Temporal evolution of patient characteristics enrolled on phase I trials.
Invest New Drugs
; 29(2): 312-5, 2011 Apr.
Article
em En
| MEDLINE
| ID: mdl-19997961
ABSTRACT
PURPOSE:
Phase I trials serve a crucial role in anticancer drug development. Given the explosion in the number of both approved anticancer therapies and agents in development, we hypothesized that the characteristics of patients enrolling on phase I clinical trials is evolving. PATIENTS ANDMETHODS:
We reviewed 476 published phase I trials over the past decade encompassing 15,100 patients and determined the following characteristics for patients enrolled age; percentage with ECOG PS of 0, 1, or 2; sex; race; and number of prior chemotherapeutic therapies received 0, 1, 2 or ≥ 3. We also identified the major tumor types enrolled colorectal, lung, renal, breast, head/neck or "other". The change of patient characteristics over time as well as between the first half of studied period (period 1 = 1998-2001) and the second half period (period 2 = 2002-2006) was analyzed.RESULTS:
Colorectal and lung cancer patients together comprise ~35% of all patients enrolled on phase I trials and this has not changed over the past decade. The contribution of "other" malignancies has however significantly increased over time. The proportion of patients with PS2 has declined while that of PS1 has increased. The proportion of patients with ≥3 prior therapies prior to study enrollment has also significantly increased.CONCLUSION:
The shifting of patient characteristics especially as related to tumor types enrolled and number of prior therapies has important implications for future design of studies and inadequate attention to these issues may slow the accrual process.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos Fase I como Assunto
/
Seleção de Pacientes
Tipo de estudo:
Prognostic_studies
/
Systematic_reviews
Limite:
Humans
Idioma:
En
Ano de publicação:
2011
Tipo de documento:
Article