WEEKLY IMPORTANT NEWS FROM MEDSCAPE AND OTHER SOURCES
Κυριακή, 27 Νοεμβρίου 2016
PREDICTIVE FACTORS OF RESPONSE TO MELANOMA TREATMENT
Long et al identified factors predictive of progression-free and overall survival with combined dabrafenib (Tafinlar) plus trametinib (Mekinist) in patients with BRAF V600E–mutant or BRAF V600K–mutant metastatic melanoma, according to a pooled individual data analysis reported in The Lancet Oncology.
The analysis included pooled data from 617 treatment-naive patients receiving the approved dose of dabrafenib (150 mg twice daily) plus trametinib (2 mg once daily) in the randomized BRF113220, COMBI-d, and COMBI-v trials. Patients with untreated brain metastases were not included in these trials.
Median follow-up was 20.0 months; 396 patients had disease progression or died, and 290 patients died. Median progression-free survival (11.1 months), median overall survival (25.6 months), 1-year progression-free survival (48%), 1-year overall survival (74%), 2-year progression-free survival (30%), and 2-year overall survival (53%) were consistent with overall findings in the individual trials.
One-year progression-free survival (68%) and overall survival (90%) and 2-year progression-free survival (46%) and overall survival (75%) were greatest in patients with a normal lactate dehydrogenase (LDH) level and < 3 organ sites with metastases (n = 237). Patients with an LDH level ≥ 2 times the upper limit of normal (n = 70) had the shortest 1-year progression-free survival (8%) and overall survival (40%) and 2-year progression-free survival (2%) and overall survival (7%). Among 379 patients with disease progression, post-progression survival was longest in 205 patients with disease progression in baseline lesions or new non–central nervous system (CNS) lesions (median = 10.0 months) and shortest in 171 patients with new CNS lesions or concurrent disease progression in baseline and new lesions (median = 4.0 months).
The investigators concluded: “Several patient and clinical characteristics at and after baseline are associated with outcomes with dabrafenib plus trametinib, and durable benefit is possible with targeted treatment in defined patient subsets.”