Patients with metastatic melanoma treated with dabrafenib demonstrated improved quality of life compared with those who received dacarbazine, according to phase 3 study results.
Initial analyses of the BREAK-3 trial indicated dabrafenib (Tafinlar; GlaxoSmithKline) prolonged median PFS compared with dacarbazine (DTIC) in patients with BRAF V600E-mutant metastatic melanoma (5.1 months vs. 2.7 months; HR=0.30; 95% CI, 0.18-0.53).
In the current analysis, researchers used the EORTC QLQ-C30 questionnaire to evaluate the quality of life.
Among patients treated with DTIC, all functional dimensions of the quality of life questionnaire — with the exception of role dimension — worsened from baseline to follow-up. However, these dimensions remained stable or improved by week 6 among patients assigned dabrafenib.
Seven symptom dimensions improved among patients assigned dabrafenib, with the greatest improvements observed for appetite loss, insomnia, nausea and vomiting, and pain. With the exception of pain, all symptom dimensions remained stable or worsened — particularly for fatigue and nausea and vomiting —by week 6 among patients assigned DTIC.
Results of mixed-model repeated measures analyses indicated dabrafenib induced significant and/or clinically meaningful improvements in emotional and social functioning, nausea and vomiting, appetite loss, diarrhea, fatigue, dyspnea and insomnia by week 6 and/or week 12.
Thirty-five patients who crossed over to treatment with dabrafenib after disease progression demonstrated improved quality-of-life dimensions by week 6 (n=31) and 12 (n=25).
“This first reported quality-of-life 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 transforms in a rapid functional and symptomatic benefit for the patient,” the researchers concluded.
Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.