Universität zu Köln

Grob, J. -J., Amonkar, M. M., Martin-Algarra, S., Demidov, L. V., Goodman, V., Grotzinger, K., Haney, P., Kaempgen, E., Karaszewska, B., Mauch, C., Miller, W. H., Jr., Millward, M., Mirakhur, B., Rutkowski, P., Chiarion-Sileni, V., Swann, S. and Hauschild, A. (2014). 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. Ann. Oncol., 25 (7). S. 1428 - 1437. OXFORD: OXFORD UNIV PRESS. ISSN 1569-8041

Full text not available from this repository.

Abstract

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. The EORTC QLQ-C30 questionnaire assessed quality of life (QoL) at baseline and follow-up visits. 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. 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Grob, J. -J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Amonkar, M. M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Martin-Algarra, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Demidov, L. V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Goodman, V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Grotzinger, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Haney, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaempgen, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Karaszewska, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mauch, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Miller, W. H., Jr. UNSPECIFIED UNSPECIFIED UNSPECIFIED Millward, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mirakhur, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rutkowski, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Chiarion-Sileni, V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Swann, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hauschild, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-435127
DOI:	10.1093/annonc/mdu154
Journal or Publication Title:	Ann. Oncol.
Volume:	25
Number:	7
Page Range:	S. 1428 - 1437
Date:	2014
Publisher:	OXFORD UNIV PRESS
Place of Publication:	OXFORD
ISSN:	1569-8041
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language QUESTIONNAIRE QLQ-C30; EUROPEAN-ORGANIZATION; MALIGNANT-MELANOMA; RELIABILITY; SURVIVAL; VALIDITY; TRIAL Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/43512