التفاصيل البيبلوغرافية
| العنوان: |
Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib |
| المؤلفون: |
Sosman, Jeffery A., Kim, Kevin B., Hersey, Peter, Kefford, Richard, Lawrence, Donald, Puzanov, Igor, Lewis, Karl D., Amaravadi, Ravi K., Chmielowski, Bartosz, Lawrence, H. Jeffrey, Shyr, Yu, Ye, Fei, Schuchter, Lynn, Gonzalez, Rene, Pavlick, Anna C., Weber, Jeffrey S., McArthur, Grant A., Hutson, Thomas E., Moschos, Stergios J., Flaherty, Keith T. |
| المساهمون: |
The University of Newcastle. Faculty of Health & Medicine, Faculty of Health |
| بيانات النشر: |
Massachusetts Medical Society |
| سنة النشر: |
2012 |
| المجموعة: |
NOVA: The University of Newcastle Research Online (Australia) |
| مصطلحات موضوعية: |
melanoma, vemurafenib, medical trial |
| الوصف: |
Background: Approximately 50% of melanomas harbor activating (V600) mutations in the serinethreonine protein kinase B-RAF (BRAF). The oral BRAF inhibitor vemurafenib (PLX4032) frequently produced tumor regressions in patients with BRAF V600-mutant metastatic melanoma in a phase 1 trial and improved overall survival in a phase 3 trial. Methods: We designed a multicenter phase 2 trial of vemurafenib in patients with previously treated BRAF V600-mutant metastatic melanoma to investigate the efficacy of vemurafenib with respect to overall response rate (percentage of treated patients with a tumor response), duration of response, and overall survival. The primary end point was the overall response rate as ascertained by the independent review committee; overall survival was a secondary end point. Results: A total of 132 patients had a median follow-up of 12.9 months (range, 0.6 to 20.1). The confirmed overall response rate was 53% (95% confidence interval [CI], 44 to 62; 6% with a complete response and 47% with a partial response), the median duration of response was 6.7 months (95% CI, 5.6 to 8.6), and the median progression-free survival was 6.8 months (95% CI, 5.6 to 8.1). Primary progression was observed in only 14% of patients. Some patients had a response after receiving vemurafenib for more than 6 months. The median overall survival was 15.9 months (95% CI, 11.6 to 18.3). The most common adverse events were grade 1 or 2 arthralgia, rash, photosensitivity, fatigue, and alopecia. Cutaneous squamous-cell carcinomas (the majority, keratoacanthoma type) were diagnosed in 26% of patients. Conclusions: Vemurafenib induces clinical responses in more than half of patients with previously treated BRAF V600-mutant metastatic melanoma. In this study with a long follow-up, the median overall survival was approximately 16 months. |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| تدمد: |
0028-4793 |
| العلاقة: |
New England Journal of Medicine Vol. 366, Issue 8, p. 707-714; http://hdl.handle.net/1959.13/1340666Test; uon:28543 |
| الإتاحة: |
http://hdl.handle.net/1959.13/1340666Test |
| حقوق: |
From New England Journal of Medicine, Jeffrey A. Sosman et al., Survival in BRAF V600–Mutant Advanced Melanoma Treated with Vemurafenib, volume no.366, Page No.707-714 Copyright © (2012) Massachusetts Medical Society. Reprinted with permission. |
| رقم الانضمام: |
edsbas.F672F378 |
| قاعدة البيانات: |
BASE |
