Rosenberg Shoshana M, Gelber Shari, Gelber Richard D, Krop Ethan, Korde Larissa A, Pagani Olivia, Partridge Ann H
1 Dana-Farber Cancer Institute , Department of Medical Oncology, Boston, Massachusetts.
2 Dana-Farber Cancer Institute , Department of Biostatistics and Computational Biology, Boston, Massachusetts.
J Adolesc Young Adult Oncol. 2017 Sep;6(3):429-434. doi: 10.1089/jayao.2017.0031. Epub 2017 Jul 7.
POSITIVE (Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsIVE breast cancer) is a prospective clinical trial assessing safety and pregnancy outcomes in premenopausal hormone receptor-positive breast cancer survivors (age ≤42) who interrupt endocrine therapy (ET) to attempt pregnancy. We sought to assess interest in this study and perspectives on fertility preservation (FP) among United States medical oncologists who had previously enrolled women at their institutions on select premenopausal endocrine studies.
From August 2015 to December 2015, 301 investigators were invited to complete a web-based survey on behalf of their institution. We assessed FP practices and attitudes, barriers to discussing FP, and willingness to open/enroll women on POSITIVE.
Of 93 respondents (31%), most were affiliated with an National Cancer Institute (NCI)-designated comprehensive cancer center (44%). Almost all said they usually or always discussed the issue of future fertility with patients (98%) and referred patients with fertility questions to specialists (97%). Over half of respondents cited discomfort with recommending women to stop ET, as well as perceived patient concern regarding ET interruption, as factors seen as influencing POSITIVE enrollment; however, 84% were willing to recommend trial participation for selected patients.
Most providers reported discussing fertility with their young patients, indicating awareness of FP guidelines for cancer patients. While most oncologists said that they would be willing to recommend POSITIVE, many also expressed discomfort in endorsing women to stop ET temporarily, underscoring the need for prospective data regarding the safety of ET interruption. High willingness to recommend POSITIVE suggests the potential for successful accrual to this study, which addresses a critical issue for young breast cancer survivors.
“积极(内分泌反应性乳腺癌女性中断治疗的妊娠结局与安全性)”是一项前瞻性临床试验,旨在评估年龄≤42岁的绝经前激素受体阳性乳腺癌幸存者中断内分泌治疗(ET)以尝试怀孕的安全性和妊娠结局。我们试图评估美国医学肿瘤学家对该研究的兴趣以及对生育力保存(FP)的看法,这些肿瘤学家此前已在其机构招募女性参与特定的绝经前内分泌研究。
2015年8月至2015年12月,邀请301名研究人员代表其机构完成一项基于网络的调查。我们评估了FP实践和态度、讨论FP的障碍以及愿意让女性参加/登记参与“积极”研究的意愿。
93名受访者(31%)中,大多数隶属于美国国立癌症研究所(NCI)指定的综合癌症中心(44%)。几乎所有人表示他们通常或总是与患者讨论未来生育问题(98%),并将有生育问题的患者转介给专家(97%)。超过一半的受访者提到,因不乐意建议女性停止ET以及认为患者担心ET中断,这些因素被视为影响“积极”研究的入组情况;然而,84%的人愿意推荐特定患者参与试验。
大多数医疗服务提供者报告称会与年轻患者讨论生育问题,这表明他们了解癌症患者的FP指南。虽然大多数肿瘤学家表示愿意推荐“积极”研究,但许多人也表示在支持女性暂时停止ET方面感到不适,这突出了需要有关ET中断安全性的前瞻性数据。对推荐“积极”研究的高度意愿表明该研究有可能成功招募受试者,该研究解决了年轻乳腺癌幸存者的一个关键问题。