Journal of Clinical Oncology, Vol 18, Issue 22
(November), 2000: 3758-3767
© 2000 American Society for Clinical Oncology
Anastrozole Is Superior to Tamoxifen as First-Line Therapy for Advanced Breast Cancer in Postmenopausal Women: Results of a North American Multicenter Randomized Trial
By J. M. Nabholtz,
A. Buzdar,
M. Pollak,
W. Harwin,
G. Burton,
A. Mangalik,
M. Steinberg,
A. Webster,
M. von Euler,
for the Arimidex Study Group
From the Cancer-Cross Institute, Edmonton, Alberta; Department of Oncology, Jewish General Hospital and McGill University, Montreal, Quebec, Canada; University of Texas M.D. Anderson Cancer Canter, Houston, TX; Florida Cancer Specialists, Fort Myers, FL; Louisiana State University Health Science Center, Shreveport, LA; University of New Mexico Cancer Center, Albuquerque, NM; AstraZeneca, Wilmington, DE; and AstraZeneca, Alderley Park, Macclesfield, United Kingdom.
Address reprint requests to J.M. Nabholtz, MD, MSc, University of California at Los Angeles, Peter Ueberroth Bldg, No 3360B, 10945 Leconte Ave, Los Angeles, CA 90095-7077; email jean-marc.nabholtz{at}bcirg.com
ABSTRACT
PURPOSE: The efficacy and tolerability of anastrozole (Arimidex; AstraZeneca, Wilmington, DE, and Macclesfield, United Kingdom) and tamoxifen were compared as first-line therapy for advanced breast cancer in 353 postmenopausal women.
PATIENTS AND METHODS: The randomized, double-blind, multicenter study was designed to evaluate anastrozole 1 mg once daily relative to tamoxifen 20 mg once daily in patients with hormone receptor–positive tumors or tumors of unknown receptor status who were eligible for endocrine therapy. Primary end points were objective response (OR), defined as complete (CR) or partial (PR) response, time to progression (TTP), and tolerability.
RESULTS: Anastrozole was as effective as tamoxifen in terms of OR (21% v 17% of patients, respectively), with clinical benefit (CR + PR + stabilization  24 weeks) observed in 59% of patients on anastrozole and 46% on tamoxifen (two-sided P = .0098, retrospective analysis). Anastrozole had a significant advantage over tamoxifen in terms of TTP (median TTP of 11.1 and 5.6 months for anastrozole and tamoxifen, respectively; two-sided P = .005). The tamoxifen:anastrozole hazards ratio was 1.44 (lower one-sided 95% confidence limit, 1.16). Both treatments were well tolerated. However, thromboembolic events and vaginal bleeding were reported in fewer patients who received anastrozole compared with those who received tamoxifen (4.1% v 8.2% [thromboembolic events] and 1.2% v 3.8% [vaginal bleeding], respectively).
CONCLUSION: Anastrozole satisfied the predefined criteria for equivalence to tamoxifen. Furthermore, we observed both a significant increase in TTP and a lower incidence of thromboembolic events and vaginal bleeding with anastrozole. These findings indicate that anastrozole should be considered as first-line therapy for postmenopausal women with advanced breast cancer.
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A. Thiantanawat, B. J. Long, and A. M. Brodie
Signaling Pathways of Apoptosis Activated by Aromatase Inhibitors and Antiestrogens
Cancer Res.,
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[Abstract]
[Full Text]
[PDF]
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C. A. Haiman, D. O. Stram, M. C. Pike, L. N. Kolonel, N. P. Burtt, D. Altshuler, J. Hirschhorn, and B. E. Henderson
A comprehensive haplotype analysis of CYP19 and breast cancer risk: the Multiethnic Cohort
Hum. Mol. Genet.,
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12(20):
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[Abstract]
[Full Text]
[PDF]
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S. Detre, S. Riddler, J. Salter, R. A'Hern, M. Dowsett, and S. R. D. Johnston
Comparison of the Selective Estrogen Receptor Modulator Arzoxifene (LY353381) with Tamoxifen on Tumor Growth and Biomarker Expression in an MCF-7 Human Breast Cancer Xenograft Model
Cancer Res.,
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[Abstract]
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[PDF]
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M. J. Ellis, A. Coop, B. Singh, Y. Tao, A. Llombart-Cussac, F. Janicke, L. Mauriac, E. Quebe-Fehling, H. A. Chaudri-Ross, D. B. Evans, et al.
Letrozole Inhibits Tumor Proliferation More Effectively than Tamoxifen Independent of HER1/2 Expression Status
Cancer Res.,
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[Abstract]
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[PDF]
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J. Baselga, A. Llombart-Cussac, M. Bellet, V. Guillem-Porta, N. Enas, K. Krejcy, E. Carrasco, L. Kayitalire, M. Kuta, A. Lluch, et al.
Randomized, double-blind, multicenter trial comparing two doses of arzoxifene (LY353381) in hormone-sensitive advanced or metastatic breast cancer patients
Ann. Onc.,
September 1, 2003;
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[Abstract]
[Full Text]
[PDF]
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R. Paridaens, L. Dirix, C. Lohrisch, L. Beex, M. Nooij, D. Cameron, L. Biganzoli, T. Cufer, L. Duchateau, A. Hamilton, et al.
Mature results of a randomized phase II multicenter study of exemestane versus tamoxifen as first-line hormone therapy for postmenopausal women with metastatic breast cancer
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September 1, 2003;
14(9):
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[Abstract]
[Full Text]
[PDF]
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M. Waeber, M. Castiglione-Gertsch, D. Dietrich, B. Thurlimann, A. Goldhirsch, K. W. Brunner, and M. M. Borner
Adjuvant therapy after excision and radiation of isolated postmastectomy locoregional breast cancer recurrence: definitive results of a phase III randomized trial (SAKK 23/82) comparing tamoxifen with observation
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[Abstract]
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A. U. Buzdar
Advances in Endocrine Treatments for Postmenopausal Women with Metastatic and Early Breast Cancer
Oncologist,
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[Abstract]
[Full Text]
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M. Piccart, L. M. Parker, and K. I. Pritchard
Oestrogen receptor downregulation: an opportunity for extending the window of endocrine therapy in advanced breast cancer
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[Abstract]
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I. E. Smith and M. Dowsett
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N. Engl. J. Med.,
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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,
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95(11):
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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
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June 1, 2003;
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J. A. Ligibel and E. P. Winer
The Aromatase Inhibitors as Adjuvant Therapy for Hormone Receptor-Positive Breast Cancer
J Natl Compr Canc Netw,
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215 - 221.
[Abstract]
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B. L. Riggs and L. C. Hartmann
Selective Estrogen-Receptor Modulators -- Mechanisms of Action and Application to Clinical Practice
N. Engl. J. Med.,
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K.-A. Phillips and J. Bernhard
Adjuvant Breast Cancer Treatment and Cognitive Function: Current Knowledge and Research Directions
J Natl Cancer Inst,
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95(3):
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[Abstract]
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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;
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[Abstract]
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K. I. Pritchard
Endocrine Therapy of Advanced Disease: Analysis and Implications of the Existing Data
Clin. Cancer Res.,
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J. A. Ligibel and E. P. Winer
Clinical Differences among the Aromatase Inhibitors
Clin. Cancer Res.,
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V. G. Vogel, J. P. Costantino, D. L. Wickerham, and W. M. Cronin
National Surgical Adjuvant Breast and Bowel Project Update: Prevention Trials and Endocrine Therapy of Ductal Carcinoma in Situ
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January 1, 2003;
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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
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September 1, 2002;
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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;
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A. Howell, J.F.R. Robertson, J. Quaresma Albano, A. Aschermannova, L. Mauriac, U.R. Kleeberg, I. Vergote, B. Erikstein, A. Webster, and C. Morris
Fulvestrant, Formerly ICI 182,780, Is as Effective as Anastrozole in Postmenopausal Women With Advanced Breast Cancer Progressing After Prior Endocrine Treatment
J. Clin. Oncol.,
August 15, 2002;
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[Abstract]
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E. P. Winer, C. Hudis, H. J. Burstein, R. T. Chlebowski, J. N. Ingle, S. B. Edge, E. P. Mamounas, J. Gralow, L. J. Goldstein, K. I. Pritchard, et al.
American Society of Clinical Oncology Technology Assessment on the Use of Aromatase Inhibitors as Adjuvant Therapy for Women With Hormone Receptor-Positive Breast Cancer: Status Report 2002
J. Clin. Oncol.,
August 1, 2002;
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[Abstract]
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E. Bajetta, A. Martinetti, N. Zilembo, P. Pozzi, I. La Torre, L. Ferrari, E. Seregni, R. Longarini, G. Salvucci, and E. Bombardieri
Biological activity of anastrozole in postmenopausal patients with advanced breast cancer: effects on estrogens and bone metabolism
Ann. Onc.,
July 1, 2002;
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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.,
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M. Morrow and W. Gradishar
Recent developments: Breast cancer
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A. U. Buzdar, H. Mouridsen, and H. A. Chaudri-Ross
Superior Efficacy of Letrozole Versus Tamoxifen as First-Line Therapy
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L. B. Michaud and K. L. Jones
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Journal of Pharmacy Practice,
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[Abstract]
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E. R. Simpson and M. Dowsett
Aromatase and Its Inhibitors: Significance for Breast Cancer Therapy
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J. R. Mackey, A. A. Joy, A. U. Buzdar, C. Brady, and H. A. Chaudri-Ross
Letrozole in Second-Line Therapy of Advanced Breast Cancer: More Questions Than Answers
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P. E. Lonning
Aromatase inhibitors and inactivators in breast cancer
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M. J. Ellis, A. Coop, B. Singh, L. Mauriac, A. Llombert-Cussac, F. Janicke, W. R. Miller, D. B. Evans, M. Dugan, C. Brady, et al.
Letrozole Is More Effective Neoadjuvant Endocrine Therapy Than Tamoxifen for ErbB-1- and/or ErbB-2-Positive, Estrogen Receptor-Positive Primary Breast Cancer: Evidence From a Phase III Randomized Trial
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A. Buzdar and A. Howell
Advances in Aromatase Inhibition: Clinical Efficacy and Tolerability in the Treatment of Breast Cancer
Clin. Cancer Res.,
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R. Bagatell, O. Khan, G. Paine-Murrieta, C. W. Taylor, S. Akinaga, and L. Whitesell
Destabilization of Steroid Receptors by Heat Shock Protein 90-binding Drugs: A Ligand-independent Approach to Hormonal Therapy of Breast Cancer
Clin. Cancer Res.,
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C. L. Shapiro and A. Recht
Side Effects of Adjuvant Treatment of Breast Cancer
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P. P. Donnellan, S. L. Douglas, D. A. Cameron, and R. C.F. Leonard
Aromatase Inhibitors and Arthralgia
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J. S. Abrams
Tamoxifen: Five Versus Ten Years--Is the End in Sight?
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