title: Outcomes of children exposed in utero to chemotherapy for breast cancer.
abstract: BACKGROUND
  The incidence of breast cancer diagnosed during pregnancy is expected to increase as more women delay childbearing in the United States. Treatment of cancer in pregnant women requires prudent judgment to balance the benefit to the cancer patient and the risks to the fetus. Prospective data on the outcomes of children exposed to chemotherapy in utero are limited for the breast cancer population.
  
  
  METHODS
  Between 1992 and 2010, 81 pregnant patients with breast cancer were treated in a single-arm, institutional review board-approved study with 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC) in the adjuvant or neoadjuvant setting. Labor and delivery records were reviewed for each patient and neonate. In addition, the parents or guardians were surveyed regarding the health outcomes of the children exposed to chemotherapy in utero.
  
  
  RESULTS
  In total, 78% of the women (or next of kin) answered a follow-up survey. At a median age of 7 years, most of the children exposed to chemotherapy in utero were growing normally without any significant exposure-related toxicity or health problems. Three children were born with congenital abnormalities: one each with Down syndrome, ureteral reflux or clubfoot. The rate of congenital abnormalities in the cohort was similar to the national average of 3%.
  
  
  CONCLUSIONS
  During the second and third trimesters, pregnant women with breast cancer can be treated with FAC safely without concerns for serious complications or short-term health concerns for their offspring who are exposed to chemotherapy in utero. Continued long-term follow-up of the children in this cohort is required.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT00510367. Other Study ID numbers: ID01-193, NCI-2012-01578. Registration date: 31 July 2007.
authors.affiliation: Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Box 1354, Houston, TX, 77030, USA. rmurthy1@mdanderson.org.
authors.forename: Rashmi K
authors.initials: RK
authors.lastname: Murthy
authors.affiliation: Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Box 1354, Houston, TX, 77030, USA. richard.theriault@yahoo.com.
authors.forename: Richard L
authors.initials: RL
authors.lastname: Theriault
authors.affiliation: Division of Pharmacy, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX, 77030, USA. cmbarnet@mdanderson.org.
authors.forename: Chad M
authors.initials: CM
authors.lastname: Barnett
authors.affiliation: Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Box 1354, Houston, TX, 77030, USA. SHodge@mdanderson.org.
authors.forename: Silvia
authors.initials: S
authors.lastname: Hodge
authors.affiliation: Department of Obstetrics/Gynecology, The University of Texas Health Science Center, 6431 Fannin Street, Houston, TX, 77030, USA. mmramirez@mdanderson.org.
authors.forename: Mildred M
authors.initials: MM
authors.lastname: Ramirez
authors.affiliation: Department of Obstetrics/Gynecology, The University of Texas Health Science Center, 6431 Fannin Street, Houston, TX, 77030, USA. amilbour@mdanderson.org.|Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 1362, Houston, TX, 77030, USA. amilbour@mdanderson.org.
authors.forename: Andrea
authors.initials: A
authors.lastname: Milbourne
authors.affiliation: Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 1362, Houston, TX, 77030, USA. sarimes@mdanderson.org.
authors.forename: Sue A
authors.initials: SA
authors.lastname: Rimes
authors.affiliation: Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Box 1354, Houston, TX, 77030, USA. ghortoba@mdanderson.org.
authors.forename: Gabriel N
authors.initials: GN
authors.lastname: Hortobagyi
authors.affiliation: Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Box 1354, Houston, TX, 77030, USA. vvalero@mdanderson.org.
authors.forename: Vicente
authors.initials: V
authors.lastname: Valero
authors.affiliation: Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Box 1354, Houston, TX, 77030, USA. jlitton@mdanderson.org.
authors.forename: Jennifer K
authors.initials: JK
authors.lastname: Litton
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D002648:Child; D003025:Clubfoot / Q000453:epidemiology; D000013:Congenital Abnormalities / Q000453:epidemiology*; D003520:Cyclophosphamide / Q000627:therapeutic use; D004314:Down Syndrome / Q000453:epidemiology; D004317:Doxorubicin / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D011247:Pregnancy; D011252:Pregnancy Complications, Neoplastic / Q000188:drug therapy*; D011297:Prenatal Exposure Delayed Effects / Q000453:epidemiology*; D012189:Retrospective Studies; D014718:Vesico-Ureteral Reflux / Q000453:epidemiology
chemical_list: D004317:Doxorubicin; D003520:Cyclophosphamide; D005472:Fluorouracil