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Journal of Clinical Oncology, Vol 19, Issue 18 (September), 2001: 3808-3816
© 2001 American Society for Clinical Oncology

RAPID PUBLICATIONS

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

By Matthew J. Ellis, Andrew Coop, Baljit Singh, Louis Mauriac, Antonio Llombert-Cussac, Fritz Jänicke, William R. Miller, Dean B. Evans, Margaret Dugan, Carolyn Brady, Erhard Quebe-Fehling, Mieke Borgs

From the Duke University Comprehensive Cancer Center, Durham, NC; Lombardi Cancer Center, Washington DC; Institut Bergonié, Bordeaux Cedex, France; Instituto Valenciano de Oncologia, Valencia, Spain; Universitaets Frauen-und Poliklinik UKE, Hamburg, Germany; Breast Research Unit, Western General Hospital, Edinburgh, United Kingdom; Novartis Pharma AG, Basel, Switzerland; and Novartis Pharmaceuticals, East Hanover, NJ.

Address reprint requests to Matthew Ellis, MB, PhD, FRCP, Duke University Breast Cancer Program, Box 3446, The Morris Building, Rm 25149F, Duke University Medical Center, Durham, NC 27710; email: ellis053{at}mc.duke.edu

PURPOSE: Expression of ErbB-1 and ErbB-2 (epidermal growth factor receptor and HER2/neu) in breast cancer may cause tamoxifen resistance, but not all studies concur. Additionally, the relationship between ErbB-1 and ErbB-2 expression and response to selective aromatase inhibitors is unknown. A neoadjuvant study for primary breast cancer that randomized treatment between letrozole and tamoxifen provided a context within which these issues could be addressed prospectively.

PATIENTS AND METHODS: Postmenopausal patients with estrogen– and/or progesterone receptor–positive (ER+ and/or PgR+) primary breast cancer ineligible for breast-conserving surgery were randomly assigned to 4 months of neoadjuvant letrozole 2.5 mg daily or tamoxifen 20 mg daily in a double-blinded study. Immunohistochemistry (IHC) for ER and PgR was conducted on pretreatment biopsies and assessed by the Allred score. ErbB-1 and ErbB-2 IHC were assessed by intensity and completeness of membranous staining according to published criteria.

RESULTS: For study biopsy-confirmed ER+ and/or PgR+ cases that received letrozole, 60% responded and 48% underwent successful breast-conserving surgery. The response to tamoxifen was inferior (41%, P = .004), and fewer patients underwent breast conservation (36%, P = .036). Differences in response rates between letrozole and tamoxifen were most marked for tumors that were positive for ErbB-1 and/or ErbB-2 and ER (88% v 21%, P = .0004).

CONCLUSION: ER+, ErbB-1+, and/or ErbB-2+ primary breast cancer responded well to letrozole, but responses to tamoxifen were infrequent. This suggests that ErbB-1 and ErbB-2 signaling through ER is ligand-dependent and that the growth-promoting effects of these receptor tyrosine kinases on ER+ breast cancer can be inhibited by potent estrogen deprivation therapy.


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N. Normanno, M. Di Maio, E. De Maio, A. De Luca, A. de Matteis, A. Giordano, F. Perrone, and on behalf of the NCI-Naples Breast Cancer Group
Mechanisms of endocrine resistance and novel therapeutic strategies in breast cancer
Endocr. Relat. Cancer, December 1, 2005; 12(4): 721 - 747.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
H. J. Huang, P. Neven, M. Drijkoningen, R. Paridaens, H. Wildiers, E. Van Limbergen, P. Berteloot, F. Amant, I. Vergote, and M. R. Christiaens
Hormone receptors do not predict the HER2/neu status in all age groups of women with an operable breast cancer
Ann. Onc., November 1, 2005; 16(11): 1755 - 1761.
[Abstract] [Full Text] [PDF]

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 JCOHome page
M. Dowsett, J. Cuzick, C. Wale, T. Howell, J. Houghton, and M. Baum
Retrospective Analysis of Time to Recurrence in the ATAC Trial According to Hormone Receptor Status: An Hypothesis-Generating Study
J. Clin. Oncol., October 20, 2005; 23(30): 7512 - 7517.
[Abstract] [Full Text] [PDF]

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 JCOHome page
X. Cui, R. Schiff, G. Arpino, C. K. Osborne, and A. V. Lee
Biology of Progesterone Receptor Loss in Breast Cancer and Its Implications for Endocrine Therapy
J. Clin. Oncol., October 20, 2005; 23(30): 7721 - 7735.
[Abstract] [Full Text] [PDF]

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 JCOHome page
A. Urruticoechea, I. E. Smith, and M. Dowsett
Proliferation Marker Ki-67 in Early Breast Cancer
J. Clin. Oncol., October 1, 2005; 23(28): 7212 - 7220.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
A. Goldhirsch, J. H. Glick, R. D. Gelber, A. S. Coates, B. Thurlimann, H.-J. Senn, and and Panel Members
Meeting Highlights: International Expert Consensus on the Primary Therapy of Early Breast Cancer 2005
Ann. Onc., October 1, 2005; 16(10): 1569 - 1583.
[Abstract] [Full Text] [PDF]

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 JCOHome page
M. Cristofanilli, A. Gonzalez-Angulo, and G. Hortobagyi
In Reply:
J. Clin. Oncol., September 20, 2005; 23(27): 6796 - 6797.
[Full Text] [PDF]

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 JCOHome page
I. E. Krop and E. P. Winer
Ovarian Suppression for Breast Cancer: An Effective Treatment in Search of a Home
J. Clin. Oncol., September 1, 2005; 23(25): 5869 - 5872.
[Full Text] [PDF]

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M. J. Ellis
Neoadjuvant Endocrine Therapy for Breast Cancer: More Questions Than Answers
J. Clin. Oncol., August 1, 2005; 23(22): 4842 - 4844.
[Full Text] [PDF]

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I. E. Smith, M. Dowsett, S. R. Ebbs, J. M. Dixon, A. Skene, J.-U. Blohmer, S. E. Ashley, S. Francis, I. Boeddinghaus, and G. Walsh
Neoadjuvant Treatment of Postmenopausal Breast Cancer With Anastrozole, Tamoxifen, or Both in Combination: The Immediate Preoperative Anastrozole, Tamoxifen, or Combined With Tamoxifen (IMPACT) Multicenter Double-Blind Randomized Trial
J. Clin. Oncol., August 1, 2005; 23(22): 5108 - 5116.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
M. De Laurentiis, G. Arpino, E. Massarelli, A. Ruggiero, C. Carlomagno, F. Ciardiello, G. Tortora, D. D'Agostino, F. Caputo, G. Cancello, et al.
A Meta-Analysis on the Interaction between HER-2 Expression and Response to Endocrine Treatment in Advanced Breast Cancer
Clin. Cancer Res., July 1, 2005; 11(13): 4741 - 4748.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
S. Tovey, B. Dunne, C. J. Witton, A. Forsyth, T. G. Cooke, and J. M.S. Bartlett
Can Molecular Markers Predict When to Implement Treatment with Aromatase Inhibitors in Invasive Breast Cancer?
Clin. Cancer Res., July 1, 2005; 11(13): 4835 - 4842.
[Abstract] [Full Text] [PDF]

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M Dowsett, S Johnston, L-A Martin, J Salter, M Hills, S Detre, M C Gutierrez, S K Mohsin, J Shou, D C Allred, et al.
Growth factor signalling and response to endocrine therapy: the Royal Marsden Experience
Endocr. Relat. Cancer, July 1, 2005; 12(Supplement_1): S113 - S117.
[Abstract] [Full Text] [PDF]

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W R Miller, T J Anderson, S White, D Evans, A Krause, and J M Dixon
Growth factor signalling in clinical breast cancer and its impact on response to conventional therapies: the Edinburgh experience
Endocr. Relat. Cancer, July 1, 2005; 12(Supplement_1): S119 - S123.
[Abstract] [Full Text] [PDF]

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H. J. Burstein and E. P. Winer
HER2 or Not HER2: That Is the Question
J. Clin. Oncol., June 1, 2005; 23(16): 3656 - 3659.
[Full Text] [PDF]

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 J. Clin. Pathol.Home page
H J Huang, P Neven, M Drijkoningen, R Paridaens, H Wildiers, E Van Limbergen, P Berteloot, F Amant, I Vergote, and M R Christiaens
Association between tumour characteristics and HER-2/neu by immunohistochemistry in 1362 women with primary operable breast cancer
J. Clin. Pathol., June 1, 2005; 58(6): 611 - 616.
[Abstract] [Full Text] [PDF]

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R. Kudachadkar and R. M. O'Regan
Aromatase Inhibitors as Adjuvant Therapy for Postmenopausal Patients With Early Stage Breast Cancer
CA Cancer J Clin, May 1, 2005; 55(3): 145 - 163.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
J. M. Lafky, A. T. Baron, E. M. Cora, D. W. Hillman, V. J. Suman, E. A. Perez, J. N. Ingle, and N. J. Maihle
Serum Soluble Epidermal Growth Factor Receptor Concentrations Decrease in Postmenopausal Metastatic Breast Cancer Patients Treated with Letrozole
Cancer Res., April 15, 2005; 65(8): 3059 - 3062.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
J. Geisler and P. E. Lonning
Aromatase Inhibition: Translation into a Successful Therapeutic Approach
Clin. Cancer Res., April 15, 2005; 11(8): 2809 - 2821.
[Abstract] [Full Text] [PDF]

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M. Dowsett, S. R. Ebbs, J. M. Dixon, A. Skene, C. Griffith, I. Boeddinghaus, J. Salter, S. Detre, M. Hills, S. Ashley, et al.
Biomarker Changes During Neoadjuvant Anastrozole, Tamoxifen, or the Combination: Influence of Hormonal Status and HER-2 in Breast Cancer--A Study from the IMPACT Trialists
J. Clin. Oncol., April 10, 2005; 23(11): 2477 - 2492.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
N. L.P. Barnes, S. Khavari, G. P. Boland, A. Cramer, W. F. Knox, and N. J. Bundred
Absence of HER4 Expression Predicts Recurrence of Ductal Carcinoma In situ of the Breast
Clin. Cancer Res., March 15, 2005; 11(6): 2163 - 2168.
[Abstract] [Full Text] [PDF]

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C. K. Osborne and R. Schiff
Estrogen-Receptor Biology: Continuing Progress and Therapeutic Implications
J. Clin. Oncol., March 10, 2005; 23(8): 1616 - 1622.
[Full Text] [PDF]

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S. Dellapasqua, M. Colleoni, R. D. Gelber, and A. Goldhirsch
Adjuvant Endocrine Therapy for Premenopausal Women With Early Breast Cancer
J. Clin. Oncol., March 10, 2005; 23(8): 1736 - 1750.
[Full Text] [PDF]

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E. P. Winer, C. Hudis, H. J. Burstein, A. C. Wolff, K. I. Pritchard, J. N. Ingle, R. T. Chlebowski, R. Gelber, S. B. Edge, J. Gralow, et al.
American Society of Clinical Oncology Technology Assessment on the Use of Aromatase Inhibitors As Adjuvant Therapy for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer: Status Report 2004
J. Clin. Oncol., January 20, 2005; 23(3): 619 - 629.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
C. K. Osborne, J. Shou, S. Massarweh, and R. Schiff
Crosstalk between Estrogen Receptor and Growth Factor Receptor Pathways as a Cause for Endocrine Therapy Resistance in Breast Cancer
Clin. Cancer Res., January 15, 2005; 11(2): 865s - 870s.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
J. N. Ingle
Endocrine Therapy Trials of Aromatase Inhibitors for Breast Cancer in the Adjuvant and Prevention Settings
Clin. Cancer Res., January 15, 2005; 11(2): 900s - 905s.
[Abstract] [Full Text] [PDF]

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R I Nicholson, C Staka, F Boyns, I R Hutcheson, and J M W Gee
Growth factor-driven mechanisms associated with resistance to estrogen deprivation in breast cancer: new opportunities for therapy
Endocr. Relat. Cancer, December 1, 2004; 11(4): 623 - 641.
[Abstract] [Full Text] [PDF]

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A. Ring and M. Dowsett
Mechanisms of tamoxifen resistance
Endocr. Relat. Cancer, December 1, 2004; 11(4): 643 - 658.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
J. S. Tobias
Recent advances in endocrine therapy for postmenopausal women with early breast cancer: implications for treatment and prevention
Ann. Onc., December 1, 2004; 15(12): 1738 - 1747.
[Abstract] [Full Text] [PDF]

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 J. Biol. Chem.Home page
S. Chen, M. Cho, K. Karlsberg, D. Zhou, and Y.-C. Yuan
Biochemical and Biological Characterization of a Novel Anti-aromatase Coumarin Derivative
J. Biol. Chem., November 12, 2004; 279(46): 48071 - 48078.
[Abstract] [Full Text] [PDF]


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