Good morning, here is the disclosure of the affiliations. I’ll talk about the new aspect of the patients with chronic myeloid leukaemia who now live normal lives due to targeted therapy and can even think about having children. However, this information is very scarce and the data about management of CML patients during pregnancy are very limited.

In order to define how this population lives, how it is controlled and what are the outcomes of pregnancy in female patients we started the study within the European LeukemiaNet. Sorry, I’m trying to go to the next slide…

Prof Anton Hagenbeek
That’s fantastic with that there; it’s beautiful.

Dr Ekaterina Chelysheva
I can talk without slides, however with slides I talk a bit better.

Prof Anton Hagenbeek
This slide has been on long enough, right? 

Dr Ekaterina Chelysheva
So we have gathered the information about 305 cases in the European LeukemiaNet registry regarding the pregnancy outcome in female patients with CML. The purpose was to describe the pregnancy conception outcomes and the management of the disease in these patients, focussing on the characteristics of patients at diagnosis and at pregnancy, focussing on the management of the CML during pregnancy, pregnancy outcomes and the characteristics of the children and their follow-up.

The ELN registry was designed as an observational study. We invited the ELN centres and participants from other countries to register to gather all retrospective and prospective cases of pregnancy in CML patients. We started since February 2014 and since that time we gathered the data of 305 cases in 234 female CML patients from 13 countries worldwide. The countries were represented not only by European countries but also countries from Asia, we gathered also cases from Argentina and the USA.

Very briefly, the results of the research were as follows. Most of the pregnancies in CML patients ended in labour, labour was the most frequent outcome so these women gave birth to children. More than two-thirds of the pregnancies were diagnosed during treatment and 71% of pregnancies were at conception with TKI treatment at conceiving. These women stopped TKIs immediately after pregnancy confirmation. Also there is a category of patients who were diagnosed with CML during pregnancy, their proportion is rather high, 21% of patients.

A major or deep molecular response which is now the goal for CML patients was only in 44% of pregnancy cases with the known molecular status. That means that not all the patients achieved good and stable remissions while they were pregnant. Therefore, a variety of treatment options were used during pregnancy, including interferon or imatinib or erlotinib at the late pregnancy stage. However, the rate of birth abnormalities was very low, 1.07%, and we didn’t observe any severe or life-threatening abnormalities in born children. Their follow-up was uneventful and now the median time of observation for these children is nearly five years.

So a normal childbirth is possible for female CML patients. We found no increased rate of birth abnormality, even when TKIs were stopped immediately after pregnancy was discovered. No situation of the abnormalities with imatinib or erlotinib used in late pregnancy, although these data are still limited.
The results of conception and pregnancy, the study of this population, may be valuable for the development of female treatment schemes, considering the variety of disease status and therapy options because we do not have the recommendations for female patients during pregnancy so far. Thank you for your attention.

Prof Anton Hagenbeek
Thank you very much for addressing this important topic in patients that live long now with CML. Any questions from the press please? In your abstract you write that most of the pregnancies, that’s 77%, ended in labour, so what happened to the 23% that did not end in labour?

Dr Ekaterina Chelysheva
The other outcomes were induced abortion, miscarriage and for 2% we have no data of the outcome. So the most frequent outcome was labour which means that these women wanted to keep their pregnancy, wanted to prolong it in spite of the risks that could be present while they were on targeted therapy.

Prof Anton Hagenbeek
And were any blast crises observed, accelerated disease in patients being pregnant and not taking tyrosine kinase inhibitors?

Dr Ekaterina Chelysheva
There were no blast crises during pregnancy. There were five deaths between all this population of more than 200 patients after the childbirth, after some period of treatment. In fact, four of these patients were treated inadequately and they were not compliant to therapy. So the compliance to therapy of the young women is another problem which we had to deal with in this population.