ABSTRACT
CONTEXT: This named patient program evaluated the safety and efficacy of ibrutinib, a selective inhibitor of Bruton's tyrosine kinase in Indian patients with relapsed/refractory chronic lymphocytic leukemia (CLL, with/without chromosome 17 deletion [del17p]) and mantle cell lymphoma (MCL). SUBJECTS AND METHODS: The eight enrolled patients (relapsed/refractory CLL: n = 6 [4/6 patients with del17p] and relapsed/refractory MCL: n = 2) had median age of 55 years (range, 52-60) and had received a median of 3 (CLL patients) and 4 (MCL patients) prior therapies. Patients received once-daily dose of ibrutinib (420 mg: CLL, 560 mg: MCL). RESULTS: In CLL patients, the median time to response was 3 months (range, 0.5-7) and five of six patients had partial response (PR) whereas one achieved complete response (CR). Median time on treatment was 11.5 months (range, 8-14); five patients continued treatment and one was recommended stem cell transplantation (SCT). Of the two MCL patients, one achieved PR and one showed CR and advanced to SCT. In CLL patients, the median (range) hemoglobin level improved from 9.8 g/dL (7.2-11) at baseline to 12.0 g/dL (9.5-13.2) and median (range) platelet count improved from 150,000 cells/µL (21,000-195,000) at baseline to 190,350 cells/µL (130,000-394,000) at the time of analysis (July 2016). Most adverse events (AEs) reported were infections (n = 2). No Grade 3-4 or serious AEs, dose reductions, or treatment discontinuation due to AEs were reported. CONCLUSIONS: In this first real-world experience in Indian patients, ibrutinib demonstrated therapeutic efficacy in relapsed/refractory CLL (with/without del17p) and MCL. Safety results were consistent with the current known profile of ibrutinib.
ABSTRACT
AIM: We describe the prevalence of overweight and obesity in four-year-old children in New Zealand, variations with ethnicity and socio-economic status, and changes over the study duration using body mass index (BMI) measurements collected as part of the B4School Check programme. METHODS: Demographic and BMI data were extracted for all children measured between 2009 and 2012. Overweight and obesity rates were estimated using International Obesity Task Force (IOTF) 2012 standards and the 85th (overweight) and 95th (obese) percentiles for BMI-for-age of the World Health Organization (WHO) 2006, Centers for Disease Control and Prevention 2000 and UK 1990 reference standards. RESULTS: A total of 168,744 BMI measurements were included in the analysis with a coverage rate of 66.5%. Mean BMI was 16.30 kg/m(2) in girls and 16.44 kg/m(2) in boys. Mean BMI z-score (WHO 2006 standards) was 0.601 in girls and 0.785 in boys. Using WHO 2006 standards, 16.9% of girls and 19.6% of boys were overweight and 13.8% of girls and 18.7% of boys were obese. Using IOTF standards, 18.3% of girls and 16.2% of boys were overweight and 5.7% of girls and 4.7% of boys were found obese. Prevalence of overweight and obesity was higher in Pacific and Maori children and those living in more socio-economically deprived areas than other children. No definite time-trends were observed over the study duration. CONCLUSIONS: The study reaffirms the high prevalence of overweight and obesity in pre-school children in New Zealand, and demonstrates the variations in prevalence when using different reference standards.
