Risks and benefits of phase 1 oncology trials, 2001 through 2012

Autor:	Erich Huang, Yoko Korenaga Fukuda, Naoko Takebe, Larry Rubinstein, S. Percy Ivy, Shanda Finnigan
Rok vydání:	2014
Předmět:	Response rate (survey) Oncology Cancer Research medicine.medical_specialty business.industry Mortality rate Alternative medicine Cancer medicine.disease Clinical trial Cancer Therapy Evaluation Program Tolerability Internal medicine medicine Risks and benefits business
Zdroj:	Journal of Clinical Oncology. 32:2552-2552
ISSN:	1527-7755 0732-183X
DOI:	10.1200/jco.2014.32.15_suppl.2552
Popis:	2552 Background: The primary objective of phase I clinical trials is to evaluate the tolerability and pharmacokinetics of a new agent. Phase I trials in oncology remain ethically controversial. Our previous analysis from year 1991 through 2002 reported a response rate of 10.6 percent and a toxicity-related death rate of 0.49 percent. An increasing number of molecular targeted agents are under investigation and these results may not reflect current phase I oncology trials. Methods: We reviewed all non-pediatric phase 1 oncology trials sponsored by the Cancer Therapy Evaluation Program at the National Cancer Institute between January 1, 2001 and December 31, 2012. We report the rates of response to treatment, of stable disease, of grade 4 toxic events, and of treatment-related deaths. Results: We analyzed 286 trials, comprising 8314 participants. All 8314 participants were evaluated for toxic events, whereas 6604 participants were evaluated for response. The overall response rate (complete and partial respo...
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::bf71a3f02e07b3926070a84b5e05c1e5 https://doi.org/10.1200/jco.2014.32.15_suppl.2552 Zobrazit plný text záznamu