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91.
Paul Declerck Georgios Bakalos Elias Zintzaras Bettina Barton Thomas Schreitmüller 《Clinical therapeutics》2018,40(5):798-809.e2
Purpose
With the introduction of biosimilars of anticancer monoclonal antibodies (mAbs) in oncology, physicians are potentially confronted with the question whether it is clinically adequate to switch patients who are clinically stable on treatment with the reference product to a newly available biosimilar (or vice versa/from 1 biosimilar to another). For a proper impact assessment of switching, robust, product-specific, and clinically relevant evidence should be required, ideally including data from appropriately designed switching studies. In this article, we assess the current body of switching data available for approved or proposed biosimilars of anticancer mAbs.Methods
PubMed was systematically searched and ClinicalTrials.gov and abstract databases of selected congresses were hand-searched to identify all switching studies including biosimilars of anticancer mAbs.Findings
We identified 8 switching studies with biosimilars of rituximab (CT-P10, GP2013, PF-05280586, and BCD-020) and trastuzumab (ABP 980). Two were performed in oncology indications and the other 6 in rheumatoid arthritis (RA). Key elements of a well-designed switching study, such as randomization and blinding, were contained in several of the studies, but significant limitations were also present. The most frequent limitations were low statistical power because of small patient numbers, lack of an appropriate control arm, short follow-up, chosen outcome measures, and (for studies performed in RA) the concern whether switching data can be extrapolated to oncology indications. Accordingly, the data from these studies need to be interpreted with caution. Of note, all identified studies included a single switch only, whereas multiple switches may occur in the real-world setting. The scientific need to evaluate the impact of repeated switching has been recognized by the US Food and Drug Administration, who incorporated such a requirement in its draft guidance on interchangeability.Implications
From the scarce data available, the consequences of switching between reference product mAbs and their biosimilar(s) in the oncology setting are as yet unknown. Additional clinical evidence from well-designed switching studies is needed to guide switching decisions. 相似文献92.
Ultrasound Appearances of Pediatric Testicular Yolk Sac Tumors: Twenty‐one Cases in a Single Institution 
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下载免费PDF全文 Qing‐Da Song MD 《Journal of ultrasound in medicine》2018,37(10):2457-2463
Testicular yolk sac tumors are rare, and analyses of relevant ultrasound (US) findings are limited. We retrospectively reviewed the US features of 21 pathologically verified cases (patients aged 10–64 months). Neoplasms were unilateral and solitary, occupying part (focal) or all (diffuse) of the testis. Focal lesions (14 cases) were usually solid and ovoid, with a homogeneous echo texture or multiple random anechoic spaces, and hypervascular. Diffuse neoplasms had heterogeneous echo textures; most were hypervascular. On spectral Doppler US imaging, 11 cases had a mean peak systolic velocity of 12.9 cm/s and a mean resistive index of 0.54. Ultrasound is a useful tool for imaging pediatric testes when a yolk sac tumor is suspected. 相似文献
93.
Anna Coughtrey Amy Millington Sophie Bennett Deborah Christie Rachael Hough Merina T. Su Matthew P. Constantinou Roz Shafran 《Journal of pain and symptom management》2018,55(3):1004-1017
Context
This review summarizes the current randomized controlled trials literature on psychological and physical outcomes of psychosocial interventions in pediatric oncology.Objectives
The objective of this study was to evaluate the effectiveness and impact of psychosocial interventions in children with cancer.Methods
A search of the literature resulted in a total of 12 randomized clinical trials and these have evaluated psychosocial interventions in children younger than 18 years with current and previous diagnoses of cancer. Outcome measures were both psychological (e.g., symptoms of anxiety, depression, quality of life, and self-esteem) and physical (e.g., cancer symptoms, treatment adherence, and pain). Interventions identified included cognitive behavioral therapy (CBT; n = 4), joint CBT and physical exercise therapy (n = 1), family therapy (n = 2), therapeutic music video (n = 2), self-coping strategies (n = 1), a wish fulfillment intervention (n = 1), and joint family therapy and CBT (n = 1).Results
Nine studies reported statistically significant improvements on psychological outcomes. These findings suggest that psychosocial interventions are effective at reducing anxiety and depressive symptoms as well as improving quality of life. Additionally, six studies found psychosocial interventions to have a positive impact on physical symptoms and well-being, including a reduction in procedural pain and symptom distress.Conclusion
These findings suggest that mental health needs in pediatric oncology patients can and should be addressed, potentially which will lead to better mental and physical health outcomes. 相似文献94.
Yen-Ni Hung Fur-Hsing Wen Tsang-Wu Liu Jen-Shi Chen Siew Tzuh Tang 《Journal of pain and symptom management》2018,55(3):755-765.e5
Context
Evidence for the association of hospice exposure with lower health care expenditures at end of life (EOL) remains inconclusive and neglects EOL care being concentrated in patients' last few months.Objective
The association between hospice exposure and health care expenditures in cancer patients' last one, three, six, and 12 months was evaluated.Methods
In this population-based, retrospective cohort study, Taiwanese cancer decedents in 2001–2010 (N = 195,228) were matched 1:1, with proportions of matched hospice users reaching 87.8%, by a hospice-utilization propensity score. For each matched pair, exposure to hospice (time from hospice enrollment to death) was matched to equivalent periods for hospice nonusers before death. Hospice-care associations with health care expenditures were evaluated by hospice use/exposure interactions with multilevel linear regression modeling using generalized estimating equations.Results
The unadjusted main effect showed lower total mean health care expenditures for hospice users than for hospice nonusers only in the last one and three months (rate ratio [95% CI]: 0.86 [0.81, 0.90] and 0.93 [0.89, 0.96], respectively). However, after accounting for exposure time, hospice care was significantly associated with lower health care expenditures at exposures of ≤30, ≤60, and ≤180 days for health care expenditures measured in the last one and three months, six months, and 12 months, respectively. Savings for patients with lengthy hospice stays were neutralized or even disappeared.Conclusion
Hospice care was associated with lower health care expenditures when it could actively intervene in EOL care. Hospice philosophy should be applied not only shortly before death but also throughout the dying trajectory to achieve maximum cost savings. 相似文献95.
Pedro E. Perez-Cruz Omar Shamieh Carlos Eduardo Paiva Jung Hye Kwon Mary Ann Muckaden Eduardo Bruera David Hui 《Journal of pain and symptom management》2018,55(3):938-945
Context
Attrition is common in longitudinal observational studies in palliative care. Few studies have examined predictors of attrition.Objectives
To identify patient characteristics at enrollment associated with attrition in palliative oncology outpatient setting.Methods
In this longitudinal observational study, advanced cancer patients enrolled in an outpatient multicenter study were assessed at baseline and two to five weeks later. We compared baseline characteristics between patients who returned for follow-up and those who dropped out.Results
Seven hundred forty-four patients were enrolled from Jordan, Brazil, Chile, Korea, and India. Attrition rate was 33%, with variation among countries (22%–39%; P = 0.023). In univariate analysis, baseline predictors for attrition were cognitive failure (odds ratio [OR] 1.23 per point in Memorial Delirium Assessment Scale; P < 0.01), functional status (OR 1.55 per 10-point decrease in Karnofsky Performance Status; P < 0.01), Edmonton Symptom Assessment Scale [ESAS] physical score (OR 1.03 per point; P < 0.01), ESAS emotional score (OR 1.05 per point; P < 0.01), and shorter duration between cancer diagnosis and palliative care referral in months (OR 0.89 per log; P = 0.028). In multivariate analysis, cognitive failure (OR 1.12 per point; P = 0.007), ESAS physical score (OR 1.18 per point; P = 0.027), functional status (OR 1.35 per 10-point decrease; P < 0.001), and shorter duration from cancer diagnosis (OR 0.86 per log; P = 0.01) remained independent predictors of attrition.Conclusion
Advanced cancer patients with cognitive failure, increased physical symptoms, poorer performance status, and shorter duration from cancer diagnosis were more likely to dropout. These results have implications for research design, patient selection, and data interpretation in longitudinal observational studies. 相似文献96.
97.
In the immune oncology era, the clinical efficacy of immune checkpoint inhibitors (ICIs) against most solid cancers is well known. In hepatocellular carcinoma, the recent success of combination therapy with targeting agents has accelerated the search for novel combination strategies. Radiotherapy (RT), an attractive modality, can be combined with ICIs, which act as strong modulators of the tumor immune microenvironment. Herein, we discuss immune modulation caused by radiation and the current trials of RT–ICI combination treatment as well as future perspectives. 相似文献
98.
99.
《Journal of hepatology》2020,72(4):725-735
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100.
Siew Tzuh Tang Chia-Hsun Hsieh Wen-Chi Chou Wen-Cheng Chang Jen-Shi Chen Fur-Hsing Wen 《Journal of pain and symptom management》2021,61(5):974-982
BackgroundPreparing family caregivers for a patient's death is an integral component of quality end-of-life care, but temporal changes in emotional preparedness for death and its associations with caregivers' psychological well-being or quality of life (QOL) while providing end-of-life caregiving are under-researched. Our study was conducted to fill this gap.MethodsFor this prospective, longitudinal study, the course of changes in adequate emotional preparedness for death and its associations with severe depressive symptoms and QOL were examined on 309 consecutive caregivers of terminally ill cancer patients by univariate and multivariate generalized estimating equation analyses, respectively.ResultsPrevalence of adequate emotional preparedness for death was 57.2%, 61.3%, 54.4%, and 46.0% at 181-365, 91-180, 31-90, and 1-30 days before the patient's death, respectively, without significant changes as the patient's death approached. Adequate emotional preparedness for death was associated with caregivers' lower likelihood of severe depressive symptoms (adjusted odds ratio [95% CI]: 0.23 [0.16, 0.32], P < 0.001) but with their better QOL (adjusted β [95% CI]: 7.65 [6.38, 8.92], P < 0.001) in the patient's last year.ConclusionsWithout active, effective clinical interventions to promote caregivers' emotional preparedness for death, they cannot automatically become more prepared for the patient's death over time. Adequate emotional preparedness for the patient's death benefits caregivers by its associations with a lower likelihood of depressive symptoms and better QOL. Supportive programs for caregivers of terminally ill cancer patients should focus on not only enhancing caregiving skills but also cultivating emotional preparedness for their relative's death to promote their psychological well-being and QOL. 相似文献