Department of Clinical Therapeutics, Alexandra Hospital, Medical School, Athens, 11528, Greece.
Medical School, National and Kapodistrian University of Athens, Athens, Greece.
BMC Cancer. 2021 Apr 26;21(1):463. doi: 10.1186/s12885-021-08162-3.
Over than one third (28-58%) of pregnancy-associated breast cancer (PABC) cases are characterized by positive epidermal growth factor receptor 2-positive (HER2) expression. Trastuzumab anti-HER2 monoclonal antibody is still the benchmark treatment of HER2-positive breast tumors. However, FDA has categorized Trastuzumab as a category D drug for pregnant patients with breast cancer. This systemic review aims to synthesize all currently available data of trastuzumab administration during pregnancy and provide an updated view of the effect of trastuzumab on fetal and maternal outcome.
Eligible articles were identified by a search of MEDLINE bibliographic database and ClinicalTrials.gov for the period up to 01/09/2020; The algorithm consisted of a predefined combination of the words "breast", "cancer", "trastuzumab" and "pregnancy". This study was performed in accordance with the PRISMA guidelines.
A total of 28 eligible studies were identified (30 patients, 32 fetuses). In more than half of cases, trastuzumab was administered in the metastatic setting. The mean duration of trastuzumab administration during gestation was 15.7 weeks (SD: 10.8; median: 17.5; range: 1-32). Oligohydramnios or anhydramnios was the most common (58.1%) adverse event reported in all cases. There was a statistically significant decrease in oligohydramnios/anhydramnios incidence in patients receiving trastuzumab only during the first trimester (P = 0.026, Fisher's exact test). In 43.3% of cases a completely healthy neonate was born. 41.7% of fetuses exposed to trastuzumab during the second and/or third trimester were born completely healthy versus 75.0% of fetuses exposed exclusively in the first trimester. All mothers were alive at a median follow-up of 47.0 months (ranging between 9 and 100 months). Of note, there were three cases (10%) of cardiotoxicity and decreased ejection fraction during pregnancy.
Overall, treatment with trastuzumab should be postponed until after delivery, otherwise pregnancy should be closely monitored.
超过三分之一（28-58%）的妊娠相关性乳腺癌（PABC）病例表现为表皮生长因子受体 2 阳性（HER2）表达阳性。曲妥珠单抗抗 HER2 单克隆抗体仍然是 HER2 阳性乳腺癌肿瘤的基准治疗方法。然而，FDA 将曲妥珠单抗归类为妊娠乳腺癌患者的 D 类药物。本系统评价旨在综合所有现有的曲妥珠单抗在妊娠期间给药的数据，并提供曲妥珠单抗对胎儿和产妇结局影响的最新观点。
通过搜索 MEDLINE 书目数据库和 ClinicalTrials.gov，确定截至 2020 年 01 月 09 日的合格文章；算法由“乳房”、“癌症”、“曲妥珠单抗”和“妊娠”等词的预定义组合组成。本研究符合 PRISMA 指南。
共确定了 28 项合格研究（30 名患者，32 名胎儿）。在超过一半的病例中，曲妥珠单抗在转移性疾病中使用。妊娠期间曲妥珠单抗给药的平均时间为 15.7 周（SD：10.8；中位数：17.5；范围：1-32）。在所有病例中，最常见的不良事件是羊水过少或无羊水（58.1%）。仅在妊娠早期接受曲妥珠单抗治疗的患者，羊水过少/无羊水的发生率有统计学显著降低（P=0.026，Fisher 确切检验）。在 43.3%的病例中，完全健康的新生儿出生。在妊娠第二和/或第三期暴露于曲妥珠单抗的 41.7%的胎儿完全健康，而仅在第一期暴露于曲妥珠单抗的胎儿为 75.0%。所有母亲在中位随访 47.0 个月（9-100 个月）时均存活。值得注意的是，有 3 例（10%）在妊娠期间出现心脏毒性和射血分数降低。
总体而言，曲妥珠单抗的治疗应推迟到分娩后进行，否则应密切监测妊娠情况。
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