Comparison of the efficacy and safety of 3-month sustained releasing gonadotropin releasing hormone agonists and 1-month sustained releasing gonadotropin releasing hormone agonists in treating early breast cancer: a Bayesian network meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

MA Linxiaoxi ^1,2 , ZUO Wenjia ^1,2 ,  MO Miao ^2,3 ,  FAN Lei ^1,2

1. Department of Breast Surgery, Fudan University Shanghai Cancer Center, Fudan University, Shanghai 200032, P.R. China;
2. Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, P.R. China;
3. Department of Cancer Prevention, Fudan University Shanghai Cancer Center, Fudan University, Shanghai 200032, P.R. China;

Corresponding author：

MO Miao, Email: woodenbird026@163.com; FAN Lei, Email: teddyfl@163.com

Keywords：

Gonadotropin-releasing hormone agonist; Breast cancer; Randomized controlled trial; Network meta-analysis

DOI：

10.7507/1672-2531.202108098

Video：

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Objective To systematically review the efficacy and safety of 3-month sustained releasing gonadotropin-releasing hormone agonist (GnRHa) (GnRHa 3M) and 1-month sustained releasing GnRHa (GnRHa 1M) in the treatment of pre-menopausal females with hormone receptor-positive breast cancer. Methods Databases including CNKI, WanFang Data, PubMed, EMbase and Web of Science were electronically searched to collect randomized controlled trials(RCTs) of GnRHa in the treatment of hormone receptor-positive breast cancer from inception to May 18^th, 2021. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of the included studies. The gemtc software package in R 3.6.1 software and Stata 15.0 software were used for network meta-analysis. Results A total of 11 RCTs including 7 484 patients were included. The network meta-analysis results showed that there was no significant difference between GnRHa 3M and GnRHa 1M in E2 level (MD=−1.3, 95%CI −13 to 9.6), DFS (HR=1.2, 95%CI 0.88 to 1.7) and OS (HR=2.0, 95%CI 0.75 to 4.9). For safety, there was no significant difference between the two groups (RR=1.0, 95%CI 0.25 to 4.2). Conclusion Current evidence shows that the efficacy and safety of GnRHa 3M is similar to that of GnRHa 1M. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusions.

Citation： MA Linxiaoxi, ZUO Wenjia, MO Miao, FAN Lei. Comparison of the efficacy and safety of 3-month sustained releasing gonadotropin releasing hormone agonists and 1-month sustained releasing gonadotropin releasing hormone agonists in treating early breast cancer: a Bayesian network meta-analysis. Chinese Journal of Evidence-Based Medicine, 2022, 22(1): 37-45. doi: 10.7507/1672-2531.202108098 Copy

1.	World Health Organization. Breast cancer. Avaiable at: https://www.who.int/news-room/fact-sheets/detail/breast-cancer.
2.	顾秀瑛, 赫捷. 2015年中国恶性肿瘤流行情况分析. 中华肿瘤杂志, 2019, 41(1): 19-28.
3.	陈建彬, 王蓓, 高秀飞. 激素受体阳性乳腺癌预后影响因素分析. 浙江医学, 2015, 37(5): 367-370.
4.	Klijn JG, Blamey RW, Boccardo F, et al. Combined tamoxifen and luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist alone in premenopausal advanced breast cancer: a meta-analysis of four randomized trials. J Clin Oncol, 2001, 19(2): 343-353.
5.	Leonard R, Yellowlees A, Mansi J, et al. The affect of goserelin on the QoL of women having chemotherapy for EBC: results from the OPTION trial. Breast, 2020, 52: 122-131.
6.	Leonard RCF, Adamson DJA, Bertelli G, et al. GnRH agonist for protection against ovarian toxicity during chemotherapy for early breast cancer: the Anglo Celtic Group OPTION trial. Ann Oncol, 2017, 28(8): 1811-1816.
7.	Limonta P, Montagnani Marelli M, Moretti RM. LHRH analogues as anticancer agents: pituitary and extrapituitary sites of action. Expert Opin Investig Drugs, 2001, 10(4): 709-720.
8.	Francis PA, Regan MM, Fleming GF, et al. Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med, 2015, 372(5): 436-446.
9.	Francis PA, Pagani O, Fleming GF, et al. Tailoring adjuvant endocrine therapy for premenopausal breast cancer. N Engl J Med, 2018, 379(2): 122-137.
10.	Fleming G, Francis PA, Lang I, et al. Randomized comparison of adjuvant tamoxifen (T) plus ovarian function suppression (OFS) versus tamoxifen in premenopausal women with hormone receptor-positive (HR plus ) early breast cancer (BC): update of the SOFT trial. Cancer Research, 2018, 78(4): GS4-03.
11.	Pagani O, Regan MM, Fleming GF, et al. Randomized comparison of adjuvant aromatase inhibitor exemestane (E) plus ovarian function suppression (OFS) vs tamoxifen (T) plus OFS in premenopausal women with hormone receptor positive (HR plus ) early breast cancer (BC): Update of the combined TEXT and SOFT trials. Cancer Research, 2018, 78(4): GS4-02.
12.	Kim HA, Lee JW, Nam SJ, et al. Adding ovarian suppression to tamoxifen for premenopausal breast cancer: a randomized phase III trial. J Clin Oncol, 2020, 38(5): 434-443.
13.	Telli ML, Gradishar WJ, Ward JH. NCCN guidelines updates: breast cancer. J Natl Compr Canc Netw, 2019, 17(5.5): 552-555.
14.	中国临床肿瘤学会乳腺癌专家委员会. 中国临床肿瘤协会(CSCO)乳腺癌诊疗指南2020. 北京: 人民卫生出版社, 2020.
15.	中国抗癌协会乳腺癌专业委员会. 中国抗癌协会乳腺癌诊治指南与规范(2019年版). 中国癌症杂志, 2019, 29(8): 609-680.
16.	Higgins JPT, Thomas J, Chandler J, et al. Cochrane Handbook for Systematic Reviews of Interventions. Chichester (UK): John Wiley & Sons, 2019.
17.	陈新林, 文艺, 胡月, 等. 生存分析资料进行Meta分析时所需主要结局指标的换算方法. 循证医学, 2016, 16(4): 244-246,252.
18.	周支瑞, 张天嵩, 李博, 等. 生存曲线中Meta分析适宜数据的提取与转换. 中国循证心血管医学杂志, 2014, (3): 243-247.
19.	Schmid P, Untch M, Wallwiener D, et al. Cyclophosphamide, methotrexate and fluorouracil (CMF) versus hormonal ablation with leuprorelin acetate as adjuvant treatment of node-positive, premenopausal breast cancer patients: preliminary results of the TABLE-study (Takeda Adjuvant Breast cancer study with Leuprorelin Acetate). Anticancer Res, 2002, 22(4): 2325-2332.
20.	Aydiner A, Kilic L, Yildiz I, et al. Two different formulations with equivalent effect. Comparison of serum estradiol suppression with monthly goserelin and trimonthly leuprolide in breast cancer patients. Med Oncol, 2013, 30(1): 354.
21.	Baum M, Hackshaw A, Houghton J, et al. Adjuvant goserelin in pre-menopausal patients with early breast cancer: results from the ZIPP study. Eur J Cancer, 2006, 42(7): 895-904.
22.	Boccardo F, Rubagotti A, Amoroso D, et al. Endocrinological and clinical evaluation of two depot formulations of leuprolide acetate in pre- and perimenopausal breast cancer patients. Cancer Chemother Pharmacol, 1999, 43(6): 461-466.
23.	Castiglione-Gertsch M, O'Neill A, et al. Adjuvant chemotherapy followed by goserelin versus either modality alone for premenopausal lymph node-negative breast cancer: a randomized trial. J Natl Cancer Inst, 2003, 95(24): 1833-1846.
24.	Karlsson P, Sun Z, Braun D, et al. Long-term results of International Breast Cancer Study Group Trial VIII: adjuvant chemotherapy plus goserelin compared with either therapy alone for premenopausal patients with node-negative breast cancer. Ann Oncol, 2011, 22(10): 2216-2226.
25.	Kaufmann M, Jonat W, Blamey R, et al. Survival analyses from the ZEBRA study. goserelin (Zoladex) versus CMF in premenopausal women with node-positive breast cancer. Eur J Cancer, 2003, 39(12): 1711-1717.
26.	Kurebayashi J, Toyama T, Sumino S, et al. Efficacy and safety of leuprorelin acetate 6-month depot, TAP-144-SR (6M), in combination with tamoxifen in postoperative, premenopausal patients with hormone receptor-positive breast cancer: a phase III, randomized, open-label, parallel-group comparative study. Breast Cancer, 2017, 24(1): 161-170.
27.	Masuda N, Iwata H, Rai Y, et al. Monthly versus 3-monthly goserelin acetate treatment in pre-menopausal patients with estrogen receptor-positive early breast cancer. Breast Cancer Res Treat, 2011, 126(2): 443-451.
28.	Schmid P, Untch M, Kossé V, et al. Leuprorelin acetate every-3-months depot versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant treatment in premenopausal patients with node-positive breast cancer: the TABLE study. J Clin Oncol, 2007, 25(18): 2509-2515.
29.	von Minckwitz G, Graf E, Geberth M, et al. CMF versus goserelin as adjuvant therapy for node-negative, hormone-receptor-positive breast cancer in premenopausal patients: a randomised trial (GABG trial IV-A-93). Eur J Cancer, 2006, 42(12): 1780-1788.
30.	Taylor CW, Green S, Dalton WS, et al. Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer: an intergroup study. J Clin Oncol, 1998, 16(3): 994-999.
31.	Noguchi S, Kim HJ, Jesena A, et al. Phase 3, open-label, randomized study comparing 3-monthly with monthly goserelin in pre-menopausal women with estrogen receptor-positive advanced breast cancer. Breast Cancer, 2016, 23(5): 771-779.
32.	范蕾, YEH Yu-Chen, 杜芬, 等. 中国绝经前激素受体阳性乳腺癌辅助内分泌治疗最小成本分析. 中国药物经济学, 2020, 15(4): 5-10.
33.	Goto R, Uda A, Hiroi S, et al. Cost analysis of leuprorelin acetate in Japanese pre-menopausal breast-cancer patients: comparison between 6-month and 3-month depot formulations. J Med Econ, 2017, 20(11): 1163-1169.
34.	Burstein HJ, Lacchetti C, Anderson H, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American Society of Clinical Oncology clinical practice guideline update on ovarian suppression. J Clin Oncol, 2016, 34(14): 1689-1701.
35.	Yeo W, Ueno T, Lin CH, et al. Treating HR+/HER2- breast cancer in premenopausal Asian women: Asian Breast Cancer Cooperative Group 2019 Consensus and position on ovarian suppression. Breast Cancer Res Treat, 2019, 177(3): 549-559.

1. World Health Organization. Breast cancer. Avaiable at: https://www.who.int/news-room/fact-sheets/detail/breast-cancer.
2. 顾秀瑛, 赫捷. 2015年中国恶性肿瘤流行情况分析. 中华肿瘤杂志, 2019, 41(1): 19-28.
3. 陈建彬, 王蓓, 高秀飞. 激素受体阳性乳腺癌预后影响因素分析. 浙江医学, 2015, 37(5): 367-370.
4. Klijn JG, Blamey RW, Boccardo F, et al. Combined tamoxifen and luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist alone in premenopausal advanced breast cancer: a meta-analysis of four randomized trials. J Clin Oncol, 2001, 19(2): 343-353.
5. Leonard R, Yellowlees A, Mansi J, et al. The affect of goserelin on the QoL of women having chemotherapy for EBC: results from the OPTION trial. Breast, 2020, 52: 122-131.
6. Leonard RCF, Adamson DJA, Bertelli G, et al. GnRH agonist for protection against ovarian toxicity during chemotherapy for early breast cancer: the Anglo Celtic Group OPTION trial. Ann Oncol, 2017, 28(8): 1811-1816.
7. Limonta P, Montagnani Marelli M, Moretti RM. LHRH analogues as anticancer agents: pituitary and extrapituitary sites of action. Expert Opin Investig Drugs, 2001, 10(4): 709-720.
8. Francis PA, Regan MM, Fleming GF, et al. Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med, 2015, 372(5): 436-446.
9. Francis PA, Pagani O, Fleming GF, et al. Tailoring adjuvant endocrine therapy for premenopausal breast cancer. N Engl J Med, 2018, 379(2): 122-137.
10. Fleming G, Francis PA, Lang I, et al. Randomized comparison of adjuvant tamoxifen (T) plus ovarian function suppression (OFS) versus tamoxifen in premenopausal women with hormone receptor-positive (HR plus ) early breast cancer (BC): update of the SOFT trial. Cancer Research, 2018, 78(4): GS4-03.
11. Pagani O, Regan MM, Fleming GF, et al. Randomized comparison of adjuvant aromatase inhibitor exemestane (E) plus ovarian function suppression (OFS) vs tamoxifen (T) plus OFS in premenopausal women with hormone receptor positive (HR plus ) early breast cancer (BC): Update of the combined TEXT and SOFT trials. Cancer Research, 2018, 78(4): GS4-02.
12. Kim HA, Lee JW, Nam SJ, et al. Adding ovarian suppression to tamoxifen for premenopausal breast cancer: a randomized phase III trial. J Clin Oncol, 2020, 38(5): 434-443.
13. Telli ML, Gradishar WJ, Ward JH. NCCN guidelines updates: breast cancer. J Natl Compr Canc Netw, 2019, 17(5.5): 552-555.
14. 中国临床肿瘤学会乳腺癌专家委员会. 中国临床肿瘤协会(CSCO)乳腺癌诊疗指南2020. 北京: 人民卫生出版社, 2020.
15. 中国抗癌协会乳腺癌专业委员会. 中国抗癌协会乳腺癌诊治指南与规范(2019年版). 中国癌症杂志, 2019, 29(8): 609-680.
16. Higgins JPT, Thomas J, Chandler J, et al. Cochrane Handbook for Systematic Reviews of Interventions. Chichester (UK): John Wiley & Sons, 2019.
17. 陈新林, 文艺, 胡月, 等. 生存分析资料进行Meta分析时所需主要结局指标的换算方法. 循证医学, 2016, 16(4): 244-246,252.
18. 周支瑞, 张天嵩, 李博, 等. 生存曲线中Meta分析适宜数据的提取与转换. 中国循证心血管医学杂志, 2014, (3): 243-247.
19. Schmid P, Untch M, Wallwiener D, et al. Cyclophosphamide, methotrexate and fluorouracil (CMF) versus hormonal ablation with leuprorelin acetate as adjuvant treatment of node-positive, premenopausal breast cancer patients: preliminary results of the TABLE-study (Takeda Adjuvant Breast cancer study with Leuprorelin Acetate). Anticancer Res, 2002, 22(4): 2325-2332.
20. Aydiner A, Kilic L, Yildiz I, et al. Two different formulations with equivalent effect. Comparison of serum estradiol suppression with monthly goserelin and trimonthly leuprolide in breast cancer patients. Med Oncol, 2013, 30(1): 354.
21. Baum M, Hackshaw A, Houghton J, et al. Adjuvant goserelin in pre-menopausal patients with early breast cancer: results from the ZIPP study. Eur J Cancer, 2006, 42(7): 895-904.
22. Boccardo F, Rubagotti A, Amoroso D, et al. Endocrinological and clinical evaluation of two depot formulations of leuprolide acetate in pre- and perimenopausal breast cancer patients. Cancer Chemother Pharmacol, 1999, 43(6): 461-466.
23. Castiglione-Gertsch M, O'Neill A, et al. Adjuvant chemotherapy followed by goserelin versus either modality alone for premenopausal lymph node-negative breast cancer: a randomized trial. J Natl Cancer Inst, 2003, 95(24): 1833-1846.
24. Karlsson P, Sun Z, Braun D, et al. Long-term results of International Breast Cancer Study Group Trial VIII: adjuvant chemotherapy plus goserelin compared with either therapy alone for premenopausal patients with node-negative breast cancer. Ann Oncol, 2011, 22(10): 2216-2226.
25. Kaufmann M, Jonat W, Blamey R, et al. Survival analyses from the ZEBRA study. goserelin (Zoladex) versus CMF in premenopausal women with node-positive breast cancer. Eur J Cancer, 2003, 39(12): 1711-1717.
26. Kurebayashi J, Toyama T, Sumino S, et al. Efficacy and safety of leuprorelin acetate 6-month depot, TAP-144-SR (6M), in combination with tamoxifen in postoperative, premenopausal patients with hormone receptor-positive breast cancer: a phase III, randomized, open-label, parallel-group comparative study. Breast Cancer, 2017, 24(1): 161-170.
27. Masuda N, Iwata H, Rai Y, et al. Monthly versus 3-monthly goserelin acetate treatment in pre-menopausal patients with estrogen receptor-positive early breast cancer. Breast Cancer Res Treat, 2011, 126(2): 443-451.
28. Schmid P, Untch M, Kossé V, et al. Leuprorelin acetate every-3-months depot versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant treatment in premenopausal patients with node-positive breast cancer: the TABLE study. J Clin Oncol, 2007, 25(18): 2509-2515.
29. von Minckwitz G, Graf E, Geberth M, et al. CMF versus goserelin as adjuvant therapy for node-negative, hormone-receptor-positive breast cancer in premenopausal patients: a randomised trial (GABG trial IV-A-93). Eur J Cancer, 2006, 42(12): 1780-1788.
30. Taylor CW, Green S, Dalton WS, et al. Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer: an intergroup study. J Clin Oncol, 1998, 16(3): 994-999.
31. Noguchi S, Kim HJ, Jesena A, et al. Phase 3, open-label, randomized study comparing 3-monthly with monthly goserelin in pre-menopausal women with estrogen receptor-positive advanced breast cancer. Breast Cancer, 2016, 23(5): 771-779.
32. 范蕾, YEH Yu-Chen, 杜芬, 等. 中国绝经前激素受体阳性乳腺癌辅助内分泌治疗最小成本分析. 中国药物经济学, 2020, 15(4): 5-10.
33. Goto R, Uda A, Hiroi S, et al. Cost analysis of leuprorelin acetate in Japanese pre-menopausal breast-cancer patients: comparison between 6-month and 3-month depot formulations. J Med Econ, 2017, 20(11): 1163-1169.
34. Burstein HJ, Lacchetti C, Anderson H, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American Society of Clinical Oncology clinical practice guideline update on ovarian suppression. J Clin Oncol, 2016, 34(14): 1689-1701.
35. Yeo W, Ueno T, Lin CH, et al. Treating HR+/HER2- breast cancer in premenopausal Asian women: Asian Breast Cancer Cooperative Group 2019 Consensus and position on ovarian suppression. Breast Cancer Res Treat, 2019, 177(3): 549-559.

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Comparison of the efficacy and safety of 3-month sustained releasing gonadotropin releasing hormone agonists and 1-month sustained releasing gonadotropin releasing hormone agonists in treating early breast cancer: a Bayesian network meta-analysis

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