The impact of the Oncotype DX Recurrence Score on treatment decisions and clinical outcomes in patients with early breast cancer: the Maccabi Healthcare Services experience with a unified testing policy.

The Oncotype DX Recurrence Score is a validated prognosticator in oestrogen receptor positive (ER+) breast cancer. Our retrospective analysis of a prospectively defined cohort summarises the clinical implications associated with Oncotype DX testing according to the Maccabi Healthcare Services (MHS) policy. The MHS eligibility criteria for testing included ER+ N0/pN1mic invasive tumours, discussion of test implications with an oncologist, ductal carcinoma 0.6-1 cm Grade 2-3, HER2 negative ductal carcinomas with 1.1-4.0 cm Grade 1-2, or lobular carcinoma. Large (> 1 cm) Grade 3 tumours could have grade reassessed. We linked Recurrence Score results with patients' information and used chi-squared tests to assess the associations thereof. Between January 2008 and December 2011, tests were performed on 751 patients (MHS-eligible, 713); 54%, 38%, and 8% of patients had low, intermediate, and high Recurrence Score results, respectively. Recurrence Score distribution varied significantly with age (P = 0.002), with increasing Recurrence Score values with decreasing age. The proportion of patients with high Recurrence Score results varied by grade/size combination and histology, occurring in 32% of small (≤ 1 cm) Grade 3 and 3% of larger (1.1-4 cm) Grade 1 ductal tumours and only in 2% of lobular carcinomas. Chemotherapy was administered to 1%, 13%, and 61% of patients with low, intermediate, and high Recurrence Score results, respectively (P < 0.0001), but only to 2% of intermediate score patients ≥ 65 years. Luteinising-hormone-releasing hormone agonists with tamoxifen were used in 27% of low Recurrence Score patients ≤ 50 years. With a median follow-up of 26 months, no systemic recurrences were documented, whereas four patients exhibited locoregional recurrences. In summary, in this low-to-moderate risk patient population, testing identified 46% of patients as intermediate/high risk. Treatment decisions were influenced by Recurrence Score results and patients' age. The current MHS policy seems to achieve the goal of promoting chemotherapy use according to the test results in a prespecified patient population.

Gender-associated differences in urea breath test for Helicobacter pylori infection referrals and results among dyspeptic patients.

AIM: To verify whether there is a gender difference in the (13)C-urea breath test results in a large cohort. METHODS: The test results of dyspeptic patients referred for (13)C-urea breath testing between January and December, 2007 were evaluated. Testing was carried out at the health insurance organization branches and evaluated at a central laboratory in Israel. RESULTS: Of a total of 28 746 test results, 18 122 (63.04%) were from females and 10 624 (36.95%) from males. Overall, 10 188 (35.4%) results [expressed as delta over baseline (DOB)] were positive (DOB (13)C > 5), 18,326 (63.7%) were negative (DOB (13)C < 3.5) and 232 (0.8%) were borderline (DOB (13)C 3.5-5). There was a significant difference between the total positive rate among females and males (34.8% vs 37.2%, respectively, P = 0.0003). The mean test value was increased by approximately 10 units for females compared to males (P < 0.01) and this difference was consistent for all age groups (i.e., between 10-80 years of age, P < 0.01). CONCLUSION: More females were referred to (13)C-urea breath testing. More males had positive results. The mean test values were significantly higher among females of all age groups, possibly representing an increased bacterial load among females and suggesting gender-associated differences in Helicobacter pylori host interactions.

[Identification of K-RAS mutations in colorectal cancer patients in Israel].

BACKGROUND: Activating mutations of the oncogene K-RAS are a common finding within cells of malignant, sporadic colorectal cancer. The existence of such mutations endows the tumor with proliferation potential which is independent of external stimuli by growth factors such as the epidermal growth factor of upstream receptor (EGFR]. Hence, anticancer, novel biologic drugs, aimed at inhibiting the EGFR, such as cetuximab, are rendered ineffective in cases of colorectal cancer harboring activated K-RAS. AIMS: Quantification and characterization of activating mutations in a large cohort of sporadic colorectal tumors in the Israeli population. METHODS: The results of a mutation analysis kit application in 419 tumor samples collected in Israel during the years 2007-2009 by the diagnostic unit of Teva in Israel--Oncotest-Advantest Ltd. RESULTS: The utilization of a direct, pre-specified mutation kit analysis (TheraScreen: K-ras Mutation Kit) has identified a total rate of 44.8% mutations. Most mutations (82.4%) were identified within codon 12 and the minority on codon 13. These results are in concordance with modern series conducted worldwide.