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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

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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				K. Wu and P. Brown Is Low-Dose Tamoxifen Useful for the Treatment and Prevention of Breast Cancer? J Natl Cancer Inst, June 4, 2003; 95(11): 766 - 767. [Full Text] [PDF]

				H. Mouridsen, M. Gershanovich, Y. Sun, R. Perez-Carrion, C. Boni, A. Monnier, J. Apffelstaedt, R. Smith, H. P. Sleeboom, F. Jaenicke, et al. 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 J. Clin. Oncol., June 1, 2003; 21(11): 2101 - 2109. [Abstract] [Full Text] [PDF]

				A. Lipton, S.M. Ali, K. Leitzel, L. Demers, H.A. Harvey, H.A. Chaudri-Ross, C. Brady, P. Wyld, and W. Carney Serum HER-2/neu and Response to the Aromatase Inhibitor Letrozole Versus Tamoxifen J. Clin. Oncol., May 15, 2003; 21(10): 1967 - 1972. [Abstract] [Full Text] [PDF]

				A. Di Leo, H. Bleiberg, and M. Buyse Overall Survival Is Not a Realistic End Point for Clinical Trials of New Drugs in Advanced Solid Tumors: A Critical Assessment Based on Recently Reported Phase III Trials in Colorectal and Breast Cancer J. Clin. Oncol., May 15, 2003; 21(10): 2045 - 2047. [Full Text] [PDF]

				V. Valero and G. N. Hortobagyi Are Anthracycline-Taxane Regimens the New Standard of Care in the Treatment of Metastatic Breast Cancer? J. Clin. Oncol., March 15, 2003; 21(6): 959 - 962. [Full Text] [PDF]

				K.-A. Phillips and J. Bernhard Adjuvant Breast Cancer Treatment and Cognitive Function: Current Knowledge and Research Directions J Natl Cancer Inst, February 5, 2003; 95(3): 190 - 197. [Abstract] [Full Text] [PDF]

				T. Tominaga, I. Adachi, Y. Sasaki, T. Tabei, T. Ikeda, Y. Takatsuka, M. Toi, T. Suwa, and Y. Ohashi Double-blind randomised trial comparing the non-steroidal aromatase inhibitors letrozole and fadrozole in postmenopausal women with advanced breast cancer Ann. Onc., January 1, 2003; 14(1): 62 - 70. [Abstract] [Full Text] [PDF]

				A. Brodie, D. Jelovac, and B. J. Long Predictions from a Preclinical Model: Studies of Aromatase Inhibitors and Antiestrogens Clin. Cancer Res., January 1, 2003; 9(1): 455S - 459S. [Abstract] [Full Text] [PDF]

				K. I. Pritchard Endocrine Therapy of Advanced Disease: Analysis and Implications of the Existing Data Clin. Cancer Res., January 1, 2003; 9(1): 460S - 467S. [Abstract] [Full Text] [PDF]

				J. A. Ligibel and E. P. Winer Clinical Differences among the Aromatase Inhibitors Clin. Cancer Res., January 1, 2003; 9(1): 473S - 479S. [Abstract] [Full Text] [PDF]

				M. Dowsett Preoperative Models to Evaluate Endocrine Strategies for Breast Cancer Clin. Cancer Res., January 1, 2003; 9(1): 502S - 510S. [Abstract] [Full Text] [PDF]

				P. Sperone, G. Gorzegno, A. Berruti, U. Familiari, and L. Dogliotti Reversible Pancytopenia Caused by Oral Letrozole Assumption in a Patient With Recurrent Breast Cancer J. Clin. Oncol., September 1, 2002; 20(17): 3747 - 3748. [Full Text] [PDF]

				E. Winquist, V. Bramwell, T. Vandenberg, J. Bonneterre, J.-M. Nabholtz, A. Budzar, J. Robertson, B. Thurlimann, M. Steinberg, A. Webster, et al. Anastrozole Versus Tamoxifen as First-Line Therapy For Advanced Breast Cancer: Methodologic Issues J. Clin. Oncol., September 1, 2002; 20(17): 3748 - 3750. [Full Text] [PDF]

				I. C. Henderson A Rose Is No Longer a Rose J. Clin. Oncol., August 15, 2002; 20(16): 3365 - 3368. [Full Text] [PDF]

				A. S. Levenson, K. M. Svoboda, K. M. Pease, S. A. Kaiser, B. Chen, L. A. Simons, B. D. Jovanovic, P. A. Dyck, and V. C. Jordan Gene Expression Profiles with Activation of the Estrogen Receptor {alpha}-Selective Estrogen Receptor Modulator Complex in Breast Cancer Cells Expressing Wild-Type Estrogen Receptor Cancer Res., August 1, 2002; 62(15): 4419 - 4426. [Abstract] [Full Text] [PDF]

				S. M. Ali, K. Leitzel, V. M. Chinchilli, L. Engle, L. Demers, H. A. Harvey, W. Carney, J. W. Allard, and A. Lipton Relationship of Serum HER-2/neu and Serum CA 15-3 in Patients with Metastatic Breast Cancer Clin. Chem., August 1, 2002; 48(8): 1314 - 1320. [Abstract] [Full Text] [PDF]

				C. Harper-Wynne, G. Ross, N. Sacks, J. Salter, N. Nasiri, J. Iqbal, R. A'Hern, and M. Dowsett Effects of the Aromatase Inhibitor Letrozole on Normal Breast Epithelial Cell Proliferation and Metabolic Indices in Postmenopausal Women: A Pilot Study for Breast Cancer Prevention Cancer Epidemiol. Biomarkers Prev., July 1, 2002; 11(7): 614 - 621. [Abstract] [Full Text] [PDF]

				R. J. Santen To Block Estrogen's Synthesis or Action: That Is the Question J. Clin. Endocrinol. Metab., July 1, 2002; 87(7): 3007 - 3012. [Full Text] [PDF]

				A. Bowman, H. Gabra, S. P. Langdon, A. Lessells, M. Stewart, A. Young, and J. F. Smyth CA125 Response Is Associated with Estrogen Receptor Expression in a Phase II Trial of Letrozole in Ovarian Cancer: Identification of an Endocrine-sensitive Subgroup Clin. Cancer Res., July 1, 2002; 8(7): 2233 - 2239. [Abstract] [Full Text] [PDF]

				B. J. Long, D. Jelovac, A. Thiantanawat, and A. M. Brodie The Effect of Second-Line Antiestrogen Therapy on Breast Tumor Growth after First-Line Treatment with the Aromatase Inhibitor Letrozole: Long-Term Studies Using the Intratumoral Aromatase Postmenopausal Breast Cancer Model Clin. Cancer Res., July 1, 2002; 8(7): 2378 - 2388. [Abstract] [Full Text] [PDF]