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Leuprorelin Acetate Every-3-Months Depot Versus Cyclophosphamide, Methotrexate, and Fluorouracil As Adjuvant Treatment in Premenopausal Patients With Node-Positive Breast Cancer: The TABLE Study

Peter Schmid, Michael Untch, Valentin Kossé, Grigorij Bondar, Leonid Vassiljev, Valerie Tarutinov, Ute Lehmann, Lutz Maubach, Juergen Meurer, Diethelm Wallwiener, Kurt Possinger

From the Medizinische Klinik mit Schwerpunkt Onkologie und Hämatologie, Charité Campus Mitte, Humboldt Universität zu Berlin; Frauenklinik, Helios Klinikum Berlin-Buch, Berlin; Institute of Oncology and Radiology, Kiew; Medical Academy, Dnepropetrowsk; Antitumor Centre, Donezk; Institute of Medical Radiology, Charkov, Ukraine; Takeda Pharma, Aachen; Omnicare CR, Cologne; Frauenklinik, Universitätsklinikum Tübingen, Eberhard-Karls-Universität Tübingen, Germany; and Charing Cross and Hammersmith Hospital, Imperial College London, London, United Kingdom

Address reprint requests to Peter Schmid, MD, PhD, Charing Cross and Hammersmith Hospital, Imperial College London, Fulham Palace Road, London, W6 8RF, United Kingdom; e-mail: p.schmid{at}imperial.ac.uk

Purpose Ovarian suppression with luteinizing hormone–releasing hormone (LHRH) agonists is an effective adjuvant treatment for premenopausal women with estrogen receptor (ER) –positive breast cancer. Whereas monthly LHRH agonist therapy has been well established, the value of every-3-months (3-monthly) formulations is unclear.

Patients and Methods This randomized phase III trial was performed to compare the 3-monthly depot LHRH agonist leuprorelin acetate (LAD-3M; n = 299) and chemotherapy with cyclophosphamide, methotrexate, and fluorouracil (CMF; n = 300) in pre- or perimenopausal patients with ER-positive, node-positive breast cancer.

Results With a median follow-up of 5.8 years, recurrence-free survival was similar for patients treated with LAD-3M or CMF (hazard ratio [HR], 1.19; 95% CI, 0.94 to 1.51; P = .15). There was no substantial heterogeneity in the relative treatment effect among subgroups defined by age, progesterone receptor (PR) status, nodal status, hormone levels, or menstrual recovery after treatment. Exploratory overall survival analysis favored LAD-3M (HR, 1.50; 95% CI, 1.13 to 1.99; P = .005). Chemotherapy-related adverse effects such as nausea, vomiting, and alopecia were more common with CMF, whereas symptoms of estrogen suppression such as hot flushes and sweating were initially more pronounced with LAD-3M.

Conclusion The 3-monthly depot LHRH-agonist leuprorelin acetate is an effective adjuvant treatment in premenopausal patients with hormone receptor–positive, node-positive breast cancer that is not inferior to CMF.

Supported by Takeda Pharma (Aachen, Germany).

Presented in part at the 38th Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 18-21, 2002; the San Antonio Breast Cancer Symposium, San Antonio, TX, December 3-6, 2003; the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004; and the San Antonio Breast Cancer Symposium, San Antonio, TX, December 8-11, 2004.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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