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

• Published in: Journal of clinical oncology Vol. 19; no. 22; pp. 4224 - 4237
• Main Authors: VAN DER HAGE, Jos A, VAN DE VELDE, Cornelis J. H, JULIEN, Jean-Pierre, TUBIANA-HULIN, Michelle, VANDERVELDEN, Cecile, DUCHATEAU, Luc
• Format: Journal Article
• Language: English
• Published: Baltimore, MD American Society of Clinical Oncology 15.11.2001; Lippincott Williams & Wilkins
• Subjects: Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Breast Neoplasms - drug therapy; Breast Neoplasms - mortality; Breast Neoplasms - surgery; Chemotherapy; Cyclophosphamide - administration & dosage; Disease-Free Survival; Epirubicin - administration & dosage; Female; Fluorouracil - administration & dosage; Gynecology. Andrology. Obstetrics; Humans; Mammary gland diseases; Mastectomy, Radical; Mastectomy, Segmental; Medical sciences; Middle Aged; Neoadjuvant Therapy; Neoplasm Recurrence, Local; Neoplasm Staging; Pharmacology. Drug treatments; Preoperative Care; Quality of Life; Receptors, Estrogen - metabolism; Survival Rate; Tumors; Europe; Antineoplastic agent; Phase III trial; Human; Indication; Treatment efficiency; Malignant tumor; Neoadjuvant treatment; Mammary gland diseases; Chemotherapy; Treatment; Established cell line; Clinical trial; Mammary gland; Preoperative
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/jco.2001.19.22.4224

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. 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). 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. 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.