Tyrosine kinase inhibitors (TKI) have improved the outcome and life expectancy of patients with chronic myeloid leukemia (CML). Patients are diagnosed with CML at younger ages, and patients treated for CML may become pregnant or choose to breastfeed. The information available to date on the safety of TKIs during pregnancy and lactation and the optimal management of these patients is largely anecdotal, based on personal or small-group experience, and heterogeneous. A panel of interested parties was convened by US Food and Drug Administration (FDA) to analyze the current data and discuss possible solutions. Possible solutions include prospective data collection, in clinical trials and in routine clinical practice, a more uniform and specific data collection, and greater coordination among involved entities. Since patients with cancer are living longer, frequently receiving therapies for extended periods of time (or for life), data on appropriate management of patients through different reproductive phases of life are needed. It is thus time to change our approach for how to study treatment of cancer (including CML) during pregnancy or breastfeeding to develop evidence-based guidelines for safe and effective patient care.

中文翻译：

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治疗妊娠期和哺乳期慢性粒细胞白血病药物开发的展望


酪氨酸激酶抑制剂（TKI）改善了慢性粒细胞白血病（CML）患者的预后和预期寿命。患者在较年轻的时候被诊断出患有 CML，接受 CML 治疗的患者可能会怀孕或选择母乳喂养。迄今为止，关于妊娠期和哺乳期 TKI 的安全性以及这些患者的最佳治疗的信息大多是基于个人或小组经验的轶事，并且存在异质性。美国食品和药物管理局 (FDA) 召集了一个由相关方组成的小组来分析当前数据并讨论可能的解决方案。可能的解决方案包括在临床试验和常规临床实践中进行前瞻性数据收集、更统一和具体的数据收集以及相关实体之间更好的协调。由于癌症患者的寿命更长，经常接受较长时间（或终生）的治疗，因此需要有关在生命的不同生殖阶段对患者进行适当管理的数据。因此，现在是时候改变我们研究妊娠或母乳喂养期间癌症（包括 CML）治疗的方法，以制定安全有效的患者护理循证指南。