Pregnancy and TKIs
The overall data regarding CML treatment during pregnancy is limited. According to the limited data available, the best outcomes for pregnancy in CML patients occur when patients and their doctors plan for a pregnancy and develop a treatment strategy where mother and baby are carefully monitored and protected. Given the generally favorable longer-term outcome with TKI therapy, a growing number of men and women with CML who are of reproductive age and are in stable remission with ongoing treatment are increasingly interested in conceiving.
Data are available from a limited number of pregnancies that have occurred accidentally in women who were taking Gleevec. While many children who were exposed to Gleevec in the uterus have been born healthy and without apparent abnormalities, there have been a few abnormalities noted both in live births and in aborted or miscarried fetuses. Regarding specific use of drugs, there is no data to suggest that Gleevec or any other TKI drug can be taken safely during pregnancy. Current recommendations include counseling so that potential parents understand the
- Need for women to stop treatment during preconception and pregnancy
- Risk of relapse, if therapy is stopped, based on the depth and duration of response
- Risk for fetal effects from Gleevec and other TKI drugs (probably greatest during the first trimester)
- Need for women on TKI therapy to refrain from breast-feeding their babies
- Uncertainty about treatment options and restoration of stable response during and after pregnancy.
Early reports of treatment cessation (stopping treatment) for pregnancy have been discouraging; risk of relapse and the chance of regaining response remain unknown. With a larger proportion of patients in stable remission and promising results from early trials of deliberate treatment cessation among a nonpregnant population, hope remains that women with CML who want to become pregnant can be better managed with lower risk to both mother and child if treatment is interrupted after achieving a deep and stable molecular response. (See the free information booklet Chronic Myeloid Leukemia to read about Treatment Cessation.) Experience has been even more limited for other TKI drugs such as Sprycel and Tasigna. Like Gleevec, these agents are considered unsafe to take during pregnancy. Women who are taking Sprycel or Tasigna should not breast-feed. There is hope that by achieving deep molecular responses in a higher proportion of patients that these new agents may facilitate more treatment interruptions, but this issue is not yet resolved.
Data are limited on men who father children while taking Gleevec or other TKIs. To date, there are no obvious causes for concern for men taking TKIs that warrant a formal contraindication for fathering a child. Nonetheless, these drugs cannot be presumed safe in this setting and, before deciding to start a family, men in treatment for CML are encouraged to discuss the matter with their doctor. In addition, TKI drugs have the potential to affect a man’s ability to conceive a child, especially after long-term use. Men of reproductive age should discuss their fertility concerns and available options with their doctor, including the cryopreservation of sperm (sperm banking) before the start of TKI therapy.