尼洛替尼暴露对女性慢性髓性白血病患者妊娠结局的影响

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. CONCLUSION: 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.