Piotr Wysocki: Pregnancy and anticancer immunotherapy – How safe is accidental exposure to immune checkpoint inhibitors?

Piotr Wysocki, Professor of Medicine and Head of the Department of Oncology at Jagiellonian University Hospital, shared on LinkedIn:

“Pregnancy during active cancer treatment is a rare condition (0.1%) of pregnancies and 0.07%-0.1% of all malignant tumors; however, the incidence is steadily increasing (L. F. McKain et al.). The main cancers associated with pregnancy are breast cancer, cervical cancer, Hodgkin’s disease, malignant melanoma, and leukemias.

With the widespread use of cancer immunotherapies, the risk of accidental exposure to this class of agents among pregnant patients has significantly increased. A recent cohort study published in JAMA Network Open analyzed the World Health Organization international pharmacovigilance database VigiBase and extracted all reports mentioning a pregnancy-related condition and antineoplastic agent use.

Among 3558 reports, 91 (2.6%) described the use of immune checkpoint inhibitor (ICI)-based immunotherapy in pregnant cancer patients. The mean patient age was 28.9 years, and the most common tumor type (43.6%) was melanoma. Patients were treated with:

• anti-PD1 (63.7%)
• anti-PD1+anti-CTLA4 (16.5%)
• anti-CTLA4 (14.3%)
• anti–PD-L1 (4.4%)
• anti-PD1+anti–LAG3 (1.1%).
• ICI + non-immunotherapy anticancer agent (11.0%)

The study demonstrated that preterm births were observed significantly more often for the anti-PD1+anti-CTLA4 combination compared with other anticancer drugs (12 of 15 [80.0%] vs 793 of 3452 [23.0%]; ROR, 13.87; 95% CI, 3.90-49.28; P < .001). However, the risk of preterm birth was not increased by anti–PD-L1 or anti-CTLA4 monotherapy. The authors have also identified three reports of possibly immune-related maternofetal events- 1 case of maternal antiphospholipid syndrome leading to spontaneous abortion:

•  1 case of pneumonitis leading to neonatal respiratory distress syndrome and death,
• 1 case of transient congenital hypothyroidism.

Moreover, compared with other anticancer drugs, none of the 45 identified classical, maternofetal adverse outcomes belonging to 7 groups (abortion, stillbirth or fetal death, congenital malformation, pregnancy complication, preterm birth, neonatal complication, and delivery complication) were overreported in the group exposed to ICIs.
The study by Gougis P et al. demonstrates that the risk of fatal maternofetal complications associated with the use of ICI in pregnant patients is relatively low; however, based on the current state of knowledge, the drugs must not be used for cancer treatment during pregnancy. ”

Source: Piotr Wysocki/LinkedIn

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