Journal of Clinical Oncology, Vol 21, Issue 11
(June), 2003: 2101-2109
© 2003 American Society for Clinical Oncology
Phase III Study of Letrozole Versus Tamoxifen as First-Line Therapy of Advanced Breast Cancer in Postmenopausal Women: Analysis of Survival and Update of Efficacy From the International Letrozole Breast Cancer Group
Henning Mouridsen,
Mikhail Gershanovich,
Yan Sun,
Ramón Pérez-Carrión,
Corrado Boni,
Alain Monnier,
Justus Apffelstaedt,
Robert Smith,
Harm P. Sleeboom,
Fritz Jaenicke,
Anna Pluzanska,
Magdolna Dank,
Dominique Becquart,
Poonamalle P. Bapsy,
Eeva Salminen,
Ray Snyder,
Hilary Chaudri-Ross,
Raquel Lang,
Peter Wyld,
Ajay Bhatnagar
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 General Andre-Boulloche, Montbeliard, 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; Z.A. Middelheim, Antwerpen, Belgium; Kidwai Memorial Institute of Oncology, Bangalore, India; Turku University Central Hospital, Turku, Finland; St. Vincent’s Hospital, Fitzroy, Victoria, Australia; Novartis Pharma AG, Basel, Switzerland.
Address reprint requests to Hilary A. Chaudri-Ross, Novartis Pharma AG, WSJ-27.2.023, CH-4002 Basel, Switzerland; email: hilary_anne.chaudri{at}pharma.novartis.com.
Purpose: To analyze overall survival (OS) and update efficacy data for letrozole versus tamoxifen as first-line therapy in postmenopausal women with locally advanced or metastatic breast cancer.
Patients and Methods: This multicenter phase III trial randomly assigned 916 patients with hormone receptor–positive or unknown tumors letrozole 2.5 mg (n = 458) or tamoxifen 20 mg (n = 458) daily until disease progression. Optional cross-over was permitted at the treating physician’s discretion. This report updates efficacy at a median follow-up of 32 months.
Results: The superiority of letrozole to tamoxifen was confirmed for time to progression (median, 9.4 v 6.0 months, respectively; P < .0001), time to treatment failure (median, 9 v 5.7 months, respectively; P < .0001), overall objective response rate (32% v 21%, respectively; P = .0002), and overall clinical benefit. Median OS was slightly prolonged for the randomized letrozole arm (34 v 30 months, respectively). Although this difference in OS is not significant, survival was improved in the randomized letrozole arm over the first 2 years of the study. Approximately one half of the patients in each arm crossed over. Total duration of endocrine therapy ("time to chemotherapy") was significantly longer (P = .005) for patients initially on letrozole (median, 16 months) than for patients initially on tamoxifen (median, 9 months). Time to worsening of Karnofsky performance score was significantly delayed with letrozole compared with tamoxifen (P = .001).
Conclusion: This study documents the superiority of letrozole over tamoxifen in first-line endocrine therapy in postmenopausal women with advanced breast cancer.
Supported by Novartis Pharma AG, Basel, Switzerland.
Peter Wyld is currently at British Biotech PLC, Oxford, UK.
The following authors own stock (not including shared held through a public mutual fund): Ajay Bhatnagar (Novartis-Pharma), Peter Wyld, Raquel Lang, Hilary Chaudri-Ross. The following authors acted as consultants within the past two years: Henning Mouridsen (Novartis, Pharmacia, Glaxo-Smith Kline), Robert Smith, Harm P. Sleeboom, Ajay Bhatnagar, (Novartis-Pharma), Alain Monnier (Pharmacia-Novartis), Hilary Chaudri-Ross. The following authors performed contract work within the past 2 years: Justin Appfelstaedt. The following authors served as an officer or member of the Board of a company: Fritz Jaenicke (Advisory Board: Novartis [European]). The following authors received more than $2,000 a year from a company for either of the past 2 years: Fritz Jaenicke (Novartis [European]), Henning Mouridsen (Novartis), Robert Smith, Harm P. Sleeboom, Peter Wyld, Alain Monnier (Pharmacia). The following authors are employees of Novartis: Hilary Chaudri-Ross, Raquel Lang, Ajay Bhatnagar (until June 30, 2001).
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Related Correspondence
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JCO 2004 22: 3199-3200
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M. Sonmezer and K. Oktay
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A. Howell, J. F.R. Robertson, P. Abram, M. R. Lichinitser, R. Elledge, E. Bajetta, T. Watanabe, C. Morris, A. Webster, I. Dimery, et al.
Comparison of Fulvestrant Versus Tamoxifen for the Treatment of Advanced Breast Cancer in Postmenopausal Women Previously Untreated With Endocrine Therapy: A Multinational, Double-Blind, Randomized Trial
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E. R. Kisanga, J. Gjerde, A. Guerrieri-Gonzaga, F. Pigatto, A. Pesci-Feltri, C. Robertson, D. Serrano, G. Pelosi, A. Decensi, and E. A. Lien
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[Abstract]
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B. J. Long, D. Jelovac, V. Handratta, A. Thiantanawat, N. MacPherson, J. Ragaz, O. G. Goloubeva, and A. M. Brodie
Therapeutic Strategies Using the Aromatase Inhibitor Letrozole and Tamoxifen in a Breast Cancer Model
J Natl Cancer Inst,
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[Abstract]
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J. Karnon, S. R. D. Johnston, T. Jones, and A. Glendenning
A trial-based cost-effectiveness analysis of letrozole followed by tamoxifen versus tamoxifen followed by letrozole for postmenopausal advanced breast cancer
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