Abstract P1-11-11: Cimicifuga racemosa extract prevents menopausal syndrome in LHRHa treatment of breast cancer: A prospective randomized research

Abstract

Abstract BACKGROUND Menopausal syndrome (MPS) is common in pre/peri-menopausal breast cancer patient receiving luteinizing-hormone releasing hormone analogue (LHRHa). According to the results of TEXT & SOFT study, it could affect patients' life quality seriously and even caused 8%˜23% treatment break. Cimicifuga racemosa (Remifemin) is previously proved effective for MPS in nature menopause patients. We aim to design a prospective randomized research for investigating the effect of Remifemin on MPS which caused by LHRHa in breast cancer (NCT03339882). METHODS The pre/peri-menopausal patients diagnosed as early breast cancer planning for LHRHa were identified and randomly divided into two groups after surgery and chemotherapy if necessary: the Remifemin group (Remifemin 20mg twice a day for 12 weeks) and the control group. The primary endpoint is Kupperman menopause index (KMI). The estradiol (E2), follicle-stimulating hormone (FSH), luteinizing hormone (LH) levels in blood were also evaluated. RESULTS From January 2017 to December 2017, totally 85 patients (42 in Remifemin group and 43 in control group) were enrolled in Zhejiang Cancer Hospital and there were no significant differences in baseline characteristics including age, BMI, tumor stage, ER, PR, HER2, KMI and hormone levels between two groups (Table 1). At the time of 4, 8, 12 weeks after treatment, the KMI of Remifenmin group were all significantly lower than control group (Table 2, P<0.01) while no significant difference in E2, FSH and LH levels between the two groups (Table 2, P>0.05).There was no significant difference in endometrial thickness, ovarian cyst and Uterine fibroids except cervical cyst (P=0.02). CONCLUSION The use of Remifemin is oncological safe and reliable in preventing MPS which caused by LHRHa in breast cancer. The clinical characteristics of two groups Remifemin groupControl groupP n=42n=43 N(%)N(%) Age(years) 37.74±6.6037.16±6.280.68BMI (body mass index) 21.90±2.8321.65±3.010.69T stage02(4.76)2 (4.65)0.16 113 (30.95)22 (51.16) 227 (64.29)19 (44.19) N stage021 (50.00)24 (55.82)0.63 110 (23.81)12 (27.91) 26 (14.29)5 (11.63) 35 (11.90)2 (4.65) ERPositive30 (71.43)35 (81.40)0.28 Negative12 (28.57)8 (18.60) PRPositive30 (71.43)32 (74.42)0.76 Negative12 (28.57)11 (25.58) HER2Positive8 (19.05)10 (23.26)0.64 Negative34 (80.95)33 (76.74) Category of LHRHaGoserelin32 (76.19)28 (65.12)0.26 Leuprorelin10 (23.81)15 (34.88) Category of endocrine drugNone10 (23.81)6 (13.95)0.20 SERM5 (11.90)11 (25.58) AI27 (64.29)26 (60.47) The endpoints of two groups Remifemin groupControl groupP n=42n=43 KMI*Base line2.45±1.452.30±1.360.62 4th week3.83±1.868.37±4.19<0.01 8th week4.21±1.8011.00±4.48<0.01 12th week4.67±2.1611.98±4.93<0.01E2Base line134.24±64.14143.49±84.190.57 4th week20.26±14.8125.24±13.310.11 8th week13.55±8.1415.65±8.020.23 12th week10.83±7.3512.53±6.350.26FSHBase line8.88±11.4010.17±9.910.58 4th week8.23±9.935.40±6.450.12 8th week4.83±8.496.53±11.500.44 12th week3.65±7.557.28±16.010.19LHBase line6.77±6.319.62±10.590.14 4th week9.08±4.877.93±4.830.28 8th week11.76±11.8210.18±12.210.55 12th week7.27±4.956.90±4.380.72*Wilcoxon test Citation Format: Yu X, Wang C, Liang C, Xuan H, Yang H. Cimicifuga racemosa extract prevents menopausal syndrome in LHRHa treatment of breast cancer: A prospective randomized research [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-11-11.