Practical consensus recommendations on duration of adjuvant hormonal therapy in breast cancer

S. Gupta; M. Singh; Amish Vora; G. Babu; M. Walia; V. Nautial; R. Saha; B. K. Smruti; J. B. Sharma; R. Koul; Purvish M. Parikh; S. Aggarwal

doi:10.4103/sajc.sajc_122_18

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Original Article

07 (

); 142-145

doi:

10.4103/sajc.sajc_122_18

Practical consensus recommendations on duration of adjuvant hormonal therapy in breast cancer

S. Gupta¹, M. Singh², Amish Vora^3,, G. Babu⁴, M. Walia⁵, V. Nautial⁶, R. Saha⁵, B. K. Smruti⁷, J. B. Sharma⁸, R. Koul⁹, Purvish M. Parikh¹⁰, S. Aggarwal¹¹

1 Department of Medical Oncology, Tata Memorial Center, Mumbai, Maharashtra

2 Department of Medical Oncology, Mahaveer Cancer Sansthan, Patna, Bihar

3 Department of Medical Oncology, Hope Clinic, New Delhi

4 Department of Medical Oncology, KMIO, Bengaluru, Karnataka

5 Department of Medical Oncology, Max Hospital, New Delhi

6 Department of Medical Oncology, Jolly Grant Himalayan Institute, Dehradoon, Uttarakhand

7 Department of Medical Oncology, Bombay Hospital, Mumbai, Maharashtra

8 Department of Medical Oncology, Action Balajee Cancer Hospital, New Delhi

9 Department of Surgical Oncology, Sir Ganga Ram Hospital, New Delhi

10 Department of Oncology, Shalby Cancer and Research Institute, Mumbai, Maharashtra

11 Department of Medical Oncology, Sir Ganga Ram Hospital, New Delhi

*Corresponding author: Dr. Amish Vora. tellamish@yahoo.com

Published: 2020-12-22

MedIntel Services Pvt Ltd. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/.)

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Abstract

Optimization of adjuvant systemic therapy in women with early-stage hormone receptor-positive breast cancer includes the consideration of chemotherapy and duration of hormone therapy. Adjuvant hormonal therapy significantly improves long-term survival of breast cancer patients with hormone receptor-positive disease. Despite the proven clinical efficacy of tamoxifen and aromatase inhibitors, many breast cancer survivors either fail to take the correct dosage at the prescribed frequency (adherence) or discontinue therapy (persistence). Expert oncologist discussed on the duration of adjuvant hormonal therapy for improvement of OS and quality of life of breast cancer patients by providing reduction in recurrence and mortality. This expert group used data from published literature, practical experience and opinion of a large group of academic oncologists to arrive at this practical consensus recommendations for the benefit of community oncologists.

Keywords

References

Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108.
Winer EP, Hudis C, Burstein HJ, Wolff AC, Pritchard KI, Ingle JN, 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 2005;23:619-29.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 2005;365:1687-717.
Kimmick G, Anderson R, Camacho F, Bhosle M, Hwang W, Balkrishnan R, et al. Adjuvant hormonal therapy use among insured, low-income women with breast cancer. J Clin Oncol 2009;27:3445-51.
Ziller V, Kalder M, Albert US, Holzhauer W, Ziller M, Wagner U, et al. Adherence to adjuvant endocrine therapy in postmenopausal women with breast cancer. Ann Oncol 2009;20:431-6.
Partridge AH, LaFountain A, Mayer E, Taylor BS, Winer E, Asnis-Alibozek A, et al. Adherence to initial adjuvant anastrozole therapy among women with early-stage breast cancer. J Clin Oncol 2008;26:556-62.
Chlebowski RT, Geller ML. Adherence to endocrine therapy for breast cancer. Oncology 2006;71:1-9.
Lash TL, Fox MP, Westrup JL, Fink AK, Silliman RA. Adherence to tamoxifen over the five-year course. Breast Cancer Res Treat 2006;99:215-20.
Partridge AH, Avorn J, Wang PS, Winer EP. Adherence to therapy with oral antineoplastic agents. J Natl Cancer Inst 2002;94:652-61.
McCowan C, Shearer J, Donnan PT, Dewar JA, Crilly M, Thompson AM, et al. Cohort study examining tamoxifen adherence and its relationship to mortality in women with breast cancer. Br J Cancer 2008;99:1763-8.
Barron TI, Connolly R, Bennett K, Feely J, Kennedy MJ. Early discontinuation of tamoxifen: A lesson for oncologists. Cancer 2007;109:832-9.
National Cancer Registry Programme, Indian Council of Medical Research. Leading sites of cancer. In: Consolidated Report of Population Based Cancer Registries 2001-2004, Incidence and Distribution of Cancer. Bangalore: Coordinating Unit, National Cancer Registry Programme (ICMR); 2006. p. 8-30.
Badwe RA, Gangawal S, Mittra I, Desai PB. Clinico-pathological features and prognosis of breast cancer in different religious communities in India. Indian J Cancer 1990;27:220-8.
Altekruse SF, Kosary CL, Krapcho M, editors. SEER Cancer Statistics Review. National Cancer Institute; 19752007.
National Cancer Registry Program. Ten Year Consolidated Report of the Hospital Based Cancer Registries, 1984–1993, an Assessment of the Burden and Care of Cancer Patients. New Delhi: Indian Council of Medical Research; 2001.
Agarwal G, Pradeep PV, Aggarwal V, Yip CH, Cheung PS. Spectrum of breast cancer in Asian women. World J Surg 2007;31:1031-40.
Magai C, Consedine N, Neugut AI, Hershman DL. Common psychosocial factors underlying breast cancer screening and breast cancer treatment adherence: A conceptual review and synthesis. J Womens Health (Larchmt) 2007;16:11-23.
Magai C, Consedine NS, Adjei BA, Hershman D, Neugut A. Psychosocial influences on suboptimal adjuvant breast cancer treatment adherence among African American women: Implications for education and intervention. Health Educ Behav 2008;35:835-54.
Escalada P, Griffiths P. Do people with cancer comply with oral chemotherapy treatments? Br J Community Nurs 2006;11:532-6.
Hershman D, McBride R, Jacobson JS, Lamerato L, Roberts K, Grann VR, et al. Racial disparities in treatment and survival among women with early-stage breast cancer. J Clin Oncol 2005;23:6639-46.
Neugut AI, Matasar M, Wang X, McBride R, Jacobson JS, Tsai WY, et al. Duration of adjuvant chemotherapy for colon cancer and survival among the elderly. J Clin Oncol 2006;24:2368-75.
Dobie SA, Baldwin LM, Dominitz JA, Matthews B, Billingsley K, Barlow W, et al. Completion of therapy by medicare patients with stage III colon cancer. J Natl Cancer Inst 2006;98:610-9.
Morris M, Platell C, Fritschi L, Iacopetta B. Failure to complete adjuvant chemotherapy is associated with adverse survival in stage III colon cancer patients. Br J Cancer 2007;96:701-7.
Winer EP, Hudis C, Burstein HJ, Wolff AC, Pritchard KI, Ingle JN, 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 2005;23:619-29.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 2005;365:1687-717.
Kimmick G, Anderson R, Camacho F, Bhosle M, Hwang W, Balkrishnan R, et al. Adjuvant hormonal therapy use among insured, low-income women with breast cancer. J Clin Oncol 2009;27:3445-51.
Ziller V, Kalder M, Albert US, Holzhauer W, Ziller M, Wagner U, et al. Adherence to adjuvant endocrine therapy in postmenopausal women with breast cancer. Ann Oncol 2009;20:431-6.
Partridge AH, LaFountain A, Mayer E, Taylor BS, Winer E, Asnis-Alibozek A, et al. Adherence to initial adjuvant anastrozole therapy among women with early-stage breast cancer. J Clin Oncol 2008;26:556-62.
Chlebowski RT, Geller ML. Adherence to endocrine therapy for breast cancer. Oncology 2006;71:1-9.
Lash TL, Fox MP, Westrup JL, Fink AK, Silliman RA. Adherence to tamoxifen over the five-year course. Breast Cancer Res Treat 2006;99:215-20.
Partridge AH, Avorn J, Wang PS, Winer EP. Adherence to therapy with oral antineoplastic agents. J Natl Cancer Inst 2002;94:652-61.
McCowan C, Shearer J, Donnan PT, Dewar JA, Crilly M, Thompson AM, et al. Cohort study examining tamoxifen adherence and its relationship to mortality in women with breast cancer. Br J Cancer 2008;99:1763-8.
Barron TI, Connolly R, Bennett K, Feely J, Kennedy MJ. Early discontinuation of tamoxifen: A lesson for oncologists. Cancer 2007;109:832-9.
Randomized trial of two versus five years of adjuvant tamoxifen for postmenopausal early stage breast cancer. Swedish Breast Cancer Cooperative Group. J Natl Cancer Inst 1996;88:1543-9.
Geiger AM, Thwin SS, Lash TL, Buist DS, Prout MN, Wei F, et al. Recurrences and second primary breast cancers in older women with initial early-stage disease. Cancer 2007;109:966-74.
Yood MU, Owusu C, Buist DS, Geiger AM, Field TS, Thwin SS, et al. Mortality impact of less-than-standard therapy in older breast cancer patients. J Am Coll Surg 2008;206:66-75.
Bryant J, Fisher B, Dignam J. Duration of adjuvant tamoxifen therapy. J Natl Cancer Inst Monogr 2001;56-61.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 2005;365:1687-717.
Jordan VC. The science of selective estrogen receptor modulators: Concept to clinical practice. Clin Cancer Res 2006;12:5010-3.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 2005;365:1687-717.
Goldhirsch A, Wood WC, Gelber RD, Coates AS, Thürlimann B, Senn HJ, et al. Meeting highlights: Updated international expert consensus on the primary therapy of early breast cancer. J Clin Oncol 2003;21:3357-65.
Peto R. Five years of tamoxifen – or more? J Natl Cancer Inst 1996;88:1791-3.
Fisher B, Dignam J, Bryant J, DeCillis A, Wickerham DL, Wolmark N, 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 1996;88:1529-42.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 2005;365:1687-717.
Fisher B, Costantino JP, Redmond CK, Fisher ER, Wickerham DL, Cronin WM, et al. Endometrial cancer in tamoxifen-treated breast cancer patients: Findings from the national surgical adjuvant breast and bowel project (NSABP) B-14. J Natl Cancer Inst 1994;86:527-37.
Jaiyesimi IA, Buzdar AU, Decker DA, Hortobagyi GN. Use of tamoxifen for breast cancer: Twenty-eight years later. J Clin Oncol 1995;13:513-29.
Clarke R, Leonessa F, Welch JN, Skaar TC. Cellular and molecular pharmacology of antiestrogen action and resistance. Pharmacol Rev 2001;53:25-71.
Early Breast Cancer Trialists' Collaborative Group. Tamoxifen for early breast cancer. (Cochrane Review). In: The Cochrane Library. Chichester: John Wiley and Sons; 2004.
Saphner T, Tormey DC, Gray R. Annual hazard rates of recurrence for breast cancer after primary therapy. J Clin Oncol 1996;14:2738-46.
Morandi P, Middleton LP, Mirza NQ. Occult breast cancer (OBC), a retrospective analysis of clinico-pathological characteristics and long-term outcome: the University of Texas MD Anderson Cancer Center experience. Breast Cancer Res Treat2004;88:S165.
Geisler J, King N, Anker G, Ornati G, Di Salle E, Lønning PE, et al. In vivo inhibition of aromatization by exemestane, a novel irreversible aromatase inhibitor, in postmenopausal breast cancer patients. Clin Cancer Res 1998;4:2089-93.
Geisler J, Haynes B, Anker G, Dowsett M, Lønning 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 2002;20:751-7.
Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes JF, et al. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet 2005;365:60-2.
Boccardo F, Rubagotti A, Puntoni M, Guglielmini P, Amoroso D, Fini A, et al. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: Preliminary results of the italian tamoxifen anastrozole trial. J Clin Oncol 2005;23:5138-47.
Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J, Delozier T, 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 2004;350:1081-92.
Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes JF, et al. Results of the ATAC (Arimidex, tamoxifen, alone or in combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet 2005;365:60-2.
Boccardo F, Rubagotti A, Puntoni M, Guglielmini P, Amoroso D, Fini A, et al. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: Preliminary results of the italian tamoxifen anastrozole trial. J Clin Oncol 2005;23:5138-47.
Boccardo F, Rubagotti A, Puntoni M; ITA Trialists. Switching to anastrozole (ANA) vs. continued tamoxifen (TAM) treatment of early breast cancer (EBC). Updated results of the Italian tamoxifen anastrozole (ITA) trial. Proc Am Soc Clin Oncol 2005;23:10s.
Jakesz R, Jonat W, Gnant M, Mittlboeck M, Greil R, Tausch C, et al. Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: Combined results of ABCSG trial 8 and ARNO 95 trial. Lancet 2005;366:455-62.
Winer EP, Hudis C, Burstein HJ, Wolff AC, Pritchard KI, Ingle JN, 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 2005;23:619-29.

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[1] Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108.

[2] Winer EP, Hudis C, Burstein HJ, Wolff AC, Pritchard KI, Ingle JN, 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 2005;23:619-29.

[3] Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 2005;365:1687-717.

[4] Kimmick G, Anderson R, Camacho F, Bhosle M, Hwang W, Balkrishnan R, et al. Adjuvant hormonal therapy use among insured, low-income women with breast cancer. J Clin Oncol 2009;27:3445-51.

[5] Ziller V, Kalder M, Albert US, Holzhauer W, Ziller M, Wagner U, et al. Adherence to adjuvant endocrine therapy in postmenopausal women with breast cancer. Ann Oncol 2009;20:431-6.

[6] Partridge AH, LaFountain A, Mayer E, Taylor BS, Winer E, Asnis-Alibozek A, et al. Adherence to initial adjuvant anastrozole therapy among women with early-stage breast cancer. J Clin Oncol 2008;26:556-62.

[7] Chlebowski RT, Geller ML. Adherence to endocrine therapy for breast cancer. Oncology 2006;71:1-9.

[8] Lash TL, Fox MP, Westrup JL, Fink AK, Silliman RA. Adherence to tamoxifen over the five-year course. Breast Cancer Res Treat 2006;99:215-20.

[9] Partridge AH, Avorn J, Wang PS, Winer EP. Adherence to therapy with oral antineoplastic agents. J Natl Cancer Inst 2002;94:652-61.

[10] McCowan C, Shearer J, Donnan PT, Dewar JA, Crilly M, Thompson AM, et al. Cohort study examining tamoxifen adherence and its relationship to mortality in women with breast cancer. Br J Cancer 2008;99:1763-8.

[11] Barron TI, Connolly R, Bennett K, Feely J, Kennedy MJ. Early discontinuation of tamoxifen: A lesson for oncologists. Cancer 2007;109:832-9.

[12] National Cancer Registry Programme, Indian Council of Medical Research. Leading sites of cancer. In: Consolidated Report of Population Based Cancer Registries 2001-2004, Incidence and Distribution of Cancer. Bangalore: Coordinating Unit, National Cancer Registry Programme (ICMR); 2006. p. 8-30.

[13] Badwe RA, Gangawal S, Mittra I, Desai PB. Clinico-pathological features and prognosis of breast cancer in different religious communities in India. Indian J Cancer 1990;27:220-8.

[14] Altekruse SF, Kosary CL, Krapcho M, editors. SEER Cancer Statistics Review. National Cancer Institute; 19752007.

[15] National Cancer Registry Program. Ten Year Consolidated Report of the Hospital Based Cancer Registries, 1984–1993, an Assessment of the Burden and Care of Cancer Patients. New Delhi: Indian Council of Medical Research; 2001.

[16] Agarwal G, Pradeep PV, Aggarwal V, Yip CH, Cheung PS. Spectrum of breast cancer in Asian women. World J Surg 2007;31:1031-40.

[17] Magai C, Consedine N, Neugut AI, Hershman DL. Common psychosocial factors underlying breast cancer screening and breast cancer treatment adherence: A conceptual review and synthesis. J Womens Health (Larchmt) 2007;16:11-23.

[18] Magai C, Consedine NS, Adjei BA, Hershman D, Neugut A. Psychosocial influences on suboptimal adjuvant breast cancer treatment adherence among African American women: Implications for education and intervention. Health Educ Behav 2008;35:835-54.

[19] Escalada P, Griffiths P. Do people with cancer comply with oral chemotherapy treatments? Br J Community Nurs 2006;11:532-6.

[20] Hershman D, McBride R, Jacobson JS, Lamerato L, Roberts K, Grann VR, et al. Racial disparities in treatment and survival among women with early-stage breast cancer. J Clin Oncol 2005;23:6639-46.

[21] Neugut AI, Matasar M, Wang X, McBride R, Jacobson JS, Tsai WY, et al. Duration of adjuvant chemotherapy for colon cancer and survival among the elderly. J Clin Oncol 2006;24:2368-75.

[22] Dobie SA, Baldwin LM, Dominitz JA, Matthews B, Billingsley K, Barlow W, et al. Completion of therapy by medicare patients with stage III colon cancer. J Natl Cancer Inst 2006;98:610-9.

[23] Morris M, Platell C, Fritschi L, Iacopetta B. Failure to complete adjuvant chemotherapy is associated with adverse survival in stage III colon cancer patients. Br J Cancer 2007;96:701-7.

[24] Winer EP, Hudis C, Burstein HJ, Wolff AC, Pritchard KI, Ingle JN, 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 2005;23:619-29.

[25] Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 2005;365:1687-717.

[26] Kimmick G, Anderson R, Camacho F, Bhosle M, Hwang W, Balkrishnan R, et al. Adjuvant hormonal therapy use among insured, low-income women with breast cancer. J Clin Oncol 2009;27:3445-51.

[27] Ziller V, Kalder M, Albert US, Holzhauer W, Ziller M, Wagner U, et al. Adherence to adjuvant endocrine therapy in postmenopausal women with breast cancer. Ann Oncol 2009;20:431-6.

[28] Partridge AH, LaFountain A, Mayer E, Taylor BS, Winer E, Asnis-Alibozek A, et al. Adherence to initial adjuvant anastrozole therapy among women with early-stage breast cancer. J Clin Oncol 2008;26:556-62.

[29] Chlebowski RT, Geller ML. Adherence to endocrine therapy for breast cancer. Oncology 2006;71:1-9.

[30] Lash TL, Fox MP, Westrup JL, Fink AK, Silliman RA. Adherence to tamoxifen over the five-year course. Breast Cancer Res Treat 2006;99:215-20.

[31] Partridge AH, Avorn J, Wang PS, Winer EP. Adherence to therapy with oral antineoplastic agents. J Natl Cancer Inst 2002;94:652-61.

[32] McCowan C, Shearer J, Donnan PT, Dewar JA, Crilly M, Thompson AM, et al. Cohort study examining tamoxifen adherence and its relationship to mortality in women with breast cancer. Br J Cancer 2008;99:1763-8.

[33] Barron TI, Connolly R, Bennett K, Feely J, Kennedy MJ. Early discontinuation of tamoxifen: A lesson for oncologists. Cancer 2007;109:832-9.

[34] Randomized trial of two versus five years of adjuvant tamoxifen for postmenopausal early stage breast cancer. Swedish Breast Cancer Cooperative Group. J Natl Cancer Inst 1996;88:1543-9.

[35] Geiger AM, Thwin SS, Lash TL, Buist DS, Prout MN, Wei F, et al. Recurrences and second primary breast cancers in older women with initial early-stage disease. Cancer 2007;109:966-74.

[36] Yood MU, Owusu C, Buist DS, Geiger AM, Field TS, Thwin SS, et al. Mortality impact of less-than-standard therapy in older breast cancer patients. J Am Coll Surg 2008;206:66-75.

[37] Bryant J, Fisher B, Dignam J. Duration of adjuvant tamoxifen therapy. J Natl Cancer Inst Monogr 2001;56-61.

[38] Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 2005;365:1687-717.

[39] Jordan VC. The science of selective estrogen receptor modulators: Concept to clinical practice. Clin Cancer Res 2006;12:5010-3.

[40] Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 2005;365:1687-717.

[41] Goldhirsch A, Wood WC, Gelber RD, Coates AS, Thürlimann B, Senn HJ, et al. Meeting highlights: Updated international expert consensus on the primary therapy of early breast cancer. J Clin Oncol 2003;21:3357-65.

[42] Peto R. Five years of tamoxifen – or more? J Natl Cancer Inst 1996;88:1791-3.

[43] Fisher B, Dignam J, Bryant J, DeCillis A, Wickerham DL, Wolmark N, 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 1996;88:1529-42.

[44] Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 2005;365:1687-717.

[45] Fisher B, Costantino JP, Redmond CK, Fisher ER, Wickerham DL, Cronin WM, et al. Endometrial cancer in tamoxifen-treated breast cancer patients: Findings from the national surgical adjuvant breast and bowel project (NSABP) B-14. J Natl Cancer Inst 1994;86:527-37.

[46] Jaiyesimi IA, Buzdar AU, Decker DA, Hortobagyi GN. Use of tamoxifen for breast cancer: Twenty-eight years later. J Clin Oncol 1995;13:513-29.

[47] Clarke R, Leonessa F, Welch JN, Skaar TC. Cellular and molecular pharmacology of antiestrogen action and resistance. Pharmacol Rev 2001;53:25-71.

[48] Early Breast Cancer Trialists' Collaborative Group. Tamoxifen for early breast cancer. (Cochrane Review). In: The Cochrane Library. Chichester: John Wiley and Sons; 2004.

[49] Saphner T, Tormey DC, Gray R. Annual hazard rates of recurrence for breast cancer after primary therapy. J Clin Oncol 1996;14:2738-46.

[50] Morandi P, Middleton LP, Mirza NQ. Occult breast cancer (OBC), a retrospective analysis of clinico-pathological characteristics and long-term outcome: the University of Texas MD Anderson Cancer Center experience. Breast Cancer Res Treat2004;88:S165.

[51] Geisler J, King N, Anker G, Ornati G, Di Salle E, Lønning PE, et al. In vivo inhibition of aromatization by exemestane, a novel irreversible aromatase inhibitor, in postmenopausal breast cancer patients. Clin Cancer Res 1998;4:2089-93.

[52] Geisler J, Haynes B, Anker G, Dowsett M, Lønning 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 2002;20:751-7.

[53] Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes JF, et al. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet 2005;365:60-2.

[54] Boccardo F, Rubagotti A, Puntoni M, Guglielmini P, Amoroso D, Fini A, et al. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: Preliminary results of the italian tamoxifen anastrozole trial. J Clin Oncol 2005;23:5138-47.

[55] Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J, Delozier T, 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 2004;350:1081-92.

[56] Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes JF, et al. Results of the ATAC (Arimidex, tamoxifen, alone or in combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet 2005;365:60-2.

[57] Boccardo F, Rubagotti A, Puntoni M, Guglielmini P, Amoroso D, Fini A, et al. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: Preliminary results of the italian tamoxifen anastrozole trial. J Clin Oncol 2005;23:5138-47.

[58] Boccardo F, Rubagotti A, Puntoni M; ITA Trialists. Switching to anastrozole (ANA) vs. continued tamoxifen (TAM) treatment of early breast cancer (EBC). Updated results of the Italian tamoxifen anastrozole (ITA) trial. Proc Am Soc Clin Oncol 2005;23:10s.

[59] Jakesz R, Jonat W, Gnant M, Mittlboeck M, Greil R, Tausch C, et al. Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: Combined results of ABCSG trial 8 and ARNO 95 trial. Lancet 2005;366:455-62.

[60] Winer EP, Hudis C, Burstein HJ, Wolff AC, Pritchard KI, Ingle JN, 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 2005;23:619-29.

Practical consensus recommendations on duration of adjuvant hormonal therapy in breast cancer

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