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- Gonzalez-Ericsson, Paula, et al.
(författare)
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The path to a better biomarker: application of a risk management framework for the implementation of PD‐L1 and TILs as immuno‐oncology biomarkers into breast cancer clinical trials and daily practice
- 2020
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Ingår i: Journal of Pathology. - : Wiley. - 1096-9896 .- 0022-3417. ; 250:5, s. 667-684
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Forskningsöversikt (refereegranskat)abstract
- Immune checkpoint inhibitor therapies targeting PD‐1/PD‐L1 are now the standard of care in oncology across several hematologic and solid tumor types, including triple negative breast cancer (TNBC). Patients with metastatic or locally advanced TNBC with PD‐L1 expression on immune cells occupying ≥1% of tumor area demonstrated survival benefit with the addition of atezolizumab to nab‐paclitaxel. However, concerns regarding variability between immunohistochemical PD‐L1 assay performance and inter‐reader reproducibility have been raised. High tumor‐infiltrating lymphocytes (TILs) have also been associated with response to PD‐1/PD‐L1 inhibitors in patients with breast cancer (BC). TILs can be easily assessed on hematoxylin and eosin–stained slides and have shown reliable inter‐reader reproducibility. As an established prognostic factor in early stage TNBC, TILs are soon anticipated to be reported in daily practice in many pathology laboratories worldwide. Because TILs and PD‐L1 are parts of an immunological spectrum in BC, we propose the systematic implementation of combined PD‐L1 and TIL analyses as a more comprehensive immuno‐oncological biomarker for patient selection for PD‐1/PD‐L1 inhibition‐based therapy in patients with BC. Although practical and regulatory considerations differ by jurisdiction, the pathology community has the responsibility to patients to implement assays that lead to optimal patient selection. We propose herewith a risk‐management framework that may help mitigate the risks of suboptimal patient selection for immuno‐therapeutic approaches in clinical trials and daily practice based on combined TILs/PD‐L1 assessment in BC.
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- Basra, R., et al.
(författare)
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Design and Validation of a New Screening Instrument for Lower Urinary Tract Dysfunction: The Bladder Control Self-Assessment Questionnaire (B-SAQ)
- 2006
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Ingår i: Eur Urol. - 0302-2838.
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: To develop and validate a short patient self-assessment screening questionnaire: bladder control self-assessment questionnaire (B-SAQ) for the evaluation of lower urinary tract symptoms. This first validation study was undertaken amongst women. PATIENTS AND METHODS: Three hundred twenty-nine women attending general gynaecology and urogynaecology clinics completed both the B-SAQ and Kings Health questionnaire prior to medical consultation, and independent physician assessment of the presence of lower urinary tract symptoms (LUTS) and need for treatment. The psychometric properties of the B-SAQ were subsequently analysed. RESULTS: The B-SAQ was quick and easy to complete, with 89% of respondents completing all items correctly in less than 5min. The internal consistency (Cronbach's alpha score 0.90-0.91), criterion validity (Pearson's correlation values of 0.79 and 0.81, p<0.0001 with the incontinence impact domain of the Kings Health questionnaire), and test-retest reliability of the questionnaire were good. The sensitivity and specificity of the questionnaire to identify patients with bothersome LUTS was 98% and 79%, respectively. CONCLUSIONS: LUTS are commonly underreported. Empowering patients to self-assess their bladder symptoms and the need for treatment will improve treatment-seeking behaviour. The B-SAQ is a psychometrically robust, short screening questionnaire that offers patients the ability to assess their bladder symptoms and the bother they cause, and the potential benefit of seeking medical help.
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- El Bairi, Khalid, et al.
(författare)
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The tale of TILs in breast cancer: A report from The International Immuno-Oncology Biomarker Working Group
- 2021
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Ingår i: npj Breast Cancer. - : Springer Science and Business Media LLC. - 2374-4677. ; 7:1
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Forskningsöversikt (refereegranskat)abstract
- The advent of immune-checkpoint inhibitors (ICI) in modern oncology has significantly improved survival in several cancer settings. A subgroup of women with breast cancer (BC) has immunogenic infiltration of lymphocytes with expression of programmed death-ligand 1 (PD-L1). These patients may potentially benefit from ICI targeting the programmed death 1 (PD-1)/PD-L1 signaling axis. The use of tumor-infiltrating lymphocytes (TILs) as predictive and prognostic biomarkers has been under intense examination. Emerging data suggest that TILs are associated with response to both cytotoxic treatments and immunotherapy, particularly for patients with triple-negative BC. In this review from The International Immuno-Oncology Biomarker Working Group, we discuss (a) the biological understanding of TILs, (b) their analytical and clinical validity and efforts toward the clinical utility in BC, and (c) the current status of PD-L1 and TIL testing across different continents, including experiences from low-to-middle-income countries, incorporating also the view of a patient advocate. This information will help set the stage for future approaches to optimize the understanding and clinical utilization of TIL analysis in patients with BC.
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- Kirby, M., et al.
(författare)
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Overactive bladder: The importance of new guidance
- 2006
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Ingår i: Int J Clin Pract. - : Hindawi Limited. - 1368-5031. ; 60:10, s. 1263-71
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Tidskriftsartikel (refereegranskat)abstract
- Overactive bladder (OAB) affects an estimated 49 million people in Europe, but only a minority receive appropriate treatment. Others are bothered by unacceptable levels of symptoms that severely impair their quality of life and represent a significant financial burden to themselves and to their healthcare providers. Recently updated guidelines from the International Consultation on Incontinence (ICI) and the European Association of Urology (EAU) take account of important new developments in the management of bladder problems in both primary and secondary care. However, local implementation of previous guidance has been variable, with many patients with OAB and other bladder problems failing to gain full benefit from current clinical and scientific understanding of these conditions. The recent expansion of the range of treatments available for OAB and stress urinary incontinence makes it especially important that physicians become aware of the differential diagnosis of these conditions - the questions they need to ask, and the investigations which will help determine the most appropriate course of action.
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- Wagg, A., et al.
(författare)
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Overactive Bladder and Continence Guidelines: implementation, inaction or frustration?
- 2008
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Ingår i: International Journal of Clinical Practice. - : Hindawi Limited. - 1742-1241 .- 1368-5031. ; 62:10, s. 1588-93
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Tidskriftsartikel (refereegranskat)abstract
- Guidelines for the management of continence and overactive bladder are generally available across Europe. For a majority of countries, these have been adopted by professional societies in either urology or gynaecology for local use. There has, however, been little monitoring of formal implementation of these guidelines and seldom any attempt to audit their operation. The state of continence care therefore remains largely unknown. This article reviews current guidelines and their status across Europe and examines what might be relevant from other disease areas to promote successful implementation.
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