Methodology and Biostatistics Unit, Centre Oscar Lambret, 3 rue Frederic Combemale, 59020, Lille cedex, France.
BMC Med Res Methodol. 2012 Jul 23;12:103. doi: 10.1186/1471-2288-12-103.
In most phase I oncology trials, it is often stated that the dose increments follow a "modified-Fibonacci sequence". This term, however, is vague.
To better characterize this sequence, we reviewed 81 phase I trials based on this concept.
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.
This confusing term should be avoided.
在大多数肿瘤学 I 期临床试验中，常规定剂量递增采用“改良 Fibonacci 序列”。然而，这个术语比较模糊。
为了更好地描述该序列，我们对基于这一概念的 81 项 I 期临床试验进行了回顾。
在 198 项肿瘤学 I 期临床试验中，81 项（41%）基于改良 Fibonacci 系列。实际递增比在 0.80 到 2.08 之间变化较大。实际增量的中位数约为 2.00、1.50、1.33、1.33、1.33、1.33、1.30、1.35……“改良 Fibonacci 序列”汇集了真实序列的异质变化，在较高剂量水平上并不趋向于常数。
这个混淆的术语应该避免使用。
