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Journal of Clinical Oncology, Vol 19, Issue 10 (May), 2001: 2596-2606
© 2001 American Society for Clinical Oncology

RAPID PUBLICATIONS

Superior Efficacy of Letrozole Versus Tamoxifen as First-Line Therapy for Postmenopausal Women With Advanced Breast Cancer: Results of a Phase III Study of the International Letrozole Breast Cancer Group

By Henning Mouridsen, Mikhail Gershanovich, Yan Sun, Ramón Pérez-Carrión, Corrado Boni, Alain Monnier, Justus Apffelstaedt, Robert Smith, Harm P. Sleeboom, Fritz Jänicke, Anna Pluzanska, Magdolna Dank, Dominique Becquart, Poonamalle P. Bapsy, Eeva Salminen, Ray Snyder, Mercedes Lassus, J. Arnold Verbeek, Beatrix Staffler, Hilary A. Chaudri-Ross, Margaret Dugan

From the Rigshospitalet, Copenhagen, Denmark; Petrov Research Institute of Oncology, St Petersburg, Russia; Chinese Academy of Medical Sciences, Beijing, China; Hospital Universitario de la Princesa, Madrid, Spain; Arcipedale Santa Maria Nuova, Reggio Emilia, Italy; Centre Hospitalier Général André-Boulloche, Montbéliard, France; University of Stellenbosch, Cape Town, South Africa; South Carolina Oncology Associates, Columbia, SC; Ziekenhuis Leyenburg, Den Haag, the Netherlands; University of Hamburg, Hamburg, Germany; Regional Center of Oncology, Lodz, Poland; Semmelweis University, Budapest, Hungary; General Hospital, Middelheim, Antwerp, Belgium; Kidwai Memorial Institute of Oncology, Bangalore, India; Turku University Central Hospital, Turku, Finland; St Vincent’s Hospital, Fitzroy, Victoria, Australia; Independent Consultant, Basel; Novartis Pharma AG, Milan, Italy; and Novartis Pharmaceuticals Corporation, East Hanover, NJ.

Address reprint requests to Hilary A. Chaudri-Ross, DEP, Novartis Pharma AG, WSJ-27.2.023, CH-4002 Basel, Switzerland; email: hilary_anne.chaudri{at}pharma.novartis.com

PURPOSE: To compare the efficacy and tolerability of tamoxifen with that of letrozole, an oral aromatase inhibitor, with tamoxifen as first-line therapy in postmenopausal women with advanced breast cancer.

PATIENTS AND METHODS: Nine hundred seven patients were randomly assigned letrozole 2.5 mg once daily (453 patients) or tamoxifen 20 mg once daily (454 patients). Patients had estrogen receptor– and/or progesterone receptor–positive tumors, or both receptors were unknown. Recurrence during adjuvant antiestrogen therapy or within the following 12 months or prior endocrine therapy for advanced disease precluded enrollment. One prior chemotherapy regimen for metastatic disease was allowed. The primary end point was time to progression (TTP). Secondary end points included overall objective response rate (ORR), its duration, rate and duration of clinical benefit, time to treatment failure (TTF), overall survival, and tolerability.

RESULTS: TTP was significantly longer for letrozole than for tamoxifen (median, 41 v 26 weeks). Treatment with letrozole reduced the risk of progression by 30% (hazards ratio, 0.70; 95% confidence interval, 0.60 to 0.82, P = .0001). TTP was significantly longer for letrozole irrespective of dominant site of disease, receptor status, or prior adjuvant antiestrogen therapy. Similarly, TTF was significantly longer for letrozole (median, 40 v 25 weeks). ORR was higher for letrozole (30% v 20%; P = .0006), as was the rate of clinical benefit (49% v 38%; P = .001). Survival data are currently immature and not reported here. Both treatments were well tolerated.

CONCLUSION: Letrozole was significantly superior to tamoxifen in TTP, TTF, ORR, and clinical benefit rate. Our results support its use as first-line endocrine therapy in postmenopausal women with advanced breast cancer.




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