Low dose metronomic cyclophosphamide, methotrexate (LDCM) and aspirin for patients with residual disease after neoadjuvant chemotherapy for stage II-III breast cancer.

e12040Background: The risk of recurrence for women who fail to achieve pathological complete response (pCR) to neoadjuvant chemotherapy is high (15-30% at 2 years). We investigated the effect of an all-oral regimen (LDCM + aspirin) in women who fail to achieve a pCR. We present 2 year follow up, toxicity and biomarker analysis. Methods: Patients with stage II-III HER-2 negative breast cancer with residual disease after neoadjuvant therapy were eligible, after completing radiotherapy and initiating hormonal therapy. Therapy consisted of 4 28-day cycles of cyclophosphamide 50 mg oral daily, and methotrexate 2.5 mg oral twice daily on days 1 and 2 each week. Aspirin 325 mg daily was added for cycles 3 and 4. Serum/plasma VEGF, IL-6 and TNF were obtained at baseline, after 2 and 4 cycles. The primary endpoint was safety with secondary endpoints of 2 year relapse free survival (RFS) and serum biomarkers. Results: 20 patients were enrolled between 5/2011 and 11/2015, 3 are excluded from this analysis (1 ineligi...