Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
ESMO Open. 2021 Oct;6(5):100262. doi: 10.1016/j.esmoop.2021.100262. Epub 2021 Sep 3.
Immune checkpoint inhibitors have been widely implemented in current clinical practice. Although cancer occurs in ∼1 out of 1000 pregnancies, treatment remains challenging. Until now, limited data exist regarding immunotherapy administration during pregnancy. This systemic review aims to synthesize all available data from immunotherapy administration in pregnant women and evaluate the efficacy and safety of immunotherapy during pregnancy.
Eligible studies were identified by a search of the PubMed Medline database and Food and Drug Administration Adverse Events Reporting System Public Dashboard for the period 1 January 2000 to 1 April 2021; the algorithm consisted of a predefined combination of the words 'immunotherapy', 'cancer' and 'pregnancy'. PRISMA guidelines were applied in this study.
Overall, seven articles (seven pregnancies, nine neonates) were retrieved. The mean duration of immunotherapy administration was 9.8 weeks [standard deviation (SD): 11.27; median: 7.0; range: 1-32]. In all cases specified, melanoma was the malignancy reported. The mean gestational age at delivery was 30.4 weeks (SD: 5.03; median: 32.0; range: 24-38), whereas the mean weight of neonates at delivery was 1267 g (SD: 412.0; median: 1400; range: 590-1701). Only one neonate was born term at 38 weeks of pregnancy (11.1%; 1/9). Complications during pregnancy were observed in 71.4% of cases: intrauterine growth restriction (three cases), HELLP syndrome (hemolysis, elevated liver enzymes, low platelet count) (one case), placental insufficiency (one case) and low fetal heart rate (one case). The mean progression-free survival and overall survival were 16.0 and 25.2 months, respectively.
The administration of immune checkpoint inhibitors during pregnancy is associated with increased incidence of pregnancy complications, prematurity and low birth weight. The administration of these regimens is not recommended during gestation. Whenever applied, close monitoring of the mother and the fetus is required.
免疫检查点抑制剂已广泛应用于临床实践。尽管癌症在每 1000 例妊娠中约有 1 例发生，但治疗仍然具有挑战性。迄今为止，关于妊娠期间免疫治疗的应用，仅有有限的数据。本系统综述旨在综合所有关于妊娠期间免疫治疗的可用数据，并评估妊娠期间免疫治疗的疗效和安全性。
通过在 PubMed Medline 数据库和食品药品监督管理局不良事件报告系统公共仪表板中搜索 2000 年 1 月 1 日至 2021 年 4 月 1 日期间的文献，确定了符合条件的研究；算法由“免疫疗法”、“癌症”和“妊娠”等词的预定义组合组成。本研究采用 PRISMA 指南。
总体而言，检索到 7 篇文章（7 例妊娠，9 例新生儿）。免疫治疗的平均持续时间为 9.8 周[标准差（SD）：11.27；中位数：7.0；范围：1-32]。在所有报告的病例中，均为黑色素瘤恶性肿瘤。分娩时的平均孕龄为 30.4 周（SD：5.03；中位数：32.0；范围：24-38），而新生儿出生时的平均体重为 1267g（SD：412.0；中位数：1400；范围：590-1701）。只有 1 例新生儿足月（38 周妊娠，11.1%；1/9）。妊娠期间观察到 71.4%的病例存在并发症：宫内生长受限（3 例）、HELLP 综合征（溶血、肝酶升高、血小板计数降低）（1 例）、胎盘功能不全（1 例）和胎儿心率低（1 例）。无进展生存期和总生存期的平均值分别为 16.0 和 25.2 个月。
妊娠期间使用免疫检查点抑制剂与妊娠并发症、早产和低出生体重的发生率增加有关。不建议在妊娠期使用这些方案。无论是否应用，都需要密切监测母婴情况。
