The DOI matches its Crossref record; 29 of the 29 references it cites were found in a registry or an index.
Dabrafenib and Trametinib Treatment in Patients With Locally Advanced or Metastatic BRAF V600–Mutant Anaplastic Thyroid Cancer
Open accessAbstract
Purpose: We report the efficacy and safety of dabrafenib (BRAF inhibitor) and trametinib (MEK inhibitor) combination therapy in BRAF V600E–mutated anaplastic thyroid cancer, a rare, aggressive, and highly lethal malignancy with poor patient outcomes and no systemic therapies with clinical benefit. Methods: In this phase II, open-label trial, patients with predefined BRAF V600E–mutated malignancies received dabrafenib 150 mg twice daily and trametinib 2 mg once daily until unacceptable toxicity, disease progression, or death. The primary end point was investigator-assessed overall response rate. Secondary end points included duration of response, progression-free survival, overall survival, and safety. Results: Sixteen patients with BRAF V600E–mutated anaplastic thyroid cancer were evaluable (median follow-up, 47 weeks; range, 4 to 120 weeks). All patients had received prior radiation treatment and/or surgery, and six had received prior systemic therapy. The confirmed overall response rate was 69% (11 of 16; 95% CI, 41% to 89%), with seven ongoing responses. Median duration of response, progression-free survival, and overall survival were not reached as a result of a lack of events, with 12-month estimates of 90%, 79%, and 80%, respectively. The safety population was composed of 100 patients who were enrolled with seven rare tumor histologies. Common adverse events were fatigue (38%), pyrexia (37%), and nausea (35%). No new safety signals were detected. Conclusion: Dabrafenib plus trametinib is the first regimen demonstrated to have robust clinical activity in BRAF V600E–mutated anaplastic thyroid cancer and was well tolerated. These findings represent a meaningful therapeutic advance for this orphan disease.
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Cites
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Self-citationCombined BRAF and MEK inhibition in melanoma with BRAF V600 mutations
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Self-citationGenomic and transcriptomic hallmarks of poorly differentiated and anaplastic thyroid cancers
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Cited by
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The next generation of evidence-based medicine
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Self-citationEvaluation of Overall Survival in Patients With Anaplastic Thyroid Carcinoma, 2000-2019
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Metadata
- Authors
- Subbiah, V., Kreitman, R. J., Wainberg, Z. A., Cho, J. Y., Schellens, J. H. M., Soria, J. C., Wen, P. Y., Zielinski, C., Cabanillas, M. E., Urbanowitz, G., Mookerjee, B., Wang, D., Rangwala, F., & Keam, B.
- Venue
- Journal of Clinical Oncology
- Published
- 2018-01-01
- Volume
- 36
- Issue
- 1
- Pages
- 7-13
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2766581537
- Cited by
- 892
- References
- 29
- FWCI
- 44.54
- Type
- journal article
- Language
- en
- Open access
- green
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- Subbiah, V., Kreitman, R. J., Wainberg, Z. A., Cho, J. Y., Schellens, J. H. M., Soria, J. C., Wen, P. Y., Zielinski, C., Cabanillas, M. E., Urbanowitz, G., Mookerjee, B., Wang, D., Rangwala, F., & Keam, B. (2018). Dabrafenib and Trametinib Treatment in Patients With Locally Advanced or Metastatic BRAF V600–Mutant Anaplastic Thyroid Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2017.73.6785
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