Aims: Treatment strategies for breast cancer continue to evolve. No uniformity exists in the UK for the management of node-positive breast cancer patients. Most centres continue to use conventional histopathology of sampled sentinel lymph nodes (SLNs), which requires delayed axillary clearance in up to 25% of patients. Some use touch imprint cytology or frozen section for intraoperative testing, although both have inherent sensitivity issues. An intraoperative molecular diagnostic approach helps to overcome some of these limitations. The aim of this study was to assess the clinical effectiveness of Metasin, a molecular method for the intraoperative evaluation of SLNs. Methods and results: RNA from 3296 lymph nodes from 1836 patients undergoing SLN assessment was analysed with Metasin. Alternate slices of tissue were examined in parallel by histology. Cases deemed to be discordant were analysed by protein gel electrophoresis. There was concordance between Metasin and histology in 94.1% of cases, with a sensitivity of 92% [95% confidence interval (CI) 88-94%] and a specificity of 97% (95% CI 2016 , 68, 875-887. DOI: 10.1111 95-97%). Positive and negative predictive values were 88% and 98%, respectively. Over half of the discordant cases (4.4%) were ascribed to tissue allocation bias (TAB).Conclusions: Clinical validation of the Metasin assay suggests that it is sufficiently sensitive and specific to make it fit for purpose in the intraoperative setting.
Objectives:
To evaluate diagnostic accuracy of mpMRI in a non-academic hospital using transperineal template prostate mapping (TPM) biopsy as a reference standard. Secondary objectives included evaluating why mpMRI missed significant cancer.
Materials and methods:
101 men received pre-biopsy mpMRI and TPM-biopsy over 16 months. Disease status was assigned at hemigland level. Primary histological definition of clinical significance was Gleason grade >/ = 4 + 3 or maximum cancer core length (MCCL) >/ = 6 mm. Positive mpMRI was defined as Prostate Imaging Reporting and Data System (PI-RADS) score >/ = 3.
Results:
Median age 69 (IQR 62–76). Median PSA 7 ng/ml (IQR 4.6–9.8). mpMRI had sensitivity 76.9%, specificity 60.7%, PPV 40.4% and NPV 88.3% at primary definitions. For detecting any Gleason >/ = 7 mpMRI had sensitivity 73.2%, specificity 60.3%, PPV 41.4% and NPV 85.4%. Mean MCCL was lower where significant cancer was missed compared to those correctly identified (5.8 mm versus 7.7 mm respectively, p = 0.035).
Conclusion:
mpMRI performance characteristics were very encouraging when compared to contemporary clinical trials. In a non-academic hospital setting, negative mpMRI was just as good at ruling-out significant disease, though the ability of positive mpMRI to accurately detect significant disease was lower. An mpMRI-guided diagnostic pathway should be accompanied by appropriate mpMRI protocol optimisation, training, and quality control.
Highlights:
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