High-risk early breast cancer in patients under 40 years of age. improved clinical outcome with total estrogen blockade and tailored chemotherapy

This multicenter prospective trial assessed the outcome in 63 patients, 40 years of age or younger, with high-risk early breast cancer (HREBC), included in an ovarian protection study. The patients were treated with a luteinizing hormone-releasing hormone (LH-RH) analogue administered for 5 years, tailored chemotherapy and an aromatase inhibitor, in estrogen receptor-positive (ER) patients. T-regulatory cells (T-regs) and vascular endothelial growth factor (VEGF) were measured at baseline and yearly. The mean age of the patients was 36 years (range 26-40). Sixty-five percent had ER+ tumors, 24% had negative axillary nodes with tumors > 1 cm and high histological grade with lymphovascular invasion, while 76% had a mean of 3.6 positive axillary nodes (range 1-21). Serum estradiol was maintained at values < 40 pg/ml in all of the patients. A statistically significant decrease in VEGF (P < 0.0001) and T-regs (P < 0.0001), with respect to baseline values, was observed after LEE-RH administration. After a median follow-up of 110 months, the 10-year progression-free and overall survival rates were 86.1 and 89.7%, respectively. These data revealed that the administration of an LH-RH analogue to HREBC patients, followed by chemotherapy and hormonal therapy, decreased VEGF and T-regs and improved the expected clinical outcome.