Serveur d'exploration sur les relations entre la France et l'Australie

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Patient perception of the benefit of a BRAF inhibitor in metastatic melanoma: quality-of-life analyses of the BREAK-3 study comparing dabrafenib with dacarbazine.

Identifieur interne : 003557 ( PubMed/Curation ); précédent : 003556; suivant : 003558

Patient perception of the benefit of a BRAF inhibitor in metastatic melanoma: quality-of-life analyses of the BREAK-3 study comparing dabrafenib with dacarbazine.

Auteurs : J-J Grob [France] ; M M Amonkar [États-Unis] ; S. Martin-Algarra [Espagne] ; L V Demidov [Russie] ; V. Goodman [États-Unis] ; K. Grotzinger [États-Unis] ; P. Haney [États-Unis] ; E. K Mpgen [Allemagne] ; B. Karaszewska [Pologne] ; C. Mauch [Allemagne] ; W H Miller [Canada] ; M. Millward [Australie] ; B. Mirakhur [États-Unis] ; P. Rutkowski [Pologne] ; V. Chiarion-Sileni [Italie] ; S. Swann [États-Unis] ; A. Hauschild [Allemagne]

Source :

RBID : pubmed:24769640

Descripteurs français

English descriptors

Abstract

In a randomized phase III study (BREAK-3), dabrafenib showed prolonged progression-free survival (PFS) (median 5.1 versus 2.7 months; hazard ratio = 0.30; 95% confidence interval 0.18-0.53; P < 0.0001) compared with dacarbazine (DTIC) in patients with BRAF V600E metastatic melanoma. Assessing how these results are transformed into a real health benefit for patients is crucial.

DOI: 10.1093/annonc/mdu154
PubMed: 24769640

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pubmed:24769640

Le document en format XML

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<term>Dacarbazine (therapeutic use)</term>
<term>Humans</term>
<term>Imidazoles (therapeutic use)</term>
<term>Melanoma (drug therapy)</term>
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<div type="abstract" xml:lang="en">In a randomized phase III study (BREAK-3), dabrafenib showed prolonged progression-free survival (PFS) (median 5.1 versus 2.7 months; hazard ratio = 0.30; 95% confidence interval 0.18-0.53; P < 0.0001) compared with dacarbazine (DTIC) in patients with BRAF V600E metastatic melanoma. Assessing how these results are transformed into a real health benefit for patients is crucial.</div>
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<Month>06</Month>
<Day>27</Day>
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<DateCompleted>
<Year>2015</Year>
<Month>08</Month>
<Day>31</Day>
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<Year>2016</Year>
<Month>10</Month>
<Day>17</Day>
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<Title>Annals of oncology : official journal of the European Society for Medical Oncology</Title>
<ISOAbbreviation>Ann. Oncol.</ISOAbbreviation>
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<ArticleTitle>Patient perception of the benefit of a BRAF inhibitor in metastatic melanoma: quality-of-life analyses of the BREAK-3 study comparing dabrafenib with dacarbazine.</ArticleTitle>
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<MedlinePgn>1428-36</MedlinePgn>
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<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In a randomized phase III study (BREAK-3), dabrafenib showed prolonged progression-free survival (PFS) (median 5.1 versus 2.7 months; hazard ratio = 0.30; 95% confidence interval 0.18-0.53; P < 0.0001) compared with dacarbazine (DTIC) in patients with BRAF V600E metastatic melanoma. Assessing how these results are transformed into a real health benefit for patients is crucial.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">The EORTC QLQ-C30 questionnaire assessed quality of life (QoL) at baseline and follow-up visits.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">For DTIC, all functional dimensions except role dimension worsened from baseline at follow-up. For dabrafenib, all functionality dimensions remained stable relative to baseline or improved at week 6; mean change in seven symptom dimensions improved from baseline, with appetite loss, insomnia, nausea and vomiting, and pain showing the greatest improvement. In the DTIC arm, symptom dimensions were unchanged or worsened from baseline for all symptoms except pain (week 6), with the greatest exacerbations observed for fatigue and nausea and vomiting. Mixed-model-repeated measures analyses showed significant (P < 0.05) and/or clinically meaningful improvements from baseline in favor of dabrafenib for emotional and social functioning, nausea and vomiting, appetite loss, diarrhea, fatigue, dyspnea, and insomnia at weeks 6 and/or 12. After crossing over to dabrafenib upon progression (n = 35), improvements in all QoL dimensions were evident after receiving dabrafenib for 6 (n = 31) to 12 (n = 25) weeks.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">This first reported QoL analysis for a BRAF inhibitor in metastatic melanoma demonstrates that the high tumor response rates and PFS superiority of dabrafenib over DTIC is not only a theoretical advantage, but also transforms in a rapid functional and symptomatic benefit for the patient. ClinicalTrials.gov Identifier: NCT01227889.</AbstractText>
<CopyrightInformation>© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.</CopyrightInformation>
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