Abstract
The management of chronic myeloid leukemia (CML) diagnosed during pregnancy is a rare and challenging situation. We report the treatment and outcome of 87 cases diagnosed in chronic phase from 2001–2022 derived from the largest international observational registry, supported by the European LeukemiaNet (ELN), of 400 pregnancies in 299 CML women. Normal childbirth occurred in 76% without an increased rate of birth abnormalities or life-threatening events, including in patients untreated or treated with interferon-α and/or imatinib in 2nd–3rd trimester. The low birth weight rate of 12% was comparable to that seen in the normal population. Elective and spontaneous abortions occurred in 21% and 3%, respectively. The complete hematologic response rate before labor was 95% with imatinib and 47% with interferon only. No disease progression during pregnancy was observed, 28% of the patients switched their therapy at varying times after delivery. Treatment options balance the efficacy and safety for mother and infant: interferon-α can commence in the 1st trimester and continued throughout in cases of good disease control and tolerability. Because of limited placental crossing, selected tyrosine kinase inhibitors (imatinib and nilotinib) seem to be safe and effective options in 2nd and 3rd trimester while hydroxycarbamide offers few benefits.
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Data availability
The data supporting the findings of this study are not openly available to preserve individuals privacy under the European General Data Protection Regulation. However, they can be obtained from the corresponding author upon reasonable request and permission.
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Acknowledgements
The authors express their gratitude to the colleagues who treated and consulted patients within the multidisciplinary team. Our warm gratitude to the patients and their children. On behalf of ELN Pregnancy Registry Committee we express our special gratitude for the contribution to collecting cases for the ELN Pregnancy Registry to Dr. Dong-Wook Kim from Catholic Hematology Hospital, Seoul St. Mary’s Hospital, Seoul, S. Korea, Dr. Konstantin Kotlyarchuk from SI ‘Institute of Blood Pathology and Transfusion Medicine UAMS, Lviv, Ukraine and Dr. Penka Ganeva from Specilaized Hospital for Active Treatment of Hematological Diseases, Sofia, Bulgaria. We are grateful to Sandro Pittori for management of the REDCap database in the international registry. We thank Mr. Christophe Bouvier, datamanager, for data collection in Lyon, France. We thank Yulia Chabaeva and Sergey Kulikov from National Medical Hematology Research Center, Moscow, for the data management and express our special gratitude to «National Hematological Society» for promoting the development of hematology, transfusiology and bone marrow transplantation in Russian Federation. JFA acknowledges the support of the Imperial College NIHR Biomedical Research Centre Our special thanks to Professor Rudiger Hehlmann for many years of inspiring support for ELN international cooperation.
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The study was supported by European LeukemiaNet.
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EC and EA were responsible for designing the study protocol, collecting and extracting the data and interpreting results. EC, JA, AT and EA were responsible for preparing the initial report. All the co-authors contributed into data collection and were involved into manuscript preparation.
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EC – speaker: Novartis, Pfizer, R-Pharm, consultancy: Ascentage Pharma, JA – speaker: Novartis, Bristol Myers Squibb, Incyte, honoraria: Novartis, Bristol Myers Squibb, Incyte, Research Funding: Pfizer, Incyte, AT – speaker: Novartis, Pfizer, R-Pharm, Amgen, consultancy/advisory board: Novartis, DR – Novartis, Incyte, Pfizer, Terns, FEN – consultancy: Sun Pharma Ltd, Novartis, speaker: Incyte Biosciences, board entity: Incyte Biosciences, Pfizer, Novartis, BMS-Celgene, research fundings: Incyte Biosciences, Novartis, ASA – consultancy: Novartis, JB – honoraria: Novartis, Incyte, Pfizer, MC – advisory board: Insight, Novartis, Italfarmaco, speaker: Servier, Abbvie, Janssen, PF – consultancy: Jazz, Jannsen, Abbvie, MMT – consultancy: Novartis, Takeda, EA – consultancy: BMS, Novaris, Incyte, Pfizer, advisory: BMS, Novaris, Incyte, Pfizer, SAK, MAY, DB, KhK, SS, HFR, RS and EP – nothing to disclose.
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Chelysheva, E., Apperley, J., Turkina, A. et al. Chronic myeloid leukemia diagnosed in pregnancy: management and outcome of 87 patients reported to the European LeukemiaNet international registry. Leukemia 38, 788–795 (2024). https://doi.org/10.1038/s41375-024-02183-0
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DOI: https://doi.org/10.1038/s41375-024-02183-0