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Functional and symp...
Functional and symptom impact of trametinib versus chemotherapy in BRAF V600E advanced or metastatic melanoma : quality-of-life analyses of the METRIC study
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Schadendorf, D. (författare)
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Amonkar, M. M. (författare)
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Milhem, M. (författare)
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visa fler...
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Grotzinger, K. (författare)
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Demidov, L. V. (författare)
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Rutkowski, P. (författare)
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Garbe, C. (författare)
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Dummer, R. (författare)
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Hassel, J. C. (författare)
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Wolter, P. (författare)
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Mohr, P. (författare)
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Trefzer, U. (författare)
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Lefeuvre-Plesse, C. (författare)
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Rutten, A. (författare)
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Steven, N. (författare)
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- Ullenhag, Gustav (författare)
- Uppsala universitet,Enheten för onkologi
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Sherman, L. (författare)
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Wu, F. S. (författare)
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Patel, K. (författare)
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Casey, M. (författare)
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Robert, C. (författare)
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(creator_code:org_t)
- Elsevier BV, 2014
- 2014
- Engelska.
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Ingår i: Annals of Oncology. - : Elsevier BV. - 0923-7534 .- 1569-8041. ; 25:3, s. 700-706
- Relaterad länk:
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- We report the first quality-of-life assessment of a MEK inhibitor in metastatic melanoma from a phase III study. Trametinib prolonged progression-free survival and improved overall survival versus chemotherapy in patients with BRAF V600 mutation-positive melanoma. Less functional impairment, smaller declines in health status, and less exacerbation of symptoms were observed with trametinib.In a randomized phase III study, trametinib prolonged progression-free survival and improved overall survival versus chemotherapy in patients with BRAF V600 mutation-positive melanoma. Patients' quality of life (QOL) was assessed at baseline and follow-up visits using the European Organisation for Research and Treatment of Cancer Core QOL questionnaire. In the primary efficacy population (BRAF V600E+, no brain metastases) from baseline to weeks 6 and 12, patients' global health status scores worsened by 4-5 points with chemotherapy but improved by 2-3 points with trametinib. Rapid and substantive reductions in QOL functionality (e.g. role functioning, 8-11 points at weeks 6 and 12) and symptom exacerbation (e.g. fatigue, 4-8 points; nausea and vomiting, 5 points, both at weeks 6 and 12) were observed in chemotherapy-treated patients. In contrast, trametinib-treated patients reported small improvements or slight worsening from baseline at week 12, depending on the functional dimension and symptom. The mean symptom-scale scores for chemotherapy-treated patients increased from baseline (symptoms worsened) for seven of eight symptoms at week 6 (except insomnia) and six of eight symptoms at week 12 (except dyspnea and insomnia). In contrast, at weeks 6 and 12, the mean symptom-scale scores for trametinib decreased from baseline (symptoms improved) for pain (11-12 points), insomnia (10-12 points), and appetite loss (1-5 points), whereas those for diarrhea worsened (15-16 points). Mixed-model repeated-measures analyses showed significant (P < 0.05) and/or clinically meaningful improvements (small to moderate) from baseline in favor of trametinib for global health; physical, role, and social functioning; fatigue; pain; insomnia; nausea and vomiting; constipation; dyspnea; and appetite at weeks 6 and/or 12. QOL results for the intent-to-treat population were consistent. This first QOL assessment for a MEK inhibitor in metastatic melanoma demonstrated that trametinib was associated with less functional impairment, smaller declines in health status, and less exacerbation of symptoms versus chemotherapy.
Nyckelord
- BRAF
- chemotherapy
- MEK
- melanoma
- quality of life
- trametinib
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
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Schadendorf, D.
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Amonkar, M. M.
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Milhem, M.
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Grotzinger, K.
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Demidov, L. V.
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Rutkowski, P.
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visa fler...
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Garbe, C.
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Dummer, R.
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Hassel, J. C.
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Wolter, P.
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Mohr, P.
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Trefzer, U.
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Lefeuvre-Plesse, ...
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Rutten, A.
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Steven, N.
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Ullenhag, Gustav
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Sherman, L.
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Wu, F. S.
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Patel, K.
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Casey, M.
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Robert, C.
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visa färre...
- Artiklar i publikationen
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Annals of Oncolo ...
- Av lärosätet
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Uppsala universitet