Dabrafenib plus trametinib versus dabrafenib monotherapy in patients with metastatic BRAF V600E/K-mutant melanoma: long-term survival and safety analysis of a phase 3 study.
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"Dabrafenib plus trametinib versus d..." refers background or methods or result in this paper
...The 3-year OS reported for DþT in this large phase 3 trial (44%) confirms preliminary results for the smaller corresponding patient subset in the randomized phase 2 BRF113220 trial (3-year OS, 38%) [11]....
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...6 months) was reported for the phase 2 BRF113220 study (part C) evaluating DþT (n1⁄4 54) versus dabrafenib monotherapy (n1⁄4 54) [11], in which DþT-treated patients had a 2- and 3-year PFS of 25% and 21%, respectively, and a 2- and 3-year OS of 51% and 38%, respectively....
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...Analyses of BRAFi-naive patients treated with DþT in the phase 2 BRF113220 study and in a pooled analysis across DþT registration trials identified significant associations between baseline LDH and number of organ sites containing metastasis and clinical outcomes [11, 14]....
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"Dabrafenib plus trametinib versus d..." refers background or methods or result in this paper
...Influences of prognostic factors on patient-derived benefit were explored with descriptive subgroup stratification by baseline factors previously identified as being predictive of outcomes in patients receiving DþT [14]....
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...0 months) showed that normal baseline serum lactate dehydrogenase (LDH) and<3 organ sites containing metastasis were the factors most predictive of durable outcomes; patients with both of these characteristics had a 2-year PFS of 46% and a 2-year OS of 75% [14]....
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...More generally, survival observed in the current analysis is consistent with previous findings for DþT in BRAF V600-mutant melanoma, since the 2-year OS reported here (52%) is similar to that reported in the randomized phase 3 COMBI-v study (51%) and in a pooled analysis across registration trials (53%) [14]....
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...Analyses of BRAFi-naive patients treated with DþT in the phase 2 BRF113220 study and in a pooled analysis across DþT registration trials identified significant associations between baseline LDH and number of organ sites containing metastasis and clinical outcomes [11, 14]....
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1,798 citations
"Dabrafenib plus trametinib versus d..." refers background in this paper
...Furthermore, it is important to note that the plateau survival pattern observed with ipilimumab [2] has not yet been demonstrated with anti-PD-1 therapies and remains a potential survival pattern for BRAFi/MEKi....
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...The anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) therapy ipilimumab was the first agent to show durable clinical benefit lasting 5 years in a subset of patients within molecularly unselected advanced melanoma populations [2]....
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1,501 citations