Uncomplicated pregnancy and delivery under ongoing nivolumab therapy for metastatic melanoma

Gambichler, Thilo; Susok, Laura

doi:10.1097/cmr.0000000000000801

Cited by 4 publications

(7 citation statements)

References 5 publications

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“…In the study cohort, the more common reason for using ICIs was melanoma, which is also the most common malignancy diagnosed during pregnancy [41]. Similar to the published clinical cases [12][13][14][15][17][18][19]21,23], we observed that in most of the safety reports, ICI exposure occurred during pregnancy, whereas no reports indicated ICI treatment at the time of conception. It is noteworthy that three safety reports recorded pregnancy-related outcomes after ICI treatment cessation with a temporal gap ranging from three months to two years.…”

Section: Discussionsupporting

confidence: 79%

“…On the one hand, studies in animal models with anti-PD-1/PD-L1 agents showed an increased risk of pregnancy loss [4][5][6][7]10], plausibly related to the role played by immune checkpoints in maintaining fetomaternal immune tolerance [2,3]. On the other hand, published case reports of women who were receiving ICI treatment at the time of conception [16,18], or who started ICI treatment during pregnancy [12][13][14][15][17][18][19]21,23], or who became pregnant after the end of ICI treatment [22] overall reported favorable pregnancy outcomes. In contrast, a recent systematic review of case reports also performed a search in the Food and Drug Administration Adverse Event Reporting System (FAERS) and found different pregnancy complications associated with ICIs, including intrauterine growth restriction, spontaneous abortion, premature delivery, and fetal distress syndrome [20].…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, using ICIs in pregnant women and women of childbearing potential (in the lack of effective contraception) is not recommended unless the clinical benefit outweighs the potential risk [11]. Nevertheless, some case reports on ICI exposure before, at, or after conception have shown favorable fetal outcomes without developmental abnormalities [12][13][14][15][16][17][18][19][20][21][22][23].…”

Section: Introductionmentioning

confidence: 99%

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Immune Checkpoint Inhibitors and Pregnancy: Analysis of the VigiBase® Spontaneous Reporting System

Noseda

Müller

Bedussi

et al. 2022

Cancers

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In pregnancy, immune checkpoint pathways are involved in the maintenance of fetomaternal immune tolerance. Preclinical studies have shown that immune checkpoint inhibitors (ICIs) increase the risk of fetal death. Despite the fact that using ICIs in pregnant women and women of childbearing potential is not recommended, some case reports of ICI exposure in pregnancy have been published showing favorable fetal outcomes. This study aimed to gain further insight into ICI safety in pregnancy by querying VigiBase®, the World Health Organization’s spontaneous reporting system. We performed raw and subgroup disproportionality analyses using the reporting odds ratio and comparing ICIs with the entire database, other antineoplastic agents, and other antineoplastic agents gathered in VigiBase® since 2011. Across 103 safety reports referring to ICI exposure during the peri-pregnancy period, 56 reported pregnancy-related outcomes, of which 46 were without concomitant drugs as potential confounding factors. No signals of disproportionate reporting were found for spontaneous abortion, fetal growth restriction, and prematurity. In light of the expanding indications of ICIs, continuous surveillance by clinicians and pharmacovigilance experts is warranted, along with pharmacoepidemiological studies on other sources of real-world evidence, such as birth records, to precisely assess ICI exposure during the peri-pregnancy period and further characterize relevant outcomes.

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Section: Discussionsupporting

confidence: 79%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Immune Checkpoint Inhibitors and Pregnancy: Analysis of the VigiBase® Spontaneous Reporting System

Noseda

Müller

Bedussi

et al. 2022

Cancers

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“…In the next 6 months of follow-up, his development was normal 71 . Another case was described where a patient became pregnant during nivolumab therapy and gave birth to a healthy child 75 . Zelin et al 9 suggested that the response in terms of immune response toward the fetus may vary depending on the patient undergoing immunotherapy.…”

Section: Methodsmentioning

confidence: 99%

“…An individual decision by the multispecialty team and the patient after assessing possible gains and losses. There are few studies where the use of these drugs (nivolumab, pembrolizumab, ipilimumab) during pregnancy did not cause significant effects on the fetus [69][70][71][73][74][75] (in one case, IUGR and hypothyroidism were observed in the child 71 ).…”

Section: Slnbmentioning

confidence: 99%

Melanoma During Pregnancy as a Complicated Medical Problem

Kościelecka¹,

Kubik-Machura²,

Kuć³

et al. 2023

Obstetrical &Amp; Gynecological Survey

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ImportancePregnancy-associated melanomas (PAMs)—this is how melanomas identified during the childbearing years or up to 1 year after birth have been defined, accounting for one third of women in whom it is diagnosed. The exact epidemiology of melanoma is difficult to determine. However, its incidence is undoubtedly increasing, most likely related to the increasing age of mothers.ObjectiveThe purpose of this study was to review the prognosis, diagnosis, and treatment; the effect of melanoma on pregnancy; and the effect of pregnancy on melanoma and melanocytic lesions.Evidence AcquisitionAn extensive manual search of major electronic databases was conducted in January 2022. The following literature review provides comprehensive coverage of PAMs.ResultsAny new nevus detected during pregnancy and changes in the nevus regarding color, diameter, symmetry, or lesion border require medical evaluation. New therapies for malignant melanoma, such as immunotherapy and targeted therapy, have improved overall survival and progression-free survival, but their use is often contraindicated in pregnant patients. Melanoma is considered to be the neoplasm most commonly involving the fetus and placenta.ConclusionsThere are reports where immunotherapy and targeted therapy used in the patient were not associated with serious consequences for the fetus, being a therapeutic option for the patient. The described cases of pregnancy outcome during modern melanoma treatment are extremely important and may allow to shape the optimal therapeutic regimen in pregnant women with melanoma.RelevanceEducation of pregnant women in the context of observation of skin lesions as well as maintenance of oncological vigilance by physicians seem to be an important element in limiting difficult decisions related to therapy of more advanced disease. Further large-scale studies using modern treatment in pregnant women with melanoma are needed.Target AudienceObstetricians and gynecologists, family physicians.Learning ObjectivesAfter completing this activity, the learner should be better able to describe the importance of oncologic vigilance in the context of developing melanoma in a pregnant woman; discuss the need for further research on the use of immunotherapy and targeted therapy in pregnant women with melanoma; and explain the need for oncologic vigilance in the context of melanoma in children of mothers who developed melanoma during pregnancy.

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Case report: Reproductive organ preservation and subsequent pregnancy for an infertility patient with lynch syndrome-associated synchronous endometrial cancer and colon cancer after treatment with a PD-1 checkpoint inhibitor

Cao

Gao²,

Zhang³

et al. 2022

Front. Immunol.

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Currently, immune checkpoint inhibitors (ICIs) are the mainstay of treatment for Lynch syndrome patients. However, the tumor regression features in radiology and pathology are inconsistent for patients who are treated with ICIs, which sometimes confuses surgical decision-making. Here, we report a case in which a 36-year-old patient suffering from infertility was diagnosed with Lynch syndrome-associated synchronous endometrial cancer and colon cancer, and persistently enlarged left iliac paravascular lymph nodes were detected after receiving sintilimab treatment, a programmed cell death 1 (PD-1) receptor inhibitor. Fortunately, when she was about to undergo hysterectomy and bilateral salpingo-oophorectomy, intraoperative pathology examination did not reveal any cancer cells in these lymph nodes, and therefore, her reproductive organs were preserved. Later, the patient successfully conceived and gave birth to a healthy male neonate with no immune-related adverse events (irAEs) during an 11-month follow-up. This case indicates that surgeons should carefully inspect the imaging characteristics after immunotherapy and that organ preservation is possible even for patients who fail to achieve complete clinical regression, which is especially important for female patients of childbearing age.

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Uncomplicated pregnancy and delivery under ongoing nivolumab therapy for metastatic melanoma

Cited by 4 publications

References 5 publications

Immune Checkpoint Inhibitors and Pregnancy: Analysis of the VigiBase® Spontaneous Reporting System

Immune Checkpoint Inhibitors and Pregnancy: Analysis of the VigiBase® Spontaneous Reporting System

Melanoma During Pregnancy as a Complicated Medical Problem

Case report: Reproductive organ preservation and subsequent pregnancy for an infertility patient with lynch syndrome-associated synchronous endometrial cancer and colon cancer after treatment with a PD-1 checkpoint inhibitor

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