Performance Status
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2021 ◽  
pp. 026921632110409
Jamilla A Hussain ◽  
Ian R White ◽  
Miriam J Johnson ◽  
Martin Bland ◽  
David C Currow

Background: Missing data compromise the internal and external validity of trial findings, however there is limited evidence on how best to reduce missing data in palliative care trials. Aim: To assess the association between participant and site level factors and missing data in palliative care trials. Design and setting: Individual participant-level data analysis of 10 phase 3 palliative care trials using multi-level cross-classified models. Results: Participants with missing data at the previous time-point and poorer performance status were more likely to have missing data for the primary outcome and quality of life outcomes, at the primary follow-up point and end of follow-up. At the end of follow-up, the number of site randomisations and number of study site personnel were significantly associated with missing data. Trial duration and the number of research personnel explained most of the variance at the trial and site-level respectively, except for the primary outcome where the amount of data requested was most important at the trial-level. Variance at the trial level was more substantial than at the site level across models and considerable variance remained unexplained for all models except quality of life at the end of follow-up. Conclusion: Participants with a poorer performance status are at higher risk of missing data in palliative care trials and require additional support to provide complete data. Performance status is a potential auxiliary variable for missing data imputation models. Reducing trial variability should be prioritised and further factors need to be identified and explored to explain the residual variance.

Children ◽  
2021 ◽  
Vol 8 (9) ◽  
pp. 814
Doina Paula Pruteanu ◽  
Elena Diana Olteanu ◽  
Rodica Cosnarovici ◽  
Emilia Mihut ◽  
Radu Ecea ◽  

(1) Background: Survival in childhood cancer has improved significantly over the last decades. However, early deaths (EDs) represent an important number of preventable deaths. Our aim was to provide more insight intoEDs in developing countries. (2) Methods: We conducted a retrospective analysis of patients aged 0–18 years with childhood cancer diagnosed between 1996 and 2008 and admitted in the Institute of Oncology “Prof. Dr. Ion Chiricuta” Cluj-Napoca (IOCN), Romania. After exclusion of patients (pts) older than 18 years at diagnosis, pts with a missing personal identification number and pts with unconfirmed diagnosis of malignancy, we included 783 pts in the final analysis. We defined ED as survival of less than one month after cancer diagnosis. We divided pts in groups according to age, major tumour categories and treatment time periods. (3) Results: ED was registered in 20 pts (2.55%). A total of 16EDs were registered in haematologic malignancies and 4 in solid tumours. Statistical analysis was performed on pts diagnosed with haematological malignancies. A statistically significant higher proportion of patients with performance status (PS) 3 and 4 died within one month after diagnosis (24.1%) than patients admitted with PS 0–2 (1%)—p < 0.01. We found no statistically significant difference regarding ED when comparing male versus female (p = 0.85), age at diagnosis or between the threeperiods of diagnosis (p = 0.7). (4) Conclusions: PS at admission is an important risk factor associated with ED in pts with haematologic malignancies. ED in our institution reflects frequent late presentation for medical care, late diagnosis and referral to specialised centres.

2021 ◽  
Evan Luther ◽  
Victor M Lu ◽  
Alexis A Morell ◽  
Turki Elarjani ◽  
Samuel Mansour ◽  

Abstract BACKGROUND Laser interstitial thermal therapy (LITT) for posterior fossa lesions remains rare as the small size of the infratentorial compartment, proximity to the brainstem, and thickness/angulation of the occipital bone creates barriers to procedural success. Furthermore, evaluation of the effect of ablation volume on outcomes is limited. OBJECTIVE To analyze our institutional experience with LITT in the posterior fossa stratifying perioperative and long-term outcomes by ablation volumes. METHODS Seventeen patients with posterior fossa lesions treated with LITT from 2013 to 2020 were identified. Local progression-free survival (PFS), overall survival, steroid dependence, and edema reduction were evaluated with Kaplan-Meier analysis grouped by ablation volume. Preoperative, postoperative, and last known Karnofsky Performance Status (KPS) were compared using a matched paired t test. RESULTS No differences in pathology, preoperative KPS, or preoperative lesion volume were found between patients with total (100%-200% increase in pre-LITT lesion volume) versus radical (&gt;200% increase in pre-LITT lesion volume) ablations. Patients who underwent radical ablation had a higher postoperative KPS (93 vs 82, P = .02) and higher KPS (94 vs 87, P = .04) and greater reduction in perilesional edema at last follow-up (P = .01). Median follow-up was 80.8 wk. CONCLUSION Despite obvious anatomical challenges, our results demonstrate that radical ablations are both feasible and safe in the posterior fossa. Furthermore, radical ablations may lead to greater decreases in perilesional edema and improved functional status both immediately after surgery and at last follow-up. Thus, LITT should be considered for patients with otherwise unresectable or radioresistant posterior fossa lesions.

Alexa Childs ◽  
Nekisa Zakeri ◽  
Yuk Ting Ma ◽  
Joanne O’Rourke ◽  
Paul Ross ◽  

Abstract Background Advanced hepatocellular carcinoma (HCC) is commonly diagnosed using non-invasive radiological criteria (NIRC) defined by the European Association for the Study of the Liver or the American Association for the Study of Liver Diseases. In 2017, The National Institute for Clinical Excellence mandated histological confirmation of disease to authorise the use of sorafenib in the UK. Methods This was a prospective multicentre audit in which patients suitable for sorafenib were identified at multidisciplinary meetings. The primary analysis cohort (PAC) was defined by the presence of Child-Pugh class A liver disease and performance status 0–2. Clinical, radiological and histological data were reported locally and collected on a standardised case report form. Results Eleven centres reported 418 cases, of which 361 comprised the PAC. Overall, 76% had chronic liver disease and 66% were cirrhotic. The diagnostic imaging was computed tomography in 71%, magnetic resonance imaging in 27% and 2% had both. Pre-existing histology was available in 45 patients and 270 underwent a new biopsy, which confirmed HCC in 93.4%. Alternative histological diagnoses included cholangiocarcinoma (CC) and combined HCC-CC. In cirrhotic patients, NIRC criteria had a sensitivity of 65.4% and a positive predictive value of 91.4% to detect HCC. Two patients (0.7%) experienced mild post-biopsy bleeding. Conclusion The diagnostic biopsy is safe and feasible for most patients eligible for systemic therapy

2021 ◽  
zhiqin lu ◽  
Yuanyuan Liang ◽  
Xia Wang ◽  
Zhimin Zeng ◽  
Congying Zhong ◽  

Abstract PurposeLeptomeningeal metastases is a fatal complication of advanced non-small cell lung cancer (NSCLC). This study aimed to assess the clinical efficacy of alectinib in ALK-positive NSCLC with LM patients previously treated with crizotinib.MethodsRetrospective study of NSCLC patients with alectinib-treated ALK- positive NSCLC and LM.ResultsFourteen patients (mean age, 55 years; 50% women) with adenocarcinoma NSCLC were included in the study. Before starting alectinib, all patients were treated with crizotinib. When LM was diagnosed, all patients had clinical symptoms. Sixteen (50%) patients had a performance status>2. Of 14 total patients, 85.7% (12/14) of the patients had a clinical and radiological responses. From the start of alectinib, median OS and PFS were 17.4 (95% CI, 8.9–25.9) and 11.6 months (95% CI: 8.4–14.8), respectively, one-year survival rate was 57.1%.ConclusionAlectinib had significant efficacy against NSCLC with LM, this efficacy was rapid in several patients, even some with poor performance status. Alectinib might be a suitable option for specific patient populations with advanced ALK-positive NSCLC with LM.

2021 ◽  
pp. oemed-2021-107622
Jarle Jakobsen ◽  
Marit B Veierød ◽  
Tom K Grimsrud ◽  
Sophie Dorothea Fosså ◽  
Bato Hammarström ◽  

ObjectivesTo examine age at diagnosis, prognostic factors and survival of prostate cancer (PCa) in Norwegian firefighters and three other occupations undergoing occupational health check-ups, and comparing with PCa cases in the general population.MethodsAll PCa cases diagnosed in 1960–2017 were extracted from the Cancer Registry of Norway. Firefighters, military employees, pilots and police officers were identified through occupational data from Statistics Norway. Age at diagnosis, clinical stage, prostate-specific antigen (PSA), Gleason score, performance status and overall survival and PCa-specific survival in cases in these occupations were compared with cases in the general population.ResultsFirefighters were significantly younger at PCa diagnosis than cases in the general population in 1960–1993 (mean difference: 2.1 years) and 2007–2017 (mean difference: 4.3 years). At diagnosis, firefighters had significantly lower PSA values, Gleason scores and performance status scores than the general population. Firefighters diagnosed in 2007–2017 had lower risk of all-cause death than the general population (crude HR 0.71 (0.53–0.95)). No difference remained after adjusting for age at diagnosis (HR 1.03 (0.77–1.37)). Firefighters were older at diagnosis in 1994–2006 (mean difference: 3.0 years), but showed no other significant differences in age at diagnosis, PSA values, Gleason scores or performance status compared with military employees, pilots and police officers.ConclusionsYounger age and better prognostic factors at PCa diagnosis among firefighters and other occupations with requirements for health check-ups than cases in the general population may indicate an increased diagnostic intensity, likely contributing to elevated PCa incidence in such occupations.

TH Open ◽  
2021 ◽  
Sandra Lee ◽  
Anika Shenoy ◽  
Daniel Shi ◽  
Mootaz Husien ◽  
Pablo E. Serrano ◽  

Background: Patients undergoing systemic cancer therapy are susceptible to developing venous thromboembolism (VTE). The most pertinent prognostic factors for VTE remain unclear. This systematic review aims to summarize prognostic factors associated with VTE in this population. Methods: MEDLINE, Embase, and CENTRAL databases were searched for observational or randomized studies that used multivariable analysis adjusted for tumour type and/or metastatic disease to model the risk of VTE. Adjusted effect estimates for each prognostic factor were collected for all of the included studies. Risk of bias was assessed using the Quality in Prognostic Factor Studies (QUIPS) tool. Results: From 5,988 search results, 15 eligible studies and 42 prognostic factors were identified. A total of 8,554 patients of whom 456 (5.33%) developed VTE were included. Fourteen studies had a high risk of bias and one study had a moderate risk. The most commonly reported prognostic factors include age, gender, tumour site, metastasis, performance status, and systemic therapy type. Poor performance status and the use of platinum-based chemotherapy compounds were associated with an increased risk of VTE across the majority of studies. The evidence to suggest that the other prognostic factors identified were associated with VTE development was inconclusive. Several individual studies identified novel biomarkers for VTE. Heterogeneity in statistical methods and prognostic factor definitions across studies precluded meta-analysis. Conclusion: Overall, many prognostic factors were identified; however, the evidence for association with development of VTE for most of the factors is inconclusive. Findings were limited by high heterogeneity and risk of bias in the included studies.

Biology ◽  
2021 ◽  
Vol 10 (9) ◽  
pp. 890
Rocío Jiménez Jiménez Galán ◽  
Elena Prado-Mel ◽  
María Antonia Pérez-Moreno ◽  
Estefanía Caballano-Infantes ◽  
Sandra Flores Moreno

The KEYNOTE-024 clinical trial showed promising results for pembrolizumab in the first-line of treatment of advanced non-small-cell lung cancer (NSCLC). However, the profile of patients in real-world practice differs from those included in this clinical trial. Here, an observational single-center retrospective study was performed through a comparative analysis of clinical outcomes after pembrolizumab therapy according to the Eastern Cooperative Oncology Group Stage Performance Status (ECOG PS). Moreover, univariate and multivariate analyses were carried out to detect prognostic factors. In our cohort, 63.7% of patients had an ECOG PS of 0–1. Regarding response rate, 31.8% of patients had a partial response (PR), 19.3% had stable disease (SD) and 23.9% had progression disease. On the other hand, patients with ECOG PS ≥ 2 showed a significantly lower rate of PR and SD to pembrolizumab than patients with a PS of 0–1. The rate of response, median overall survival (OS) and progression-free survival (PFS) were significantly higher in patients with ECOG PS 0–1 than in those with ECOG PS ≥ 2. In the current study, we found ECOG PS as the only independent predictor of OS and PFS. Due to the ECOG PS scale being a subjective parameter, other tools are needed to identify treatment effectiveness to each patient.

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