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Journal of Clinical Oncology, Vol 19, Issue 22 (November), 2001: 4224-4237
© 2001 American Society for Clinical Oncology

Preoperative Chemotherapy in Primary Operable Breast Cancer: Results From the European Organization for Research and Treatment of Cancer Trial 10902

By Jos A. van der Hage, Cornelis J.H. van de Velde, Jean-Pierre Julien, Michelle Tubiana-Hulin, Cecile Vandervelden, Luc Duchateau, and Cooperating Investigators

From the European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium; Leiden University Medical Center, Department of Surgery, Leiden, the Netherlands; Centre Henri Becquerel, Department of Surgery, Rouen; and Centre René Huguenin, Department of Medical Oncology, St Cloud, France.

Address reprint requests to C.J.H. van de Velde, MD, PhD, Department of Surgery, D6-43, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, the Netherlands; email: velde{at}lumc.nl

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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