Pregnancy and TKIs
A growing number of women with CML who are in stable remission with ongoing treatment are showing increasing interest in becoming pregnant. Data are available from a limited number of pregnancies that have occurred accidentally in women who were taking Gleevec. While a substantial proportion of children who were exposed to Gleevec in the uterus have been born healthy and without apparent abnormalities, there have been a few abnormalities noted in children and in aborted fetuses. It thus cannot be convincingly stated or assumed that Gleevec can be safely taken 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 (probably greatest during the first trimester)
- Need for women on Gleevec to refrain from breast-feeding
- Uncertainty about treatment options and restoration of stable response during and after pregnancy.
Early reports of treatment cessation 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 Clinical Trials for more information about treatment cessation.
Data are limited on men who father children while taking Gleevec, but to date do not reveal any obvious causes for concern. Nonetheless, Gleevec cannot be presumed safe in this setting.
For Sprycel and Tasigna, experience has been even more limited, and, like Gleevec, these agents are considered unsafe to take during pregnancy at the present time. Women who are on Sprycel or Tasigna should not breast-feed. There is hope that by achieving deep molecular responses in a higher proportion of patients, these new agents may facilitate more treatment interruptions, but this issue is not yet resolved.