[Effect of nilotinib on pregnancy outcome in female patients with chronic myeloid leukemia].

Objective: To observe the pregnancy outcome among patients with chronic myeloid leukemia (CML) treated with Nilotinib (NIL) . Methods: Clinical data of pregnancy delivery in CML patients treated with NIL from March 2015 to January 2019 were retrospectively collected. Results: A total of 11 patients were recruited with median pregnancy age 28 (25-40) years. The median duration of NIL treatment before pregnancy was 34 (3-48) months. There were 12 pregnancies, included 2 planned ones and 10 (83.3%) unplanned. In the 10 unplanned patients, 9 (90.0%) received NIL 600 mg/d. The median exposure time were 4 (4-7) weeks. In eight patients with delivery outcomes, 5 cases had well-developed babies, 2 had spontaneous abortion and 1 case with an baby of syndactyly deformity, whose mother was exposed to NIL 600 mg/d for 7 weeks in the early trimester of pregnancy. Seven infants were 4 boys and 3 girls with the median height at birth 50 (41-54) cm and median weight 3.2 (3.0-4.6) kg. They all grew with a normal pattern and well developed. Now the median age is 19 (4-41) months. The disease status during 12 pregnancies included 3 cases in CMR, 2 cases in MR(4.0), 3 cases in MMR, 4 cases not acquiring MMR. The median time of drug discontinuation was 35 (15-36) weeks during pregnancy. No patient lost CHR during this period. Conclusions: Female CML patients exposed to NIL 600 mg/d for 4 weeks in early pregnancy can give birth to normal babies, but there is still a risk of spontaneous abortion and congenital malformations.目的： 观察尼洛替尼（NIL）治疗期间女性慢性髓性白血病（CML）患者的妊娠结果。 方法： 回顾性收集2015年3月至2019年1月接受NIL治疗期间妊娠的CML患者的治疗情况和生育相关信息。 结果： 11例患者，妊娠时中位年龄28（25~40）岁。妊娠前NIL中位治疗34（3~48）个月。11例患者共妊娠12例次，计划妊娠2例次，意外妊娠10例次（83.3%）。10例次意外妊娠患者，妊娠早期NIL暴露剂量600 mg/d者9例（90.0%），NIL中位暴露4（4~7）周，NIL暴露4周者8例次（80.0%）。已知生育结果8例次，其中5例次生产正常婴儿，2例次自然流产，1例次生产并指畸形男婴，其母亲妊娠早期NIL 600 mg/d暴露7周。11例女性患者共生产7例婴儿，男4例，女3例，出生时中位身高50（41~54）cm，中位体重3.2（3.0~4.6）kg。目前，7例患者所生子女生长发育均正常，中位年龄19（4~41）个月。12例次患者妊娠时疾病状态：完全分子学反应3例次、分子学反应4.0（MR(4.0)）2例次、主要分子学反应（MMR）3例次、未达MMR 4例次，妊娠期间中位停药35（15~36）周，无患者失去完全血液学反应。 结论： 妊娠早期NIL 600 mg/d暴露4周的女性CML患者可生产正常婴儿，但仍有自然流产和生产先天畸形儿的可能。.