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Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation
Open accessAbstract
BACKGROUND: Phase 1 and 2 clinical trials of the BRAF kinase inhibitor vemurafenib (PLX4032) have shown response rates of more than 50% in patients with metastatic melanoma with the BRAF V600E mutation. METHODS: We conducted a phase 3 randomized clinical trial comparing vemurafenib with dacarbazine in 675 patients with previously untreated, metastatic melanoma with the BRAF V600E mutation. Patients were randomly assigned to receive either vemurafenib (960 mg orally twice daily) or dacarbazine (1000 mg per square meter of body-surface area intravenously every 3 weeks). Coprimary end points were rates of overall and progression-free survival. Secondary end points included the response rate, response duration, and safety. A final analysis was planned after 196 deaths and an interim analysis after 98 deaths. RESULTS: At 6 months, overall survival was 84% (95% confidence interval [CI], 78 to 89) in the vemurafenib group and 64% (95% CI, 56 to 73) in the dacarbazine group. In the interim analysis for overall survival and final analysis for progression-free survival, vemurafenib was associated with a relative reduction of 63% in the risk of death and of 74% in the risk of either death or disease progression, as compared with dacarbazine (P<0.001 for both comparisons). After review of the interim analysis by an independent data and safety monitoring board, crossover from dacarbazine to vemurafenib was recommended. Response rates were 48% for vemurafenib and 5% for dacarbazine. Common adverse events associated with vemurafenib were arthralgia, rash, fatigue, alopecia, keratoacanthoma or squamous-cell carcinoma, photosensitivity, nausea, and diarrhea; 38% of patients required dose modification because of toxic effects. CONCLUSIONS: Vemurafenib produced improved rates of overall and progression-free survival in patients with previously untreated melanoma with the BRAF V600E mutation. (Funded by Hoffmann-La Roche; BRIM-3 ClinicalTrials.gov number, NCT01006980.).
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“Vemurafenib, a selective oral inhibitor of the BRAF V600 kinase, achieved an approximately 50% response and improved survival among metastatic melanoma patients with the BRAF V600E mutation [97].”
From Resistance to anti-EGFR therapies in metastatic colorectal cancer: underlying mechanisms and reversal strategies (2021) · cites this paper as [97]
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“Maturation of survival data also increased the ESMO-MCBS score of vemurafenib in the treatment of metastatic melanoma [116, 117] from ESMO-MCBS 3 based on PFS to 4, based on OS.”
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Metadata
- Authors
- Chapman, P. B., Hauschild, A., Robert, C., Haanen, J. B., Ascierto, P., Larkin, J., Dummer, R., Garbe, C., Testori, A., Maio, M., Hogg, D., Lorigan, P., Lebbe, C., Jouary, T., Schadendorf, D., Ribas, A., O'Day, S. J., Sosman, J. A., Kirkwood, J. M., Eggermont, A. M. M., Dreno, B., Nolop, K., Li, J., Nelson, B., Hou, J., Lee, R. J., Flaherty, K. T., & McArthur, G. A.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- Christian-Albrechts-Universität zu Kiel (DE)
- Institut Gustave Roussy (FR)
- The Netherlands Cancer Institute (NL)
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
- Royal Marsden Hospital (GB)
- University of Zurich (CH)
- University of Tübingen (DE)
- European Institute of Oncology (IT)
- Tumour Institute of Tuscany (IT)
- University Health Network (CA)
- University of Manchester (GB)
- Hôpital Saint-André (FR)
- Essen University Hospital (DE)
- University of California, Los Angeles (US)
- Angeles Clinic and Research Institute (US)
- Vanderbilt University (US)
- University of Pittsburgh (US)
- Plexxikon (United States) (US)
- Genentech (US)
- Massachusetts General Hospital (US)
- Peter MacCallum Cancer Centre (AU)
- ORCID
- Chapman, Paul B.
- Hauschild, Axel
- Robert, Caroline
- Haanen, John B.
- Ascierto, Paolo
- Larkin, James
- Dummer, Reinhard
- Garbe, Claus
- Testori, Alessandro
- Maio, Michele
- Hogg, David
- Lorigan, Paul
- Jouary, Thomas
- Schadendorf, Dirk
- Ribas, Antoni
- O'Day, Steven J.
- Sosman, Jeffrey A.
- Kirkwood, John M.
- Eggermont, Alexander M.M.
- Li, Jiang
- Hou, Jeannie
- Lee, Richard J.
- Flaherty, Keith T.
- McArthur, Grant A.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2011-06-30
- Volume
- 364
- Issue
- 26
- Pages
- 2507-2516
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC3549296
- OpenAlex
- W2128542677
- Cited by
- 7,720
- References
- 28
- Citations by year
- 2026: 141 · 2025: 187 · 2024: 265 · 2023: 276 · 2022: 401 · 2021: 377 · 2020: 423 · 2019: 470 · 2018: 496 · 2017: 613 · 2016: 660 · 2015: 829 · 2014: 844 · 2013: 865 · 2012: 693
- FWCI
- 332.77
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- Research Explorer (The University of Manchester) (acceptedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- PubMed Central (acceptedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- National Institutes of Health (UL1TR000005)
- National Cancer Institute (K24CA097588)
- National Center for Advancing Translational Sciences
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Melanoma and MAPK Pathways
- Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Keywords
- vemurafenib, dacarbazine, metastatic melanoma, BRAF V600E mutation, BRAF inhibitors, overall survival, progression-free survival, drug toxicity, keratoacanthoma, photosensitivity
- MeSH terms
- Vemurafenib, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Dacarbazine, Female, Humans, Indoles, Male, Melanoma, Middle Aged, Mutation, Sulfonamides, Survival Analysis, Disease-Free Survival, Proto-Oncogene Proteins B-raf, Young Adult, Intention to Treat Analysis
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