Open Access 01-12-2012 | Research article
What does a modified-Fibonacci dose-escalation actually correspond to?
Published in: BMC Medical Research Methodology | Issue 1/2012
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Background
In most phase I oncology trials, it is often stated that the dose increments follow a “modified-Fibonacci sequence”. This term, however, is vague.
Methods
To better characterize this sequence, we reviewed 81 phase I trials based on this concept.
Results
Out of 198 phase I oncology trials, 81 (41%) are based on modified-Fibonacci series. Actual incremental ratios varied in a large range from 0.80 to 2.08. The median of actual increments was about 2.00, 1.50, 1.33, 1.33, 1.33, 1.33, 1.30, 1.35…. The “modified Fibonacci-sequence” gathers heterogeneous variation of the genuine sequence, which does not tend to a constant number at higher dose-levels.
Conclusion
This confusing term should be avoided.