Background:Tumour gene expression analysis is useful in predicting adjuvant chemotherapy benefit in early breast cancer patients. This study aims to examine the implications of routine Oncotype DX testing in the UK.Methods:Women with oestrogen receptor positive (ER+), pNO or pN1mi breast cancer were assessed for adjuvant chemotherapy and subsequently offered Oncotype DX testing, with changes in chemotherapy decisions recorded. A subset of patients completed questionnaires about their uncertainties regarding chemotherapy decisions pre- and post-testing. All patients were asked to complete a diary of medical interactions over the next 6 months, from which economic data were extracted to model the cost-effectiveness of testing.Results:Oncotype DX testing resulted in changes in chemotherapy decisions in 38 of 142 (26.8%) women, with 26 of 57 (45.6%) spared chemotherapy and 12 of 85 (14.1%) requiring chemotherapy when not initially recommended (9.9% reduction overall). Decision conflict analysis showed that Oncotype DX testing increased patients' confidence in treatment decision making. Economic analysis showed that routine Oncotype DX testing costs £6232 per quality-adjusted life year gained.Conclusion:Oncotype DX decreased chemotherapy use and increased confidence in treatment decision making in patients with ER+ early-stage breast cancer. Based on these findings, Oncotype DX is cost-effective in the UK setting.

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Interest in estimating HIV-1 incidence using specimens obtained as part of cross-sectional surveys has led to the development of new methods to detect recent HIV-1 infection through the testing of a single anti-HIV-positive specimen. These assays are based on quantitative and qualitative differences in anti-HIV-1 antibodies between recent and long-standing infections. An ongoing vaccine preparedness study enrolled female sex workers in the Dominican Republic. Specimens from women found to be HIV positive at baseline were tested for recent HIV-1 infection using the detuned assay, avidity index, and BED-CEIA assay. An unweighted kappa statistic in pairwise comparisons was used to estimate the correlation of recent HIV-1 infection detection by the three methods. Nineteen (3.9%) of 482 women were positive for HIV-1 infection. The incidence of HIV infection was 1.4% [95% confidence interval (CI): 0.2, 5.3], 0.9%(95% CI: 0.1, 4.4), and 1.0%(95% CI: 0.1, 4.4) using detuned assay, avidity index, and BED-CEIA techniques, respectively. The overall agreement between both detuned assay and avidity index and detuned assay and BED-CEIA was 94%(kappa = 0.8, 95% CI; 0.3, 1.0). The correlation was highest between BED-CEIA and avidity index methods (100%; kappa = 1.0). All three methods performed similarly in detecting recent HIV-1 infection in this region dominated by clade B HIV-1 infection. Although incidence estimates were slightly higher using the detuned assay method, they were not significantly different. These assays may be of value in both clinical research and practice. The utility of individual assays for recent infection detection will depend upon operating characteristics, HIV-1 subtype limitations, and selection of appropriate assay cutoff values.

Goals: International guidelines support the use of the Oncotype DX derived Recurrence Score (RS) to provide additional prognostic and predictive information in early breast cancer but experience in the UK is limited. In our prospective study we evaluate this test for the NHS and its impact on costs (subject of a separate abstract) and treatment recommendations by UK oncologists.Methods: 150 tests were made available to consecutive patients with ER+, pN0 or pN1mic early breast cancer who had no contraindication to adjuvant chemotherapy (CT) and who would accept chemotherapy if recommended. CT recommendations of oncologists based on Adjuvant! Online figures were recorded at an initial consultation and again after a second consultation once the RS was available.Results: Analysis is based on 142 patients. (150 tests performed, 3 failed to give a result, 3 repeated tests giving a result on the second block, one bilateral and one test stopped because the patient withdrew from the study). Initial treatment recommendations changed in 38 (26.8%) cases. Of the patients initially recommended CT + HT (total 57 patients), 26 (45.6%) patients were spared chemotherapy after review of the RS. Of the 85 patients initially recommended HT only (total 85 patients), 12 (14.1%) were changed to HT+CT. Further analysis shows that Grade and PR by IHC are correlated to RS. (Spearman rank correlation for grade is 0.05, 95%, Cl 0.36 to 0.61 and for PR by IHC is -0.49, 95%, Cl -0.60 to -0.35). If testing had been confined to patients initially recommended chemotherapy and patients with Grade 2/3 tumours plus a PR by IHC of 6 or less (84 patients) then 35 of the 38 (92.1%) changes in CT recommendations would have been included and the cost the test avoided in 58 (40.8%) of the patients. Conclusion:The results of our study suggest that Oncotype DX is applicable and feasible to perform in UK patients with a reduction in the use of adjuvant chemotherapy consistent with findings of other reported studies. RS added prognostic information beyond information provided by Adjuvant!

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