Ki-67: Biomarkers in Presurgical Breast Cancer Trial

In breast cancer presurgical trials, the Ki-67 labeling index predicts disease outcome and offers clues to the preventive potential of drugs. We conducted a placebo-controlled trial to evaluate the activity of exemestane and celecoxib before surgery. The main endpoint was the change in Ki-67. Secondary endpoints were the modulation of circulating biomarkers. Postmenopausal women with histologically confirmed estrogen receptor–positive breast cancer were randomly assigned to exemestane 25 mg/day (n = 50), or celecoxib 800 mg/day (n = 50), or placebo (n = 25) for 6 weeks before surgery. Changes in biomarkers were analyzed through an ANCOVA model adjusting for baseline values. Exemestane showed a median absolute 10% reduction in Ki-67 [from 22 (interquartile range, IQR, 16–27), to 8 (IQR 5–18)], and a 15% absolute reduction in PgR expression [from 50 (IQR 3–90) to 15 (IQR –0–30)] after 6 weeks of treatment. Exemestane significantly increased testosterone [median change 0.21 ng/mL, (IQR 0.12–0.35)], decreased SHBG [median change –14.6 nmol/L, (IQR –23.1 to –8.6)], decreased total and HDL cholesterol by –10 mg/dL (IQR –21–2) and –7 mg/dL, (IQR –14 to –2), respectively. Triglycerides were reduced by both agents [median change –0.5 mg/dL (IQR –17.5–13.5) and –8 mg/dL (IQR –28–9) for celecoxib and exemestane, respectively]. Exemestane showed a remarkable...

Source: Cancer Prevention Research - April 30, 2016 Category: Cancer & Oncology Authors: Aristarco, V., Serrano, D., Gandini, S., Johansson, H., Macis, D., Guerrieri-Gonzaga, A., Lazzeroni, M., Feroce, I., Pruneri, G., Pagani, G., Toesca, A., Caldarella, P., DeCensi, A., Bonanni, B. Tags: Research Articles Source Type: research