Mother and Baby Fine After First Reported Use of Immune-Checkpoint Inhibitor During Pregnancy

By Megan Brooks

April 19, 2022

NEW YORK (Reuters Health) - A woman who suffered a relapse of classic Hodgkin lymphoma while pregnant was successfully treated with the immune-checkpoint inhibitor nivolumab, in what is believed to be the first reported case in the literature.

"Long story short, the patient did amazing. She carried the pregnancy to term and delivered spontaneously at 38 weeks," said Dr. Andrew M. Evens of Rutgers Cancer Institute of New Jersey and Robert Wood Johnson University Hospital, in New Brunswick.

"She had a bone-marrow transplant about three months after delivery. Now almost a year later, both mother and baby are doing fantastic," he told Reuters Health by phone.

Dr. Evens and colleagues describe the case in the American Journal of Hematology.

"There have been reports in the medical literature of the use of immune checkpoint inhibitors for patients with cancer with unexpected pregnancy, including patients who were on clinical trials when pregnancy was discovered," the researchers note in their paper.

"However, this is the first known case of a lymphoma patient treated with an immune checkpoint inhibitor during pregnancy and the only report of this therapy given past week 33 of gestation," they say.

Cancer as a complication during pregnancy occurs approximately one in every 1,000 gestations, with lymphoma being one of the most common.

The 31-year-old pregnant woman Dr. Evens and colleagues encountered had a relapse of classic Hodgkin lymphoma (cHL) that occurred at about week 13 of gestation.

She failed a standard chemotherapy regimen, showing continued progressive disease that was life-threatening for herself and the baby.

"It was unequivocally life-threatening. We had to urgently admit her to the hospital to stabilize her," Dr. Evens told Reuters Health.

After counseling about the potential risks and benefits, including a lack of safety data in pregnancy, she proceeded with single-agent checkpoint-inhibitor therapy given its well-established track record in cHL.

Due to a paucity of data to guide treatment, Dr. Evens and colleagues established a rapid collaboration with the National Cancer Institute to analyze pharmacokinetics on the patient's blood, umbilical cord and placenta to determine the appropriate nivolumab regimen.

Administration of a single dose of nivolumab (240 mg at 26 weeks' gestation) led to rapid improvement in symptoms and laboratory findings. Nivolumab was continued every two weeks for six total antenatal treatments over 78 days.

"The woman tolerated nivolumab therapy well, and it resulted in a partial remission by computed tomogram and magnetic resonance imaging after three nivolumab doses at gestation 32 weeks," the study team reports.

She received her final antenatal nivolumab dose at 37 weeks' gestation. The patient had induction of labor at 38.2 weeks and had an uncomplicated vaginal delivery. Postnatal evaluation of the newborn boy was normal. No quantifiable nivolumab was measured in the placental tissue.

Restaging PET-computed tomogram two weeks after delivery confirmed complete metabolic remission.

Based in part on the patient's wishes, she had a two-month delay before proceeding to autologous stem-cell transplant. The patient has remained in complete remission nine months post-transplant.

"The decision to initiate anticancer therapy during pregnancy is highly personalized involving the collaboration and guidance of a multidisciplinary team with each patient weighing potential adverse effects of fetal exposure during treatment against the potential benefits for the patient and fetus. The multidisciplinary team should include hematology-oncology, maternal-fetal medicine, neonatology, and other relevant subspecialties," the authors say in their paper.

Dr. Evens told Reuters Health that since publication of this case, he's had two colleagues reach out to him saying they were grappling with similar cases and this case was able to help guide them.

"Hopefully, our publication will lead to more research and attention to this rare but really very unmet need," Dr. Evens told Reuters Health.

SOURCE: https://bit.ly/3xDoIh5 American Journal of Hematology, online March 14, 2022.

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