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
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. A...
| Autores: | , , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Fecha de publicación: | 2014 |
| País: | España |
| Institución: | Universidad de Navarra |
| Repositorio: | Dadun. Depósito Académico Digital de la Universidad de Navarra |
| Idioma: | inglés |
| OAI Identifier: | oai:dadun.unav.edu:10171/68521 |
| Acceso en línea: | https://hdl.handle.net/10171/68521 |
| Access Level: | acceso abierto |
| Palabra clave: | Melanoma Quality of life Dabrafenib Chemotherapy BRAF |
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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 dacarbazineGrob, J.J. (Jean-Jacques)|||/items/81200b16-b21e-4433-b311-c1d8512d8a03Amonkar, M.M. (M. M.)|||/items/a8901552-c8e5-485f-9e1a-461c16c551a6Martin-Algarra, S. (Salvador)|||/items/2fba8e8b-e087-4ab0-82e3-a4d157f1e0ccDemidov, L.V. (Lev V.)|||/items/87ad79ed-2ba2-4b49-9cc3-133b5003a315Goodman, V. (Vicki)|||/items/00a307d1-2eef-4e89-8114-8c88d67af426Grotzinger, K. (K.)|||/items/2bf3f22f-f5e4-4330-9e71-9a3e8e41ed1bHaney, P. (Patricia)|||/items/0e750dce-dea0-45b1-a537-041badb41a28Kämpgen, E. (E.)|||/items/21012e52-f4ee-4311-b349-1521ecda89fcKaraszewska, B. (Boguslawa)|||/items/98212bd3-c189-4260-8237-f717c708b7b6Mauch, C. (Cornelia)|||/items/76af1ce9-7624-4eed-b5f1-23d4a5756f2cMiller, W.H. (Wilson H.)|||/items/c1c673c5-9236-49c8-924f-0816f50a4c4eMillward, M. (Michael)|||/items/09efa4e0-87d3-41b8-9720-ed241f0adf7aMirakhur, B. (Beloo)|||/items/28618d4b-585d-4497-b324-adcced55c093Rutkowski, P. (Piotr)|||/items/7501027a-f585-455c-9400-ac5a1dfe8ad0Chiarion-Sileni, V. (Vanna)|||/items/e744d49e-a2dd-47cd-b585-45cfbf575a63Swann, S. (Suzanne)|||/items/b02a7144-c5fb-4b1d-8ef7-5b4e8746518dHauschild, A. (A.)|||/items/1dc435a8-48e6-4659-a79a-99f0aad8901bMelanomaQuality of lifeDabrafenibChemotherapyBRAFBackground: 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. Methods: The EORTC QLQ-C30 questionnaire assessed quality of life (QoL) at baseline and follow-up visits. 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. 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.Elsevier BVDadun. Depósito Académico Digital Universidad de Navarra20242024-01-2420142014-01-0120142014-01-01journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10171/68521reponame:Dadun. Depósito Académico Digital de la Universidad de Navarrainstname:Universidad de NavarraInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:dadun.unav.edu:10171/685212026-06-21T12:47:57Z |
| dc.title.none.fl_str_mv |
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 |
| title |
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 |
| spellingShingle |
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 Grob, J.J. (Jean-Jacques)|||/items/81200b16-b21e-4433-b311-c1d8512d8a03 Melanoma Quality of life Dabrafenib Chemotherapy BRAF |
| title_short |
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 |
| title_full |
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 |
| title_fullStr |
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 |
| title_full_unstemmed |
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 |
| title_sort |
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 |
| dc.creator.none.fl_str_mv |
Grob, J.J. (Jean-Jacques)|||/items/81200b16-b21e-4433-b311-c1d8512d8a03 Amonkar, M.M. (M. M.)|||/items/a8901552-c8e5-485f-9e1a-461c16c551a6 Martin-Algarra, S. (Salvador)|||/items/2fba8e8b-e087-4ab0-82e3-a4d157f1e0cc Demidov, L.V. (Lev V.)|||/items/87ad79ed-2ba2-4b49-9cc3-133b5003a315 Goodman, V. (Vicki)|||/items/00a307d1-2eef-4e89-8114-8c88d67af426 Grotzinger, K. (K.)|||/items/2bf3f22f-f5e4-4330-9e71-9a3e8e41ed1b Haney, P. (Patricia)|||/items/0e750dce-dea0-45b1-a537-041badb41a28 Kämpgen, E. (E.)|||/items/21012e52-f4ee-4311-b349-1521ecda89fc Karaszewska, B. (Boguslawa)|||/items/98212bd3-c189-4260-8237-f717c708b7b6 Mauch, C. (Cornelia)|||/items/76af1ce9-7624-4eed-b5f1-23d4a5756f2c Miller, W.H. (Wilson H.)|||/items/c1c673c5-9236-49c8-924f-0816f50a4c4e Millward, M. (Michael)|||/items/09efa4e0-87d3-41b8-9720-ed241f0adf7a Mirakhur, B. (Beloo)|||/items/28618d4b-585d-4497-b324-adcced55c093 Rutkowski, P. (Piotr)|||/items/7501027a-f585-455c-9400-ac5a1dfe8ad0 Chiarion-Sileni, V. (Vanna)|||/items/e744d49e-a2dd-47cd-b585-45cfbf575a63 Swann, S. (Suzanne)|||/items/b02a7144-c5fb-4b1d-8ef7-5b4e8746518d Hauschild, A. (A.)|||/items/1dc435a8-48e6-4659-a79a-99f0aad8901b |
| author |
Grob, J.J. (Jean-Jacques)|||/items/81200b16-b21e-4433-b311-c1d8512d8a03 |
| author_facet |
Grob, J.J. (Jean-Jacques)|||/items/81200b16-b21e-4433-b311-c1d8512d8a03 Amonkar, M.M. (M. M.)|||/items/a8901552-c8e5-485f-9e1a-461c16c551a6 Martin-Algarra, S. (Salvador)|||/items/2fba8e8b-e087-4ab0-82e3-a4d157f1e0cc Demidov, L.V. (Lev V.)|||/items/87ad79ed-2ba2-4b49-9cc3-133b5003a315 Goodman, V. (Vicki)|||/items/00a307d1-2eef-4e89-8114-8c88d67af426 Grotzinger, K. (K.)|||/items/2bf3f22f-f5e4-4330-9e71-9a3e8e41ed1b Haney, P. (Patricia)|||/items/0e750dce-dea0-45b1-a537-041badb41a28 Kämpgen, E. (E.)|||/items/21012e52-f4ee-4311-b349-1521ecda89fc Karaszewska, B. (Boguslawa)|||/items/98212bd3-c189-4260-8237-f717c708b7b6 Mauch, C. (Cornelia)|||/items/76af1ce9-7624-4eed-b5f1-23d4a5756f2c Miller, W.H. (Wilson H.)|||/items/c1c673c5-9236-49c8-924f-0816f50a4c4e Millward, M. (Michael)|||/items/09efa4e0-87d3-41b8-9720-ed241f0adf7a Mirakhur, B. (Beloo)|||/items/28618d4b-585d-4497-b324-adcced55c093 Rutkowski, P. (Piotr)|||/items/7501027a-f585-455c-9400-ac5a1dfe8ad0 Chiarion-Sileni, V. (Vanna)|||/items/e744d49e-a2dd-47cd-b585-45cfbf575a63 Swann, S. (Suzanne)|||/items/b02a7144-c5fb-4b1d-8ef7-5b4e8746518d Hauschild, A. (A.)|||/items/1dc435a8-48e6-4659-a79a-99f0aad8901b |
| author_role |
author |
| author2 |
Amonkar, M.M. (M. M.)|||/items/a8901552-c8e5-485f-9e1a-461c16c551a6 Martin-Algarra, S. (Salvador)|||/items/2fba8e8b-e087-4ab0-82e3-a4d157f1e0cc Demidov, L.V. (Lev V.)|||/items/87ad79ed-2ba2-4b49-9cc3-133b5003a315 Goodman, V. (Vicki)|||/items/00a307d1-2eef-4e89-8114-8c88d67af426 Grotzinger, K. (K.)|||/items/2bf3f22f-f5e4-4330-9e71-9a3e8e41ed1b Haney, P. (Patricia)|||/items/0e750dce-dea0-45b1-a537-041badb41a28 Kämpgen, E. (E.)|||/items/21012e52-f4ee-4311-b349-1521ecda89fc Karaszewska, B. (Boguslawa)|||/items/98212bd3-c189-4260-8237-f717c708b7b6 Mauch, C. (Cornelia)|||/items/76af1ce9-7624-4eed-b5f1-23d4a5756f2c Miller, W.H. (Wilson H.)|||/items/c1c673c5-9236-49c8-924f-0816f50a4c4e Millward, M. (Michael)|||/items/09efa4e0-87d3-41b8-9720-ed241f0adf7a Mirakhur, B. (Beloo)|||/items/28618d4b-585d-4497-b324-adcced55c093 Rutkowski, P. (Piotr)|||/items/7501027a-f585-455c-9400-ac5a1dfe8ad0 Chiarion-Sileni, V. (Vanna)|||/items/e744d49e-a2dd-47cd-b585-45cfbf575a63 Swann, S. (Suzanne)|||/items/b02a7144-c5fb-4b1d-8ef7-5b4e8746518d Hauschild, A. (A.)|||/items/1dc435a8-48e6-4659-a79a-99f0aad8901b |
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author author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Dadun. Depósito Académico Digital Universidad de Navarra |
| dc.subject.none.fl_str_mv |
Melanoma Quality of life Dabrafenib Chemotherapy BRAF |
| topic |
Melanoma Quality of life Dabrafenib Chemotherapy BRAF |
| description |
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. Methods: The EORTC QLQ-C30 questionnaire assessed quality of life (QoL) at baseline and follow-up visits. 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. 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. |
| publishDate |
2014 |
| dc.date.none.fl_str_mv |
2014 2014-01-01 2014 2014-01-01 2024 2024-01-24 |
| dc.type.none.fl_str_mv |
journal article http://purl.org/coar/resource_type/c_6501 |
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info:eu-repo/semantics/article |
| format |
article |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/10171/68521 |
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https://hdl.handle.net/10171/68521 |
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Inglés eng |
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Inglés |
| language |
eng |
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open access http://purl.org/coar/access_right/c_abf2 |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 |
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openAccess |
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application/pdf |
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Elsevier BV |
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Elsevier BV |
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reponame:Dadun. Depósito Académico Digital de la Universidad de Navarra instname:Universidad de Navarra |
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Universidad de Navarra |
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Dadun. Depósito Académico Digital de la Universidad de Navarra |
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Dadun. Depósito Académico Digital de la Universidad de Navarra |
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