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Primary hormonal therapy with exemestane in patients with breast tumors >3 cm in diameter: Results of a Spanish multicenter phase II trial
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2004
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Surgical OncologyBreast OncologyBreast Cancer TumorCancer ManagementGynecologyPharmacotherapyPrimary Hormonal TherapiesBreast TumorsGynecology OncologyOncologyClinical TrialsPrimary Hormonal TherapyBreast SurgeryRadiation OncologyCancer ResearchHealth SciencesAromataseCancer TreatmentEndocrine-related CancerBreast CancerMedicineOral Exemestane 25
603 Background: Primary hormonal therapies have demonstrated great activity in elderly women with locally advanced and hormone-dependent breast tumors. Exemestane, a steroidal aromatase inactivator, is effective in a metastatic setting. The primary aim of this study was to analyze the efficacy of exemestane as a neoadjuvant treatment. Methods: 55 patients (p) were recruited. Inclusion criteria were histologic diagnosis of infiltrating breast carcinoma, no metastatic disease, tumor >3 cm (T2, T3, T4a-b), >50% ER+, and no previous hormonal treatment/chemotherapy. At baseline, all p were considered noneligible for breast-conserving surgery. Treatment: oral exemestane 25 mg/d for 6 months. Response was estimated by mammography and breast ultrasound every 2 months (RECIST criteria). Secondary endpoints were rate of breast-conserving surgery, time to progression, duration of response, and toxicity. To date, 50 p have been evaluated for response and 5 remain under treatment. Results: Patient characteristics: median age 77 (67–88); tumor stage: T2: 25, T3: 7 and T4a-b: 23; nodal status: N0: 30, N1: 20 and N2: 5; tumor grade I: 3, II: 24, III: 6 and unknown: 22. Responses were CR: 1, PR: 24, SD: 24 and PD: 1. Overall clinical response: 25 of 50 evaluable p (45% ITT) (95% CI 36.1%–63.8%). Median time to surgery: 7 months. Surgery type: conservative 21 p, mastectomy 17 p, no operation 12 p (various reasons). Pathologic complete response was observed in the breast and axilla in 3 p; partial pathologic remission was seen in 14 p. Grade I-II toxicity: hot flushes, nausea, dizziness, and pain. No patient was withdrawn for toxic events. Conclusions: Exemestane was found to be a well-tolerated and effective neoadjuvant treatment in elderly patients with a breast cancer tumor >3 cm in diameter. Conservative surgery was possible in most responding patients. No severe treatment-related adverse events were detected. No significant financial relationships to disclose.