Current Status of Extended Adjuvant Endocrine Therapy in Early Stage Breast Cancer

Current Treatment Options in Oncology

Volumn 19, Issue 5, 2018, Pages

  van Hellemond, Irene E G ^a   Geurts, Sandra M E ^a   Tjan Heijnen, Vivianne C G ^a  

^a MAASTRICHT UNIVERSITY   (Netherlands)

Author keywords

Adjuvant therapy; Aromatase inhibitor; Breast cancer; Endocrine therapy; Postmenopausal; Tamoxifen

Indexed keywords

ABEMACICLIB; ANASTROZOLE; AROMATASE INHIBITOR; EVEROLIMUS; GONADORELIN AGONIST; LETROZOLE; PALBOCICLIB; PLACEBO; RIBOCICLIB; TAMOXIFEN; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; IMMUNOLOGICAL ADJUVANT;

ADJUVANT THERAPY; ARTHRALGIA; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER HORMONE THERAPY; CARDIOVASCULAR DISEASE; DISEASE FREE SURVIVAL; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; HUMAN; MEDICATION COMPLIANCE; MONOTHERAPY; MYALGIA; OVARY FUNCTION; OVERALL SURVIVAL; PATIENT COMPLIANCE; POSTMENOPAUSE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENCE FREE SURVIVAL; REVIEW; SYSTEMATIC REVIEW; TREATMENT DURATION; BREAST TUMOR; CANCER STAGING; FEMALE; HORMONE SUBSTITUTION; MULTIMODALITY CANCER THERAPY; PATHOLOGY; PROCEDURES; TUMOR RECURRENCE;

ADJUVANTS, IMMUNOLOGIC; ANTINEOPLASTIC AGENTS, HORMONAL; AROMATASE INHIBITORS; BREAST NEOPLASMS; COMBINED MODALITY THERAPY; DISEASE-FREE SURVIVAL; FEMALE; HORMONE REPLACEMENT THERAPY; HUMANS; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; TAMOXIFEN;

EID: 85045985877     PISSN: 15272729     EISSN: 15346277     Source Type: Journal    
DOI: 10.1007/s11864-018-0541-1     Document Type: Review

References (57)

1. Burstein HJ, Temin S, Anderson H, Buchholz TA, Davidson NE, Gelmon KE, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: american society of clinical oncology clinical practice guideline focused update. J Clin Oncol. 2014;32(21):2255–69.
2. Dowsett M, Forbes JF, Bradley R, Ingle J, Aihara T, et al. Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015;386(10001):1341–52. Important patient-level meta-analysis comparing several strategies of 5-year adjuvant endocrine therapy.
3. •Tjan-Heijnen VCG, van Hellemond IEG, Peer PGM, Swinkels ACP, Smorenburg CH, van der Sangen MJC, Kroep JR, De Graaf H, Honkoop AH, Erdkamp FLG, van den Berkmortel F, de Boer M, de Roos WK, Linn SC, Imholz ALT, Seynaeve CM, Dutch Breast Cancer Research Group for the DI (2017) Extended adjuvant aromatase inhibition after sequential endocrine therapy (DATA): a randomised, phase 3 trial. Lancet Oncol 18 (11):1502-1511. Trial on extended adjuvant aromatase inhibitor therapy.
4. • Blok EJ, Kroep JR, Meershoek-Klein Kranenbarg E, Duijm-de Carpentier M, Putter H, van den Bosch J, Maartense E, van Leeuwen-Stok AE, Liefers GJ, Nortier JWR, Rutgers EJT, van de Velde CJH, Group IS (2018) Optimal Duration of Extended Adjuvant Endocrine Therapy for Early Breast Cancer; Results of the IDEAL Trial (BOOG 2006-05). J Natl Cancer Inst 110 (1). Trial on extended adjuvant aromatase inhibitor therapy.
5. • Mamounas EP, Bandos H, Lembersky BC, Geyer JCE, Fehrenbacher L, Graham ML, Chia SL, Brufsky AM, Hennessy BT, Soori GS, Dakil SR, Seay TE, Wade IJL, McCarron EC, Paik S, Swain SM, Wickerham DL, Wolmark N A Randomized, double-blinded, placebo-controlled clinical trial of extended adjuvant endocrine therapy (tx) with letrozole (L) in postmenopausal women with hormone-receptor (+) breast cancer (BC) who have completed previous adjuvant tx with an aromatase inhibitor (AI): results from NRG Oncology/NSABP B-42. In: Presented at: 2016 San Antonio Breast Cancer Symposium; December 6–10; San Antonio, TX, 2016. Trial on extended adjuvant aromatase inhibitor therapy.
6. • Goss PE, Ingle JN, Pritchard KI, Robert NJ, Muss H, Gralow J, et al. Extending aromatase-inhibitor adjuvant therapy to 10 years. N Engl J Med. 2016;375(3):209–19. Trial on extended adjuvant aromatase inhibitor therapy.
7. Tierney JF, Stewart LA, Ghersi D, Burdett S, Sydes MR. Practical methods for incorporating summary time-to-event data into meta-analysis. Trials. 2007;8:16.
8. Controlled trial of tamoxifen as adjuvant agent in management of early breast cancer. Interim analysis at four years by Nolvadex Adjuvant Trial Organisation. Lancet.1983;1(8319):257–261.
9. Controlled trial of tamoxifen as a single adjuvant agent in the management of early breast cancer. Br J Cancer. 1988;57(6):608–611.
10. Cyclophosphamide and tamoxifen as adjuvant therapies in the management of breast cancer. Br J Cancer. 1988;57(6):604–607.
11. 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(21):1543–1549.
12. Early Breast Cancer Trialists’ Collaborative G. 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(9472):1687–717.
13. Davies C, Godwin J, Gray R, Clarke M, Cutter D, et al. Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials. Lancet. 2011;378(9793):771–84.
14. Hackshaw A, Roughton M, Forsyth S, Monson K, Reczko K, Sainsbury R, et al. Long-term benefits of 5 years of tamoxifen: 10-year follow-up of a large randomized trial in women at least 50 years of age with early breast cancer. J Clin Oncol. 2011;29(13):1657–63.
15. Cuzick J, Sestak I, Baum M, Buzdar A, Howell A, Dowsett M, et al. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trial. Lancet Oncol. 2010;11(12):1135–41.
16. Regan MM, Neven P, Giobbie-Hurder A, Goldhirsch A, Ejlertsen B, Mauriac L, 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. 2011;12(12):1101–8.
17. van de Velde CJ, Rea D, Seynaeve C, Putter H, Hasenburg A, Vannetzel JM, et al. Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial. Lancet. 2011;377(9762):321–31.
18. Bliss JM, Kilburn LS, Coleman RE, Forbes JF, Coates AS, Jones SE, et al. Disease-related outcomes with long-term follow-up: an updated analysis of the intergroup exemestane study. J Clin Oncol. 2012;30(7):709–17.
19. Boccardo F, Guglielmini P, Bordonaro R, Fini A, Massidda B, Porpiglia M, et al. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: long term results of the Italian Tamoxifen Anastrozole trial. Eur J Cancer. 2013;49(7):1546–54.
20. Aihara T, Takatsuka Y, Ohsumi S, Aogi K, Hozumi Y, Imoto S, et al. Phase III randomized adjuvant study of tamoxifen alone versus sequential tamoxifen and anastrozole in Japanese postmenopausal women with hormone-responsive breast cancer: N-SAS BC03 study. Breast Cancer Res Treat. 2010;121(2):379–87.
21. Kaufmann M, Jonat W, Hilfrich J, Eidtmann H, Gademann G, Zuna I, 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. 2007;25(19):2664–70.
22. Dubsky PC, Jakesz R, Mlineritsch B, Postlberger S, Samonigg H, Kwasny W, et al. Tamoxifen and anastrozole as a sequencing strategy: a randomized controlled trial in postmenopausal patients with endocrine-responsive early breast cancer from the Austrian Breast and Colorectal Cancer Study Group. J Clin Oncol. 2012;30(7):722–8.
23. • Derks MGM, Blok EJ, Seynaeve C, Nortier JWR, Kranenbarg EM, Liefers GJ, et al. Adjuvant tamoxifen and exemestane in women with postmenopausal early breast cancer (TEAM): 10-year follow-up of a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017;18(9):1211–20. Trial on adjuvant aromatase inhibitors with a long follow-up.
24. •• Pan H, Gray R, Braybrooke J, Davies C, Taylor C, McGale P, et al. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med. 2017;377(19):1836–46.Important trial on the annual hazard of breast cancer recurrence after adjuvant endocrine therapy in hormone receptor positive breast cancer.
25. Saphner T, Tormey DC, Gray R. Annual hazard rates of recurrence for breast cancer after primary therapy. J Clin Oncol. 1996;14(10):2738–46.
26. Davies C, Pan H, Godwin J, Gray R, Arriagada R, Raina V, et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013;381(9869):805–16.
27. Gray R. aTTom: long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years in 6,934 women with early breast cancer. J Clin Oncol. 2008;31((suppl)):abstr 5.
28. Rea DW, Gray RG, Bowden SJ, et al. Overall and subgroup findings of the aTTom trial: a randomised comparison of continuing adjuvant tamoxifen to 10 years compared to stopping after 5 years in 6953 women with ER positive or ER untested early breast cancer. ECC. 2013:1860.
29. Tormey DC, Gray R, Falkson HC. Postchemotherapy adjuvant tamoxifen therapy beyond five years in patients with lymph node-positive breast cancer. Eastern Coop Oncol Group J Natl Cancer Inst. 1996;88(24):1828–33.
30. Stewart HJ, Prescott RJ, Forrest AP. Scottish adjuvant tamoxifen trial: a randomized study updated to 15 years. J Natl Cancer Inst. 2001;93(6):456–62.
31. Fisher B, Dignam J, Bryant J, Wolmark N. Five versus more than five years of tamoxifen for lymph node-negative breast cancer: updated findings from the National Surgical Adjuvant Breast and Bowel Project B-14 randomized trial. J Natl Cancer Inst. 2001;93(9):684–90.
32. Jakesz R, Greil R, Gnant M, Schmid M, Kwasny W, Kubista E, 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. 2007;99(24):1845–53.
33. Mamounas EP, Jeong JH, Wickerham DL, Smith RE, Ganz PA, Land SR, 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. 2008;26(12):1965–71.
34. Jin H, Tu D, Zhao N, Shepherd LE, Goss PE. Longer-term outcomes of letrozole versus placebo after 5 years of tamoxifen in the NCIC CTG MA.17 trial: analyses adjusting for treatment crossover. J Clin Oncol. 2012;30(7):718–21.
35. • Goldvaser H, AlGorashi I, Ribnikar D, Seruga B, Templeton AJ, Ocana A, et al. Efficacy of extended adjuvant therapy with aromatase inhibitors in early breast cancer among common clinicopathologically-defined subgroups: a systematic review and meta-analysis. Cancer Treat Rev. 2017;60:53–9. Meta-analysis on extended adjuvant aromatase inhibitor therapy.
36. • Colleoni M, Luo W, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, et al. Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018;19(1):127–38. Trial on extended adjuvant aromatase inhibitor therapy.
37. Chirgwin JH, Giobbie-Hurder A, Coates AS, Price KN, Ejlertsen B, Debled M, et al. Treatment adherence and its impact on disease-free survival in the Breast International Group 1-98 trial of tamoxifen and letrozole, alone and in sequence. J Clin Oncol. 2016;34(21):2452–9.
38. Perez EA. Safety profiles of tamoxifen and the aromatase inhibitors in adjuvant therapy of hormone-responsive early breast cancer. Ann Oncol. 2007;18(Suppl 8):viii26–35.
39. Cuppone F, Bria E, Verma S, Pritchard KI, Gandhi S, Carlini P, et al. Do adjuvant aromatase inhibitors increase the cardiovascular risk in postmenopausal women with early breast cancer? Meta-analysis of randomized trials. Cancer. 2008;112(2):260–7.
40. Henry NL, Azzouz F, Desta Z, Li L, Nguyen AT, Lemler S, et al. Predictors of aromatase inhibitor discontinuation as a result of treatment-emergent symptoms in early-stage breast cancer. J Clin Oncol. 2012;30(9):936–42.
41. Hershman DL, Kushi LH, Shao T, Buono D, Kershenbaum A, Tsai WY, et al. Early discontinuation and nonadherence to adjuvant hormonal therapy in a cohort of 8,769 early-stage breast cancer patients. J Clin Oncol. 2010;28(27):4120–8.
42. Partridge AH, LaFountain A, Mayer E, Taylor BS, Winer E, Asnis-Alibozek A. Adherence to initial adjuvant anastrozole therapy among women with early-stage breast cancer. J Clin Oncol. 2008;26(4):556–62.
43. Barron TI, Connolly R, Bennett K, Feely J, Kennedy MJ. Early discontinuation of tamoxifen: a lesson for oncologists. Cancer. 2007;109(5):832–9.
44. Murphy CC, Bartholomew LK, Carpentier MY, Bluethmann SM, Vernon SW. Adherence to adjuvant hormonal therapy among breast cancer survivors in clinical practice: a systematic review. Breast Cancer Res Treat. 2012;134(2):459–78.
45. Huiart L, Ferdynus C, Giorgi R. A meta-regression analysis of the available data on adherence to adjuvant hormonal therapy in breast cancer: summarizing the data for clinicians. Breast Cancer Res Treat. 2013;138(1):325–8.
46. Smith IE, Dowsett M. Aromatase inhibitors in breast cancer. N Engl J Med. 2003;348(24):2431–42.
47. Goldvaser H, Barnes TA, Seruga B, Cescon DW, Ocana A, Ribnikar D, Amir E. Toxicity of extended adjuvant therapy with aromatase inhibitors in early breast cancer: a systematic review and meta-analysis. J Natl Cancer Inst. (2018);110 (1). Meta-analysis on the toxicity of extended adjuvant aromatase inhibitor therapy.
48. van Hellemond IEG, Vriens IJH, Peer PGM, Swinkels ACP, Smorenburg CH, Seynaeve CM, et al. Ovarian function recovery during anastrozole in breast cancer patients with chemotherapy-induced ovarian function failure. JNCI. 2017;109(12)
49. Tjan-Heijnen VC, Hellemond IV, Vriens I, Peer P, Swinkels A, Smorenburg CH. Anastrozole after tamoxifen in early breast cancer patients with chemotherapy-induced ovarian function failure. J Clin Oncol. 2017;35(15_suppl):523.
50. Bellet M, Gray KP, Francis PA, Lang I, Ciruelos E, Lluch A, et al. Twelve-month estrogen levels in premenopausal women with hormone receptor-positive breast cancer receiving adjuvant triptorelin plus exemestane or tamoxifen in the suppression of ovarian function trial (SOFT): the SOFT-EST substudy. J Clin Oncol. 2016;34(14):1584–93.
51. Francis PA, Regan MM, Fleming GF, Lang I, Ciruelos E, Bellet M, et al. Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med. 2015;372(5):436–46.
52. Gnant M, Mlineritsch B, Stoeger H, Luschin-Ebengreuth G, Knauer M, Moik M, et al. Zoledronic acid combined with adjuvant endocrine therapy of tamoxifen versus anastrozol plus ovarian function suppression in premenopausal early breast cancer: final analysis of the Austrian Breast and Colorectal Cancer Study Group Trial 12. Ann Oncol. 2015;26(2):313–20.
53. Dignam JJ, Dukic V, Anderson SJ, Mamounas EP, Wickerham DL, Wolmark N. Hazard of recurrence and adjuvant treatment effects over time in lymph node-negative breast cancer. Breast Cancer Res Treat. 2009;116(3):595–602.
54. Ades F, Zardavas D, Bozovic-Spasojevic I, Pugliano L, Fumagalli D, de Azambuja E, et al. Luminal B breast cancer: molecular characterization, clinical management, and future perspectives. J Clin Oncol. 2014;32(25):2794–803.
55. Krop I, Ismaila N, Andre F, Bast RC, Barlow W, Collyar DE, et al. Use of biomarkers to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update. J Clin Oncol. 2017;35(24):2838–47.
56. Sestak I, Cuzick J, Dowsett M, Lopez-Knowles E, Filipits M, Dubsky P, et al. Prediction of late distant recurrence after 5 years of endocrine treatment: a combined analysis of patients from the Austrian breast and colorectal cancer study group 8 and arimidex, tamoxifen alone or in combination randomized trials using the PAM50 risk of recurrence score. J Clin Oncol. 2015;33(8):916–22.
57. Buus R, Sestak I, Kronenwett R, Denkert C, Dubsky P, Krappmann K, et al. Comparison of EndoPredict and EPclin with oncotype DX recurrence score for prediction of risk of distant recurrence after endocrine therapy. J Natl Cancer Inst. 2016;108(11):djw149.