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• W2890153210 abstract "6087 Background: mutations (BRAFm) are the most common mutations in thyroid cancer. BRAF inhibitors (DAB) are active in BRAFm melanoma, but there is less activity noted in BRAFm thyroid cancer. Preclinically, BRAF inhibitors inhibit BRAFm thyroid cancers only transiently due to activation of HER2/HER3, driven by a neuregulin-dependent autocrine loop. The addition of LAP, a HER2/HER3 kinase inhibitor, sensitizes the cell to growth suppression by BRAF inhibitors (Cancer Discov 5(3):520, 2013). This study evaluates the safety and efficacy of the combination of DAB and LAP. Methods: Eligibility included thyroid cancers with the presence of a BRAFV600E mutation. Any prior treatment was allowed. All patients received DAB 150 mg bid starting 2 weeks prior to LAP. Doses of daily lapatinib were escalated in a standard 3+3 design at (1) 750 mg; (2) 1250 mg; (3) 1500 mg. Patients removed before the start of LAP were not included in the analysis. An additional 6 patients were added at the MTD. Responses were defined using RECIST 1.1. Results: 21 evaluable patients were enrolled on the phase I portion of the study. Gender – 14/21 (67%) male; median age – 63 years; histology – differentiated thyroid cancer (DTC) 19 (90%), anaplastic thyroid cancer (ATC) 2 (10%); brain metastases – 5 (24%); prior BRAF inhibitor – 5 (24%); prior BRAF or tyrosine kinase inhibitor – 13 (62%). There was one DLT - Grade 5 event unlikely related to drugs in a patient with ATC. Grade 4 toxicities – 0. Grade 3 toxicities –lymphocytes (1); uveitis (1). Median progression-free survival (PFS) and overall response rate (RR) of the subsets in the DTC only group are listed in the table. Clinical trial information: NCT01947023. Conclusions: The combination of DAB 150 mg bid and LAP 1500 mg daily was safe and well-tolerated. Despite the number of subjects with prior treatment (including with BRAF inhibitors) and brain metastases, excellent activity was found with this combination in DTC. Further investigation with this regimen is warranted. # RR PFS (months) DTC 19 58% 18 Dose Level 1 (LAP 750 mg) 5 60% 11 Dose Level 2 (LAP 1250 mg) 2 50% 16 Dose Level 3 (LAP 1500 mg) 12 58% 18 No prior BRAF inhibitor 14 64% 20 No brain metastases 14 57% 20 No prior BRAF inhibitor or brain metastases 11 64% 29" @default.
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• W2890153210 date "2018-05-20" @default.
• W2890153210 modified "2023-09-30" @default.
• W2890153210 title "Combination of dabrafenib (DAB) and lapatinib (LAP) for the treatment of <i>BRAF</i>-mutant thyroid cancer." @default.
• W2890153210 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.6087" @default.
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