Management of pregnant chronic myeloid leukemia patients

Abruzzese, Elisabetta; Trawinska, Malgorzata Monika; Fabritiis, Paolo de; Baccarani, Michele

doi:10.1080/17474086.2016.1205479

Cited by 53 publications

(48 citation statements)

References 67 publications

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“…Nilotinib does not cross the placenta in a significative concentration and does not seem to be teratogenic, but data are limited. A recent review summarized reported cases and provided recommendations of management of pregnancy in CML; so far no case of pregnancy in a CML patient associated with bosutinib and ponatinib therapy has been described 22. However, as in our case, treatment is not always mandatory; it is necessary if white cell count exceeds 100×10 9 /L and platelet count exceeds 500×10 9 /L, as reported by Milojkovic and Apperley 23.…”

Section: Discussionsupporting

confidence: 57%

Onset of chronic myeloid leukemia with complex karyotype in a pregnant patient: case report and revision of literature

Sgherza

Abruzzese

Perla

et al. 2017

TCRM

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Approximately 10%–12% of patients in chronic-phase chronic myeloid leukemia (CP-CML) have additional chromosomal aberrations at diagnosis; moreover, CML occurs in up to 10% of pregnancy-associated leukemias, with an annual incidence of 1 per 100,000 pregnancies. In this report we describe the case of a 36-year-old female with CP-CML diagnosed in the 18th week of pregnancy and with a new complex variant translocation t(4;9;22;21)(q24;q34;q11;q22) and an additional chromosomal aberration t(1;20)(p36;p11). In consideration of her pregnancy, the patient strictly monitored her blood cell count without any specific treatment. At 32 weeks of pregnancy, the patient delivered via cesarean section a healthy baby girl. After 10 days from childbirth, dasatinib was started at a standard dosage of 100 mg/day and 3 months later complete cytogenetic response and major molecular response were obtained, with the achievement of an optimal response according to European Leukemia Net recommendations and showing efficacy of this tyrosine kinase inhibitor (TKI) in the presence of a complex karyotype.

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Section: Discussionsupporting

confidence: 57%

Onset of chronic myeloid leukemia with complex karyotype in a pregnant patient: case report and revision of literature

Sgherza

Abruzzese

Perla

et al. 2017

TCRM

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“…We cannot deny that imatinib therapy during pregnancy is associated with an increased risk of spontaneous abortions and serious congenital malformations. Abruzzese et al (2016) recently presented a complete review on the subject; they suggested that treatment with TKIs has no limitations in male patients trying to conceive, while effective contraception should be encouraged in all female patients because of the risk of fetal complications associated with drug exposure. Conception should be planned and TKI therapy discontinued in female patients during pregnancy, and individual risks need to be considered when an unplanned pregnancy occurs.…”

Section: Discussionmentioning

confidence: 99%

Successful pregnancy and delivery in a patient with chronic myeloid leukemia: a case report and review of the literature

Sheng

Sun

2016

SpringerPlus

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IntroductionComplications associated with chronic myeloid leukemia (CML) during pregnancy are rare, and management is challenging because very limited data are available on this patient group.Case descriptionWe herein report a successful pregnancy and delivery in a patient diagnosed with CML. The patient was treated with imatinib (400 mg/day) as a first-line therapy. However, she became pregnant while she was in complete hematological remission and had a complete cytogenetic response. Because she elected to continue the pregnancy to term, imatinib treatment was stopped after 5 months of gestation and the patient was then treated with interferon-alpha for the remainder of her pregnancy. However, the CML did not relapse. She successfully gave birth to a male infant at 39 weeks by cesarean section with no adverse sequelae or malformations.Discussion and EvaluationThe treatment of pregnant women with CML is difficult because of few available therapeutic options and limited data regarding the potential harm to the fetus. Conception should be planned and TKI therapy discontinued in female patients during pregnancy, and individual risks need to be considered when an unplanned pregnancy occurs.ConclusionsOur experience will be useful for counseling patients inadvertently exposed to tyrosine kinase inhibitors such as imatinib during pregnancy.

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“…Since Pye et al first reported the outcomes of 180 female patients exposed to imatinib during pregnancy , more evidence has accumulated to indicate the potential embryotoxic and teratogenic effect of TKIs including imatinib , nilotinib , and dasatinib during pregnancy. Currently, for female patients with CML wishing to consider pregnancy, it is accepted that at least an MMR should be achieved prior to conception, and patients should remain off TKI during pregnancy, especially during the crucial first trimester . As to the specific degree and duration of the response that should be achieved before planned pregnancy, there is no consensus.…”

Section: Discussionmentioning

confidence: 99%

Planned Pregnancy in Female Patients with Chronic Myeloid Leukemia Receiving Tyrosine Kinase Inhibitor Therapy

et al. 2019

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Background The aim of this study was to explore outcomes of planned pregnancy in female patients with chronic myeloid leukemia (CML) on tyrosine kinase inhibitors (TKIs). Materials and Methods Data of female patients proceeding with a planned pregnancy were retrospectively reviewed. Results A total of 17 patients with CML who achieved at least a major molecular response (MMR) during imatinib (n = 13) or nilotinib (n = 4) therapy prior to a planned pregnancy were enrolled. At the time of TKI interruption, six were in MMR, two in molecular response 4 (MR4), and nine in molecular response 4.5 (MR4.5). TKI therapy was discontinued 6 weeks (range, 2–15 weeks) before conception in 4 patients and at gestational age of 4 weeks (range, 2–5 weeks) after determination of pregnancy in 13 patients. Apart from 1 patient who suffered a spontaneous abortion, 16 patients delivered uneventfully. A total of 10 patients lost MMR after stopping TKIs; 8 lost molecular response 2, and 3 lost complete hematological response. Log‐rank analyses showed achieving MR4 (p = .030) or MR4.5 (p = .031), complete cytogenetic response duration ≥3.5 years (p = .049), and MMR duration ≥3.5 years (p = .040) were significantly associated with longer MMR‐failure‐free survival during TKI interruption. Conclusion Planned pregnancy might be pragmatic in female patients with CML on TKIs. Achieving deep molecular response and, importantly, MMR duration ≥3.5 years were significantly associated with maintaining MMR during pregnancy. Implications for Practice Female patients with chronic myeloid leukemia on tyrosine kinase inhibitors (TKIs) wishing to conceive are currently advised to discontinue TKIs before conception. However, the ideal degree and duration of response before stopping TKI, in addition to whether there will be any adverse effect caused by a short exposure of TKI, is unknown. Data of 17 female patients, who achieved at least a major molecular response (MMR) before TKI interruption, was revised, and it was found that achieving deep molecular response and MMR duration ≥3.5 years was significantly associated with maintaining MMR during pregnancy. This provides direct evidence for a planned pregnancy strategy, and stopping TKI immediately after determination of pregnancy in female patients might be pragmatic.

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Management of pregnant chronic myeloid leukemia patients

Cited by 53 publications

References 67 publications

Onset of chronic myeloid leukemia with complex karyotype in a pregnant patient: case report and revision of literature

Onset of chronic myeloid leukemia with complex karyotype in a pregnant patient: case report and revision of literature

Successful pregnancy and delivery in a patient with chronic myeloid leukemia: a case report and review of the literature

Planned Pregnancy in Female Patients with Chronic Myeloid Leukemia Receiving Tyrosine Kinase Inhibitor Therapy

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