American Association for Cancer Research
10780432ccr150636-sup-146808_1_supp_2961020_nngcmg.pdf (1.02 MB)

Supplementary Figure 2 from Patients with Slowly Proliferative Early Breast Cancer Have Low Five-Year Recurrence Rates in a Phase III Adjuvant Trial of Capecitabine

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journal contribution
posted on 2023-03-31, 18:48 authored by Joyce O'Shaughnessy, Hartmut Koeppen, Yuanyuan Xiao, Mark R. Lackner, Devchand Paul, Christopher Stokoe, John Pippen, Lea Krekow, Frankie Ann Holmes, Svetislava Vukelja, Deborah Lindquist, Scot Sedlacek, Ragene Rivera, Robert Brooks, Kristi McIntyre, Carrie Brownstein, Silke Hoersch, Joanne L. Blum, Stephen Jones

Figure S2: Distribution of central Ki-67 scores in (A) ER-positive/HER2-negative breast cancer (n=824) and (B) TNBC (n=454)



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).Experimental Design: Treatment comprised eight cycles of AC→T (T dose: 100 mg/m2 on day 1) or AC→XT (X dose: 825 mg/m2 twice daily, days 1–14; T dose: 75 mg/m2 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 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.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. Clin Cancer Res; 21(19); 4305–11. ©2015 AACR.

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