The DOI matches its Crossref record; 9 of the 9 references it cites were found in a registry or an index.
Dabrafenib in patients with melanoma, untreated brain metastases, and other solid tumours: a phase 1 dose-escalation trial
Open accessAbstract
Background Dabrafenib (GSK2118436) is a potent ATP-competitive inhibitor of BRAF kinase and was highly selective for mutant BRAF in kinase panel screening, cell lines, and xenografts. Methods A Phase I trial of dabrafenib was conducted to evaluate safety and tolerability in patients with incurable solid tumours. Efficacy at the recommended Phase II dose (RP2D) was studied in patients with BRAF-mutant tumours, including those with non-V600E mutations, in three cohorts: (1) metastatic melanoma, (2) melanoma with untreated brain metastases, and (3) non-melanoma solid tumours. Findings 184 patients enrolled, and 150 mg twice daily was chosen as the RP2D, based on safety, pharmacokinetic, and pharmacodynamic data. At the RP2D in patients with V600 BRAF-mutant melanoma, a response rate of 69% (a confirmed response rate of 50%) was observed overall and a 78% response rate (a confirmed response rate of 56%) in V600E BRAF-mutant melanoma. In V600 BRAF-mutant melanoma, responses were durable, with 17 patients (47%) on treatment for more than 6 months and a median progression-free survival (PFS) of 5·5 months. Responses were observed in patients with non-V600E BRAF mutations, including V600K and V600G. In the RP2D expansion of melanoma with untreated brain metastases, nine of ten patients (90%) showed reduction in brain lesion size and the median PFS was 4.2 months. Among BRAF-mutant non-melanoma solid tumours, antitumour activity was observed in gastrointestinal stromal tumour, papillary thyroid, non-small cell lung, ovarian, and colorectal cancer. Interpretation Dabrafenib is a highly active inhibitor of V600-mutant BRAF with a high response rate in V600E melanoma, and is the first drug of its class to demonstrate activity in melanoma brain metastases. Funding This study was funded and sponsored by GlaxoSmithKline
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Mutations of the BRAF gene in human cancer
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Self-citationSurvival in BRAF V600-mutant advanced melanoma treated with vemurafenib
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Self-citationCOT drives resistance to RAF inhibition through MAP kinase pathway reactivation
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Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial
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Self-citationA Confidence Interval for the Median Survival Time
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Cited by
Haugen, B. R., Alexander, E. K., Bible, K. C., Doherty, G. M., Mandel, S. J., Nikiforov, Y. E., Pacini, F., Randolph, G. W., Sawka, A. M., Schlumberger, M., et al. (2016) · Thyroid® · doi:10.1089/thy.2015.0020 · Cited by 16,535
Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations
Flaherty, K. T., Infante, J. R., Daud, A., Gonzalez, R., Kefford, R. F., Sosman, J., Hamid, O., Schuchter, L., Cebon, J., Ibrahim, N., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1210093 · Cited by 2,810
Self-citationGershenwald, J. E., Scolyer, R. A., Hess, K. R., Sondak, V. K., Long, G. V., Ross, M. I., Lazar, A. J., Faries, M. B., Kirkwood, J. M., McArthur, G. A., et al. (2017) · CA: A Cancer Journal for Clinicians · doi:10.3322/caac.21409 · Cited by 2,283
Self-citationCombined BRAF and MEK Inhibition versus BRAF Inhibition Alone in Melanoma
Long, G. V., Stroyakovskiy, D., Gogas, H., Levchenko, E., de Braud, F., Larkin, J., Garbe, C., Jouary, T., Hauschild, A., Grob, J. J., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1406037 · Cited by 1,899
Self-citationTargeted agents and immunotherapies: optimizing outcomes in melanoma
Luke, J. J., Flaherty, K. T., Ribas, A., & Long, G. V. (2017) · Nature Reviews Clinical Oncology · doi:10.1038/nrclinonc.2017.43 · Cited by 1,254
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Metadata
- Authors
- Falchook, G. S., Long, G. V., Kurzrock, R., Kim, K. B., Arkenau, T. H., Brown, M. P., Hamid, O., Infante, J. R., Millward, M., Pavlick, A. C., O’Day, S. J., Blackman, S. C., Curtis, C. M., Lebowitz, P., Ma, B., Ouellet, D., & Kefford, R. F.
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2012-05
- Volume
- 379
- Issue
- 9829
- Pages
- 1893-1901
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2106494998
- Cited by
- 943
- References
- 9
- FWCI
- 50.53
- Type
- journal article
- Language
- en
- Open access
- green
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- Falchook, G. S., Long, G. V., Kurzrock, R., Kim, K. B., Arkenau, T. H., Brown, M. P., Hamid, O., Infante, J. R., Millward, M., Pavlick, A. C., O’Day, S. J., Blackman, S. C., Curtis, C. M., Lebowitz, P., Ma, B., Ouellet, D., & Kefford, R. F. (2012). Dabrafenib in patients with melanoma, untreated brain metastases, and other solid tumours: a phase 1 dose-escalation trial. The Lancet. https://doi.org/10.1016/s0140-6736(12)60398-5
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