.CCR-15-0636