Abstract P3-14-03: PRESAGE : Prospective multicenter feasibility study of fertility preservation before neoadjuvant or adjuvant chemotherapy for breast cancer: Preliminary results
Authors: Bordes V , Frick C , Leperlier F , Dezellus A , De Blay P , Maigne F , Sauterey B , Augereau P , Lefeuvre-Plesse C , Campone M , Mirallie S 
Published: February 2018

Background: Breast cancer is the most frequent form of cancer for 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. There are no guidelines to prevent subfertility for young women on cytotoxic treatments. 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 Tamoxifene or Letrozole combined with FSH to protect patients of the potential deleterious effects of the COS. We are currently conducting a study: PRESAGE, the first French prospective multicenter feasibility study of fertility preservation by COS combined with Tamoxifene 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: To evaluate the feasibility of a COS associating Tamoxifène with FSH followed by an oocyte more and less embryo cryopreservation. The secondary objectives: evaluation of the average deadline prior to the beginning of the chemotherapy, 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 BiostaTGV software.

Results: The 50 first patients were included between February 2014 and May 2016. Mean age of the patients was 31 years, half of it was nulliparous (25/50) and 20 % (10/50) were single. They presented mainly SBR II (23/50, 46 %) or III (25/50, 50 %) lesions, ER + (34/50, 68 %). 13 patients benefited from a NAC and 37 of an AC. In the NAC group, the time between the first oncologist's consultation and the fertility specialist's consultation was 3,5 +/- 3,9 days and the time between the first oncologist's consultation and the beginning of the chemotherapy was 24,5 +/- 6 days. The success rate of the COS procedure was 88 % (44/50) with no significant difference between the groups according to the type of COS (conventional-start vs. random-start p = 0.61) but there was a significant difference according to the type of chemotherapy (AC vs. NAC p= 0,03). In the 44 patients who had oocyte retrieval, the number of oocytes was 11,6 +/- 6,3 and an IVF was performed with 11,3% of patients (5/44) with 5,4 +/- 4,6 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 an 88% success rate, our study suggests that COS with Tamoxifene and FSH is feasible before adjuvant or neoadjuvant chemotherapy with less success in this context but without any impact on the number of oocytes collected. We hope that these preliminary results will be confirmed at the end of the study.

Citation Format: Bordes V, Frick C, Leperlier F, Dezellus A, De Blay P, Maigne F, Sauterey B, Augereau P, Lefeuvre-Plesse C, Campone M, Mirallie S. PRESAGE : Prospective multicenter feasibility study of fertility preservation before neoadjuvant or adjuvant chemotherapy for breast cancer: Preliminary results [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P3-14-03.