Dose-levels and first signs of efficacy in contemporary oncology phase 1 clinical trials.

<h4>Purpose</h4>Phase 1 trials play a crucial role in oncology by translating laboratory science into efficient therapies. Molecular targeted agents (MTA) differ from traditional cytotoxics in terms of both efficacy and toxicity profiles. Recent reports suggest that higher doses are not...

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Autores principales:	Charles Ferte, Jean-Charles Soria, Nicolas Penel
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2011
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/5a2a81cdc79344aebd66a927e68dc8c6
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spelling	oai:doaj.org-article:5a2a81cdc79344aebd66a927e68dc8c62021-11-18T06:57:51ZDose-levels and first signs of efficacy in contemporary oncology phase 1 clinical trials.1932-620310.1371/journal.pone.0016633https://doaj.org/article/5a2a81cdc79344aebd66a927e68dc8c62011-03-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/21415927/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Purpose</h4>Phase 1 trials play a crucial role in oncology by translating laboratory science into efficient therapies. Molecular targeted agents (MTA) differ from traditional cytotoxics in terms of both efficacy and toxicity profiles. Recent reports suggest that higher doses are not essential to produce the optimal anti-tumor effect. This study aimed to assess if MTA could achieve clinical benefit at much lower dose than traditional cytotoxics in dose seeking phase 1 trials.<h4>Patients and methods</h4>We reviewed 317 recent phase 1 oncology trials reported in the literature between January 1997 and January 2009. First sign of efficacy, maximum tolerated dose (MTD) and their associated dose level were recorded in each trial.<h4>Results</h4>Trials investigating conventional cytotoxics alone, MTA alone and combination of both represented respectively 63.0% (201/317), 23.3% (74/317) and 13.7% (42/317) of all trials. The MTD was reached in 65.9% (209/317) of all trials and was mostly observed at the fifth dose level. First sign of efficacy was less frequently observed at the first three dose-levels for MTA as compared to conventional cytotoxics or combinations regimens (48.3% versus 63.2% and 61.3%). Sign of efficacy was observed in the same proportion whatever the treatment type (73-82%). MTD was less frequently established in trials investigating MTA alone (51.3%) or combinations (42.8%) as compared to conventional cytotoxic agents (75.6%).<h4>Conclusion</h4>First sign of efficacy was less frequently reported at the early dose-levels and MTD was less frequently reached in trials investigating molecular targeted therapy alone. Similar proportion of trials reported clinical benefit.Charles FerteJean-Charles SoriaNicolas PenelPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 6, Iss 3, p e16633 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Charles Ferte Jean-Charles Soria Nicolas Penel Dose-levels and first signs of efficacy in contemporary oncology phase 1 clinical trials.
description	<h4>Purpose</h4>Phase 1 trials play a crucial role in oncology by translating laboratory science into efficient therapies. Molecular targeted agents (MTA) differ from traditional cytotoxics in terms of both efficacy and toxicity profiles. Recent reports suggest that higher doses are not essential to produce the optimal anti-tumor effect. This study aimed to assess if MTA could achieve clinical benefit at much lower dose than traditional cytotoxics in dose seeking phase 1 trials.<h4>Patients and methods</h4>We reviewed 317 recent phase 1 oncology trials reported in the literature between January 1997 and January 2009. First sign of efficacy, maximum tolerated dose (MTD) and their associated dose level were recorded in each trial.<h4>Results</h4>Trials investigating conventional cytotoxics alone, MTA alone and combination of both represented respectively 63.0% (201/317), 23.3% (74/317) and 13.7% (42/317) of all trials. The MTD was reached in 65.9% (209/317) of all trials and was mostly observed at the fifth dose level. First sign of efficacy was less frequently observed at the first three dose-levels for MTA as compared to conventional cytotoxics or combinations regimens (48.3% versus 63.2% and 61.3%). Sign of efficacy was observed in the same proportion whatever the treatment type (73-82%). MTD was less frequently established in trials investigating MTA alone (51.3%) or combinations (42.8%) as compared to conventional cytotoxic agents (75.6%).<h4>Conclusion</h4>First sign of efficacy was less frequently reported at the early dose-levels and MTD was less frequently reached in trials investigating molecular targeted therapy alone. Similar proportion of trials reported clinical benefit.
format	article
author	Charles Ferte Jean-Charles Soria Nicolas Penel
author_facet	Charles Ferte Jean-Charles Soria Nicolas Penel
author_sort	Charles Ferte
title	Dose-levels and first signs of efficacy in contemporary oncology phase 1 clinical trials.
title_short	Dose-levels and first signs of efficacy in contemporary oncology phase 1 clinical trials.
title_full	Dose-levels and first signs of efficacy in contemporary oncology phase 1 clinical trials.
title_fullStr	Dose-levels and first signs of efficacy in contemporary oncology phase 1 clinical trials.
title_full_unstemmed	Dose-levels and first signs of efficacy in contemporary oncology phase 1 clinical trials.
title_sort	dose-levels and first signs of efficacy in contemporary oncology phase 1 clinical trials.
publisher	Public Library of Science (PLoS)
publishDate	2011
url	https://doaj.org/article/5a2a81cdc79344aebd66a927e68dc8c6
work_keys_str_mv	AT charlesferte doselevelsandfirstsignsofefficacyincontemporaryoncologyphase1clinicaltrials AT jeancharlessoria doselevelsandfirstsignsofefficacyincontemporaryoncologyphase1clinicaltrials AT nicolaspenel doselevelsandfirstsignsofefficacyincontemporaryoncologyphase1clinicaltrials
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Dose-levels and first signs of efficacy in contemporary oncology phase 1 clinical trials.

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