Abstract P4-16-02: Fertility preservation before neoadjuvant or adjuvant chemotherapy for breast cancer: Final results of PRESAGE trial (2019)

Abstract Background: Breast cancer is the most frequent form of cancer in young women. For these patients, breast cancer is generally more aggressive and chemotherapy is more often needed. Chemotherapy is commonly associated with amenorrhea and a decrease of ovarian reserve depending on the patient's age, agents and dose. Embryo, oocyte and ovarian tissue cryopreservation are the three options to preserve fertility. Embryo and oocyte cryopreservation require controlled ovarian stimulation (COS). The use of COS is associated with an increase of estradiol levels. It led to develop protocols using Tamoxifen or Letrozole combined with FSH to protect patients of the potential deleterious effects of the COS. PRESAGE is the first French prospective multicenter feasibility study about fertility preservation by COS combined with Tamoxifen and oocyte +/- embryo cryopreservation before neoadjuvant (NAC) or adjuvant (AC) chemotherapy for breast cancer. Material and method: Prospective multicenter study for patients of less than 40 years, with a breast cancer, for whom a treatment of NAC or AC is indicated and who wish to preserve their fertility. The main objective was to evaluate the feasibility of a COS associating Tamoxifen with FSH followed by an oocyte+/- embryo cryopreservation. The secondary objectives were to evaluate the average deadline prior to the beginning of the chemotherapy and the impact of the type of COS (depending on the phase of the menstrual cycle, conventional-start or random-start COS protocol) on the number and the quality of oocytes harvested. Statistical analysis was performed using SAS statistical software version 9.4 (SAS Institute, Cary, NC). Results: 101 patients were included between February 2014 and July 2017 and 97 patients were eligible for statistical analysis. Mean age of the patients was 31,5 +/- 4 years, the half of them was nulliparous (53/97) and 23,7 % (23/97) were single. They presented mainly SBR II or III (91/96, 94,8 %) lesions, ER + (66/96, 68,7 %). 38 patients benefited from a NAC and 59 of an AC. We have found a significant shorter care (time between the first oncologist's consultation and the beginning of the chemotherapy) according to the type of chemotherapy: 29,7 +/- 15,6 days in NAC group vs 45,2 +/- 21,5 days in AC group (p=0,003) with the same duration of ovarian stimulation in the two groups (10,5 +/-2 days). The success rate of the COS procedure was 90,7 % (88/97) with no significant difference between the groups according to the type of COS (p = 0.06) or the type of chemotherapy (AC vs. NAC p= 0,3). In the 88 patients who had oocyte retrieval, the number of oocytes harvested per patient was 12,8 +/- 7,8 , the number of oocytes preserved was 9,7 +/- 6,1 and an IVF was performed in 12,5% of patients (11/88) with 5,1 +/- 3,1 embryos obtained. We have found no impact of the type of chemotherapy or the type of COS on the number of oocytes or embryos preserved. Conclusion: with a high success rate (90,7%), our study suggests that COS with Tamoxifen and FSH is feasible before adjuvant or neoadjuvant chemotherapy in breast cancer patients. We also show that COS procedure before neoadjuvant chemotherapy can be realized without increasing the time before introducing chemotherapy. Citation Format: Bordes V, Palpacuer C, FRICK C, Leperlier F, Dezellus A, De Blay P, Delay F, Sauterey B, Augereau P, Duros S, Lefeuvre-Plesse C, Lavau S, Durand LM, Mouret MA, Gremeau AS, Campone M, Mirallie S. Fertility preservation before neoadjuvant or adjuvant chemotherapy for breast cancer: Final results of PRESAGE trial [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 P4-16-02.