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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

2014; Elsevier BV; Volume: 25; Issue: 7 Linguagem: Inglês

10.1093/annonc/mdu154

1569-8041

Jean‐Jacques Grob, Mayur M. Amonkar, Salvador Martín‐Algarra, Lev Demidov, Vicki Goodman, Kelly M. Grotzinger, Patricia Haney, Eckhart Kämpgen, Bogusława Karaszewska, Cornelia Mauch, Wilson H. Miller, Michael Millward, Beloo Mirakhur, Piotr Rutkowski, Vanna Chiarion‐Sileni, S. Swann, Axel Hauschild,

Colorectal Cancer Treatments and Studies

BackgroundIn 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.MethodsThe EORTC QLQ-C30 questionnaire assessed quality of life (QoL) at baseline and follow-up visits.ResultsFor 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.ConclusionsThis 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.Clinical Trials.gov identifierNCT01227889.