Critical appraisal:Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, et al 2017
Critical Appraisal
Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, et al. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol 2017 Apr;18(4):435-445 Available from: http://www.ncbi.nlm.nih.gov/pubmed/28284557.
Key Facts
randomised controlled trial
To compare the efficacy of binimetinib with dacarbazine in patients (either treatment-naïve or received previous immunotherapy) with advanced unresectable or metastatic melanoma harbouring an NRAS mutation.
402
269 assigned to Binimeinib part of intention to treat analysis. 133 assigned to the dacarbazine population as part of the intention to treat analysis.
Progression free survival (PFS)
Overall Survival (OS)
Response Rate (RR)
Median PFS = 2·8 months (95% CI 2·8–3·6) in binimetinib group; 1·5 months (1·5–1·7) in dacarbazine group (HR 0·62 [95% CI 0·47–0·80]; one-sided p<0·001
Median OS = 11·0 months (95% CI 8·9–13·6) in binimetinib group; 10·1 months (7·0–16·5) in dacarbazine group (HR 1·00 [95% CI 0·75–1·33]; one-sided p=0·50
Median duration of objective response was 11·1 months (95% CI 2·8–not evaluable) in the binimetinib group versus
4·1 months (95% not evaluable) in the dacarbazine group.
no
Evidence ratings
II
High risk of bias | Comments: Please replace this text and include any additional comments in regards to your risk of bias rating |
- Article
- Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, et al. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol 2017 Apr;18(4):435-445 Available from: http://www.ncbi.nlm.nih.gov/pubmed/28284557.
- Assigned to
- User:Meghna.kakani
- Topic area
- Guidelines:Melanoma
- Clinical question
Section below only relevant for Cancer Council Project Officer