Outcome of pregnancy in chronic myeloid leukaemia patients treated with tyrosine kinase inhibitors: Short report from a single centre

Alizadeh, Hussain; Jaafar, Hassan; Rajnics, Péter; Khan, Mubbsher Munawar; Kajtár, Béla

doi:10.1016/j.leukres.2014.10.002

Cited by 23 publications

(14 citation statements)

References 26 publications

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“…Furthermore, the miscarriage or fetal abnormality rate is not elevated in female partners of men on TKI therapy. [228][229][230][231][232] The situation is more complex for women, as TKI therapy during pregnancy has been associated with both a higher rate of miscarriage and fetal abnormalities. Limited evidence from case reports on women with CML exposed to imatinib, dasatinib, or nilotinib during pregnancy indicates the need for close monitoring, a prolonged washout period prior to pregnancy, and prompt consideration of holding TKI therapy if pregnancy occurs while on imatinib, nilotinib, or dasatinib.…”

Section: Tki Therapy and Conceptionmentioning

confidence: 99%

Chronic Myeloid Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology

Deininger

Shah

Altman³

et al. 2020

Journal of the National Comprehensive Cancer Network

165

210

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Chronic myeloid leukemia (CML) is defined by the presence of Philadelphia chromosome (Ph) which results from a reciprocal translocation between chromosomes 9 and 22 [t(9;22] that gives rise to a BCR-ABL1 fusion gene. CML occurs in 3 different phases (chronic, accelerated, and blast phase) and is usually diagnosed in the chronic phase. Tyrosine kinase inhibitor therapy is a highly effective first-line treatment option for all patients with newly diagnosed chronic phase CML. This manuscript discusses the recommendations outlined in the NCCN Guidelines for the diagnosis and management of patients with chronic phase CML.

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Section: Tki Therapy and Conceptionmentioning

confidence: 99%

Chronic Myeloid Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology

Deininger

Shah

Altman³

et al. 2020

Journal of the National Comprehensive Cancer Network

165

210

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“…5 Several single-center reports describing a normal childbirth with imatinib use in pregnancy have been published. 6,7 As almost all those cases with fetal abnormalities (10 of 12) from the early literature report 4 were attributed to imatinib use in the 1st trimester of pregnancy (in two cases, the trimester was unknown), and given that there were no cases of birth defects with imatinib use in the 2nd-3rd pregnancy trimester, the possible role of a blood-placental barrier is being discussed. The authors state that, in general, no TKI should be used during pregnancy and at the same time emphasize that consideration of imatinib and nilotinib can be made in the late pregnancy stage.…”

Section: Dear Editor!mentioning

confidence: 99%

Risks and challenges of CML management during pregnancy: Looking for a balanced decision

Chelysheva

Turkina

2019

European J of Haematology

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On the other hand, in many situations, pregnant patients with CML may be observed without any therapy for the whole pregnancy period. New data about the kinetics of the leukemic clone during pregnancy indicate the possibility of slowly increasing BCR-ABL levels after TKI cessation. 12 Moreover, patients with non-sustained DMR and even with a major molecular response (MMR or BCR-ABL ≤0.1% IS) who lose their response when TKI is interrupted during pregnancy, restore their initial response after re-initiation of TKIs. 13 However, the probability of restoring MMR was 78% two years after resuming TKI in patients with an initial MMR. Again, these findings need further confirmation and a longer follow-up with careful | 379 LETTER TO THE EDITOR molecular monitoring in order to find the optimal degree of remission to be observed without therapy during pregnancy.The authors suggest the possibility of imatinib or nilotinib use after the 16th week of pregnancy and note that an unplanned pregnancy needs to be managed relative to TKI exposure and the CML disease state. In fact, we have been using this approach with just the same timepoint for treatment initiation in our center for several years. The results of the LET (leukemia and term-related) scheme were presented at the 2018 annual meeting of the European Hematology Association. Briefly, 49 CML pregnancy cases were managed in accordance with the level of BCR-ABL and pregnancy stage. 14 Any TKIs were immediately discontinued after pregnancy confirmation, and none of them were used during organogenesis before the 15th week of pregnancy. Imatinib or nilotinib was used after the 15th week of pregnancy for the benefit of patients with no complete hematological response (CHR) or MR2 loss (BCR-ABL >1%); 26 patients were given imatinib and four patients received nilotinib. No other TKIs were administered at any stage of pregnancy.Observation without IFN was used if at least MR2 remained (BCR-ABL <1%). If no CHR was observed before the 15th week, an IFN could be administered. The newborns were healthy, and no congenital abnormalities occurred. A single case of hypospadias was observed with no association of TKI use as the mother received IFN for the whole pregnancy.The article by Abruzzese et al gives directions for the development of recommendations in patients with CML during pregnancy.We are encouraged by the current vision of international experts from different countries, which accords well with our considerations and experience, and we hope that our experience may contribute to a consensus in the practical management of CML patients during pregnancy.

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“…Among those, 5 reported problems in the offspring including 1 primum atrial septal defect requiring surgery [29], 1 hypospadia and 1 mild hydrocephalus [30], 1 clinodactily and low set ears [31] and 1 macrocephalic (GIMEMA). All those abnormalities resulted in patients exposed variably to imatinib during 1 st trimester and during organogenesis.…”

Section: Imatinibmentioning

confidence: 99%

Management of pregnant chronic myeloid leukemia patients

Abruzzese

Trawinska

Fabritiis

et al. 2016

Expert Review of Hematology

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Data published and informations acquired in terms of fertility, conception, pregnancy, pregnancy outcome and illness control for all the approved TKIs will be reviewed, as well as suggest how to manage a planned and/or unplanned pregnancy/conception. Literature search methodology included examination of PubMed index, meeting presentations, and updated Investigator's brochures and data files of TKIs companies. Expert commentary: Male patients trying to conceive apparently have no limitation in the use of TKIs, while effective contraception should be encouraged in all female patients due to the risk of fetal complications after drug exposure. In a female patient pregnancy should be planned and TKI therapy discontinued, while individual risks need to be considered when an unplanned pregnancy occurs.

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Outcome of pregnancy in chronic myeloid leukaemia patients treated with tyrosine kinase inhibitors: Short report from a single centre

Cited by 23 publications

References 26 publications

Chronic Myeloid Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology

Chronic Myeloid Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology

Risks and challenges of CML management during pregnancy: Looking for a balanced decision

Management of pregnant chronic myeloid leukemia patients

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