Document Detail


Quality control of end results in a Danish adjuvant breast cancer multi-center study.
MedLine Citation:
PMID:  9490088     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
In a Danish multi-center study, quality control was performed on off-study data for high-risk breast cancer patients included in protocols of adjuvant therapy. In the two protocols 4455 patients were randomized and 2477 were registered off-study. Data from these patients were validated by reviewing the patients' records. Incorrect data were observed in 16.2% of the cases who went off-study due to recurrence, other malignant disease or death. In 258 of 2133 patients unidentical locations were demonstrated. Of these, 104 showed a time difference also. A major difference in site of recurrence was found in 107 patients (5.0%), 43 of whom were upstaged from local to a distant recurrence and 64 were downstaged. A time difference of more than 30 days was found in 192 patients (9.0%) and in 17 the difference exceeded 366 days. A time difference only was found in 88 patients (4%). The major parameter in the statistical analysis of the two protocols, i.e. recurrence-free survival, was not significantly influenced by the validation.
Authors:
P S Hansen; E Andersen; K W Andersen; H T Mouridsen
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Acta oncologica (Stockholm, Sweden)     Volume:  36     ISSN:  0284-186X     ISO Abbreviation:  Acta Oncol     Publication Date:  1997  
Date Detail:
Created Date:  1998-03-05     Completed Date:  1998-03-05     Revised Date:  2009-05-12    
Medline Journal Info:
Nlm Unique ID:  8709065     Medline TA:  Acta Oncol     Country:  NORWAY    
Other Details:
Languages:  eng     Pagination:  711-4     Citation Subset:  IM    
Affiliation:
Department of Internal Medicine, Viborg Hospital, Denmark.
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MeSH Terms
Descriptor/Qualifier:
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Breast Neoplasms / drug therapy*,  epidemiology,  mortality
Chemotherapy, Adjuvant
Denmark / epidemiology
Disease-Free Survival
Female
Humans
Neoplasm Recurrence, Local*
Quality Control
Survival Rate
Time Factors
Treatment Outcome

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


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