| 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? | |
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MedLine Citation:
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PMID: 18550361 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Hendrik-Tobias Arkenau; David Olmos; Joo Ern Ang; Jorge Barriuso; Vasilios Karavasilis; Sue Ashley; Johann de Bono; Ian Judson; Stan Kaye |
Publication Detail:
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Type: Comparative Study; Journal Article Date: 2008-06-10 |
Journal Detail:
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Title: European journal of cancer (Oxford, England : 1990) Volume: 44 ISSN: 0959-8049 ISO Abbreviation: Eur. J. Cancer Publication Date: 2008 Jul |
Date Detail:
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Created Date: 2008-07-08 Completed Date: 2008-12-02 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9005373 Medline TA: Eur J Cancer Country: England |
Other Details:
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Languages: eng Pagination: 1536-40 Citation Subset: IM |
Affiliation:
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Drug Development Unit, Royal Marsden Hospital and Institute of Cancer Research, Downs Road, SM2 5PT Sutton, United Kingdom. hendrik-tobias.arkenau@icr.ac.uk |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Aged, 80 and over Case-Control Studies Clinical Trials, Phase I as Topic / mortality* Cohort Studies Female Humans Male Middle Aged Neoplasms / mortality* Patient Selection* Prognosis Retrospective Studies Risk Factors Survival Analysis |
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