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Preservation of ovarian function in young women treated with neoadjuvant chemotherapy for breast cancer: A randomized trial using the GnRH agonist (triptorelin) during chemotherapy
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2008
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Reproductive SciencesBreast OncologyReproductive HealthAdjuvant ChemotherapyGynecologyGynecology OncologyOvarian CancerReproductive EndocrinologyFemale InfertilityGnrh AgonistReproductive MedicinePublic HealthMenopause Hormone TherapyInfertilityMedicinePharmacologyGnrh AnaloguesOvarian HormoneFertility PreservationEndocrine-related CancerNeoadjuvant ChemotherapyGnrh UseBreast CancerMenopauseOncologyWomen's Health
524 Background: There is conflicting evidence on the use of gonadotropin releasing hormone (GnRH) analogues to preserve fertility in women undergoing adjuvant chemotherapy. This is the first randomized clinical trial designed to evaluate the benefit of GnRH use during chemotherapy. Methods: This prospective, randomized clinical trial explored whether the administration of the GnRH agonist (triptorelin) versus no triptorelin (control) affected the degree of chemotherapy related amenorrhea and fertility in premenopausal (age less than 44, FSH <40) women receiving (neo) adjuvant chemotherapy for breast cancer. Patients were stratified by age (<35, 35–39, >39), ER status, and treatment type. Menstrual status, levels of FSH, Inhibin levels were monitored every 6 months. Results: Forty-nine patients (median age 39 years, range 21–43) were enrolled with 6- month follow-up data available on 44 patients, 12-month data on 42 patients, and 18 month data on 34 patients. In the triptorelin group, menses returned after a median of 6.1 (range 1–19) versus 4.70 months (range 0–22) in the control arm (p=0.79). Menstruation had resumed at 6, 12, and 18 months post chemotherapy in the respective groups as follows: triptorelin vs control: 44% vs 60%, 83% vs 79% and 88% vs 84%. FSH levels and Inhibin B levels were inversely correlated. Two spontaneous pregnancies were noted in the control group. These differences were not significant and the study was stopped at that point. Conclusions: The use of GnRH analogues does not appear to benefit patients in preserving menstrual status. FSH levels in patients in whom menstruation has returned is not significantly different in the triptorelin arm versus the control arm. FSH levels in women with menses Months Postchemotherapy Average FSH Prechemotherapy 3 6 12 18 30 Control < 35 4.5 23.0 5.4 1.7 1.2 n/a 35–39 5.6 38.1 12.4 12.7 7.6 4 > 39 5.3 40.3 5.7 18.7 23.5 14.4 Triptorelin < 35 4.7 18.1 5.5 7.0 6.7 n/a 35-39 4.3 19.6 6.3 11.6 11.3 9.8 > 39 5.9 14.4 4.7 13.5 21.44 n/a No significant financial relationships to disclose.