The lancet oncology
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The lancet oncology · Feb 2020
ReviewInternational standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium.
Patient-reported outcomes (PROs), such as symptoms, function, and other health-related quality-of-life aspects, are increasingly evaluated in cancer randomised controlled trials (RCTs) to provide information about treatment risks, benefits, and tolerability. However, expert opinion and critical review of the literature showed no consensus on optimal methods of PRO analysis in cancer RCTs, hindering interpretation of results. ⋯ Four issues were prioritised: developing a taxonomy of research objectives that can be matched with appropriate statistical methods, identifying appropriate statistical methods for PRO analysis, standardising statistical terminology related to missing data, and determining appropriate ways to manage missing data. This Policy Review presents recommendations for PRO analysis developed through critical literature reviews and a structured collaborative process with diverse international stakeholders, which provides a foundation for endorsement; ongoing developments of these recommendations are also discussed.
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The lancet oncology · Feb 2020
ReviewCAR T-cell product performance in haematological malignancies before and after marketing authorisation.
Chimeric antigen receptor (CAR) T cells represent a potent new approach to treat haematological malignancies. Two CAR T-cell therapies, tisagenlecleucel and axicabtagene ciloleucel, have been approved in Europe and the USA, as well as several other countries, for the treatment of leukaemia and lymphoma. ⋯ However, the clinical development and regulatory evaluation of these innovative therapies faced several challenges that are considered important lessons learned for future similar products. Here, we examine the products' non-clinical and clinical data packages to outline the challenges encountered during the regulatory evaluation process in Europe, and to provide an update on their performance after authorisation.
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The lancet oncology · Feb 2020
ReviewGlioma patient-reported outcome assessment in clinical care and research: a Response Assessment in Neuro-Oncology collaborative report.
Clinical trials of treatments for high-grade gliomas have traditionally relied on measures of response or time-dependent metrics; however, these endpoints have limitations because they do not characterise the functional or symptomatic effect of the condition on the person. Including clinical outcome assessments, such as patient- reported outcomes (PROs), to determine net clinical benefit of a treatment strategy is needed because of the substantial burden of symptoms and impaired functioning in this patient population. The US National Cancer Institute convened a meeting to review previous recommendations and existing PRO measures of symptoms and function that can be applied to current trials and clinical practice for high-grade gliomas. ⋯ The group also relied on patient input including the results of an online survey, a literature review on available clinical outcomes, expert opinion, and alignment with work done by other organisations. A core set of priority constructs was proposed that allows more comprehensive evaluation of therapies and comparison of outcomes among studies, and enhances efforts to improve the measurement of these core clinical outcomes. The proposed set of constructs was then presented to the Society for Neuro-Oncology Response Assessment in Neuro-Oncology Working Group and feedback was solicited.
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The lancet oncology · Feb 2020
ReviewMRI-guided adaptive radiotherapy for liver tumours: visualising the future.
MRI-guided radiotherapy is a novel and rapidly evolving technology that might enhance the risk-benefit ratio. Through direct visualisation of the tumour and the nearby healthy tissues, the radiation oncologist can deliver highly accurate treatment even to mobile targets. ⋯ Future work will allow us to expand the population eligible for curative-intent radiotherapy, optimise and customise radiation doses to specific tumours, and hopefully create opportunities for improving outcomes through machine learning and radiomics-based approaches. This Review outlines the current and future applications for MRI-guided radiotherapy with respect to metastatic and primary liver cancers.