Effect of the gonadotropin-releasing hormone analogue triptorelin on the occurrence of chemotherapy-induced early menopause in premenopausal women with breast cancer: A randomized trial

JAMA

Volumn 306, Issue 3, 2011, Pages 269-276

  Del Mastro, Lucia ^a   Boni, Luca ^b   Michelotti, Andrea ^c   Gamucci, Teresa ^d   Olmeo, Nina ^e   Gori, Stefania ^f   Giordano, Monica ^g   Garrone, Ornella ^h   Pronzato, Paolo ^a   Bighin, Claudia ^a   Levaggi, Alessia ^a   Giraudi, Sara ^a   Cresti, Nicola ^c   Magnolfi, Emanuela ^d   Scotto, Tiziana ^e   Vecchio, Carlo ^a   Venturini, Marco ⁱ  

^a UNIVERSITY OF GENOA   (Italy)

^b CAREGGI UNIVERSITY HOSPITAL   (Italy)

^c UNIVERSITY HOSPITAL OF PISA   (Italy)

^d Ospedale S Trinità di Sora   (Italy)

^e SS Annunziata Hospital   (Italy)

^f SANTA MARIA DELLA MISERICORDIA HOSPITAL   (Italy)

^g SANT ANNA HOSPITAL   (Italy)

^h S CROCE E CARLE HOSPITAL   (Italy)

ⁱ SACRO CUORE DON CALABRIA HOSPITAL   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRACYCLINE; CYCLOPHOSPHAMIDE; ESTRADIOL; FLUOROURACIL; FOLLITROPIN; METHOTREXATE; TAMOXIFEN; TAXANE DERIVATIVE; TRIPTORELIN;

ADULT; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CONTROLLED STUDY; EARLY MENOPAUSE; FEMALE; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; OPEN STUDY; OVULATION INHIBITION; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL; PREGNANCY RATE; PREMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; UNSPECIFIED SIDE EFFECT;

EID: 79960545091     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2011.991     Document Type: Article

References (36)

1. Surveillance, Epidemiology and End Results (SEER) Web site. http://www.seer.cancer.gov. April 2010, based on the November 2009 submission. Accessed June 20, 2011.
2. Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010;60(5):277-300.
3. Adami HO, Malker B, Holmberg L, Persson I, Stone B. The relation between survival and age at diagnosis in breast cancer. N Engl J Med. 1986;315(9):559-563. (Pubitemid 16052469)
4. de la Rochefordiere A, Asselain B, Campana F, et al. Age as prognostic factor in premenopausal breast carcinoma. Lancet. 1993;341(8852):1039-1043. (Pubitemid 23114394)
5. Anders CK, Hsu DS, Broadwater G, et al. Young age at diagnosis correlates with worse prognosis and defines a subset of breast cancers with shared patterns of gene expression. J Clin Oncol. 2008;26(20):3324-3330.
6. Partridge A, Gelber S, Gelber RD, Castiglione-Gertsch M, Goldhirsch A, Winer E. Age of menopause among womenwhoremainpremenopausalfollowing treatment for early breast cancer: long-term results from International Breast Cancer Study Group Trials V and VI. Eur J Cancer. 2007;43(11):1646-1653. (Pubitemid 47042368)
7. Gerber B, Dieterich M, Müller H, Reimer T. Controversies in preservation of ovary function and fertility in patients with breast cancer. Breast Cancer Res Treat. 2008;108(1):1-7. (Pubitemid 351623232)
8. Petrek JA, Naughton MJ, Case LD, et al. Incidence, time course, and determinants of menstrual bleeding after breast cancer treatment: a prospective study. J Clin Oncol. 2006;24(7):1045-1051. (Pubitemid 46638800)
9. Schover LR. Premature ovarian failure and its consequences: vasomotor symptoms, sexuality, and fertility. J Clin Oncol. 2008;26(5):753-758. (Pubitemid 351264388)
10. Partridge AH, Gelber S, Peppercorn J, et al. Webbased survey of fertility issues in young women with breast cancer. J Clin Oncol. 2004;22(20):4174-4183. (Pubitemid 41185188)
11. Avis NE, Crawford S, Manuel J. Psychosocial problems among younger women with breast cancer. Psychooncology. 2004;13(5):295-308. (Pubitemid 38714192)
12. Lee SJ, Schover LR, Partridge AH, et al; American Society of Clinical Oncology. American Society of Clinical Oncology recommendations on fertility preservation in cancer patients. J Clin Oncol. 2006;24(18):2917-2931. (Pubitemid 46655598)
13. Bokser L, Szende B, Schally AV. Protective effects of D-Trp6-luteinising hormone-releasing hormone microcapsules against cyclophosphamideinduced gonadotoxicity in female rats. Br J Cancer. 1990;61(6):861-865. (Pubitemid 20196992)
14. Ataya K, Rao LV, Lawrence E, Kimmel R. Luteinizing hormone-releasing hormone agonist inhibits cyclophosphamide-induced ovarian follicular depletion in rhesus monkeys. Biol Reprod. 1995;52(2):365-372.
15. Del Mastro L, Catzeddu T, Boni L, et al. Prevention of chemotherapy-induced menopause by temporary ovarian suppression with goserelin in young, early breast cancer patients. Ann Oncol. 2006;17(1):74-78. (Pubitemid 43033843)
16. Urruticoechea A, Arnedos M, Walsh G, Dowsett M, Smith IE. Ovarian protection with goserelin during adjuvant chemotherapy for pre-menopausal women with early breast cancer (EBC). Breast Cancer Res Treat. 2008;110(3):411-416. (Pubitemid 351962592)
17. Recchia F, Saggio G, Amiconi G, et al. Gonadotropin-releasing hormone analogues added to adjuvant chemotherapy protect ovarian function and improve clinical outcomes in young women with early breast carcinoma. Cancer. 2006;106(3):514-523. (Pubitemid 43157613)
18. Common Toxicity Criteria version 2.0. National Cancer Institute Web site. http://ctep.cancer.gov/protocoldevelopment/electronic-applications/docs/ctcv20- 4-30-992.pdf. 1999. Accessed June 20, 2011.
19. Bines J, Oleske DM, Cobleigh MA. Ovarian function in premenopausal women treated with adjuvant chemotherapy for breast cancer. J Clin Oncol. 1996;14(5):1718-1729. (Pubitemid 26134232)
20. Brookmeyer R, Crowley JJ. Confidence interval for the median survival time. Biometrics. 1982;38:29-41.
21. Fornier MN, Modi S, Panageas KS, Norton L, Hudis C. Incidence of chemotherapy-induced, long-term amenorrhea in patients with breast carcinoma age 40 years and younger after adjuvant anthracycline and taxane. Cancer. 2005;104(8):1575-1579.
22. Ravdin PM, Fritz NF, Tormey DC, Jordan VC. Endocrine status of premenopausal node-positive breast cancer patients following adjuvant chemotherapy and long-term tamoxifen. Cancer Res. 1988;48(4):1026-1029. (Pubitemid 18061906)
23. Goodwin PJ, Ennis M, Pritchard KI, Trudeau M, Hood N. Risk of menopause during the first year after breast cancer diagnosis. J Clin Oncol. 1999;17(8):2365-2370. (Pubitemid 29368234)
24. Badawy A, Elnashar A, El-Ashry M, Shahat M. Gonadotropin-releasing hormone agonists for prevention of chemotherapy-induced ovarian damage: prospective randomized study. Fertil Steril. 2009;91(3):694-697.
25. Gerber B, von Minckwitz G, Stehle H, et al. Effect of luteinizing hormone-releasing hormone agonist on ovarian function after modern adjuvant breast cancer chemotherapy: the GBG 37 ZORO study [published online ahead of print May 2, 2011]. J Clin Oncol. doi:10.1200/JCO.2010.32.5704.
26. Leonard RC, Adamson D, Anderson R, et al. The OPTION trial of adjuvant ovarian protection by goserelin in adjuvant adjuvant chemotherapy for early breast cancer [abstract]. J Clin Oncol. 2010;28(suppl):15S.
27. Ismail-Khan R, Minton S, Cox C, et al. Preservation of ovarian function in young women treated with neoadjuvant chemotherapy for breast cancer: a randomized trial using the GnRH agonist (triptorelin) during chemotherapy [abstract]. J Clin Oncol. 2008 (suppl):26.
28. Kim SS, Lee JR, Jee BC, et al. Use of hormonal protection for chemotherapy-induced gonadotoxicity. Clin Obstet Gynecol. 2010;53(4):740-752.
29. World Health Organization (WHO). Research on the Menopause. Geneva, Switzerland: WHO; 1991. Technical Report Series 670.
30. Blumenfeld Z. How to preserve fertility in young women exposed to chemotherapy? the role of GnRH agonist cotreatment in addition to cryopreservation of embrya, oocytes, or ovaries. Oncologist. 2007;12(9):1044-1054. (Pubitemid 350007016)
31. International Breast Cancer Study Group. Late effects of adjuvant oophorectomy and chemotherapy upon premenopausal breast cancer patients. Ann Oncol. 1990;1(1):30-35.
32. Rivkin SE, Green S, O'Sullivan J, et al. Adjuvant CMFVP versus adjuvant CMFVP plus ovariectomy for premenopausal, node-positive, and estrogen receptor - positive breast cancer patients: a Southwest Oncology Group study. J Clin Oncol. 1996;14(1):46-51.
33. Arriagada R, Lê MG, Spielmann M, et al. Randomized trial of adjuvant ovarian suppression in 926 premenopausal patients with early breast cancer treated with adjuvant chemotherapy. Ann Oncol. 2005;16(3):389-396. (Pubitemid 40458314)
34. Del Mastro L, Venturini M, Sertoli MR, Rosso R. Amenorrhea induced by adjuvant chemotherapy in early breast cancer patients: prognostic role and clinical implications. Breast Cancer Res Treat. 1997;43(2):183-190. (Pubitemid 27165879)
35. Swain SM, Jeong JH, Geyer CE Jr, et al. Longer therapy, iatrogenic amenorrhea, and survival in early breast cancer. N Engl J Med. 2010;362(22):2053-2065.
36. Jonat W, Kaufmann M, Sauerbrei W, et al; Zoladex Early Breast Cancer Research Association Study. Goserelin versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy in premenopausal patients with node-positive breast cancer: the Zoladex Early Breast Cancer Research Association Study. J Clin Oncol. 2002;20(24):4628-4635. (Pubitemid 36025278)