ABSTRACT
PURPOSE: High activity of the intracellular phosphatidylinositol-3 kinase (PI3K) pathway is common in breast cancer. Here, we explore differences in expression of important PI3K pathway regulators: the activator, phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA), and the tumour suppressor, phosphatase and tensin homolog (PTEN), in breast carcinoma tissue and normal breast tissue. Furthermore, we examine whether expression of PIK3CA and PTEN mRNA and occurrence of PIK3CA mutations are associated with lymph node metastases in patients with primary breast cancer. METHODS: Paired tissue samples of breast carcinoma and normal breast tissue were obtained from 175 breast cancer patients at the time of primary surgery, of these 105 patients were lymph node positive. Expression of PIK3CA and PTEN mRNA was quantified with Quantitative Real Time PCR. Somatic mutations in exon 9 and exon 20 of the PIK3CA gene were identified by genotyping. RESULTS: Both PIK3CA and PTEN mRNA expression was significantly increased in breast carcinoma tissue compared to normal breast tissue (p = 2 × 10(-11)) and (p < 0.001), respectively. PIK3CA mutations were present in 68 out of 175 patients (39%), but were not associated with PIK3CA expression (p = 0.59). Expression of PIK3CA and PTEN mRNA, and PIK3CA mutations in breast carcinomas were not associated with presence of lymph node metastases. CONCLUSIONS: The expression of PTEN and PIK3CA mRNA is increased in breast carcinoma tissue compared to normal breast tissue, and PIK3CA mutations are frequent in primary breast carcinoma, however these factors were not associated with lymph node metastases.
ABSTRACT
INTRODUCTION: Self-monitoring of blood glucose (SMBG) is important in diabetes management. Reliable and user-friendly instruments are essential. OneTouch Verio(®) is a new blood glucose concentration-measuring system designed to be used by patients with diabetes and healthcare professionals. The objective of the present study was to evaluate the analytical performance of the OneTouch Verio(®). METHOD: The OneTouch Verio(®) was evaluated by the Scandinavian evaluation of laboratory equipment for primary healthcare (SKUP) according to a protocol based on ISO 15197 and the American Diabetes Association (ADA) quality goals. Blood samples were collected and measured on the OneTouch Verio(®) by laboratory personnel and patients with diabetes (n = 91, randomized into groups receiving personal training or mail instructions for the OneTouch Verio(®) system). Results were compared to a validated routine method, imprecision and bias were calculated. User-friendliness was evaluated with a questionnaire. RESULTS: Quality specifications for blood glucose concentration monitoring systems according to ISO 15197 were fulfilled. The mean coefficients of variation (CV%) of repeatability was 3.4% when tested by laboratory personnel and within the goal of imprecision suggested by ADA. Mean CV% of repeatability for patient self-monitoring was 5.0% and 5.1% in the training- and the mail group, respectively. Total error was 6.4-10.0%. The OneTouch Verio(®) showed no hematocrit interference or variation between strip lots. CONCLUSION: The OneTouch Verio(®) displayed sufficient analytical quality and satisfactory user-friendliness. It is suitable for point-of-care testing of blood glucose concentration when handled by patients and healthcare professionals.
