Lambertini Matteo, Anserini Paola, Fontana Valeria, Poggio Francesca, Iacono Giuseppina, Abate Annalisa, Levaggi Alessia, Miglietta Loredana, Bighin Claudia, Giraudi Sara, D'Alonzo Alessia, Blondeaux Eva, Buffi Davide, Campone Francesco, Merlo Domenico F, Del Mastro Lucia
Department of Medical Oncology, U.O. Sviluppo Terapie Innovative, IRCCS AOU San Martino-IST, Largo Rosanna Benzi, 10, 16132, Genova, Italy.
Breast Cancer Translational Research Laboratory, Department of Medicine, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.
BMC Cancer. 2017 May 19;17(1):346. doi: 10.1186/s12885-017-3348-8.
Fertility and pregnancy issues are of key importance for young breast cancer patients. Despite several advances in the field, there are still multiple unmet needs and barriers in discussing and dealing with these concerns. To address the significant challenges related to fertility and pregnancy issues, the PREgnancy and FERtility (PREFER) study was developed as a national comprehensive program aiming to optimize care and improve knowledge around these topics.
The PREFER study is a prospective cohort study conducted across several Italian institution affiliated with the Gruppo Italiano Mammella (GIM) group evaluating patterns of care and clinical outcomes of young breast cancer patients dealing with fertility and pregnancy issues. It is composed of two distinctive studies: PREFER-FERTILITY and PREFER-PREGNANCY. The PREFER-FERTILITY study is enrolling premenopausal patients aged 18-45 years, diagnosed with non-metastatic breast cancer, who are candidates to (neo)adjuvant chemotherapy and not previously exposed to anticancer therapies. The primary objective is to obtain and centralize data about patients' preferences and choices towards the available fertility preserving procedures. The success and safety of these strategies and the hormonal changes during chemotherapy and study follow-up are secondary objectives. The PREFER-PREGNANCY study is enrolling survivors achieving a pregnancy after prior history of breast cancer and patients diagnosed with pregnancy-associated breast cancer (PABC). The primary objectives are to obtain and centralize data about the management and clinical outcomes of these women. Patients' survival outcomes, and the fetal, obstetrical and paediatric care of their children are secondary objectives. For both studies, the initial planned recruitment period is 5 years and patients will remain in active follow-up for up to 15 years. The PREFER-FERTILITY study was first activated in November 2012, and the PREFER-PREGNANCY study in May 2013.
The PREFER study is expected to support and improve oncofertility counseling in Italy, to explore the real need of fertility preserving procedures, and to acquire prospectively more robust data on the efficacy and safety of the available strategies for fertility preservation, on the management of breast cancer survivors achieving a pregnancy and of women with PABC (including the possible short- and long-term complications in their children).
ClinicalTrials.gov identifier: NCT02895165 (Retrospectively registered in August 2016).
生育和妊娠问题对年轻乳腺癌患者至关重要。尽管该领域已取得多项进展，但在讨论和处理这些问题时仍存在多种未满足的需求和障碍。为应对与生育和妊娠问题相关的重大挑战，开展了妊娠与生育（PREFER）研究，这是一项全国性综合项目，旨在优化护理并增进对这些主题的了解。
PREFER研究是一项前瞻性队列研究，在意大利多个隶属于意大利乳腺癌研究组（GIM）的机构开展，评估年轻乳腺癌患者在处理生育和妊娠问题时的护理模式及临床结局。它由两项不同的研究组成：PREFER - FERTILITY和PREFER - PREGNANCY。PREFER - FERTILITY研究纳入年龄在18至45岁之间、诊断为非转移性乳腺癌、有资格接受（新）辅助化疗且此前未接受过抗癌治疗的绝经前患者。主要目标是获取并集中关于患者对现有生育保留程序的偏好和选择的数据。这些策略的成功率和安全性以及化疗和研究随访期间的激素变化是次要目标。PREFER - PREGNANCY研究纳入既往有乳腺癌病史后怀孕的幸存者以及诊断为妊娠相关乳腺癌（PABC）的患者。主要目标是获取并集中关于这些女性的管理和临床结局的数据。患者的生存结局以及其子女的胎儿、产科和儿科护理是次要目标。两项研究的初始计划招募期均为5年，患者将接受长达15年的积极随访。PREFER - FERTILITY研究于2012年11月首次启动，PREFER - PREGNANCY研究于2013年5月启动。
PREFER研究有望支持并改善意大利的肿瘤生育咨询，探索生育保留程序的实际需求，并前瞻性地获取关于现有生育保留策略的疗效和安全性、乳腺癌幸存者怀孕的管理以及PABC女性（包括其子女可能出现的短期和长期并发症）更有力的数据。
ClinicalTrials.gov标识符：NCT02895165（于2016年8月追溯注册）。
