Document Detail


Treatment of breast cancer during pregnancy: an observational study.
MedLine Citation:
PMID:  22902483     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Little is known about the treatment of breast cancer during pregnancy. We aimed to determine whether treatment for breast cancer during pregnancy is safe for both mother and child.
METHODS: We recruited patients from seven European countries with a primary diagnosis of breast cancer during pregnancy; data were collected retrospectively if the patient was diagnosed before April, 2003 (when the registry began), or prospectively thereafter, irrespective of the outcome of pregnancy and the type and timing of treatment. The primary endpoint was fetal health for up to 4 weeks after delivery. The registry is ongoing. The study is registered with ClinicalTrials.gov, number NCT00196833.
FINDINGS: From April, 2003, to December, 2011, 447 patients were registered, 413 of whom had early breast cancer. Median age was 33 years (range 22-51). At the time of diagnosis, median gestational age was 24 weeks (range 5-40). 197 (48%) of 413 women received chemotherapy during pregnancy with a median of four cycles (range one to eight). 178 received an anthracycline, 15 received cyclophosphamide, methotrexate, and fluorouracil, and 14 received a taxane. Birthweight was affected by chemotherapy exposure after adjustment for gestational age (p=0·018), but not by number of chemotherapy cycles (p=0·71). No statistical difference between the two groups was observed for premature deliveries before the 37th week of gestation. 40 (10%) of 386 infants had side-effects, malformations, or new-born complications; these events were more common in infants born before the 37th week of gestation than they were in infants born in the 37th week or later (31 [16%] of 191 infants vs nine [5%] of 195 infants; p=0·0002). In infants for whom maternal treatment was known, adverse events were more common in those who received chemotherapy in utero compared with those who were not exposed (31 [15%] of 203 vs seven [4%] of 170 infants; p=0·00045). Two infants died; both were exposed to chemotherapy and delivered prematurely, but both deaths were thought not to be related to treatment. Median disease-free survival for women with early breast cancer was 70·6 months (95% CI 62·1-105·5) in women starting chemotherapy during pregnancy and 94·4 months (lower 95% CI 64·4; upper 95% CI not yet reached) in women starting chemotherapy after delivery (unadjusted hazard ratio 1·13 [95% CI 0·76-1·69]; p=0·539).
INTERPRETATION: Although our data show that infants exposed to chemotherapy in utero had a lower birthweight at gestational age than did those who were unexposed, and had more complications, these differences were not clinically significant and, since none of the infants was exposed to chemotherapy in the first trimester, were most likely related to premature delivery. Delay of cancer treatment did not significantly affect disease-free survival for mothers with early breast cancer. Because preterm birth was strongly associated with adverse events, a full-term delivery seems to be of paramount importance.
FUNDING: BANSS Foundation, Biedenkopf, Germany and the Belgian Cancer Plan, Ministry of Health, Belgium.
Authors:
Sibylle Loibl; Sileny N Han; Gunter von Minckwitz; Marijke Bontenbal; Alistair Ring; Jerzy Giermek; Tanja Fehm; Kristel Van Calsteren; Sabine C Linn; Bettina Schlehe; Mina Mhallem Gziri; Pieter J Westenend; Volkmar Müller; Liesbeth Heyns; Brigitte Rack; Ben Van Calster; Nadia Harbeck; Miriam Lenhard; Michael J Halaska; Manfred Kaufmann; Valentina Nekljudova; Frederic Amant
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2012-08-16
Journal Detail:
Title:  The Lancet. Oncology     Volume:  13     ISSN:  1474-5488     ISO Abbreviation:  Lancet Oncol.     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-08-31     Completed Date:  2012-10-31     Revised Date:  2014-08-18    
Medline Journal Info:
Nlm Unique ID:  100957246     Medline TA:  Lancet Oncol     Country:  England    
Other Details:
Languages:  eng     Pagination:  887-96     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Elsevier Ltd. All rights reserved.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00196833
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MeSH Terms
Descriptor/Qualifier:
Abnormalities, Drug-Induced / epidemiology*
Adult
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Apgar Score
Birth Weight / drug effects*
Breast Neoplasms / diagnosis,  drug therapy*,  pathology,  surgery
Carcinoma, Ductal / diagnosis,  drug therapy,  pathology,  secondary
Carcinoma, Lobular / diagnosis,  drug therapy,  pathology,  secondary,  surgery
Cohort Studies
Delivery, Obstetric / statistics & numerical data
Disease-Free Survival
Europe
Female
Humans
Incidence
Infant, Newborn
Infant, Newborn, Diseases / chemically induced*,  epidemiology*
Lymphatic Metastasis
Male
Middle Aged
Multivariate Analysis
Neoplasm Staging
Organ Preservation
Pregnancy
Pregnancy Complications, Neoplastic / drug therapy
Pregnancy Outcome / epidemiology*
Registries
Retrospective Studies
Young Adult
Comments/Corrections
Comment In:
Lancet Oncol. 2012 Sep;13(9):852-4   [PMID:  22902484 ]
Nat Rev Clin Oncol. 2012 Oct;9(10):549   [PMID:  22965152 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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