This ongoing multicentre, observational cohort study is being conducted to assess the general health, cardiac function, and neuro-developmental outcomes, including intelligence, memory, attention, and executive functions, in children who were prenatally exposed to chemotherapy. The study began in March 2005 in 3 European countries and the authors present an interim analysis based on data at a cut off of March 2011.

The interim analysis assesses children prenatally exposed to maternal cancer staging and treatment, including chemotherapy. The researchers assessed children at birth, at age 18 months, and at age 5-6, 8-9, 11-12, 14-15, or 18 years. Clinical neurological examinations, tests of the general level of cognitive functioning (Bayley or intelligence quotient [IQ] test), electrocardiography and echocardiography were carried out, and a questionnaire on general health and development was also administered. From age 5 years, the researchers carried out audiometry, the Auditory Verbal Learning Test, and subtasks of the Children's Memory Scale, and the Test of Everyday Attention for Children, and also completed the Child Behaviour Checklist.

Overall, 236 cycles of chemotherapy were administered in 68 pregnancies. The researchers assessed 70 children, born at a median gestational age of 35.7 weeks (range 28.3-41.0; IQR 3.3; 47 women at <37 weeks), with a median follow-up period of 22.3 months (range 16.8-211.6; IQR 54.9). The following results are reported:

• When controlling for age, sex, and country, the score for IQ increased by an average 11.6 points (95% CI 6.0-17.1) for each additional month of gestation (p<0.0001).

• Measurements of the children's behaviour, general health, hearing, and growth corresponded with those of the general population.

• Cardiac dimensions and functions were within normal ranges.

• The researchers identified a severe neurodevelopmental delay in both members of one twin pregnancy.

The researchers note, “Despite prenatal exposure to chemotherapy, radiotherapy, staging examinations, and co-medications, the outcome for children in our study is not different from the general population.” They discuss the limitations to their study and conclude, “Foetal exposure to chemotherapy was not associated with increased CNS, cardiac or auditory morbidity, or with impairments to general health and growth compared with the general population. However, subtle changes in cardiac and neurocognitive measurements emphasise the need for longer follow-up. Prematurity was common and was associated with impaired cognitive development. Therefore, iatrogenic preterm delivery should be avoided when possible.”

The author of a related Comment article discusses the results of this interim analysis and adds that some key questions remain unanswered. She writes that the study has the “potential to affect clinical practice: if we can present this reassuring data to pregnant women with cancer, women might be more likely to accept treatment during pregnancy when indicated.”