Efficacy and safety of the hormone receptor modulator and the third generation of aromatase inhibitors for postmenopausal hormone receptor-positive breast cancer patients: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

YANG Ruijie , WANG Xinshuai , FENG Yingying ,  FENG Xiaoshan

Department of Cancer, The First Affiliated Hospital, College of Clinical Medicine, Henan University of Science and Technology, Luoyang, 471003, P.R.China;

Corresponding author：

FENG Xiaoshan, Email: doctorfengxs@163.com

Keywords：

Breast cancer; Aromatase inhibitors; Tamoxifen; Survival; Meta-analysis; Systematic review; Randomized controlled trial

DOI：

10.7507/1672-2531.201701057

Video：

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ObjectiveTo investigate the efficacy and safety of using tamoxifen sequential with the third generation aromatase inhibitors versus the third generation aromatase inhibitors or tamoxifen alone for postmenopausal hormone receptor-positive breast cancer patients.MethodsThe Cochrane Library (Issue 10, 2016), PubMed, EMbase, CNKI, and WanFang Data were searched to collect randomized controlled trials on using tamoxifen sequential with the third generation aromatase inhibitors versus the third generation aromatase inhibitors or tamoxifen alone for postmenopausal hormone receptor-positive breast cancer patients from inception to October, 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 9 studies involving 22 005 patients were included. The results of meta-analysis showed that the sequential therapy group was superior to the tamoxifen monotherapy group on overall survival (HR=0.71, 95%CI 0.52 to 0.98, P=0.04) and recurrence-free survival (HR=0.60, 95%CI 0.46 to 0.79, P=0.000 3). However, no significant difference was found in overall survival and disease free survival between the sequential therapy group and the aromatase inhibitors monotherapy group. As to adverse events, compared with the tamoxifen monotherapy group, the sequential therapy group could reduce the incidence of endometrial hyperplasia (OR=0.22, 95%CI 0.11 to 0.45, P<0.000 01), death (OR=0.74, 95%CI 0.66 to 0.84, P<0.000 01) and metastasis (OR=0.79, 95%CI 0.68 to 0.91, P=0.001); however, the incidence of bone fracture was higher in sequential therapy group compared with intamoxifen monotherapy group (OR=1.31, 95%CI 1.13 to 1.51, P=0.000 3).ConclusionThe sequential therapy using tamoxifen and the third generation of aromatase inhibitors is better than tamoxifen monotherapy for postmenopausal hormone receptor-positive breast cancer patients. However, there is no significant difference in survival benefit between the sequential therapy and aromatase inhibitors monotherapy.

Citation： YANG Ruijie, WANG Xinshuai, FENG Yingying, FENG Xiaoshan. Efficacy and safety of the hormone receptor modulator and the third generation of aromatase inhibitors for postmenopausal hormone receptor-positive breast cancer patients: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2017, 17(6): 669-676. doi: 10.7507/1672-2531.201701057 Copy

1.	Carpenter R. Choosing early adjuvant therapy for postmenopausal women with hormone-sensitive breast cancer: aromatase inhibitors versus tamoxifen. Eur J Surg Oncol, 2008, 34(7): 746-755.
2.	O’leary CG, Ellis H, Higgins M. Extended adjuvant endocrine therapy in hormone-receptor-positive early breast cancer. Curr Opin Oncol, 2016, 28(6): 455-460.
3.	Aapro M, Van De Velde CJ, Markopoulos C, et al. Should all postmenopausal patients with hormone receptor-positive breast cancer receive initial therapy with aromatase inhibitors? Breast, 2013, 22(4): 488-494.
4.	Del Mastro L, Rossi G, Lambertini M, et al. New insights on the role of luteinizing hormone releasing hormone agonists in premenopausal early breast cancer patients. Cancer Treat Rev, 2016, 42(1): 18-23.
5.	Chen XL, Du F, Hong RX, et al. Hormonal therapy might be a better choice as maintenance treatment than capecitabine after response to first-line capecitabine-based combination chemotherapy for patients with hormone receptor-positive and HER2-negative, metastatic breast cancer. Chin J Cancer, 2016, 35(1): 39.
6.	Aihara T, Takatsuka Y, Ohsumi 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): 379-387.
7.	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, 2007, 25(19): 2664-2670.
8.	Boccardo F, Rubagotti A, Aldrighetti D, et al. Switching to an aromatase inhibitor provides mortality benefit in early breast carcinoma: pooled analysis of 2 consecutive trials. Cancer, 2007, 109(6): 1060-1067.
9.	Bliss JM, Kilburn LS, Coleman RE, et al. Disease-related outcomes with long-term follow-up: an updated analysis of the intergroup exemestane study. J Clin Oncol, 2012, 30(7): 709-717.
10.	Bertelli G, Hall E, Ireland E, et al. Long-term endometrial effects in postmenopausal women with early breast cancer participating in the Intergroup Exemestane Study (IES)—a randomised controlled trial of exemestane versus continued tamoxifen after 2-3 years tamoxifen. Ann Oncol, 2010, 21(3): 498-505.
11.	Jakesz R, Jonat W, Gnant M, 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(9484): 455-462.
12.	van De Velde CJH, Rea D, Seynaeve C, et al. Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial. Lancet, 2011, 377(9762): 321-331.
13.	van De Water W, Fontein DB, Van Nes JG, et al. Influence of semi-quantitative oestrogen receptor expression on adjuvant endocrine therapy efficacy in ductal and lobular breast cancer-a TEAM study analysis. Eur J Cancer, 2013, 49(2): 297-304.
14.	Regan MM, Neven P, Giobbie-Hurder A, 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): 1101-1108.
15.	Liu J, Chen K, Jiang W, et al. Chemotherapy response and survival of inflammatory breast cancer by hormone receptor-and HER2-defined molecular subtypes approximation: an analysis from the National Cancer Database. J Cancer Res Clin Oncol, 2016, 143(1): 161-168.
16.	Wise J. Tamoxifen benefits women who have had invasive breast cancer, community study finds. BMJ, 2016, 355(10): 5442.
17.	Dent SF, Gaspo R, Kissner M, et al. Aromatase inhibitor therapy: toxicities and management strategies in the treatment of postmenopausal women with hormone-sensitive early breast cancer. Breast Cancer Res Treat, 2011, 126(2): 295-310.
18.	Lee AV. The Endocrine Society Centennial: 40 Years of Aromatase Inhibitors as Targeted Therapy for Breast Cancer. Endocrinology, 2016, 157(10): 3697-3698.
19.	Abdel-Qadir H, Amir E, Fischer HD, et al. The risk of myocardial infarction with aromatase inhibitors relative to tamoxifen in post-menopausal women with early stage breast cancer. Eur J Cancer, 2016, 68(1): 11-21.
20.	Moschetti I, Cinquini M, Lambertini M, et al. Follow-up strategies for women treated for early breast cancer. Cochrane Database Syst Rev, 2016, (5): CD001768.
21.	Chiba A, Hoskin TL, Heins CN, et al. Trends in neoadjuvant endocrine therapy use and impact on rates of breast conservation in hormone receptor-positive breast cancer: a national cancer data base study. Ann Surg Oncol, 2017, 24(2): 418-424.

1. Carpenter R. Choosing early adjuvant therapy for postmenopausal women with hormone-sensitive breast cancer: aromatase inhibitors versus tamoxifen. Eur J Surg Oncol, 2008, 34(7): 746-755.
2. O’leary CG, Ellis H, Higgins M. Extended adjuvant endocrine therapy in hormone-receptor-positive early breast cancer. Curr Opin Oncol, 2016, 28(6): 455-460.
3. Aapro M, Van De Velde CJ, Markopoulos C, et al. Should all postmenopausal patients with hormone receptor-positive breast cancer receive initial therapy with aromatase inhibitors? Breast, 2013, 22(4): 488-494.
4. Del Mastro L, Rossi G, Lambertini M, et al. New insights on the role of luteinizing hormone releasing hormone agonists in premenopausal early breast cancer patients. Cancer Treat Rev, 2016, 42(1): 18-23.
5. Chen XL, Du F, Hong RX, et al. Hormonal therapy might be a better choice as maintenance treatment than capecitabine after response to first-line capecitabine-based combination chemotherapy for patients with hormone receptor-positive and HER2-negative, metastatic breast cancer. Chin J Cancer, 2016, 35(1): 39.
6. Aihara T, Takatsuka Y, Ohsumi 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): 379-387.
7. 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, 2007, 25(19): 2664-2670.
8. Boccardo F, Rubagotti A, Aldrighetti D, et al. Switching to an aromatase inhibitor provides mortality benefit in early breast carcinoma: pooled analysis of 2 consecutive trials. Cancer, 2007, 109(6): 1060-1067.
9. Bliss JM, Kilburn LS, Coleman RE, et al. Disease-related outcomes with long-term follow-up: an updated analysis of the intergroup exemestane study. J Clin Oncol, 2012, 30(7): 709-717.
10. Bertelli G, Hall E, Ireland E, et al. Long-term endometrial effects in postmenopausal women with early breast cancer participating in the Intergroup Exemestane Study (IES)—a randomised controlled trial of exemestane versus continued tamoxifen after 2-3 years tamoxifen. Ann Oncol, 2010, 21(3): 498-505.
11. Jakesz R, Jonat W, Gnant M, 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(9484): 455-462.
12. van De Velde CJH, Rea D, Seynaeve C, et al. Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial. Lancet, 2011, 377(9762): 321-331.
13. van De Water W, Fontein DB, Van Nes JG, et al. Influence of semi-quantitative oestrogen receptor expression on adjuvant endocrine therapy efficacy in ductal and lobular breast cancer-a TEAM study analysis. Eur J Cancer, 2013, 49(2): 297-304.
14. Regan MM, Neven P, Giobbie-Hurder A, 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): 1101-1108.
15. Liu J, Chen K, Jiang W, et al. Chemotherapy response and survival of inflammatory breast cancer by hormone receptor-and HER2-defined molecular subtypes approximation: an analysis from the National Cancer Database. J Cancer Res Clin Oncol, 2016, 143(1): 161-168.
16. Wise J. Tamoxifen benefits women who have had invasive breast cancer, community study finds. BMJ, 2016, 355(10): 5442.
17. Dent SF, Gaspo R, Kissner M, et al. Aromatase inhibitor therapy: toxicities and management strategies in the treatment of postmenopausal women with hormone-sensitive early breast cancer. Breast Cancer Res Treat, 2011, 126(2): 295-310.
18. Lee AV. The Endocrine Society Centennial: 40 Years of Aromatase Inhibitors as Targeted Therapy for Breast Cancer. Endocrinology, 2016, 157(10): 3697-3698.
19. Abdel-Qadir H, Amir E, Fischer HD, et al. The risk of myocardial infarction with aromatase inhibitors relative to tamoxifen in post-menopausal women with early stage breast cancer. Eur J Cancer, 2016, 68(1): 11-21.
20. Moschetti I, Cinquini M, Lambertini M, et al. Follow-up strategies for women treated for early breast cancer. Cochrane Database Syst Rev, 2016, (5): CD001768.
21. Chiba A, Hoskin TL, Heins CN, et al. Trends in neoadjuvant endocrine therapy use and impact on rates of breast conservation in hormone receptor-positive breast cancer: a national cancer data base study. Ann Surg Oncol, 2017, 24(2): 418-424.

Chinese Journal of Evidence-Based Medicine

Efficacy and safety of the hormone receptor modulator and the third generation of aromatase inhibitors for postmenopausal hormone receptor-positive breast cancer patients: a meta-analysis

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