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Journal of Clinical Oncology, Vol 18, Issue 22 (November), 2000: 3758-3767
© 2000 American Society for Clinical Oncology


RAPID PUBLICATIONS

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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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; 14(9): 1383 - 1390.
[Abstract] [Full Text] [PDF]


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Ann OncolHome page
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
Ann. Onc., September 1, 2003; 14(9): 1391 - 1398.
[Abstract] [Full Text] [PDF]


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DTBHome page
Should aromatase inhibitors replace tamoxifen?
DTB, August 1, 2003; 41(8): 57 - 59.
[Abstract] [Full Text] [PDF]


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Ann OncolHome page
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
Ann. Onc., August 1, 2003; 14(8): 1215 - 1221.
[Abstract] [Full Text] [PDF]


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The OncologistHome page
A. U. Buzdar
Advances in Endocrine Treatments for Postmenopausal Women with Metastatic and Early Breast Cancer
Oncologist, August 1, 2003; 8(4): 335 - 341.
[Abstract] [Full Text] [PDF]


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Ann OncolHome page
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
Ann. Onc., July 1, 2003; 14(7): 1017 - 1025.
[Abstract] [Full Text] [PDF]


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NEJMHome page
I. E. Smith and M. Dowsett
Aromatase Inhibitors in Breast Cancer
N. Engl. J. Med., June 12, 2003; 348(24): 2431 - 2442.
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JNCI J Natl Cancer InstHome page
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.
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JCOHome page
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.
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J Natl Compr Canc NetwHome page
J. A. Ligibel and E. P. Winer
The Aromatase Inhibitors as Adjuvant Therapy for Hormone Receptor-Positive Breast Cancer
J Natl Compr Canc Netw, April 1, 2003; 1(2): 215 - 221.
[Abstract] [PDF]


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NEJMHome page
B. L. Riggs and L. C. Hartmann
Selective Estrogen-Receptor Modulators -- Mechanisms of Action and Application to Clinical Practice
N. Engl. J. Med., February 13, 2003; 348(7): 618 - 629.
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JNCI J Natl Cancer InstHome page
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.
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Clin. Cancer Res.Home page
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]


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Clin. Cancer Res.Home page
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.
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Clin. Cancer Res.Home page
J. A. Ligibel and E. P. Winer
Clinical Differences among the Aromatase Inhibitors
Clin. Cancer Res., January 1, 2003; 9(1): 473s - 479s.
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Clin. Cancer Res.Home page
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
Clin. Cancer Res., January 1, 2003; 9(1): 495s - 501s.
[Abstract] [Full Text]


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JCOHome page
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.
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JCOHome page
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.
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JCOHome page
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; 20(16): 3396 - 3403.
[Abstract] [Full Text] [PDF]


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JCOHome page
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; 20(15): 3317 - 3327.
[Abstract] [Full Text] [PDF]


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Ann OncolHome page
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; 13(7): 1059 - 1066.
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Clin. Cancer Res.Home page
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]


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BMJHome page
M. Morrow and W. Gradishar
Recent developments: Breast cancer
BMJ, February 16, 2002; 324(7334): 410 - 414.
[Full Text] [PDF]


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JCOHome page
A. U. Buzdar, H. Mouridsen, and H. A. Chaudri-Ross
Superior Efficacy of Letrozole Versus Tamoxifen as First-Line Therapy
J. Clin. Oncol., February 1, 2002; 20(3): 876 - 878.
[Full Text] [PDF]


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Journal of Pharmacy PracticeHome page
L. B. Michaud and K. L. Jones
Recent Advances in the Systemic Management of Metastatic Breast Cancer
Journal of Pharmacy Practice, February 1, 2002; 15(1): 52 - 61.
[Abstract] [PDF]


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Recent Prog Horm ResHome page
E. R. Simpson and M. Dowsett
Aromatase and Its Inhibitors: Significance for Breast Cancer Therapy
Recent Prog. Horm. Res., January 1, 2002; 57(1): 317 - 338.
[Abstract] [Full Text] [PDF]


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JCOHome page
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
J. Clin. Oncol., December 1, 2001; 19(23): 4353 - 4355.
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BMJHome page
P. E. Lonning
Aromatase inhibitors and inactivators in breast cancer
BMJ, October 20, 2001; 323(7318): 880 - 881.
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JCOHome page
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
J. Clin. Oncol., September 15, 2001; 19(18): 3808 - 3816.
[Abstract] [Full Text] [PDF]


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Clin. Cancer Res.Home page
A. Buzdar and A. Howell
Advances in Aromatase Inhibition: Clinical Efficacy and Tolerability in the Treatment of Breast Cancer
Clin. Cancer Res., September 1, 2001; 7(9): 2620 - 2635.
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Clin. Cancer Res.Home page
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., July 1, 2001; 7(7): 2076 - 2084.
[Abstract] [Full Text] [PDF]


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NEJMHome page
C. L. Shapiro and A. Recht
Side Effects of Adjuvant Treatment of Breast Cancer
N. Engl. J. Med., June 28, 2001; 344(26): 1997 - 2008.
[Full Text] [PDF]


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JCOHome page
P. P. Donnellan, S. L. Douglas, D. A. Cameron, and R. C.F. Leonard
Aromatase Inhibitors and Arthralgia
J. Clin. Oncol., May 15, 2001; 19(10): 2767 - 2767.
[Full Text] [PDF]


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JNCI J Natl Cancer InstHome page
J. S. Abrams
Tamoxifen: Five Versus Ten Years--Is the End in Sight?
J Natl Cancer Inst, May 2, 2001; 93(9): 662 - 664.
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