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- W2166380979 abstract "Purpose To evaluate the use and objectives of expansion cohorts in phase I cancer trials and to explore trial characteristics associated with their use. Methods We performed a systematic review of MEDLINE and EMBASE, limiting studies to single-agent phase I trials recruiting adults and published after 2006. Eligibility assessment and data extraction were performed by two reviewers. Data were assessed descriptively, and associations were tested by univariable and multivariable logistic regression. Results We identified 611 unique phase I cancer trials, of which 149 (24%) included an expansion cohort. The trials were significantly more likely to use an expansion cohort if they were published more recently, were multicenter, or evaluated a noncytotoxic agent. Objectives of the expansion cohort were reported in 74% of trials. In these trials, safety (80%), efficacy (45%), pharmacokinetics (28%), pharmacodynamics (23%), and patient enrichment (14%) were cited as objectives. Among expansion cohorts with safety objectives, the recommended phase II dose was modified in 13% and new toxicities were described in 54% of trials. Among trials aimed at assessing efficacy, only 11% demonstrated antitumor activity assessed by response criteria that was not previously observed during dose escalation. Conclusion The utilization of expansion cohorts has increased with time. Safety and efficacy are common objectives, but 26% fail to report explicit aims. Expansion cohorts may provide useful supplementary data for phase I trials, particularly with regard to toxicity and definition of recommended dose for phase II studies." @default.
- W2166380979 created "2016-06-24" @default.
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- W2166380979 date "2013-11-20" @default.
- W2166380979 modified "2023-10-01" @default.
- W2166380979 title "Evolution of Clinical Trial Design in Early Drug Development: Systematic Review of Expansion Cohort Use in Single-Agent Phase I Cancer Trials" @default.
- W2166380979 cites W1965431780 @default.
- W2166380979 cites W1965749310 @default.
- W2166380979 cites W1967210005 @default.
- W2166380979 cites W1967445526 @default.
- W2166380979 cites W1969692667 @default.
- W2166380979 cites W1975161112 @default.
- W2166380979 cites W1975218397 @default.
- W2166380979 cites W1976402300 @default.
- W2166380979 cites W1978810702 @default.
- W2166380979 cites W1979665794 @default.
- W2166380979 cites W1980459448 @default.
- W2166380979 cites W1985355814 @default.
- W2166380979 cites W1985620267 @default.
- W2166380979 cites W1992973512 @default.
- W2166380979 cites W1993170960 @default.
- W2166380979 cites W1993510744 @default.
- W2166380979 cites W1996833191 @default.
- W2166380979 cites W1999464994 @default.
- W2166380979 cites W2001856011 @default.
- W2166380979 cites W2003888937 @default.
- W2166380979 cites W2004000621 @default.
- W2166380979 cites W2005326402 @default.
- W2166380979 cites W2010102975 @default.
- W2166380979 cites W2010121426 @default.
- W2166380979 cites W2011118089 @default.
- W2166380979 cites W2015646798 @default.
- W2166380979 cites W2016364458 @default.
- W2166380979 cites W2020050105 @default.
- W2166380979 cites W2021288638 @default.
- W2166380979 cites W2021424812 @default.
- W2166380979 cites W2022556541 @default.
- W2166380979 cites W2022765594 @default.
- W2166380979 cites W2023342930 @default.
- W2166380979 cites W2023634716 @default.
- W2166380979 cites W2027114592 @default.
- W2166380979 cites W2029642612 @default.
- W2166380979 cites W2031091007 @default.
- W2166380979 cites W2034072253 @default.
- W2166380979 cites W2040104879 @default.
- W2166380979 cites W2040176056 @default.
- W2166380979 cites W2049092411 @default.
- W2166380979 cites W2049172739 @default.
- W2166380979 cites W2050328756 @default.
- W2166380979 cites W2050693077 @default.
- W2166380979 cites W2051990692 @default.
- W2166380979 cites W2056061415 @default.
- W2166380979 cites W2056558455 @default.
- W2166380979 cites W2060286792 @default.
- W2166380979 cites W2060374179 @default.
- W2166380979 cites W2062447884 @default.
- W2166380979 cites W2065302180 @default.
- W2166380979 cites W2066159416 @default.
- W2166380979 cites W2069433719 @default.
- W2166380979 cites W2072015866 @default.
- W2166380979 cites W2072874976 @default.
- W2166380979 cites W2075333933 @default.
- W2166380979 cites W2076942267 @default.
- W2166380979 cites W2080495631 @default.
- W2166380979 cites W2083433702 @default.
- W2166380979 cites W2083676244 @default.
- W2166380979 cites W2086506462 @default.
- W2166380979 cites W2087681835 @default.
- W2166380979 cites W2090437722 @default.
- W2166380979 cites W2090457708 @default.
- W2166380979 cites W2092941122 @default.
- W2166380979 cites W2094994198 @default.
- W2166380979 cites W2095771928 @default.
- W2166380979 cites W2096617104 @default.
- W2166380979 cites W2097339599 @default.
- W2166380979 cites W2097574458 @default.
- W2166380979 cites W2097926940 @default.
- W2166380979 cites W2098588666 @default.
- W2166380979 cites W2099050005 @default.
- W2166380979 cites W2100100860 @default.
- W2166380979 cites W2100483340 @default.
- W2166380979 cites W2103704392 @default.
- W2166380979 cites W2104027625 @default.
- W2166380979 cites W2104338481 @default.
- W2166380979 cites W2104564014 @default.
- W2166380979 cites W2104830962 @default.
- W2166380979 cites W2105961905 @default.
- W2166380979 cites W2106122285 @default.
- W2166380979 cites W2106543129 @default.
- W2166380979 cites W2108502796 @default.