Use of aromatase inhibitors and bisphosphonates as an anticancer therapy in postmenopausal breast cancer

Expert Review of Anticancer Therapy

Volumn 10, Issue 11, 2010, Pages 1825-1836

  Mouridsen, Henning T ^a   Lønning, Per ^b   Beckmann, Matthias W ^c   Blackwell, Kimberly ^d   Doughty, Julie ^e   Gligorov, Joseph ^f   Llombart Cussac, Antonio ^g   Robidoux, Andre ^h   Thürlimann, Beat ⁱ   Gnant, Michael ^j  

^a University of Copenhagen   (Denmark)

^b UNIVERSITY OF BERGEN   (Norway)

^c UNIVERSITY HOSPITAL ERLANGEN   (Germany)

^d DUKE UNIVERSITY MEDICAL CENTER   (United States)

^e WESTERN INFIRMARY   (United Kingdom)

^f HÔPITAL TENON   (France)

^g HOSPITAL UNIVERSITARI ARNAU DE VILANOVA   (Spain)

^h CENTRE HOSPITALIER DE L UNIVERSITÉ DE MONTRÉAL   (Canada)

ⁱ CANTONAL HOSPITAL ST GALLEN   (Switzerland)

^j MEDICAL UNIVERSITY OF VIENNA   (Austria)

more..

Author keywords

anticancer; aromatase inhibitors; bisphosphonates; breast cancer; distant metastases

Indexed keywords

ALENDRONIC ACID; ANASTROZOLE; AROMATASE INHIBITOR; BISPHOSPHONIC ACID DERIVATIVE; CLODRONIC ACID; DENOSUMAB; DOCETAXEL; EPIRUBICIN; EXEMESTANE; FLUOROURACIL; GEMCITABINE; GOSERELIN; IBANDRONIC ACID; LETROZOLE; PAMIDRONIC ACID; RISEDRONIC ACID; TAMOXIFEN; ZOLEDRONIC ACID;

BONE DENSITY; BREAST CANCER; CANCER RECURRENCE; CLINICAL TRIAL; DRUG POTENCY; HUMAN; METASTASIS; OSTEOLYSIS; POSTMENOPAUSE; REVIEW;

EID: 78649308424     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/era.10.160     Document Type: Review

References (84)

1. Peng J, Sengupta S, Jordan VC. Potential of selective estrogen receptor modulators as treatments and preventives of breast cancer. Anticancer Agents Med. Chem. 9(5), 481-499 (2009).
2. Jaiyesimi IA, Buzdar AU, Decker DA, Hortobagyi GN. Use of tamoxifen for breast cancer: twenty-eight years later. J. Clin. Oncol. 13(2), 513-529 (1995).
3. Fisher B, Dignam J, Bryant J et al. Five versus more than five years of tamoxifen therapy for breast cancer patients with negative lymph nodes and estrogen receptor-positive tumors. J. Natl Cancer Inst. 88(21), 1529-1542 (1996).
4. Ward JH. Duration of adjuvant endocrine therapy of breast cancer: how much is enough? Curr. Opin. Obstet. Gynecol. 22(1), 51-55 (2010).
5. Miller WR, Dixon JM. Antiaromatase agents: preclinical data and neoadjuvant therapy. Clin. Breast Cancer 1 (Suppl. 1), S9-S14 (2000).
6. Hiscox S, Davies EL, Barrett-Lee P. Aromatase inhibitors in breast cancer. Maturitas 63(4), 275-279 (2009).
7. Geisler J, King N, Anker G et al. In vivo inhibition of aromatization by exemestane, a novel irreversible aromatase inhibitor, in postmenopausal breast cancer patients. Clin. Cancer Res. 4(9), 2089-2093 (1998).
8. Geisler J, King N, Dowsett M et al. Influence of anastrozole (Arimidex), a selective, non-steroidal aromatase inhibitor, on in vivo aromatisation and plasma oestrogen levels in postmenopausal women with breast cancer. Br. J. Cancer 74(8), 1286-1291 (1996).
9. Dowsett M, Jones A, Johnston SR et al. In vivo measurement of aromatase inhibition by letrozole (CGS 20267) in postmenopausal patients with breast cancer. Clin. Cancer Res. 1(12), 1511-1515 (1995).
10. Geisler J, Haynes B, Anker G, Dowsett M, Lonning PE. Influence of letrozole and anastrozole on total body aromatization and plasma estrogen levels in postmenopausal breast cancer patients evaluated in a randomized, cross-over study. J. Clin. Oncol. 20(3), 751-757 (2002).
11. Johannessen DC, Engan T, Di Salle E et al. Endocrine and clinical effects of exemestane (PNU 155971), a novel steroidal aromatase inhibitor, in postmenopausal breast cancer patients: a Phase I study. Clin. Cancer Res. 3(7), 1101-1108 (1997).
12. Tobias JS. Recent advances in endocrine therapy for postmenopausal women with early breast cancer: implications for treatment and prevention. Ann. Oncol. 15(12), 1738-1747 (2004).
13. Herold CI, Blackwell KL. The impact of adjuvant endocrine therapy on reducing the risk of distant metastases in hormone-responsive breast cancer. Breast 17 (Suppl. 1), S15-S24 (2008).
14. Mansell J, Monypenny IJ, Skene AI et al. The effect of quantitative oestrogen receptor expression on recurrence in postmenopausal women with early stage breast cancer. Presented at: 31st Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 10-14 December 2008 (Abstract 1131).
15. Mauriac L, Keshaviah A, Debled M et al. Predictors of early relapse in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial. Ann. Oncol. 18(5), 859-867 (2007).
16. Howell A, Cuzick J, Baum M 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(9453), 60-62 (2005).
17. Forbes JF, Cuzick J, Buzdar A et al Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial. Lancet Oncol. 9(1), 45-53 (2008). • Key aromatase inhibitor (AI)-related publication that represents the key clinical trials - completed and ongoing - assessing the efficacy and safety of third-generation AIs in postmenopausal (PM) breast cancer (BC). Anastrozole and Tamoxifen Alone and in Combination (ATAC) trial data.
18. Mouridsen H, Giobbie-Hurder A, Goldhirsch A et al. Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer. N. Engl. J. Med. 361(8), 766-776 (2009). • Key AI-related publication that represents the key clinical trials - completed and ongoing - assessing the efficacy and safety of third-generation AIs in PM BC. Breast International Group (BIG)-198 trial data.
19. Saphner T, Tormey DC, Gray R. Annual hazard rates of recurrence for breast cancer after primary therapy. J. Clin. Oncol 14(10), 2738-2746 (1996).
20. Houghton J. Initial adjuvant therapy with anastrozole (A) reduces rates of early breast cancer recurrence and adverse events compared with tamoxifen (T) - data reported on behalf of the ATAC (Arimidex', Tamoxifen, Alone or in Combination) Trialists' Group. Ann. Oncol. 17 (Suppl. 9) (2006) (Abstract 243PD).
21. Thurlimann B, Keshaviah A, Coates AS et al. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N. Engl. J. Med. 353(26), 2747-2757 (2005).
22. Tang SC. Reducing the risk of distant metastases: a better end point in adjuvant aromatase inhibitor breast cancer trials? Cancer Invest. 26(5), 481-490 (2008).
23. Rugo HS. The importance of distant metastases in hormone-sensitive breast cancer. Breast 17 (Suppl. 1), S3-S8 (2008).
24. Jassem J. Intergroup Exemestane Study mature analysis: overall survival data. Anticancer Drugs 19 (Suppl. 1), S3-S7 (2008).
25. Coombes RC, Kilburn LS, Snowdon CF et al. Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet 369(9561), 559-570 (2007).
26. Kaufmann M, Jonat W, Hilfrich J et al. Improved overall survival in postmenopausal women with early breast cancer after anastrozole initiated after treatment with tamoxifen compared with continued tamoxifen: the ARNO 95 Study. J. Clin. Oncol. 25(19), 2664-2670 (2007).
27. Boccardo F, Rubagotti A, Puntoni M et al. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: preliminary results of the Italian Tamoxifen Anastrozole Trial. J. Clin. Oncol. 23(22), 5138-5147 (2005).
28. Mamounas EP, Jeong JH, Wickerham DL et al. Benefit from exemestane as extended adjuvant therapy after 5 years of adjuvant tamoxifen: intention-to-treat analysis of the National Surgical Adjuvant Breast and Bowel Project B-33 trial. J. Clin. Oncol. 26(12), 1965-1971 (2008).
29. Gnant M, Mlineritsch B, Luschin-Ebengreuth G et al. Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 5-year follow-up of the ABCSG-12 bone-mineral density substudy. Lancet Oncol. 9(9), 840-849 (2008).
30. Rea D, Seynaeve C, Jones SE et al. Five years of exemestane as initial therapy compared to 5 years of tamoxifen followed by exemestane: rhe TEAM trial, a prospective, randomized, Phase III trial in postmenopausal women with hormonesensitive early breast cancer. Presented at: 32nd Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 9-13 December 2009 (Abstract 11).
31. Goss PE. Letrozole in the extended adjuvant setting: MA.17. Breast Cancer Res. Treat. 105 (Suppl. 1), 45-53 (2007).
32. Jakesz R, Greil R, Gnant M et al. Extended adjuvant therapy with anastrozole among postmenopausal breast cancer patients: results from the randomized Austrian Breast and Colorectal Cancer Study Group Trial 6a. J. Natl Cancer Inst. 99(24), 1845-1853 (2007).
33. Geisler J, Lonning PE. Aromatase inhibition: translation into a successful therapeutic approach. Clin. Cancer Res. 11(8), 2809-2821 (2005).
34. Sainsbury R. Aromatase inhibition in the treatment of advanced breast cancer: is there a relationship between potency and clinical efficacy? Br. J. Cancer 90(9), 1733-1739 (2004).
35. Geisler J, Helle H, Ekse D et al. Letrozole is superior to anastrozole in suppressing breast cancer tissue and plasma estrogen levels. Clin. Cancer Res. 14(19), 6330-6335 (2008).
36. Lonning PE. Aromatase inhibitors in breast cancer. Endocr. Relat. Cancer 11(2), 179-189 (2004).
37. Jones AL, Powles TJ, Law M et al. Adjuvant aminoglutethimide for postmenopausal patients with primary breast cancer: analysis at 8 years. J. Clin. Oncol. 10(10), 1547-1552 (1992).
38. Boccardo F, Rubagotti A, Amoroso D et al. Sequential tamoxifen and aminoglutethimide versus tamoxifen alone in the adjuvant treatment of postmenopausal breast cancer patients: results of an Italian cooperative study. J. Clin. Oncol. 19(22), 4209-4215 (2001).
39. Rose C, Vtoraya O, Pluzanska A et al. An open randomised trial of second-line endocrine therapy in advanced breast cancer. Comparison of the aromatase inhibitors letrozole and anastrozole. Eur. J. Cancer 39(16), 2318-2327 (2003).
40. Gershanovich M, Chaudri HA, Campos D et al. Letrozole, a new oral aromatase inhibitor: randomised trial comparing 2.5 mg daily, 0.5 mg daily and aminoglutethimide in postmenopausal women with advanced breast cancer. Letrozole International Trial Group (AR/BC3). Ann. Oncol. 9(6), 639-645 (1998).
41. Bonneterre J, Buzdar A, Nabholtz JM et al. Anastrozole is superior to tamoxifen as first-line therapy in hormone receptor positive advanced breast carcinoma. Cancer 92(9), 2247-2258 (2001).
42. Mouridsen H, Gershanovich M, Sun Y 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. 21(11), 2101-2109 (2003).
43. Smith I, Cataliotti L; on behalf of the IMPACT and PROACT Trialists. Anastrozole versus tamoxifen as neoadjuvant therapy for oestrogen receptor-positive breast cancer in postmenopausal women: the IMPACT and PROACT trials. Presented at: European Breast Cancer Conference. Hamburg, Germany, 16-20 March 2004 (Abstract 47).
44. Smith IE, Dowsett M, Ebbs SR 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(22), 5108-5116 (2005).
45. Eiermann W, Paepke S, Appfelstaedt J et al Preoperative treatment of postmenopausal breast cancer patients with letrozole: a randomized double-blind multicenter study. Ann. Oncol. 12(11), 1527-1532 (2001).
46. Goldhirsch A, Wood WC, Gelber RD et al. Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Ann. Oncol. 18(7), 1133-1144 (2007).
47. Goldhirsch A, Ingle JN, Gelber RD et al Thresholds for therapies: highlights of the St Gallen International Expert Consensus on the primary therapy of early breast cancer 2009. Ann. Oncol. 20(8), 1319-1329 (2009). • The 2009 St Gallen Consensus publication - the majority of the panel was in alignment with this as it relates to several issues including definitions of risk categories, estrogen receptor/progesterone receptor status and cytochrome P450 2D6 (CYP2D6) inhibitors.
48. Mamounas EP, Lembersky B, Jeong JH et al. NSABP B-42: a clinical trial to determine the efficacy of five years of letrozole compared with placebo in patients completing five years of hormonal therapy consisting of an aromatase inhibitor (AI) or tamoxifen followed by an AI in prolonging disease-free survival in postmenopausal women with hormone receptor-positive breast cancer. Clin. Breast Cancer 7(5), 416-421 (2006).
49. Burstein HJ, Prestrud AA, Seidenfeld J et al. American Society of Clinical Oncology clinical practice guideline: update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer. J. Clin. Oncol. 28(23), 3784-3796 (2010).
50. Hadji P. An economic analysis of arthralgia/myalgia versus recurrence in women with hormone receptor-positive (HR+) breast cancer (BC) on aromatase inhibitors (AIs). J. Clin. Oncol 27 (15 Suppl.) (2009) (Abstract e1 1601).
51. Coates AS, Keshaviah A, Thurlimann B et al. Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrineresponsive early breast cancer: update of study BIG 1-98. J. Clin. Oncol. 25(5), 486-492 (2007).
52. Hoskins JM, Carey LA, McLeod HL. CYP2D6 and tamoxifen: DNA matters in breast cancer. Nat. Rev. Cancer 9(8), 576-586 (2009).
53. Schroth W, Goetz MP, Hamann U et al. Association between CYP2D6 polymorphisms and outcomes among women with early stage breast cancer treated with tamoxifen. JAMA 302(13), 1429-1436 (2009).
54. Gligorov J KI, Luporsi E, Namer M. Recommandations pour la pratique clinique: Nice-Saint-Paul-de-Vence 2009 « cancers du sein » et « soins de support » Partie I - Cancers du sein. Oncologie 11, 497-505 (2009).
55. Landesberg R, Eisig S, Fennoy I, Siris E. Alternative indications for bisphosphonate therapy. J. Oral Maxillofac. Surg. 67 (5 Suppl.), 27-34 (2009).
56. Gnant M, Dubsky P, Fitzal F et al. Maintaining bone density in patients undergoing treatment for breast cancer: is there an adjuvant beneft? Clin. Breast Cancer 9 (Suppl. 1), S18-S27 (2009).
57. Brufsky AM, Bosserman LD, Caradonna RR et al. Zoledronic acid effectively prevents aromatase inhibitor-associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole: Z-FAST study 36-month follow-up results. Clin. Breast Cancer 9(2), 77-85 (2009).
58. Brufsky A, Harker WG, Beck JT et al. The Effect of Zoledronic Acid on Aromatase Inhibitor-Associated Bone Loss in Postmenopausal Women with Early Breast Cancer Receiving Adjuvant Letrozole: The Z-FAST Study 5-Year Final Follow-Up. Presented at: 32nd Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 9-13 December 2009 (Abstract 4083).
59. Eidtmann H, DeBoer R, Llombart A et al. The effect of zoledronic acid on aromatase inhibitor associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole: 36 months follow-up of ZO-FAST. Presented at: 31st Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 10-14 December 2008 (Abstract 44).
60. Eidtmann H, de Boer R, Bundred N et al. Efficacy of zoledronic acid in postmenopausal women with early breast cancer receiving adjuvant letrozole: 36-month results of the ZO-FAST Study. Ann. Oncol. DOI: 10.1093/annonc/mdq217 (2010) (Epub ahead of print).
61. LLombarto A, Frassoldati A, Paija O et al. Effect of zoledronic acid on aromatase inhibitor-associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole: E-ZO-FAST 36-month follow up. Presented at: ASCO 2009 Breast Cancer Symposium. San Francisco, CA, USA, 8-10 October 2009 (Abstract 213).
62. Nogués X, Peña MJ, Martinez M et al Bone health in postmenopausal women treated with adjuvant aromatase inhibitors for early breast cancer: 12 months follow-up. Presented at: 32nd Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 9-13 December 2009 (Abstract 3175).
63. Body JJ, Lichinitser M, Tjulandin S, Garnero P, Bergstrom B. Oral ibandronate is as active as intravenous zoledronic acid for reducing bone turnover markers in women with breast cancer and bone metastases. Ann. Oncol. 18(7), 1165-1171 (2007).
64. Stopeck A, Fujiwara Y, Lichinitser M et al. A comparison of denosumab versus zoledronic acid for the prevention of skeletal-related events in breast cancer patients with bone metastases. Presented at: 32nd Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 9-13 December 2009 (Abstract 22).
65. Winter MC, Holen I, Coleman RE. Exploring the antitumour activity of bisphosphonates in early breast cancer. Cancer Treat. Rev. 34(5), 453-475 (2008). • Key bisphosphonate-related publication that represents key studies with supporting evidence for the role of bisphosphonates as anticancer therapy. Adjuvant Zoledronic Acid to Reduce Recurrence (AZURE) trial data.
66. Guise TA. Antitumor effects of bisphosphonates: promising preclinical evidence. Cancer Treat. Rev. 34 (Suppl. 1), S19-S24 (2008).
67. Santini D, Vincenzi B, Avvisati G et al. Pamidronate induces modifications of circulating angiogenetic factors in cancer patients. Clin. Cancer Res. 8(5), 1080-1084 (2002).
68. Santini D, Vincenzi B, Galluzzo S et al. Repeated intermittent low-dose therapy with zoledronic acid induces an early, sustained, and long-lasting decrease of peripheral vascular endothelial growth factor levels in cancer patients. Clin. Cancer Res. 13 (15 Pt 1), 4482-4486 (2007).
69. Shiozawa Y, Havens AM, Pienta KJ, Taichman RS. The bone marrow niche: habitat to hematopoietic and mesenchymal stem cells, and unwitting host to molecular parasites. Leukemia 22(5), 941-950 (2008).
70. Rack BK, Genss E-M, Schoberth A et al. Effect of zoledronate on persisting isolated tumor cells in the bone marrow of patients without recurrence of early breast cancer. Presented at: 30th Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 13-16 December 2007 (Abstract 511).
71. Aft R, Ylagan L, Chavez-MacGregor M et al. Effect of zoledronic acid on bone marrow micrometastases in women undergoing neoadjuvant chemotherapy for breast cancer. J. Clin. Oncol. 26 (20 Suppl.) (2008) (Abstract 1021).
72. Lin AP, Scott J W, Melisko J et al Zoledronic acid as adjuvant therapy for women with early stage breast cancer and disseminated tumor cells in bone marrow. J. Clin. Oncol. 26 (20 Suppl.) (2008) (Abstract 559).
73. Solomayer E, Hirnle P, Janni W et al. Influence of zoledronic acid on disseminated tumor cells (DTC) in primary breast cancer patients. Presented at: 31st Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 10-14 December 2008 (Abstract 2048).
74. Gnant M, Mlineritsch B, Schippinger W et al. Endocrine therapy plus zoledronic acid in premenopausal breast cancer. N. Engl. J. Med. 360(7), 679-691 (2009). • Key bisphosphonate-related publications that represents key studies with supporting evidence for the role of bisphosphonates as anticancer therapy. Austrian Breast and Colorectal Cancer Study Group (ABCSG)-12 trial data.
75. Coleman R, de Boer R, Llombarto A et al Impact of Zoledronic Acid in Postmenopausal Women with Early Breast Cancer Receiving Adjuvant Letrozole: Z-FAST, ZO-FAST, and E-ZO-FAST. Presented at: 32nd Annual San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 9-13 December 2009 (Abstract 4082). • Zometa-Femara Adjuvant Synergy Trials (Z-FAST), ZO-FAST and E-ZO-FAST disease-free survival data.
76. Gnant M, Blaha P, Dubsky P et al Adjuvant bisphosphonates in endocrineresponsive breast cancer: what is their place in therapy? Ther. Adv. Med. Oncol. 1(3), 123-136 (2009).
77. Gnant M, Fitzal F, Jakesz R et al Bisphosphonates as adjuvant therapy for breast cancer. Curr. Breast Cancer Rep. 1, 54-63 (2009).
78. Coleman RE, Winter MC, Cameron D et al. The effects of adding zoledronic acid to neoadjuvant chemotherapy on tumour response: exploratory evidence for direct anti-tumour activity in breast cancer. Br. J. Cancer 102(7), 1099-1105 (2010).
79. Kohno N, Aogi K, Minami H et al Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: a randomized, placebo-controlled trial. J. Clin. Oncol. 23(15), 3314-3321 (2005).
80. Black DM, Delmas PD, Eastell R et al Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N. Engl J. Med. 356(18), 1809-1822 (2007).
81. Daubine F, Le Gall C, Gasser J, Green J, Clezardin P. Antitumor effects of clinical dosing regimens of bisphosphonates in experimental breast cancer bone metastasis. J. Natl Cancer Inst. 99(4), 322-330 (2007).
82. Kristensen B, Ejlertsen B, Mouridsen HT et al. Bisphosphonate treatment in primary breast cancer: results from a randomised comparison of oral pamidronate versus no pamidronate in patients with primary breast cancer. Acta Oncol. 47(4), 740-746 (2008).
83. Hadji P, Body JJ, Aapro MS et al. Practical guidance for the management of aromatase inhibitor-associated bone loss. Ann. Oncol 19(8), 1407-1416 (2008).
84. Aebi S, Davidson T, Gruber G, Castiglione M. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann. Oncol. 21 (Suppl. 5), v9-v14 (2010). • These recently updated guidelines support many of the opinions presented within this article.