Overall Survival and Durable Responses in Patients With BRAF V600-Mutant Metastatic Melanoma Receiving Dabrafenib Combined With Trametinib.

PURPOSE: To report the overall survival (OS) and clinical characteristics of BRAF inhibitor-naive long-term responders and survivors treated with dabrafenib plus trametinib in a phase I and II study of patients with BRAF V600 mutation-positive metastatic melanoma. METHODS: BRAF inhibitor-naive patients treated with dabrafenib 150 mg twice daily plus trametinib 2 mg daily (the 150/2 group) from the non-randomly assigned (part B) and randomly assigned (part C) cohorts of the study were analyzed for progression-free and OS separately. Baseline characteristics and factors on treatment were analyzed for associations with durable responses and OS. RESULTS: For BRAF inhibitor-naive patients in the 150/2 groups (n = 78), the progression-free survival at 1, 2, and 3 years was 44%, 22%, and 18%, respectively, for part B (n = 24) and 41%, 25%, and 21%, respectively, for part C (n = 54). Median OS was 27.4 months in part B and 25 months in part C. OS at 1, 2, and 3 years was 72%, 60%, and 47%, respectively, for part B and 80%, 51%, and 38%, respectively, for part C. Prolonged survival was associated with metastases in fewer than three organ sites and lower baseline lactate dehydrogenase. OS at 3 years was 62% in patients with normal baseline lactate dehydrogenase and 63% in patients with a complete response. CONCLUSION: Dabrafenib plus trametinib results in a median OS of more than 2 years in BRAF inhibitor-naive patients with BRAF V600 mutation-positive metastatic melanoma, and approximately 20% were progression free at 3 years. Durable responses occurred in patients with good prognostic features at baseline, which may be predictive.

Vaccination rates among the general adult population and high-risk groups in the United States.

BACKGROUND: In order to adequately assess the effectiveness of vaccination in helping to control vaccine-preventable infectious disease, it is important to identify the adherence and uptake of risk-based recommendations. METHODS: The current project includes data from five consecutive datasets of the National Health and Wellness Survey (NHWS): 2007 through 2011. The NHWS is an annual, Internet-based health questionnaire, administered to a nationwide sample of adults (aged 18 or older) which included items on vaccination history as well as high-risk group status. Vaccination rates and characteristics of vaccinees were reported descriptively. Logistic regressions were conducted to predict vaccination behavior from sociodemographics and risk-related variables. RESULTS: The influenza vaccination rate for all adults 18 years and older has increased significantly from 28.0% to 36.2% from 2007 to 2011 (ps<.05). Compared with those not at high risk (25.1%), all high-risk groups were vaccinated at a higher rate, from 36.8% (pregnant women) to 69.7% (those with renal/kidney disease); however, considerable variability among high-risk groups was observed. Vaccination rates among high-risk groups for other vaccines varied considerably though all were below 50%, with the exception of immunocompromised respondents (57.5% for the hepatitis B vaccine and 52.5% for the pneumococcal vaccine) and the elderly (50.4% for the pneumococcal). Multiple risk factors were associated with increased rate of vaccination for most vaccines. Significant racial/ethnic differences with influenza, hepatitis, and herpes zoster vaccination rates were also observed (ps<.05). CONCLUSIONS: Rates of influenza vaccination have increased over time. Rates varied by high-risk status, demographics, and vaccine. There was a pattern of modest vaccination rate increases for individuals with multiple risk factors. However, there were relatively low rates of vaccination for most risk-based recommendations and all fell below national goals.