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...

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Autores: 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
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
Descripción
Sumario: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.

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