Immunotherapy with ipilimumab plus nivolumab in a stage IV melanoma patient during pregnancy

Menzer, Christian; Beedgen, B.; Rom, Joachim; Duffert, Christin Maria; Volckmar, Anna‐Lena; Sedlaczek, Oliver; Richtig, Erika; Enk, Alexander H.; Jäger, Dirk; Hassel, Jessica C.

doi:10.1016/j.ejca.2018.09.008

Cited by 47 publications

(69 citation statements)

References 9 publications

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“…We do not have extensive obstetrical information because our database focuses on patients with melanoma and not their children. However, there is no evidence in our study that suggests melanoma affected the health of the children, which is in line with the obstetrical data from other recent studies, which includes two reports of placental metastases where both fetuses were unharmed [8,9,[13][14][15][17][18][19][20]. There is a single case series from 2003 that includes several fetal metastases that resulted in fetal demise [7].…”

Section: Discussionsupporting

confidence: 88%

“…Before targeted therapy and immunotherapy were available, four women received chemotherapy and one received Gamma Knife radiosurgery [17]. Since the development of new therapies, two women received vemurafenib, one received ipilimumab alone, and two received ipilimumab plus nivolumab [8,9,[18][19][20]. One woman also became pregnant while being treated with nivolumab, which was stopped after the pregnancy was discovered [21].…”

Section: Discussionmentioning

confidence: 99%

“…One woman also became pregnant while being treated with nivolumab, which was stopped after the pregnancy was discovered [21]. Healthy children were born in all 11 cases; however, one woman had severe complications that resulted in extreme premature spontaneous delivery [8,9,[17][18][19][20][21].…”

Section: Discussionmentioning

confidence: 99%

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Management of Melanoma during Pregnancy: A Case Series of 11 Women Treated at NYU Langone Health

et al. 2020

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Objectives: Melanoma is one of the most common malignancies diagnosed during pregnancy. This study examined the impact of pregnancy on management decisions of melanoma patients treated at NYU Langone Health (NYULH). Methods: We analyzed data for patients who were pregnant at initial or recurrent melanoma diagnosis at NYULH from 2012 to 2019 with prospective protocol-driven follow-up. Results: Of the 900 female patients accrued during this period, 11 women in the childbearing range were pregnant at melanoma diagnosis. Six patients presented with early (stage 0 or I) disease and five with advanced (stage III or IV) melanoma. Women with early stage disease had normal deliveries and minimal changes to their treatment timeline and regimen. However, patients with more advanced stage disease opted for either termination of the pregnancy or early delivery and altered treatment timelines because of pregnancy. Conclusion: Both melanoma stage and gestational age at diagnosis contribute to the differences in the therapeutic management of melanoma in pregnant women. Given the complexity and variety of each case of melanoma during pregnancy, informed discussion between patients and physicians allows for individualized treatment plans that address each patient’s unique situation.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

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Management of Melanoma during Pregnancy: A Case Series of 11 Women Treated at NYU Langone Health

et al. 2020

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“…A total of five cases have been reported (all in metastatic melanoma) of ICI administration in pregnancy: one introduced at week 9 of pregnancy, one in the second trimester, and in three cases conception occurred whilst the patient was receiving ICI (Supplementary Table S4, available at https://doi.org/ 10.1016/j.annonc.2021.03.199). [131][132][133][134] Obstetric complications occurred in three cases [one placental insufficiency and fetal bradycardia (ICI started at the ninth week; discontinued in the second trimester), 132 two intrauterine growth restrictions (in both, conception occurred on ICI; one discontinued in the first trimester and one continued until elective delivery at week 32) 131,135 ]; upon follow-up, all infants were meeting developmental milestones and/or were in good health. These limited cases illustrate that favourable outcomes can be achieved in fetuses with in utero ICI exposure and offer some experience for the management of pregnancies in patients on ICI, but the knowledge is extremely limited.…”

Section: Pregnancymentioning

confidence: 99%

Immunotherapy use outside clinical trial populations: never say never?

et al. 2021

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Background: Based on favourable outcomes in clinical trials, immune checkpoint inhibitors (ICIs), most notably programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen-4 (CTLA-4) inhibitors, are now widely used across multiple cancer types. However, due to their strict inclusion and exclusion criteria, clinical studies often do not address challenges presented by non-trial populations. Design: This review summarises available data on the efficacy and safety of ICIs in trial-ineligible patients, including those with autoimmune disease, chronic viral infections, organ transplants, organ dysfunction, poor performance status, and brain metastases, as well as the elderly, children, and those who are pregnant. In addition, we review data concerning other real-world challenges with ICIs, including timing of therapy switch, relationships to radiotherapy or surgery, re-treatment after an immune-related toxicity, vaccinations in patients on ICIs, and current experience around ICI and coronavirus disease-19. Where possible, we provide recommendations to aid the oftendifficult decision-making process in those settings. Conclusions: Data suggest that ICIs are often active and have an acceptable safety profile in the populations described above, with the exception of PD-1 inhibitors in solid organ transplant recipients. Decisions about whether to treat with ICIs should be personalised and require multidisciplinary input and careful counselling of patients with respect to potential risks and benefits. Clinical judgements need to be carefully weighed, considering factors such as underlying cancer type, feasibility of alternative treatment options, or activity in trial-eligible patients.

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“…Their aim is to break immune tolerance for the tumor but they can also hinder maternal tolerance for the fetus, therefore increasing risk of spontaneous abortions. This is proved by animal studies for anti-PD-1 agents that are thus labeled as pregnancy category D for US FDA, but not for anti-CTLA4, labeled as FDA category C. The use of immunotherapy in pregnancy could lead to immune-related adverse effects and cause malformations and endocrine alterations in the newborn such as congenital hypothyroidism [ 47–49 ]. However good outcomes without apparent harm to the newborn are also reported for ipilimumab alone [ 50 ] and even for ipilimumab-nivolumab combination [ 48 ] suggesting that immune-mediated response to the fetus during the therapy could be patient specific.…”

Section: Introductionmentioning

confidence: 99%

Melanoma in Pregnancy: Certainties Unborn

et al. 2020

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Melanoma diagnosed during childbearing period or up to 1 year after delivery is defined as pregnancy-associated melanoma (PAM). There is some evidence that PAM has worse prognosis if compared with melanoma in nonpregnant women, although literature is still inconclusive. Many biological mechanisms could explain this behavior, such as hormonal and immune status, increased lymphangiogenesis but also delay in diagnostic and therapeutic management. If PAM is suspected, a prompt excisional biopsy under local anesthesia can be performed regardless of the gestational period. Conversely, additional staging procedures (such as sentinel lymph node biopsy or imaging) and systemic therapy are still debatable during pregnancy. A multidisciplinary tailored approach should be preferred, together with exhaustive counseling of the mother.

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Immunotherapy with ipilimumab plus nivolumab in a stage IV melanoma patient during pregnancy

Cited by 47 publications

References 9 publications

Management of Melanoma during Pregnancy: A Case Series of 11 Women Treated at NYU Langone Health

Management of Melanoma during Pregnancy: A Case Series of 11 Women Treated at NYU Langone Health

Immunotherapy use outside clinical trial populations: never say never?

Melanoma in Pregnancy: Certainties Unborn

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