Patient-reported outcomes in patients with resected, high-risk melanoma with BRAF
| Autor: | Dirk, Schadendorf, Axel, Hauschild, Mario, Santinami, Victoria, Atkinson, Mario, Mandalà, Vanna, Chiarion-Sileni, James, Larkin, Marta, Nyakas, Caroline, Dutriaux, Andrew, Haydon, Caroline, Robert, Laurent, Mortier, Thierry, Lesimple, Ruth, Plummer, Jacob, Schachter, Kohinoor, Dasgupta, Stephanie, Manson, Roy, Koruth, Bijoyesh, Mookerjee, Richard, Kefford, Reinhard, Dummer, John M, Kirkwood, Georgina V, Long |
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| Rok vydání: | 2018 |
| Předmět: |
Proto-Oncogene Proteins B-raf
Skin Neoplasms Time Factors Pyridones Dermatologic Surgical Procedures Imidazoles Pyrimidinones Risk Assessment Progression-Free Survival Chemotherapy Adjuvant Risk Factors Antineoplastic Combined Chemotherapy Protocols Mutation Oximes Biomarkers Tumor Disease Progression Quality of Life Humans Patient Reported Outcome Measures Neoplasm Recurrence Local Melanoma Protein Kinase Inhibitors Neoplasm Staging |
| Zdroj: | The Lancet. Oncology. 20(5) |
| ISSN: | 1474-5488 |
| Popis: | In the phase 3 COMBI-AD study, patients with resected, stage III melanoma with BRAFCOMBI-AD was a randomised, double-blind, placebo-controlled, phase 3 study done at 169 sites in 25 countries. Study participants were aged 18 years or older and had complete resection of stage IIIA (lymph node metastases1 mm), IIIB, or IIIC cutaneous melanoma as per American Joint Committee on Cancer 7th edition criteria, with BRAFBetween Jan 31, 2013, and Dec 11, 2014, 870 patients were enrolled and randomly assigned to receive dabrafenib plus trametinib (n=438) or matching placebos (n=432). Data were collected until the data cutoff for analyses of the primary endpoint (June 30, 2017). The median follow-up was 34 months (IQR 28-39) in the dabrafenib plus trametinib group and 33 months (20·5-39) in the placebo group. During the 12-month treatment phase, there were no significant or clinically meaningful changes from baseline between groups in EQ-5D-3L visual analogue scale (EQ-VAS) or utility scores. During treatment, there were no clinically meaningful differences in VAS scores or utility scores in the dabrafenib plus trametinib group between patients who did and did not experience the most common adverse events. During long-term follow-up (range 15-48 months), VAS and utility scores were similar between groups and did not differ from baseline scores. At recurrence, there were significant decreases in VAS scores in both the dabrafenib plus trametinib group (mean change -6·02, SD 20·57; p=0·0032) and the placebo group (-6·84, 20·86; p0·0001); the mean change in utility score also differed significantly at recurrence for both groups (dabrafenib plus trametinib -0·0626, 0·1911, p0·0001; placebo -0·0748, 0·2182, p0·0001).These findings show that dabrafenib plus trametinib did not affect patient-reported outcome scores during or after adjuvant treatment, and suggest that preventing or delaying relapse with adjuvant therapy could be beneficial in this setting.Novartis. |
| Databáze: | OpenAIRE |
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