The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.
Phase II Trial (BREAK-2) of the BRAF Inhibitor Dabrafenib (GSK2118436) in Patients With Metastatic Melanoma
Abstract
Purpose: Dabrafenib (GSK2118436) is a potent inhibitor of mutated BRAF kinase. Our multicenter, single-arm, phase II study assessed the safety and clinical activity of dabrafenib in BRAF V600E/K mutation–positive metastatic melanoma (mut + MM). Patients and Methods: Histologically confirmed patients with stage IV BRAF V600E/K mut + MM received oral dabrafenib 150 mg twice daily until disease progression, death, or unacceptable adverse events (AEs). The primary end point was investigator-assessed overall response rate in BRAF V600E mut + MM patients. Secondary end points included progression-free survival (PFS) and overall survival (OS). Exploratory objectives included the comparison of BRAF mutation status between tumor-specific circulating cell-free DNA (cfDNA) and tumor tissue, and the evaluation of cfDNA as a predictor of clinical outcome. Results: Seventy-six patients with BRAF V600E and 16 patients with BRAF V600K mut + MM were enrolled onto the study. In the BRAF V600E group, 45 patients (59%) had a confirmed response (95% CI, 48.2 to 70.3), including five patients (7%) with complete responses. Two patients (13%) with BRAF V600K mut + MM had a confirmed partial response (95% CI, 0 to 28.7). In the BRAF V600E and BRAF V600K groups, median PFS was 6.3 months and 4.5 months, and median OS was 13.1 months and 12.9 months, respectively. The most common AEs were arthralgia (33%), hyperkeratosis (27%), and pyrexia (24%). Overall, 25 patients (27%) experienced a serious AE and nine patients (10%) had squamous cell carcinoma. Baseline cfDNA levels predicted response rate and PFS in BRAF V600E mut + MM patients. Conclusion: Dabrafenib was well tolerated and clinically active in patients with BRAF V600E/K mut + MM. cfDNA may be a useful prognostic and response marker in future studies.
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Cites
Improved survival with vemurafenib in melanoma with BRAF V600E mutation
Chapman, P. B., Hauschild, A., Robert, C., Haanen, J. B., Ascierto, P., Larkin, J., Dummer, R., Garbe, C., Testori, A., Maio, M., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1103782 · Cited by 7,720
Self-citationInhibition of Mutated, Activated BRAF in Metastatic Melanoma
Flaherty, K. T., Puzanov, I., Kim, K. B., Ribas, A., McArthur, G. A., Sosman, J. A., O'Dwyer, P. J., Lee, R. J., Grippo, J. F., Nolop, K., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1002011 · Cited by 3,103
Self-citationHauschild, A., Grob, J.-J., Demidov, L. V., Jouary, T., Gutzmer, R., Millward, M., Rutkowski, P., Blank, C. U., Miller, W. H., Kaempgen, E., et al. (2012) · The Lancet · doi:10.1016/s0140-6736(12)60868-x · Cited by 2,989
Self-citationMelanomas acquire resistance to B-RAF(V600E) inhibition by RTK or N-RAS upregulation
Nazarian, R., Shi, H., Wang, Q., Kong, X., Koya, R. C., Lee, H., Chen, Z., Lee, M.-K., Attar, N., Sazegar, H., et al. (2010) · Nature · doi:10.1038/nature09626 · Cited by 2,192
Self-citationImproved Survival with MEK Inhibition in BRAF-Mutated Melanoma
Flaherty, K. T., Robert, C., Hersey, P., Nathan, P., Garbe, C., Milhem, M., Demidov, L. V., Hassel, J. C., Rutkowski, P., Mohr, P., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1203421 · Cited by 2,160
Self-citationSurvival in BRAF V600-mutant advanced melanoma treated with vemurafenib
Sosman, J. A., Kim, K. B., Schuchter, L., Gonzalez, R., Pavlick, A. C., Weber, J. S., McArthur, G. A., Hutson, T. E., Moschos, S. J., Flaherty, K. T., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1112302 · Cited by 2,156
Self-citationRAF inhibitor resistance is mediated by dimerization of aberrantly spliced BRAF(V600E)
Poulikakos, P. I., Persaud, Y., Janakiraman, M., Kong, X., Ng, C., Moriceau, G., Shi, H., Atefi, M., Titz, B., Gabay, M. T., et al. (2011) · Nature · doi:10.1038/nature10662 · Cited by 1,454
Self-citationImproved survival with MEK Inhibition in BRAF-mutated melanoma for the METRIC Study Group
Flaherty, K. T., Robert, C., Hersey, P., Nathan, P., Garbe, C., Milhem, M. M., Демидов, Л. В., Hassel, J. C., Rutkowski, P. L., Mohr, P., et al. (2012) · Zurich Open Repository and Archive (University of Zurich) · doi:10.5167/uzh-63198 · Cited by 1,330
Self-citationPrognostic and Clinicopathologic Associations of Oncogenic BRAF in Metastatic Melanoma
Long, G. V., Menzies, A. M., Nagrial, A. M., Haydu, L. E., Hamilton, A. L., Mann, G. J., Hughes, T. M., Thompson, J. F., Scolyer, R. A., & Kefford, R. F. (2011) · Journal of Clinical Oncology · doi:10.1200/jco.2010.32.4327 · Cited by 1,042
Self-citationDissecting Therapeutic Resistance to RAF Inhibition in Melanoma by Tumor Genomic Profiling
Wagle, N., Emery, C., Berger, M. F., Davis, M. J., Sawyer, A., Pochanard, P., Kehoe, S. M., Johannessen, C. M., MacConaill, L. E., Hahn, W. C., et al. (2011) · Journal of Clinical Oncology · doi:10.1200/jco.2010.33.2312 · Cited by 1,005
Cited by
Gao, H., Korn, J. M., Ferretti, S., Monahan, J. E., Wang, Y., Singh, M., Zhang, C., Schnell, C., Yang, G., Zhang, Y., et al. (2015) · Nature Medicine · doi:10.1038/nm.3954 · Cited by 1,393
Merker, J. D., Oxnard, G. R., Compton, C., Diehn, M., Hurley, P., Lazar, A. J., Lindeman, N., Lockwood, C. M., Rai, A. J., Schilsky, R. L., et al. (2018) · Journal of Clinical Oncology · doi:10.1200/jco.2017.76.8671 · Cited by 959
MEK1 and MEK2 inhibitors and cancer therapy: the long and winding road
Caunt, C. J., Sale, M. J., Smith, P. D., & Cook, S. J. (2015) · Nature Reviews Cancer · doi:10.1038/nrc4000 · Cited by 606
Negative feedback regulation of the ERK1/2 MAPK pathway
Lake, D., Corrêa, S. A. L., & Müller, J. (2016) · Cellular and Molecular Life Sciences · doi:10.1007/s00018-016-2297-8 · Cited by 565
Long, G. V., Fung, C., Menzies, A. M., Pupo, G. M., Carlino, M. S., Hyman, J., Shahheydari, H., Tembe, V., Thompson, J. F., Saw, R. P., et al. (2014) · Nature Communications · doi:10.1038/ncomms6694 · Cited by 375
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Metadata
- Authors
- Ascierto, P. A., Minor, D., Ribas, A., Lebbe, C., O'Hagan, A., Arya, N., Guckert, M., Schadendorf, D., Kefford, R. F., Grob, J.-J., Hamid, O., Amaravadi, R., Simeone, E., Wilhelm, T., Kim, K. B., Long, G. V., Martin, A.-M., Mazumdar, J., Goodman, V. L., & Trefzer, U.
- Venue
- Journal of Clinical Oncology
- Published
- 2013-09-10
- Volume
- 31
- Issue
- 26
- Pages
- 3205-3211
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2167059308
- Cited by
- 432
- References
- 21
- FWCI
- 23.53
- Type
- journal article
- Language
- en
- Open access
- closed
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- Ascierto, P. A., Minor, D., Ribas, A., Lebbe, C., O'Hagan, A., Arya, N., Guckert, M., Schadendorf, D., Kefford, R. F., Grob, J.-J., Hamid, O., Amaravadi, R., Simeone, E., Wilhelm, T., Kim, K. B., Long, G. V., Martin, A.-M., Mazumdar, J., Goodman, V. L., & Trefzer, U. (2013). Phase II Trial (BREAK-2) of the BRAF Inhibitor Dabrafenib (GSK2118436) in Patients With Metastatic Melanoma. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2013.49.8691
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