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Leukemia Therapy With Imatinib During Pregnancy May Cause Infant Abnormalities
While doctors already
face many challenges in treating patients with cancer, treating pregnant
women with the disease, in particular, can be quite difficult as studies
suggest that certain therapies can harm developing fetuses. According to
the results of a study prepublished today online in Blood, the official
journal of the American Society of Hematology, expectant women treated with
imatinib, a commonly used therapy for chronic myeloid leukemia (CML), may
be at moderate risk of developing fetal abnormalities.
Imatinib was introduced for the treatment of CML in 1998 and has become
a primary therapy for most patients, turning the previously fatal disease
into a mostly chronic condition in the last decade. The drug's label warns
that women of child-bearing age should avoid pregnancy while taking the
drug based on earlier studies that suggested it may penetrate the placenta
and cause damage to developing cells.
The retrospective study reviewed records of 180 cases of CML treatment
during pregnancy reported to Novartis, the Hammersmith Hospital in London,
or The University of Texas M. D. Anderson Cancer Center to determine the
real risks of imatinib therapy. Specific outcomes data were available for
125 of the cases, as 55 cases had incomplete pregnancy-related data.
Half of the pregnancies resulted in the birth of normal live infants
(n=63). Thirty-five women underwent elective terminations, three following
the identification of fetal abnormalities. At least 18 pregnancies resulted
in miscarriage. The remainder of the births resulted in infants with
congenital abnormalities (n=9, one still birth). In total, 12 pregnancies
resulted in infants with fetal abnormalities (9.6 percent) and of those,
there were eight live births, one still birth and three terminations
(mentioned above). Some of the abnormalities in the infants were similar,
including exomphalos (umbilical hernia), renal agenesis (undeveloped
kidney), and hemivertebrae (underdeveloped spine). The stillborn child
suffered from meningocoele (cerebral hernia).
The study showed that a significant proportion of pregnancies exposed
to imatinib result in a normal outcome and a healthy infant. The
miscarriage rate in the study was 14.4 percent, which is within the
expected range for the general population. However, the fact that some of
the abnormalities seen in the 12 infants were similar to results found in
early animal studies with imatinib suggests the possibility of an
imatinib-induced effect.
"Our study suggests that a concern about conceiving a child while
taking imatinib is justified and that patients should be advised to avoid
conception while on treatment," said Dr. Seonaid Pye, of the Department of
Hematology, Imperial College of London and lead author of the study. "In
those patients who do become pregnant, balancing the risk of the fetus from
taking therapy to the risk of the mother from interrupting therapy will be
an individual decision."
The majority of women in the study were being treated for CML at the
time of conception; just four cases were exposed after the first trimester.
The dose and the exact duration of imatinib therapy are unknown for most
cases, with insufficient information to assess a dose-related relationship.
There were no reports of maternal exposure to alcohol, drugs, or tobacco
addiction during pregnancy, and none of the mothers had received other
high-dose chemotherapy prior to their pregnancies.
"The risks and benefits to an expectant woman fighting cancer and her
fetus are challenging and must be evaluated on an individual basis with
careful counseling," said Dr. Pye. "Ultimately, the treatment of CML during
pregnancy clearly remains a considerable clinical challenge."
The American Society of Hematology (http://www.hematology.org) is the world's
largest professional society concerned with the causes and treatment of
blood disorders. Its mission is to further the understanding, diagnosis,
treatment, and prevention of disorders affecting blood, bone marrow, and
the immunologic, hemostatic, and vascular systems, by promoting research,
clinical care, education, training, and advocacy in hematology.
Blood, the official journal of the American Society of Hematology, is
the most cited peer-reviewed publication in the field. Blood is issued to
Society members and other subscribers twice per month, available in print
and online at http://www.hematology.org.
American Society of Hematology
http://www.hematology.org
Leucemie terapiei cu imatinib în timpul sarcinii poate provoca anomalii de copil - Leukemia Therapy With Imatinib During Pregnancy May Cause Infant Abnormalities - articole medicale engleza - startsanatate