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Algazi, Alain P; Othus, Megan; Daud, Adil I; Lo, Roger S; Mehnert, Janice M; Truong, Thach-Giao; Conry, Robert; Kendra, Kari; Doolittle, Gary C; Clark, Joseph I; Messino, Michael J; Moore, Jr, Dennis F; Lao, Christopher; Faller, Bryan A; Govindarajan, Rangaswamy; Harker-Murray, Amy; Dreisbach, Luke; Moon, James; Grossmann, Kenneth F; Ribas, Antoni
Nature medicine, 10/2020, Letnik: 26, Številka: 10Journal Article
Preclinical modeling suggests that intermittent BRAF inhibitor therapy may delay acquired resistance when blocking oncogenic BRAF in melanoma . We conducted S1320, a randomized, open-label, phase 2 clinical trial (NCT02196181) evaluating whether intermittent dosing of the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib improves progression-free survival in patients with metastatic and unresectable BRAF melanoma. Patients were enrolled at 68 academic and community sites nationally. All patients received continuous dabrafenib and trametinib during an 8-week lead-in period, after which patients with non-progressing tumors were randomized to either continuous or intermittent dosing of both drugs on a 3-week-off, 5-week-on schedule. The trial has completed accrual and 206 patients with similar baseline characteristics were randomized 1:1 to the two study arms (105 to continuous dosing, 101 to intermittent dosing). Continuous dosing yielded a statistically significant improvement in post-randomization progression-free survival compared with intermittent dosing (median 9.0 months versus 5.5 months, P = 0.064, pre-specified two-sided α = 0.2). Therefore, contrary to the initial hypothesis, intermittent dosing did not improve progression-free survival in patients. There were no differences in the secondary outcomes, including overall survival and the overall incidence of treatment-associated toxicity, between the two groups.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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in: SICRIS
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