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Journal of Clinical Oncology, Vol 16, 453-461, Copyright © 1998 by American Society of Clinical Oncology

ARTICLES

Letrozole, a new oral aromatase inhibitor for advanced breast cancer: double-blind randomized trial showing a dose effect and improved efficacy and tolerability compared with megestrol acetate

P Dombernowsky, I Smith, G Falkson, R Leonard, L Panasci, J Bellmunt, W Bezwoda, G Gardin, A Gudgeon, M Morgan, A Fornasiero, W Hoffmann, J Michel, T Hatschek, T Tjabbes, HA Chaudri, U Hornberger and PF Trunet

PURPOSE: To compare two doses of letrozole and megestrol acetate (MA) as second-line therapy in postmenopausal women with advanced breast cancer previously treated with antiestrogens. PATIENTS AND METHODS: Five hundred fifty-one patients with locally advanced, locoregionally recurrent or metastatic breast cancer were randomly assigned to receive letrozole 2.5 mg (n = 174), letrozole 0.5 mg (n = 188), or MA 160 mg (n = 189) once daily in a double-blind, multicenter trial. Data were analyzed for tumor response and safety variables up to 33 months of follow-up evaluation and for survival up to 45 months. RESULTS: Letrozole 2.5 mg produced a significantly higher overall objective response rate (24%) compared with MA (16%; logistic regression, P = .04) or letrozole 0.5 mg (13%; P = .004). Duration of objective response was significantly longer for letrozole 2.5 mg compared with MA (Cox regression, P = .02). Letrozole 2.5 mg was significantly superior to MA and letrozole 0.5 mg in time to treatment failure (P = .04 and P = .002, respectively). For time to progression, letrozole 2.5 mg was superior to letrozole 0.5 mg (P = .02), but not to MA (P = .07). There was a significant dose effect in overall survival in favor of letrozole 2.5 mg (P = .03) compared with letrozole 0.5 mg. Letrozole was significantly better tolerated than MA with respect to serious adverse experiences, discontinuation due to poor tolerability, cardiovascular side effects, and weight gain. CONCLUSION: The data show letrozole 2.5 mg once daily to be more effective and better tolerated than MA in the treatment of postmenopausal women with advanced breast cancer previously treated with antiestrogens.
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J. M. Nabholtz, A. Buzdar, M. Pollak, W. Harwin, G. Burton, A. Mangalik, M. Steinberg, A. Webster, and M. von Euler
Anastrozole Is Superior to Tamoxifen as First-Line Therapy for Advanced Breast Cancer in Postmenopausal Women: Results of a North American Multicenter Randomized Trial
J. Clin. Oncol., November 15, 2000; 18(22): 3758 - 3767.
[Abstract] [Full Text] [PDF]

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P. E. Lonning, E. Bajetta, R. Murray, M. Tubiana-Hulin, P. D. Eisenberg, E. Mickiewicz, L. Celio, P. Pitt, M. Mita, N. K. Aaronson, et al.
Activity of Exemestane in Metastatic Breast Cancer After Failure of Nonsteroidal Aromatase Inhibitors: A Phase II Trial
J. Clin. Oncol., June 11, 2000; 18(11): 2234 - 2244.
[Abstract] [Full Text] [PDF]

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M. Kaufmann, E. Bajetta, L. Y. Dirix, L. E. Fein, S. E. Jones, N. Zilembo, J.-L. Dugardyn, C. Nasurdi, R. G. Mennel, J. Cervek, et al.
Exemestane Is Superior to Megestrol Acetate After Tamoxifen Failure in Postmenopausal Women With Advanced Breast Cancer: Results of a Phase III Randomized Double-Blind Trial
J. Clin. Oncol., April 7, 2000; 18(7): 1399 - 1411.
[Abstract] [Full Text] [PDF]

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A. U. Buzdar, H. A. Chaudri, and P. F. Trunet
Letrozole: Which Dose to Be Used?
J. Clin. Oncol., April 1, 2000; 18(8): 1802 - 1803.
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H. A. Chaudri and P. F. Trunet
Letrozole: Updated Duration of Response
J. Clin. Oncol., December 1, 1999; 17(12): 3856 - 3860.
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S. Jones, C. Vogel, A. Arkhipov, L. Fehrenbacher, P. Eisenberg, B. Cooper, S. Honig, A. Polli, F. Whaley, E. di Salle, et al.
Multicenter, Phase II Trial of Exemestane as Third-Line Hormonal Therapy of Postmenopausal Women With Metastatic Breast Cancer
J. Clin. Oncol., November 1, 1999; 17(11): 3418 - 3425.
[Abstract] [Full Text] [PDF]

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M. Dowsett, C. Pfister, S. R. D. Johnston, D. W. Miles, S. J. Houston, J. A. Verbeek, H. Gundacker, A. Sioufi, and I. E. Smith
Impact of Tamoxifen on the Pharmacokinetics and Endocrine Effects of the Aromatase Inhibitor Letrozole in Postmenopausal Women with Breast Cancer
Clin. Cancer Res., September 1, 1999; 5(9): 2338 - 2343.
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J. N. Ingle, V. J. Suman, P. A. Johnson, J. E. Krook, J. A. Mailliard, R. H. Wheeler, C. L. Loprinzi, E. A. Perez, V. C. Jordan, and M. Dowsett
Evaluation of Tamoxifen plus Letrozole with Assessment of Pharmacokinetic Interaction in Postmenopausal Women with Metastatic Breast Cancer
Clin. Cancer Res., July 1, 1999; 5(7): 1642 - 1649.
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G. B. Anker, H. Refsum, P. M. Ueland, D. C. Johannessen, E. A. Lien, and P. E. Lonning
Influence of Aromatase Inhibitors on Plasma Total Homocysteine in Postmenopausal Breast Cancer Patients
Clin. Chem., February 1, 1999; 45(2): 252 - 256.
[Abstract] [Full Text] [PDF]

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P. E. Goss, E. P. Winer, I. F. Tannock, and L. H. Schwartz on behalf of the North American Vorozole
Randomized Phase III Trial Comparing the New Potent and Selective Third-Generation Aromatase Inhibitor Vorozole With Megestrol Acetate in Postmenopausal Advanced Breast Cancer Patients
J. Clin. Oncol., January 1, 1999; 17(1): 52 - 52.
[Abstract] [Full Text] [PDF]


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