Taxotere During Pregnancy and Breastfeeding

Is it safe to administer Taxotere (docetaxel) in pregnant or breastfeeding women? This chemotherapy drug is, in fact, often used to treat breast and lung cancer in male and female subjects. Although a woman may actively try to avoid conception during an antiblastic treatment course, some unfortunate individuals may receive a cancer diagnosis only after they ended up pregnant or while breastfeeding their newborn. Choosing whether to delay treatment or take termination of pregnancy into consideration is a difficult decision to take. The patient should weight the risks and know that cancer treatment may affect her chances to get pregnant again over the course of her life. Depending on the severity of the malignancy, in fact, the benefit of using Taxotere may be superior to the risk of harming the baby. Talking to your doctor is always the most recommended course of action, though. Your health care provider may help you fully understand how urgent is to start treatment by considering all the benefits and risks of using a chemotherapy agent or any other type of cancer therapy (hormone, radiation, surgery).

Pregnancy risk category

The United States Food and Drug Administration (FDA) classifies drugs into five different categories of risk which depend on their safety during pregnancy. Ranging from the safest (A) to the most dangerous (X), the five categories are A, B, C, D and X. Docetaxel falls into “Pregnancy Category D”, meaning that some clinical studies showed there are some clear evidence of possible risks to an unborn child if the medication is taken during the gestation period. Thus, the standard recommendation is to advise women of childbearing potential against conceiving during therapy and for the 6 months following therapy. Women with early-stage breast cancer are also recommended to wait for two more years since the risk of recurrence is higher during this timeframe, and a new treatment may thus be necessary.

However, although a risk for the fetus to suffer irreversible damage or malformations is present, a Pregnancy Category D classification still means that, despite the risks, the drug’s potential benefits may warrant its use in some instances even if a woman is pregnant. In particular, no controlled data of Taxotere’s safety during human gestation is present, and the only studies that proved its dangerousness come from animal subjects (rats and rabbits) where evidence of fetotoxicity, embryotoxicity and increased risk of miscarriages has emerged.

Can Taxotere be safer than we expected during pregnancy?

Although birth control methods can be effectively used to avoid pregnancy during chemotherapy, whenever a woman is expecting a child already at the time of diagnosis there’s not much else she can do. As her options dwindle, it’s critical to adequately understand how dangerous is to keep taking Taxotere during gestation for her health and the baby’s one. Probably the most important thing to know is that the placental barrier is usually sufficient to block any tumor cells from reaching the baby’s body or his or he blood supply. Is then safe to assume that an infant won’t get cancer from his or her mother.

There’s a general consensus among doctors that chemotherapy regimens should not be administered during the first trimester (from week 1 to week 14) or close to the delivery date (later than week 32). The first recommendation is given because, during the first three months of gestation, the fetus’s organs are quickly developing, and there’s a risk of malformations which may lead to birth defects. The last dose of medications should be instead given 8 weeks before childbirth to avoid neutropenia, a common side effect associated with taxanes that reduce white blood cell counts, increasing the risk of infection for the baby and the mother as well. Administering docetaxel after the first trimester and before delivery can then significantly reduce the risk of harming the child.

An observational study published in 2012 in the clinical journal The Lancet Oncology, reviewed the experiences of 447 women who received antiblastic agents during pregnancy to treat breast cancer. The researchers compared the risk of complications in infants who were exposed to chemotherapy while they were in the womb, to infants whose mothers waited to be treated until after delivery. The evidence showed that the difference was statistically non-significant (15 percent versus 4 percent), and may have very well been caused by other, unrelated factors. Early delivery was the most common adverse reaction, but, again, the increased risk was not significantly higher than normal, since this one still is one of the most widespread complications of pregnancy even in healthy subjects.

Other studies that collected data on the safety of docetaxel and paclitaxel found pharmacological evidence that supported their safety even during second and third trimesters of pregnancy. The toxicity profile of these drugs may be much more favorable than expected, although more studies are required to confirm this information and define the best way to handle them in pregnant cancer patients.

Taxotere and Breastfeeding

No clinical study ever provided any convincing data on whether docetaxel is excreted in human breast milk and my thus harm a nursing infant during lactation. However, radiolabeled samples of this substance have been detected in rat milk, which caused signs of delayed development in the offspring of animals who were treated with it. However, after the treatment cycles are over, as long as you’re not receiving chemotherapy anymore, it is safe to breastfeed your baby. Regardless of your choice to lactate or not, you may still love and cuddle your newborn during feeding time to provide him (and you) with comfort and intimate contact.

Article written by Dr. Claudio Butticè, Pharm.D.

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