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BackgroundAtezolizumab is a humanised antiprogrammed death-ligand 1 (PD-L1) monoclonal antibody that inhibits PD-L1 and programmed death-1 (PD-1) and PD-L1 and B7-1 interactions, reinvigorating anticancer immunity. We assessed its efficacy and safety versus docetaxel in previously treated patients with non-small-cell lung cancer.MethodsWe did a randomised, open-label, phase 3 trial (OAK) in 194 academic or community oncology centres in 31 countries. We enrolled patients who had squamous or non-squamous non-small-cell lung cancer, were 18 years or older, had measurable disease per Response Evaluation Criteria in Solid Tumors, and had an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients had received one to two previous cytotoxic chemotherapy regimens (one or more platinum based combination therapies) for stage IIIB or IV non-small-cell lung cancer. Patients with a history of autoimmune disease and those who had received previous treatments with docetaxel, CD137 agonists, anti-CTLA4, or therapies targeting the PD-L1 and PD-1 pathway were excluded. Patients were randomly assigned (1:1) to intravenously receive either atezolizumab 1200 mg or docetaxel 75 mg/m2 every 3 weeks by permuted block randomisation (block size of eight) via an interactive voice or web response system. Coprimary endpoints were overall survival in the intention-to-treat (ITT) and PD-L1-expression population TC1/2/3 or IC1/2/3 (≥1% PD-L1 on tumour cells or tumour-infiltrating immune cells). The primary efficacy analysis was done in the first 850 of 1225 enrolled patients. This study is registered with ClinicalTrials.gov, number NCT02008227.FindingsBetween March 11, 2014, and April 29, 2015, 1225 patients were recruited. In the primary population, 425 patients were randomly assigned to receive atezolizumab and 425 patients were assigned to receive docetaxel. Overall survival was significantly longer with atezolizumab in the ITT and PD-L1-expression populations. In the ITT population, overall survival was improved with atezolizumab compared with docetaxel (median overall survival was 13·8 months [95% CI 11·8-15·7] vs 9·6 months [8·6-11·2]; hazard ratio [HR] 0·73 [95% CI 0·62-0·87], p=0·0003). Overall survival in the TC1/2/3 or IC1/2/3 population was improved with atezolizumab (n=241) compared with docetaxel (n=222; median overall survival was 15·7 months [95% CI 12·6-18·0] with atezolizumab vs 10·3 months [8·8-12·0] with docetaxel; HR 0·74 [95% CI 0·58-0·93]; p=0·0102). Patients in the PD-L1 low or undetectable subgroup (TC0 and IC0) also had improved survival with atezolizumab (median overall survival 12·6 months vs 8·9 months; HR 0·75 [95% CI 0·59-0·96]). Overall survival improvement was similar in patients with squamous (HR 0·73 [95% CI 0·54-0·98]; n=112 in the atezolizumab group and n=110 in the docetaxel group) or non-squamous (0·73 [0·60-0·89]; n=313 and n=315) histology. Fewer patients had treatment-related grade 3 or 4 adverse events with atezolizumab (90 [15%] of 609 patients) versus docetaxel (247 [43%] of 578 patients). One treatment-related death from a respiratory tract infection was reported in the docetaxel group.InterpretationTo our knowledge, OAK is the first randomised phase 3 study to report results of a PD-L1-targeted therapy, with atezolizumab treatment resulting in a clinically relevant improvement of overall survival versus docetaxel in previously treated non-small-cell lung cancer, regardless of PD-L1 expression or histology, with a favourable safety profile.FundingF. Hoffmann-La Roche Ltd, Genentech, Inc.

Patients with cancer receiving infusional chemotherapy show negative symptoms such as worry about their survival, anxiety, anguish, depression, fear, magnified perception of the passage of time, and difficulty managing boredom. Patients also suffer various side effects produced by chemotherapy such as nausea, vomiting, pain, and fatigue, which, together with psychological distress, drastically reduce their quality of life and adherence to therapy with a corresponding reduction in the probability of the individual's survival. Virtual Reality is one of the most innovative and promising digital health interventions, capable of quickly and effectively producing a positive influence on the psychosomatic axis, improving patients' quality of life during chemotherapy. Virtual Reality, through its 3-dimensional multisensory technology, isolates sensory channels from the negative external environment and enables an experience of being physically and psychologically present within virtual scenarios, in which patients can perceive sensations, emotions, cognitions, and interactions as if they really were in different surroundings. This article systematically expounds the scientific conditions necessary for effective, appropriate, and safe implementation of Virtual Reality interventions in holistic nursing practice, describing the underpinning conceptual framework, the types, technological characteristics, methods of use, duration, type of virtual content, and implementation procedure of Virtual Reality. [ABSTRACT FROM AUTHOR]

This study aims to assess the effects of immersive Virtual Reality in people with cancer undergoing antiblastic therapy, on anxiety, fatigue and pain. This is a randomized controlled three-arm trial. Seventy-four cancer patients were recruited from a regional hospital in Italy, and randomly allocated into three groups: a Virtual Reality group (n=25), a narrative medicine group (n=25) and a standard care group (n=24). The primary outcome was anxiety. Secondary outcomes included fatigue and pain. The outcomes were evaluated immediately before and after the interventions. The findings showed that anxiety decreased more in the Virtual Reality group (Δpre-post = 6.24, 95% CI 2.578 to 9.902, p =.001, d = 0.63) than in the narrative medicine group, whereas it did not change for those in the standard care group. Fatigue decreased in the Virtual Reality group (Δpre-post = 0.576, 95% CI 0.246 to 0.907, p =.001, d = 0.23), while remaining stable in the narrative medicine group, and increasing in the standard care group. Average levels of pain did not change before and after the intervention [F(1,71) = 1.06, p =.307, ηp2 =.015]. Findings show that virtual reality is effective to reduce anxiety and fatigue in people with cancer undergoing antiblastic therapy. Virtual Reality can be recommended as an complementary intervention to manage anxiety and fatigue in people with cancer during antiblastic therapy. ClinicalTrials.gov NCT05629507. [ABSTRACT FROM AUTHOR]

This Systematic review and meta-analysis aimed to assess the effectiveness of Virtual Reality on anxiety, fatigue and pain in patients with cancer during chemotherapy and provide evidence for decision-making in clinical practice. A systematic literature search was performed in the databases PubMed, Web of Science, Scopus, Cumulative Index of Nursing and Allied Health Literature and the Cochrane Library. Risk of Bias was used to assess the quality of individual studies, and Grading of Recommendations Assessment, Development and Evaluation was used to assess confidence for each individual outcome. A random-effects model was used to examine the overall effect. Four randomized controlled trials and four crossover studies were included, with an overall sample of 459 patients. Results showed that Virtual Reality compared with standard care had a significant reduction of anxiety only (MD = −6.57, 95% CI: −11.59 to −1.54, p = 0.01) but with considerable heterogeneity (I2 = 92%), while Virtual Reality was not significantly different from integrative interventions. The trials included showed small sample sizes, lack of statistical power, low methodological quality, high heterogeneity, and different Virtual Reality technology types, lengths and frequencies. The quality of evidence is very low and the strength of recommendation is weak. Further research has large potential for reducing uncertainty about the effects of Virtual Reality in patients with cancer receiving chemotherapy. This study was registered with PROSPERO as CRD42020223375. • There is a lack of recommendations regarding the use of Virtual Reality. • Virtual Reality was compared with both standard care and integrative interventions. • Virtual Reality showed a significant reduction of anxiety than standard care only. • The quality of evidence was very low and the strength of recommendation weak. [ABSTRACT FROM AUTHOR]

Inpatients with cancer are likely to experience care dependency and would benefit from nurses' evaluation of such dependency. The Care Dependency Scale (CDS) is a 15-item instrument widely used to assess patients' dependency in different populations and settings. This study aimed to test the psychometric properties of the proxy Italian version of the CDS in inpatients with cancer. A multicentre cross-sectional cross-validation study was conducted between February 2016 and October 2017 in a convenience sample of 517 adult patients with cancer admitted to four hospitals in Italy. The sample was randomly divided into two subsamples. The factor structure of the CDS based on previous studies was tested on a subsample through confirmatory factor analyses (CFAs). The best fitting model was cross-validated through CFA on the second subsample and on the total sample. The sample mean age was 65.68 years, 51.5% were male. The CFAs performed on the first subsample (n = 258), on the second subsample (n = 259) and on the total sample yielded acceptable fit indexes. The factors Physical care dependency and Psychosocial care dependency with a second-order factor were confirmed. Reliability in terms of internal consistency and inter-rater reliability were satisfactory. The Care Dependency Scale is a tool able to assess the level of care dependency in patients with cancer with adequate validity and reliability. The Care Dependency Scale can help to distinguish between physical and psychosocial needs and to create a base for personalized patient care. What is already known about the topic? • The Care Dependency Scale (CDS) is a specific measure of nursing care dependence. • Oncology nurses need an instrument to measure the patients' degree of care dependency. What this paper adds • The CDS is valid and reliable and can be used by oncology nurses helping them to distinguish physical and psychosocial care dependence. • The CDS helps nurses to identify the patient' needs and plan individualized care. [ABSTRACT FROM AUTHOR]

To investigate the degree of concordance on fatigue assessment between children and adolescents with cancer and their parents, and its changes over time. Multicentre longitudinal study. Data from 134 dyads were analysed. The mean age of patients was 11.7 years; caregivers had a mean age of 44.1 years. Almost 90% of patients already reported mild or moderate fatigue at the time of diagnosis, decreasing to 69.7% after one year. Concordance on the total fatigue improved over time for the total sample, moving from moderate at the time of diagnosis to good concordance after one year. This was the first study with a longitudinal design investigating concordance between paediatric self-reports and parent proxy reports on fatigue. It showed how concordance between proxies and patients changed over time reaching a good level after one year from the cancer diagnosis. • Fatigue is a prevalent problem for children and adolescents diagnosed with cancer. • The prevalence and intensity of fatigue decrease over time. • Concordance between proxy and patient on fatigue level is higher one year after diagnosis. [ABSTRACT FROM AUTHOR]