Characteristics of elderly-specific oncology trials registered in ClinicalTrials.gov.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12040-12040
Author(s):  
Bian Wu ◽  
Yun Yang ◽  
Yun Tang ◽  
Yongqiang Zheng ◽  
Mingxing Xie ◽  
...  
Keyword(s):  
The Elderly ◽  
Solid Cancer ◽  
Cancer Type ◽  
Blood Cancer ◽  
Patients With Cancer ◽  
End Point ◽  
Elder Patients ◽  
Time Period ◽  
Incidence And Mortality ◽  
Patient Reported

12040 Background: Clinical trials dedicated to the elderly cancer patients are essential to help to define optimal cancer therapy for this rapidly growing population. Our study aimed to analyze the characteristics and the evolution of elderly-specific oncology trials registered in ClinicalTrials.gov. Methods: A dataset of 61120 oncology trials registered in ClinicalTrials.gov between Jan 1th, 2000 and Dec 17th, 2019 was downloaded. Interventional trials were identified and systematically reviewed to validate classification into elderly-specific (at least using a chronological landmark to define the elderly) and age-unspecified trials. Cancer type and other registration information were extracted. Characteristics of elderly-specific trials were compared with characteristics of age-unspecified trials. Chronological shifts in elderly-specific trials between 2000 to 2009, and 2010 to 2019 were analyzed. Results: Of the 49273 trials eligible for analysis, only 791 (1.6%) were elderly-specific. The most frequently used threshold to define the old was 60 years (36%), followed by 70 years (28%) and 65 years (26%). More than half of the elderly-specific trials were phase 2 (56.8%) trials and enrolled 100 or fewer participants (59.4%). Compared with age-unspecified trials, elderly-specific trials were less likely to be funded by industry (28.3% vs 37.1%; p < 0.001), and more likely to be conducted in Europe (42.1% vs 24.5%, p < 0.001). During the two time periods between 2000 to 2009, and 2010 to 2019, the proportion of elderly-specific trials of all the oncology trials remained stable (1.57% vs 1.62%). The proportion of treatment-oriented trials decreased from 91.9% to 71.4% (p < 0.001) while supportive care-oriented trials increased from 1.9% to 13.2% (p < 0.001). Industry-funded elderly-specific trials decreased from 34.0% to 25.6% (p = 0.014). Concerningly, the use of clinically meaningful end points in elderly such as disease-specific survival, patient-reported outcomes (PROs) and functional status as a primary end point were uncommon (0.5%, 8.0%, and 6.9%, respectively). However, the use of PROs as a primary end point tended to increase in the second time period, from 2.4% to 10.5% (p < 0.001). There was no correlation between the number of trials for a given cancer type and relative incidence and mortality. 336/791 (42.5%) of the trials were conducted for patients with blood cancer, although the incidence and mortality of blood cancer were relatively low. The most common solid cancer types were breast cancer (13.9%), lung cancer (10.0%), and colorectal cancer (7.8%). Conclusions: Although the majority of all new cases of cancer occur in the elderly population, elderly-specific trials account for only a minority of all oncology trials. Our study helps us to better understand the current state of elderly-specific trials and provides insights for future development that can improve the care of elder patients with cancer.

scholarly journals Impact of Comorbidities on Length of Stay and Mortality in Hospitalized Patients with Cancer and Febrile Neutropenia

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2601-2601 ◽  
Author(s):  
Eva Culakova ◽  
Marek S. Poniewierski ◽  
Jeffrey Crawford ◽  
David C. Dale ◽  
Gary H. Lyman
Keyword(s):  
Length Of Stay ◽  
Hospital Mortality ◽  
Research Funding ◽  
Infectious Complications ◽  
Hospitalized Patients ◽  
Cancer Type ◽  
Patients With Cancer ◽  
Time Period ◽  
Increased Risk ◽  
The Impact

Background: Hematologic toxicities are common side effects of cancer chemotherapy. Despite advances in supportive care, febrile neutropenia (FN) continues to represent a serious adverse event often requiring hospitalization and is associated with an increased risk of mortality. The purpose of this analysis was to investigate the impact of comorbidities and infectious complications on in-patient length of stay (LOS) and mortality in hospitalized patients with cancer and neutropenia over the past decade. Methods: Hospitalization data from the University Health Consortium database inclusive of the years 2004-2012 from 239 US medical centers were analyzed. Cancer type, presence of neutropenia, comorbidities, and infection type were based on ICD-9-CM codes recorded during hospitalization. This analysis includes adult patients with malignant disease and neutropenia. Patients undergoing bone marrow or stem cell transplantation were excluded. For patients with multiple hospitalizations, the first admission during the time period studied was utilized. Primary study outcomes included hospital length of stay (LOS≥10 days) and in-hospital mortality. Multivariate logistic regression analysis was utilized to study the impact of major comorbidities on the primary outcomes. Major comorbidities under consideration included heart, liver, lung, renal, cerebrovascular, peripheral-vascular disease, diabetes and venous thromboembolism. Results: Among 135,309 patients with cancer hospitalized with neutropenic events, one-third were age 65 years or older and 51% were male. Approximately one-quarter (24.5%) of patients experienced more than one admission with FN. The mean (median) length of stay increased progressively from 11.1 (6) days in 2004 to 12.8 (7) days in 2012. Patients with leukemia, lymphoma and central nervous system (CNS) malignancies experienced the longest mean LOS (21.4, 10.5, 10.2 days, respectively). Overall, 50,846 (37.6%) had a LOS≥10 days and 10,261 (7.6%) patients died during the hospitalization with no difference seen over the time period of observation. (P=.30). Greater rates of mortality were observed in patients with lung (11.2%) or CNS (9.3%) malignancies, and leukemia (9.3%). Infectious complications were documented in 59.5% of patients and their presence was associated with greater LOS≥10 days (48.2% vs. 22.0%) and higher mortality (11.2% vs. 2.3%). Greater LOS≥10 days (51.6% vs. 37.1%) and increased mortality (9.8% vs. 7.5%) were also observed among obese patients with cancer. Likewise, patients with multiple comorbid conditions had more prolonged hospitalizations and a greater risk of in-hospital mortality. (Table) Abstract 2601. Table Solid tumors Lymphoma LeukemiaNo. of comorbiditiesNo. of patients% died% with LOS≥10 daysNo. of patients% died% with LOS≥10 daysNo. of patients% died% with LOS≥10 days017,8580.911.28,1890.617.010,3950.853.5118,1723.417.97,7512.626.611,3803.463.2214,2508.927.25,3868.141.08,6039.769.937,49918.038.42,86118.455.25,04022.877.742,70525.151.41,06033.670.52,00438.183.1≥ 560235.262.327839.980.657749.087.0All patients*61,0867.022.625,5256.632.237,9999.265.4 LOS – length of stay; * 10,699 patients with other type or multiple tumors not included in the table The trend toward longer LOS and greater mortality with increased number of comorbidities persisted in multivariate analyses after adjusting for cancer type, age, gender, ethnicity and type of infection (odds ratio (OR) per +1 comorbidity increase: [mortality: OR =1.89; 95% CI: 1.85-1.92; P<.0001], [LOS: OR=1.56; 95% CI: 1.54-1.58; P<.0001]). Conclusions: Major medical comorbidities are common among hospitalized patients with cancer and neutropenia. Importantly, such comorbidities are associated with prolonged hospitalization and increased risk of in-hospital mortality with significantly worse outcomes in patients with lymphoma or leukemia. Greater awareness of risk factors associated with poor prognosis in cancer patients hospitalized with neutropenic complications as well as validated risk tools to better identify low risk as well high risk patients may guide more personalized cancer care, potentially improving clinical outcomes and lowering the cost of care. Disclosures Crawford: Amgen: Consultancy. Dale:Amgen: Consultancy, Honoraria, Research Funding. Lyman:Amgen: Research Funding.

scholarly journals Using patient reported outcomes in oncology clinical practice

2016 ◽  
Vol 13 (1) ◽  
pp. 6-11 ◽  
Author(s):  
Sarah A. Kelleher ◽  
Tamara J. Somers ◽  
Tracie Locklear ◽  
Alexandra D. Crosswell ◽  
Amy P. Abernethy
Keyword(s):  
Symptom Severity ◽  
Psychosocial Functioning ◽  
Self Efficacy ◽  
Symptom Management ◽  
Patient Reported Outcomes ◽  
Tablet Computer ◽  
Cancer Type ◽  
Pain Symptom ◽  
Patients With Cancer ◽  
Patient Reported

AbstractBackground and aimsPatient reported outcomes (PROs) are increasingly being implemented into the care of patients with cancer. The use of a standard set of PROs (e.g., pain) in cancer is becoming established and there is interest in what additional PROs might provide valuable information. The goal of this observational study was to examine how the PROs of self-efficacy for pain and other symptoms assessed at the point of service were associated with pain, symptom severity and distress, and physical and psychosocial functioning in a sample of breast and gastrointestinal patients. We also sought to examine differences in these relationships by cancer type (breast and gastrointestinal) as well as understand differences in self-assessment mode (paper/pencil or electronic tablet).Methods178 patients with breast (n = 65) and gastrointestinal cancer (n = 113) completed the Chronic Pain Self Efficacy Scale, M.D. Anderson Symptom Inventory, and Functional Assessment of Cancer Therapy – General questionnaires. Measures were completed with paper and pencil and electronically using a tablet computer while patients waited for their clinical appointment. Responses from the initial completed questionnaires on both the paper and electronic instruments were analyzed.ResultsPatients’ self-efficacy scores for pain and other symptoms correlated positively with pain, symptom severity and distress, and physical and psychosocial functioning; patients with lower levels of self-efficacy reported poorer outcomes and functioning overall. The results were independent of cancer type and mode of assessment. No statistically significant differences were found in the PROs when collected by electronic technology versus paper-pencil mode; patients were very satisfied with using the tablet computer to complete the PRO measures.Conclusions and implicationsOur results suggest that self-efficacy for pain and symptom management may be a beneficial addition to clinic-based PRO assessment batteries for patients with cancer and other chronic diseases. Existing short, validated symptom self-efficacy scales could easily be integrated into clinical practice to help healthcare providers identify patients that might benefit from intervention. Study results also support existing research that suggests electronic approaches are a practical way to collect PRO data, including self-efficacy data, in the clinic. Overall, our data suggest that patients who have particularly low levels of self-efficacy for pain and symptom management may be at risk for higher levels of pain and disability. Thus, if self-efficacy for pain and symptom management were routinely collected at the time of clinical service, psychosocial interventions to improve self-efficacy for pain and symptom management, and in turn overall quality of life, could be implemented in a timely fashion.

Incidence of atrial fibrillation in cancer patients according to cancer type

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P.S Yang ◽  
M Shim ◽  
S.H Kang ◽  
S.H Kim ◽  
W.J Kim ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Atrial Fibrillation ◽  
Cancer Patients ◽  
The Elderly ◽  
Incidence Rates ◽  
Solid Cancer ◽  
Cancer Type ◽  
Hematologic Cancer ◽  
Korean National Health Insurance ◽  
Elderly Cohort

Abstract Background and objectives The prevalence of both atrial fibrillation (AF) and cancer are increasing especially in the elderly. The occurrence of AF in cancer may be related to comorbidities of patients, cancer treatment, or a direct tumor effect. The objectives of this study were to investigate the incidence of AF according to cancer type. Methods From the Korean National Health Insurance Service elderly (NHIS-elderly) cohort (age &gt;60), we identified 67,077 patients with newly diagnosed cancer and without previous AF. Incidence rates of new onset AF were evaluated. Results The mean age of the cancer patients was 75.1 year and 53.5% were males. During a median follow-up period of 25 months, the incidence rate of AF among overall cancer patients was higher than that of age-sex matched non-cancer population (1.42 vs. 0.69 per 100 person-years, respectively). Compared with solid cancer, the risk of incident AF in patients with hematologic cancer was significantly higher (hazard ratio [HR]: 1.53, 95% confidence interval [CI]: 1.39–1.72, p&lt;0.001). Among patients with solid cancer, thoracic (lung cancer, esophageal cancer, mediastinal cancer, etc.) and breast cancer was associated with a higher risk of AF incidence compared with other solid cancer (HR: 1.64, 95% CI: 1.53–1.76, p&lt;0.001). Conclusions Cancer was associated with an increased incidence of AF. Hematologic cancer was associated with higher risk of AF incidence than solid cancer. Among solid cancer, thoracic and breast cancer was most strongly associated with the risk of AF incidence. Funding Acknowledgement Type of funding source: None

scholarly journals Defining, Measuring and Preventing the Diagnosis of Cancer as an Emergency: A Critical Review of Current Evidence

2018 ◽  
Vol 4 (Supplement 2) ◽  
pp. 48s-48s
Author(s):  
Y. Zhou ◽  
G. Abel ◽  
W. Hamilton ◽  
K. Pritchard-Jones ◽  
C. Gross ◽  
...  
Keyword(s):  
Health Care ◽  
Developed Countries ◽  
Health Care Use ◽  
Current Evidence ◽  
Cancer Type ◽  
Patients With Cancer ◽  
Emergency Presentation ◽  
Combination Methods ◽  
Patient Reported ◽  
Diagnosis Of Cancer

Background: Many patients with cancer are diagnosed through an emergency presentation, which is associated with inferior clinical and patient-reported outcomes compared with those of patients who are diagnosed electively or through screening. Reducing the proportion of patients with cancer who are diagnosed as emergencies is, therefore, desirable; however, the optimal means of achieving this aim are uncertain owing to the involvement of different tumor, patient and health-care factors, often in combination. Methods: We searched the literature to identify all population-based studies that examined emergency presentation as a diagnosis or independent variable. Results: Most relevant evidence relates to patients with colorectal or lung cancer in a few economically developed countries, and defines emergency presentations contextually (that is, whether patients presented to emergency health-care services and/or received emergency treatment shortly before their diagnosis) as opposed to clinically (whether patients presented with life-threatening manifestations of their cancer). Consistent inequalities in the risk of emergency presentations by patient characteristics and cancer type have been described, but limited evidence is available on whether, and how, such presentations can be prevented. Evidence on patients' symptoms and health-care use before presentation as an emergency is sparse. Conclusion: In this review, we describe the extent, causes and implications of a diagnosis of cancer following an emergency presentation, and provide recommendations for public health and health-care interventions, and research efforts aimed at addressing this underresearched aspect of cancer diagnosis.

Should Sequential Bilateral Total Knee Arthroplasty Be Limited to Patients Younger than 80? A Two-Arm Propensity Matched Study

2020 ◽  
Author(s):  
Antonio Klasan ◽  
Sven Edward Putnis ◽  
Wai Weng Yeo ◽  
Darli Myat ◽  
Brett Andrew Fritsch ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Patient Selection ◽  
Knee Arthroplasty ◽  
Major Complication ◽  
The Elderly ◽  
Complication Rates ◽  
Bilateral Total Knee Arthroplasty ◽  
Proper Patient Selection ◽  
Patient Reported ◽  
Total Knee

AbstractDespite multiple studies, there remains a debate on the safety of bilateral total knee arthroplasty (BTKA) in the average age patient, with a paucity of data on the outcome of BTKA in an elderly population. This study included 89 patients aged 80 years and older undergoing sequential BTKA over 14 years were identified in a prospectively collected database. Two matched comparison groups were created: patients under 80 undergoing sequential BTKA and patients over 80 undergoing unilateral TKA (UTKA). An analysis of complications, mortality, revision, and patient-reported outcome measures was performed. Mean age of the elderly cohorts was similar: 82.6 for BTKA and 82.9 for UTKA. The average age BTKA cohort had a mean age of 69.1. Complication rates were higher in bilateral cohorts, more so in the elderly BTKA cohort. Pulmonary embolism (PE) was observed in bilateral cohorts only. In these patients, history of PE and ischemic heart disease was a strong predictive factor for developing a major complication. There was no difference in revision rates and infection rates between the three cohorts, and no difference in patient survivorship between the two elderly cohorts. Through the combination of low revision and high survivorship rates and comparable clinical outcomes, this article demonstrates that simultaneous BTKA is an appropriate option to consider for an elderly patient, with proper patient selection and perioperative management. The demonstrated risk groups show that emphasis on patient selection should be focused on medical history rather than chronological age.

scholarly journals Secondary Normal-Pressure Hydrocephalus in Rheumatoid Meningitis

2021 ◽  
pp. 434-440
Author(s):  
Micaela Owens ◽  
Na Tosha Gatson ◽  
Gino Mongelluzzo ◽  
Oded Goren ◽  
Eric Newman ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Normal Pressure Hydrocephalus ◽  
Immune Suppression ◽  
Normal Pressure ◽  
The Elderly ◽  
Common Cause ◽  
Gait Abnormality ◽  
Ventriculoperitoneal Shunting ◽  
Patient Reported ◽  
Rheumatoid Meningitis

Normal-pressure hydrocephalus (NPH) is a common cause of gait apraxia, cognitive impairment, and urinary incontinence in the elderly. It is usually a primary idiopathic disorder but can be secondary. We present a case of secondary NPH due to biopsy-confirmed rheumatoid meningitis initially refractory to intravenous (IV) immunotherapy. Our patient reported an excellent response right after shunting. Her gait remains normal one and a half years later. We searched PubMed for similar cases of rheumatoid meningitis with gait abnormality for additional clinicopathologic discussion. The patient’s movement disorder initially improved with steroid taper. However, she developed progressive symptoms, later on, refractory to IV solumedrol and rituximab. She underwent ventriculoperitoneal shunting (VPS) and reported an outstanding outcome. This is the first reported biopsy-confirmed case of rheumatoid meningitis causing NPH to undergo shunting for immediate improvement. Previous cases of rheumatoid meningitis-associated Parkinsonism have improved with steroid induction. Although our patient’s rheumatoid arthritis is now controlled, her case illustrates that NPH in autoinflammatory conditions may not recover with immune suppression alone. VPS is an option for a faster response in secondary NPH due to rheumatoid meningitis or other inflammatory disorders with progressive symptoms despite standard induction therapy.

scholarly journals Safety of High-Dose Dabigatran in Elderly and Younger Patients with a Low Bleeding Risk: A Prospective Observational Study

Cardiology ◽  
2021 ◽  
pp. 1-5
Author(s):  
Aharon Erez ◽  
Gregory Golovchiner ◽  
Robert Klempfner ◽  
Ehud Kadmon ◽  
Gustavo Ruben Goldenberg ◽  
...  
Keyword(s):  
Observational Study ◽  
Elderly Patients ◽  
Prospective Observational Study ◽  
Bleeding Risk ◽  
The Elderly ◽  
High Dose ◽  
World Population ◽  
Younger Patients ◽  
End Point

<b><i>Introduction:</i></b> In patients with atrial fibrillation (AF) at risk for stroke, dabigatran 150 mg twice a day (DE150) is superior to warfarin for stroke prevention. However, there is paucity of data with respect to bleeding risk at this dose in elderly patients (≥75 years). We aimed to evaluate the safety of DE150 in comparison to warfarin in a real-world population with AF and low bleeding risk (HAS-BLED score ≤2). <b><i>Methods:</i></b> In this prospective observational study, 754 consecutive patients with AF and HAS-BLED score ≤2 were included. We compared outcome of elderly patients (age ≥75 tears) to younger patients (age &#x3c;75 years). The primary end point was the combined incidence of all-cause mortality, stroke, systemic emboli, and major bleeding event during a mean follow-up of 1 year. <b><i>Results:</i></b> There were 230 (30%) elderly patients, 151 patients were treated with warfarin, and 79 were treated with DE150. Fifty-two patients experienced the primary endpoint during the 1-year follow-up. Among the elderly, at 1-year of follow-up, the cumulative event rate of the combined endpoint in the DE150 and warfarin was 8.9 and 15.9% respectively (<i>p</i> = 0.14). After adjustment for age and gender, patients who were treated with DE150 had a nonsignificant difference in the risk for the combined end point as patients treated with warfarin both among the elderly and among the younger population (HR 0.58, 95% C.I = 0.25–1.39 and HR = 1.12, 95% C.I 0.62–2.00, respectively [<i>p</i> for age-group-by-treatment interaction = 0.83). <b><i>Conclusions:</i></b> Our results suggest that Dabigatran 150 mg twice a day can be safely used among elderly AF patients with low bleeding risk.

scholarly journals The role of EORTC QLQ-C15-PAL scores and inflammatory biomarkers in predicting survival in terminally ill patients with cancer

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nanako Koyama ◽  
Chikako Matsumura ◽  
Yoshihiro Shitashimizu ◽  
Morito Sako ◽  
Hideo Kurosawa ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Cox Regression ◽  
Terminally Ill ◽  
Inflammatory Biomarkers ◽  
Survival Curves ◽  
Patients With Cancer ◽  
Terminally Ill Patients ◽  
Patient Reported ◽  
Eortc Qlq

Abstract Background The clinical use of patient-reported outcomes as compared to inflammatory biomarkers for predicting cancer survival remains a challenge in palliative care settings. We evaluated the role of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative scores (EORTC QLQ-C15-PAL) and the inflammatory biomarkers C-reactive protein (CRP), albumin (Alb), and neutrophil-lymphocyte ratio (NLR) for survival prediction in patients with advanced cancer. Methods This was an observational study in terminally ill patients with cancer hospitalized in a palliative care unit between June 2018 and December 2019. Patients’ data collected at the time of hospitalization were analyzed. Cox regression was performed to examine significant factors influencing survival. A receiver operating characteristic (ROC) analysis was performed to estimate cut-off values for predicting survival within 3 weeks, and a log-rank test was performed to compare survival curves between groups divided by the cut-off values. Results Totally, 130 patients participated in the study. Cox regression suggested that the QLQ-C15-PAL dyspnea and fatigue scores and levels of CRP, Alb, and NLR were significantly associated with survival time, and cut-off values were 66.67, 66.67, 3.0 mg/dL, 2.5 g/dL, and 8.2, respectively. The areas under ROC curves of these variables were 0.6–0.7. There were statistically significant differences in the survival curves between groups categorized using each of these cut-off values (p < .05 for all cases). Conclusion Our findings suggest that the assessment of not only objective indicators for the systemic inflammatory response but also patient-reported outcomes using EORTC QLQ-C15-PAL is beneficial for the prediction of short-term survival in terminally ill patients with cancer.

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