Document Detail

90-Days mortality rate in patients treated within the context of a phase-I trial: how should we identify patients who should not go on trial?
MedLine Citation:
PMID:  18550361     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The primary objectives of phase-I trials include the definition of drug toxicities and the recommendation of phase-II doses. In order to safeguard the well-being of its participants, a common inclusion criterion is that of life expectancy >3 months. However, previous studies have shown that about 20% of these patients do not survive beyond this time-point. METHODS: We identified 97 patients who died within the first 90 days of treatment out of a total of 654 consecutively treated phase-I patients, from June 2003 to June 2007. This cohort was compared to a control group comprising 215 patients who lived >90 days on phase-I studies and were treated from January 2005 to June 2006. RESULTS: In keeping with our recently reported phase-I survival risk score, multivariate analysis demonstrated that patients who died within the first 90 days had lower albumin (p=0.010), greater number of metastatic sites (p=0.00001) and higher frequency of elevated LDH (p=0.0002). This analysis also showed that 86% of patients who died during the first 90 days had an increased risk score of 2/3 compared to 39% in the control group. Furthermore, three additional factors were identified, namely younger age (p=0.024), higher white cell count (p=0.028) and poorer ECOG PS (p=0.012) but the addition of these did not improve the ability to predict 90-day mortality compared to the afore-mentioned risk score. CONCLUSIONS: There is good evidence that our easily derivable scoring system provides an objective method to identify patients with a very limited life expectancy in whom participation in phase-I trials should be carefully evaluated.
Hendrik-Tobias Arkenau; David Olmos; Joo Ern Ang; Jorge Barriuso; Vasilios Karavasilis; Sue Ashley; Johann de Bono; Ian Judson; Stan Kaye
Publication Detail:
Type:  Comparative Study; Journal Article     Date:  2008-06-10
Journal Detail:
Title:  European journal of cancer (Oxford, England : 1990)     Volume:  44     ISSN:  0959-8049     ISO Abbreviation:  Eur. J. Cancer     Publication Date:  2008 Jul 
Date Detail:
Created Date:  2008-07-08     Completed Date:  2008-12-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9005373     Medline TA:  Eur J Cancer     Country:  England    
Other Details:
Languages:  eng     Pagination:  1536-40     Citation Subset:  IM    
Drug Development Unit, Royal Marsden Hospital and Institute of Cancer Research, Downs Road, SM2 5PT Sutton, United Kingdom.
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MeSH Terms
Aged, 80 and over
Case-Control Studies
Clinical Trials, Phase I as Topic / mortality*
Cohort Studies
Middle Aged
Neoplasms / mortality*
Patient Selection*
Retrospective Studies
Risk Factors
Survival Analysis

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

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