Use of neoadjuvant data to design adjuvant endocrine therapy trials for breast cancer

Nature Reviews Clinical Oncology

Volumn 9, Issue 4, 2012, Pages 223-229

  Goncalves, Rodrigo ^a   Ma, Cynthia ^a   Luo, Jingqin ^b   Suman, Vera ^c   Ellis, Matthew James ^a  

^a WASHINGTON UNIVERSITY   (United States)

^b MO   (United States)

^c MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANASTROZOLE; BIOLOGICAL MARKER; ESTRADIOL; EVEROLIMUS; EXEMESTANE; GOSERELIN; KI 67 ANTIGEN; LETROZOLE; RAPAMYCIN DERIVATIVE; TAMOXIFEN;

BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER HORMONE THERAPY; CANCER SURVIVAL; CLINICAL STUDY; COMPARATIVE EFFECTIVENESS; DISEASE FREE SURVIVAL; DRUG EFFICACY; DRUG USE; EVENT FREE SURVIVAL; HORMONE INHIBITION; HUMAN; OVERALL SURVIVAL; POSTMENOPAUSE; PRIORITY JOURNAL; REVIEW; TREATMENT DURATION;

ANTINEOPLASTIC AGENTS, HORMONAL; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CLINICAL TRIALS AS TOPIC; FEMALE; HUMANS; NEOADJUVANT THERAPY; PROGNOSIS;

EID: 84859444513     PISSN: 17594774     EISSN: 17594782     Source Type: Journal    
DOI: 10.1038/nrclinonc.2012.21     Document Type: Review

References (38)

1. Anderson, W. F., Chen, B. E., Jatoi, I. & Rosenberg, P. S. Effects of estrogen receptor expression and histopathology on annual hazard rates of death from breast cancer. Breast Cancer Res. Treat. 100, 121-126 (2006).
2. Howell, A. et al. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet 365, 60-62 (2005).
3. Mouridsen, H. et al. Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer. N. Engl. J. Med. 361, 766-776 (2009).
4. Coombes, R. C. et al. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N. Engl. J. Med. 350, 1081-1092 (2004).
5. Dowsett, M. 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. 23, 2477-2492 (2005).
6. Gerdes, J., Schwab, U., Lemke, H. & Stein, H. Production of a mouse monoclonal antibody reactive with a human nuclear antigen associated with cell proliferation. Int. J. Cancer 31, 13-20 (1983).
7. Harris, L. et al. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J. Clin. Oncol. 25, 5287-5312 (2007).
8. Goldhirsch, A. et al. Strategies for subtypes-dealing with the diversity of breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann. Oncol. 22, 1736-1747 (2011).
9. Cheang, M. C. et al. Ki67 index, HER2 status, and prognosis of patients with luminal B breast cancer. J. Natl Cancer Inst. 101, 736-750 (2009).
10. Dowsett, M. et al. Assessment of Ki67 in breast cancer: recommendations from the International Ki67 in Breast Cancer Working Group. J. Natl Cancer Inst. 103, 1656-1664 (2011).
11. Colozza, M., Sidoni, A. & Piccart-Gebhart, M. Value of Ki67 in breast cancer: the debate is still open. Lancet Oncol. 11, 414-415 (2010).
12. Luporsi, E. et al. Ki-67: level of evidence and methodological considerations for its role in the clinical management of breast cancer: analytical and critical review. Breast Cancer Res. Treat. doi:10.1007/s10549- 011-1837-z.
13. Ellis, M. J. et al. Letrozole inhibits tumor proliferation more effectively than tamoxifen independent of HER1/2 expression status. Cancer Res. 63, 6523-6531 (2003).
14. Dowsett, M. et al. Short-term changes in Ki-67 during neoadjuvant treatment of primary breast cancer with anastrozole or tamoxifen alone or combined correlate with recurrence-free survival. Clin. Cancer Res. 11, 951s-958s (2005).
15. Dowsett, M. et al. Prognostic value of Ki67 expression after short-term presurgical endocrine therapy for primary breast cancer. J. Natl Cancer Inst. 99, 167-170 (2007).
16. Thürlimann, B. et al. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N. Engl. J. Med. 353, 2747-2757 (2005).
17. Regan, M. M. et al. Assessment of letrozole and tamoxifen alone and in sequence for postmenopausal women with steroid hormone receptor-positive breast cancer: the BIG 1-98 randomised clinical trial at 8.1 years median follow-up. Lancet Oncol. 12, 1101-1108 (2011).
18. Eiermann, W. et al. Preoperative treatment of postmenopausal breast cancer patients with letrozole: A randomized double-blind multicenter study. Ann. Oncol. 12, 1527-1532 (2001).
19. Ellis, M. J. 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. 19, 3808-3816 (2001).
20. Chin, S. F. et al. Using array-comparative genomic hybridization to define molecular portraits of primary breast cancers. Oncogene 26, 1959-1970 (2007).
21. Horobin, J. M., Preece, P. E., Dewar, J. A., Wood, R. A. & Cuschieri, A. Long-term follow-up of elderly patients with locoregional breast cancer treated with tamoxifen only. Br. J. Surg. 78, 213-217 (1991).
22. Ellis, M. J. et al. Outcome prediction for estrogen receptor-positive breast cancer based on postneoadjuvant endocrine therapy tumor characteristics. J. Natl Cancer Inst. 100, 1380-1388 (2008).
23. Dowsett, M. et al. Assessment of Ki67 in breast cancer: Recommendations from the International Ki67 in Breast Cancer Working Group. J. Natl Cancer Inst. 103, 1656-1664 (2011).
24. Baum, M. et al. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet 359, 2131-2139 (2002).
25. Cuzick, J. et al. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trial. Lancet Oncol. 11, 1135-1141 (2010).
26. Smith, I. E. et al. 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. 23, 5108-5116 (2005).
27. Dowsett, M. et al. Endocrine therapy, new biologicals, and new study designs for presurgical studies in breast cancer. J. Natl Cancer Inst. Monogr. 2011, 120-123 (2011).
28. Goss, P. E. et al. Final analysis of NCIC CTG MA.27: a randomized phase III trial of exemestane versus anastrozole in postmenopausal women with hormone receptor positive primary breast cancer [abstract]. In 33rd Annual San Antonio Breast Cancer Symposium. S1-1 (San Antonio, Texas, 2010).
29. Ellis, M. J. et al. Randomized phase II neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-rich stage 2 to 3 breast cancer: clinical and biomarker outcomes and predictive value of the baseline PAM50-based intrinsic subtype-ACOSOG Z1031. J. Clin. Oncol. 29, 2342-2349 (2011).
30. US National Library of Medicine. ClinicalTrials.gov [online], http://clinicaltrials.gov/ct2/show/NCT00248170.
31. Dixon, J. M. et al. Letrozole suppresses plasma estradiol and estrone sulphate more completely than anastrozole in postmenopausal women with breast cancer. J. Clin. Oncol. 26, 1671-1676 (2008).
32. Gnant, M. et al. Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 62-month follow-up from the ABCSG-12 randomised trial. Lancet Oncol. 12, 631-641 (2011).
33. Masuda, N. et al. Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial. Lancet Oncol. doi: 10.1016/S1470-2045(11)70373-4
34. Kinoshita, T. et al. Neoadjuvant anastrozole or tamoxifen for premenopausal breast cancer: Ki67 expression data from the STAGE study. J. Clin. Oncol. 29 (Suppl. 15), 501 (2011).
35. Baselga, J. et al. Phase II randomized study of neoadjuvant everolimus plus letrozole compared with placebo plus letrozole in patients with estrogen receptor-positive breast cancer. J. Clin. Oncol. 27, 2630-2637 (2009).
36. Baselga, J. et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N. Engl. J. Med. doi:10.1056/NEJMoa1109653 (2011).
37. Crowder, R. J. et al. PIK3CA and PIK3CB inhibition produce synthetic lethality when combined with estrogen deprivation in estrogen receptor-positive breast cancer. Cancer Res. 69, 3955-3962 (2009).
38. Sanchez, C. G. et al. Preclinical modeling of combined phosphatidylinositol-3-kinase inhibition with endocrine therapy for estrogen receptor-positive breast cancer. Breast Cancer Res. 13, R21 (2011).