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Preoperative Chemotherapy in Primary Operable Breast Cancer: Results From the European Organization for Research and Treatment of Cancer Trial 10902
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2001
Year
The study assessed whether preoperative neoadjuvant chemotherapy improves overall survival, relapse‑free survival, and increases breast‑conserving surgery rates compared with postoperative chemotherapy in operable breast cancer patients. A randomized phase III trial enrolled 698 patients with T1c–T4b, N0–1, M0 disease, assigning them to four cycles of fluorouracil, epirubicin, and cyclophosphamide preoperatively or postoperatively, with follow‑up for OS, PFS, and locoregional recurrence. At 56‑month median follow‑up, preoperative chemotherapy showed no significant advantage in OS, PFS, or locoregional control, but downstaged 23% of patients and allowed more breast‑conserving surgery, suggesting future trials should evaluate quality of life.
PURPOSE: To evaluate whether preoperative neoadjuvant chemotherapy in patients with primary operable breast cancer results in better overall survival (OS) and relapse-free survival rates and whether preoperative chemotherapy permits more breast-conserving surgery procedures than postoperative chemotherapy. PATIENTS AND METHODS: Six hundred ninety-eight breast cancer patients (T1c, T2, T3, T4b, N0 to 1, and M0) were enrolled onto a randomized phase III trial that compared four cycles of fluorouracil, epirubicin, and cyclophosphamide administered preoperatively versus the same regimen administered postoperatively (the first cycle administered within 36 hours after surgery). Patients were followed up for OS, progression-free survival (PFS), and locoregional recurrence (LRR). RESULTS: At a median follow-up of 56 months, there was no significant difference in terms of OS (hazards ratio, 1.16; P = .38), PFS (hazards ratio, 1.15; P = .27), and time to LRR (hazards ratio, 1.13; P = .61). Fifty-seven patients (23%) were downstaged by the preoperative chemotherapy, whereas 14 patients (18%) underwent mastectomy and not the planned breast-conserving therapy. CONCLUSION: The use of preoperative chemotherapy yields similar results in terms of PFS, OS, and locoregional control compared with conventional postoperative chemotherapy. In addition, preoperative chemotherapy enables more patients to be treated with breast-conserving surgery. Because preoperative chemotherapy does not improve disease outcome compared with postoperative chemotherapy, future trials should involve quality-of-life studies to investigate whether patients will benefit from this treatment modality.
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