TY - JOUR
T1 - Quality of life in patients with BRAF-mutant melanoma receiving the combination encorafenib plus binimetinib
T2 - Results from a multicentre, open-label, randomised, phase III study (COLUMBUS)
AU - Gogas, Helen
AU - Dummer, Reinhard
AU - Ascierto, Paolo A.
AU - Arance, Ana
AU - Mandalà, Mario
AU - Liszkay, Gabriella
AU - Garbe, Claus
AU - Schadendorf, Dirk
AU - Krajsová, Ivana
AU - Gutzmer, Ralf
AU - Sileni, Vanna Chiarion
AU - Dutriaux, Caroline
AU - Yamazaki, Naoya
AU - Loquai, Carmen
AU - Queirolo, Paola
AU - Jan de Willem, Groot
AU - Sellier, Abir Tadmouri
AU - Suissa, Jeanne
AU - Murris, Juliette
AU - Gollerkeri, Ashwin
AU - Robert, Caroline
AU - Flaherty, Keith T.
N1 - Publisher Copyright:
© 2021 Elsevier Ltd
PY - 2021/7/1
Y1 - 2021/7/1
N2 - Background: In COLUMBUS, treatment with encorafenib plus binimetinib in patients with advanced BRAF-mutant melanoma showed improved progression-free and overall survival with favourable tolerability compared to vemurafenib treatment. Here, results on health-related quality of life (HRQoL) are presented. Methods: COLUMBUS was a two-part, open-label, randomised, phase III study in patients with BRAF-mutant melanoma. In PART-I, 577 patients were randomised (1:1:1) to encorafenib plus binimetinib, encorafenib or vemurafenib. The primary objective was to assess progression-free survival. As a secondary objective, HRQoL was assessed by the EQ-5D, the EORTC QLQ-C30 and the FACT-M questionnaires. Furthermore, time to definitive 10% deterioration was estimated with a Kaplan–Meier analysis and differences in mean scores between groups were calculated with a mixed-effect model for repeated measures. Hospitalisation rate and the impact of hospitalisation on HRQoL were also assessed. Results: Patients receiving the combination treatment showed improvement of their FACT-M and EORTC QLQ-C30 global health status scores, compared to those receiving vemurafenib (post-baseline score differences: 3.03 [p < 0.0001] for FACT M and 5.28 [p = 0.0042] for EORTC QLQ-C30), indicative of a meaningful change in patient's status. Furthermore, a delay in the deterioration of QoL was observed in non-hospitalised patients compared to hospitalised patients (hazard ratio [95% CI]: 1.16 [0.80; 1.68] for EORTC QLQ-C30 and 1.27 [0.81; 1.99] for FACT-M) and a risk reduction of 10% deterioration, favoured the combination in both groups. Conclusion: The improved efficacy of encorafenib plus binimetinib compared to vemurafenib, translates into a positive impact on the perceived health status as assessed by the HRQoL questionnaires. The study is registered with ClinicalTrials.gov, number NCT01909453 and EudraCT number 2013-001176-38.
AB - Background: In COLUMBUS, treatment with encorafenib plus binimetinib in patients with advanced BRAF-mutant melanoma showed improved progression-free and overall survival with favourable tolerability compared to vemurafenib treatment. Here, results on health-related quality of life (HRQoL) are presented. Methods: COLUMBUS was a two-part, open-label, randomised, phase III study in patients with BRAF-mutant melanoma. In PART-I, 577 patients were randomised (1:1:1) to encorafenib plus binimetinib, encorafenib or vemurafenib. The primary objective was to assess progression-free survival. As a secondary objective, HRQoL was assessed by the EQ-5D, the EORTC QLQ-C30 and the FACT-M questionnaires. Furthermore, time to definitive 10% deterioration was estimated with a Kaplan–Meier analysis and differences in mean scores between groups were calculated with a mixed-effect model for repeated measures. Hospitalisation rate and the impact of hospitalisation on HRQoL were also assessed. Results: Patients receiving the combination treatment showed improvement of their FACT-M and EORTC QLQ-C30 global health status scores, compared to those receiving vemurafenib (post-baseline score differences: 3.03 [p < 0.0001] for FACT M and 5.28 [p = 0.0042] for EORTC QLQ-C30), indicative of a meaningful change in patient's status. Furthermore, a delay in the deterioration of QoL was observed in non-hospitalised patients compared to hospitalised patients (hazard ratio [95% CI]: 1.16 [0.80; 1.68] for EORTC QLQ-C30 and 1.27 [0.81; 1.99] for FACT-M) and a risk reduction of 10% deterioration, favoured the combination in both groups. Conclusion: The improved efficacy of encorafenib plus binimetinib compared to vemurafenib, translates into a positive impact on the perceived health status as assessed by the HRQoL questionnaires. The study is registered with ClinicalTrials.gov, number NCT01909453 and EudraCT number 2013-001176-38.
KW - BRAF mutant Melanoma
KW - BRAF/MEK inhibitors Combination
KW - Encorafenib plus binimetinib
KW - Health-related quality of life
KW - Hospitalisation rate
UR - http://www.scopus.com/inward/record.url?scp=85107650414&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2021.04.028
DO - 10.1016/j.ejca.2021.04.028
M3 - Article
C2 - 34091420
AN - SCOPUS:85107650414
SN - 0959-8049
VL - 152
SP - 116
EP - 128
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -