Objective: To explore Fertility and disease outcomes in patients with chronic myeloid leukemia (CML) . Methods: Clinical and fertility outcomes of male (from Jul. 1998 to Feb. 2018) and female CML (from Sep. 2009 to Feb. 2018) patients were retrospectively analyzed at Peking University People's Hospital. Results: A total of 49 male CML patients and their spouses were enrolled. Before their spouses conceived, 34 patients were receiving tyrosine kinase inhibitor (TKI) imatinib, 9 with nilotinib, and 6 with dasatinib. At the time of conception, the median age of these male patients was 32 years (range, 25-48 years) , and the median TKI treatment duration was 36 months (range, 0.2-198 months) . One male patient having achieved complete hematologic response yet discontinuing TKI for a year developed a disease progression to blast crisis. The other 48 patients sustained stable disease. The total conception times were 61 and finally 55 infants were born including one with premature birth, two with low birth weight, and one with hypospadias receiving surgery. The other 18 female patients after pregnancy were enrolled. Two patients developed spontaneous abortions. Two received induced abortions. Fourteen gave birth to healthy infants without congenital malformation. The interval from diagnosis of CML to initiation of TKI was 4 months (range, 0.3-16 months) . During a median follow-up of 45 months (range from 7-114 months) , the estimated complete cytogenetic response (CCyR) rate, major molecular response (MMR) rate and molecular response(4.5) (MR(4.5)) rate by 5 years were 88.9%, 85.3% and 35.1%, respectively. The estimated failure-free survival, progression-free survival and overall survival were 64.2%, 90.9% and 90.9%, respectively. All 14 babies developed as normal. Conclusions: It seems that TKIs do not affect pregnancy outcome in the spouses of male CML patients, suggesting that withdrawal of TKIs is not necessary. Female CML patients have good pregnancy and disease outcomes in the TKI era.
目的： 报道服用酪氨酸激酶抑制剂（TKI）的男性慢性髓性白血病（CML）患者配偶和女性妊娠期诊断CML患者的生育和疾病结局。 方法： 将1998年7月至2018年2月确诊并服用TKI治疗的男性CML患者及2009年10月至2018年2月期间妊娠期诊断CML的女性患者纳入研究。采用收集病历资料、问卷调查和门诊及电话随访方式收集患者疾病和生育相关信息。 结果： 共收集服用TKI期间配偶妊娠的49例男性CML患者数据，其配偶初次受孕前，男性患者服用伊马替尼34例、尼洛替尼9例、达沙替尼6例，配偶受孕时，患者中位年龄为32（25~48）岁，TKI治疗时间为36（0.2~198）个月，除1例在仅获得完全血液学反应状态下为备孕而停药1年患者发生疾病进展外，其余48例男性患者均处于疾病稳定状态。所有男性患者的配偶共妊娠61次，生产55例婴儿，早产1例、生产低体重儿2例，其中1例合并尿道下裂，出生后行手术修复，其余均为足月健康婴儿。共收集18例女性妊娠期诊断CML的患者数据，2例自然流产，2例人工流产，14例分娩健康婴儿，未见先天畸形，确诊CML至开始TKI（伊马替尼15例，尼洛替尼3例）治疗时间为4（0.3~16）个月，中位随访45（7~114）个月，5年完全分子学反应、主要分子学反应、分子学反应4.5（MR(4.5)）获得率分别为88.9%、85.3%和35.1%，5年无失败生存、无进展生存和总生存率分别为64.2%、90.9%和90.9%，所有婴儿均正常发育。 结论： 男性CML患者服用TKI对生育结局无不良影响，应避免盲目停药备孕。TKI时代，女性妊娠合并CML患者生育和疾病结局良好。.
Keywords: Leukemia, chronic, myeloid; Pregnancy; Tyrosine kinase inhibitor.