scholarly journals Environmental Sars-Cov-2 Surface Testing: Low Incidence of Virus Positivity in Outpatient and Inpatient Hematology/Oncology Settings

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 24-25
Author(s):  
Mansi R Shah ◽  
Imraan Jan ◽  
Jeremy Johns ◽  
Kuldip Singh ◽  
Pallavi Kumar ◽  
...  
Keyword(s):  
Infection Control ◽  
Cancer Patients ◽  
Real World ◽  
Research Funding ◽  
Positive Sample ◽  
Viral Rna ◽  
Social Distancing ◽  
Environmental Surfaces ◽  
The One ◽  
Surface Testing

Introduction: Current evidence suggests that the COVID-19 related mortality and morbidity is higher in cancer patients due to increased visits to healthcare facilities (e.g., doctor's visits, phlebotomy, imaging, social work, financial consultations, therapy administration, etc) and inherent or therapy-induced immunosuppression. Patients with hematologic malignancies harboring SARS-CoV-2 have the highest mortality compared with other cancer patients. Although COVID-19 is knowingly transmitted person to person via respiratory droplets, there is potential for infection from contact with surfaces (e.g. plastic, metal, cardboard, etc) polluted with fomites that have been shown to have viable virus up to 72 hours in laboratory settings (Van Doremalen et al. NEJM 2020). The risk of nosocomial infections is hypothesized to be due to environmental contact and contamination, but there are no real-world analyses that exist that demonstrate the impact of recently established infection control policies (e.g., strict use of personal protective equipment (PPE), social distancing, hand hygiene, disinfectant protocols, etc) in hematology/oncology patient settings. This study evaluated the frequency of SARS-CoV-2 on a multitude of environmental surfaces in outpatient and inpatient settings in a large tertiary COVID-19 referral cancer center in New Jersey. Methods: IRB approval was obtained to conduct the study in a COVID-19 referral center in 2 large, freestanding outpatient clinics (i.e., malignant hematology and medical oncology) and co-localized infusion suites as well as two physically separated inpatient units (i.e., a leukemia/lymphoma/CART unit and an active COVID-19 floor, the latter housing cancer patients actively infected with SARS-CoV-2 and persons under investigation (PUI) for infection). Surface testing for viral RNA in the outpatient infusions suites included spaces where several patients with recent SARS-CoV-2 infection were receiving cancer treatment in the outpatient setting. High-impact areas were selected based on frequency of use, patient and healthcare provider contact, and risk of contamination from COVID-19 positive subjects (COVID-19+) and PUIs due to virus transmissibility. Surfaces were sampled on Mondays, Wednesdays and Fridays from 6/17/20 through 6/29/20 prior to scheduled cleaning and disinfection services, but after patient or staff use, following WHO protocols for COVID-19 surface sampling. Specimens were analyzed with real-time reverse transcriptase PCR analysis. Results: Overall, 204 total environmental samples were collected over the study period. Testing sites were categorized as 1) Public areas (waiting rooms, infusion areas, bathrooms, floors, elevator banks, doors, and exam rooms included designated isolation rooms for known COVID-19+/PUIs); 2) Staff areas (computer equipment, pneumatic tubing stations, pharmacy bench, and medication rooms); and 3) Medical equipment (IV poles, chemotherapy bags, vitals monitor, telemetry stations, and linen carts). Among the 130 surfaces examined from the two outpatient hematology-oncology clinics and 36 tests from the inpatient leukemia/lymphoma/CART cell unit, all 166 surfaces were negative for SARS-CoV-2 viral RNA (see Table). Among the inpatient COVID-19+ and PUI units, one of 38 samples were positive (2.6%). The one positive sample was taken from the floor of an elderly patient with multiple medical comorbidities being treated with remdesevir, dexamethasone, and apixaban for SARS-CoV-2 pneumonia. Altogether, the positive test rate for SARS-CoV-2 RNA across all surfaces in the combined outpatient and inpatient hematology/oncology units was 0.5% (1/204). Discussion : This systematic investigation of 'real world' environmental surfaces performed in outpatient and inpatient hematology-oncology units revealed overall negligible detection of active SARS-CoV-2 RNA. It highlights the efficacy of current, detailed infection control policies (e.g., screening, nursing-directed triage for PUIs/COVID-19+ patients, visitor restriction, telehealth, social distancing, and disinfection protocols) and should also mitigate concerns of healthcare providers and patients, particularly those in the healthcare setting with blood disorders. Additionally, the one positive sample from a COVID-19 unit emphasizes the need for physical separation of patients with SARS-CoV-2. Disclosures Evens: Research To Practice: Honoraria, Speakers Bureau; Merck: Consultancy, Honoraria, Research Funding; Pharmacyclics: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; MorphoSys: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria, Research Funding; Epizyme: Consultancy, Honoraria, Research Funding; Mylteni: Consultancy, Honoraria.

Real-World Analysis of Venous Thromboembolism Rates and Thromboprophylaxis Prescribing In US Patients with Cancer.

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3802-3802
Author(s):  
Alpesh N Amin ◽  
Jay Lin ◽  
Stephen Thompson ◽  
Daniel Wiederkehr
Keyword(s):  
Cancer Patients ◽  
Hospital Discharge ◽  
Real World ◽  
Research Funding ◽  
Outpatient Setting ◽  
Index Hospitalization ◽  
Post Discharge ◽  
Pharmacological Prophylaxis ◽  
Mechanical Prophylaxis ◽  
Patients With Cancer

Abstract Abstract 3802 Background: Deep-vein thrombosis (DVT) is a frequent complication of cancer and treatment of cancer. Among clinical guidelines, there is broad consensus regarding the importance of thromboprophylaxis in hospitalized cancer patients, including prolonged prophylaxis in high-risk patients. The objective of this analysis was to assess the real-world use of prophylaxis for DVT, as well as symptomatic rates of DVT and pulmonary embolism (PE) in cancer patients, both during hospitalization and after hospital discharge. Methods: Data were extracted from the US Premier Perspective(tm)-i3 Pharma Informatics linked database for non-surgical cancer patients who were admitted to hospital from January 2005 to November 2007. Included patients were aged ≥ 18 years and had ≥ 6 months' continuous plan enrollment. Patients were excluded if they were discharged to an acute-care facility, had length of hospital stay ≤ 0 or > 30 days, had missing/unknown gender or age data, or if they were diagnosed with atrial fibrillation during index hospitalization. Clinical rates of DVT/PE, as well as thromboprophylaxis status and duration were evaluated for during hospitalization and post-discharge. Results: Of the 3,759 cancer patients analyzed, 51.9% received inpatient pharmacological and/or mechanical prophylaxis, and 2.8% received outpatient pharmacological prophylaxis in the 14 days following discharge. During index hospitalization 40.0% of patients received mechanical prophylaxis and 21.1% pharmacological prophylaxis, with 9.3% of patients receiving a combination of mechanical and pharmacological prophylaxis. Mean (± standard deviation) duration of prophylaxis was 1.3 (± 2.3) days for inpatients and 0.7 (± 4.5) days post-discharge among all cancer patients. Symptomatic DVT/PE occurred in 2.4% of patients during hospitalization. In the 30 days following hospital discharge, 1.7% of patients was either rehospitalized for DVT/PE or treated for DVT/PE in the outpatient setting. Conclusions: This real-world analysis demonstrates considerable symptomatic rates of DVT/PE in hospitalized cancer patients, with approximately half of patients not receiving any thromboprophylaxis. The risk of DVT/PE persisted into the outpatient setting, but few patients received anticoagulants post-discharge. Further efforts are needed to ensure that patients with cancer receive appropriate thromboprophylaxis and that it is of adequate duration to reduce the large burden of DVT/PE. Acknowledgment: This study was funded by sanofi-aventis U.S., Inc. The authors received editorial/writing support in the preparation of this abstract provided by Tessa Hartog, PhD of Excerpta Medica, funded by sanofi-aventis U.S., Inc. Disclosures: Amin: sanofi-aventis US Inc.: Honoraria, Speakers Bureau. Lin:sanofi-aventis US Inc.: Employment, Research Funding. Thompson:sanofi-aventis US Inc.: Employment. Wiederkehr:sanofi-aventis US Inc.: Research Funding.

An Italian, multicenter, real-world, retrospective study of first-line pazopanib in unselected metastatic renal-cell carcinoma patients: the ‘Pamerit’ study

2020 ◽  
Author(s):  
Alessandra Mosca ◽  
Ugo De Giorgi ◽  
Giuseppe Procopio ◽  
Umberto Basso ◽  
Giacomo Cartenì ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Renal Cell Cancer ◽  
Real World ◽  
Renal Cell ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
First Line ◽  
Free Survival ◽  
Metastatic Renal Cell Cancer ◽  
Metastatic Rcc

Abstract Objective Despite the current immunotherapy era, VEGFR inhibitors maintain effectiveness in metastatic renal cell cancer. Real-world data concerning pazopanib are limited. The aim of this study is to add information about efficacy and safety of pazopanib as first-line treatment in metastatic renal cell cancer patients not enrolled into clinical trials. Methods Retrospective analysis (the PAMERIT study) of first-line pazopanib in real-world metastatic renal cell cancer patients among 39 Centers in Italy. Outcomes were progression-free survival, overall survival, objective response rate and treatment-related adverse events. Kaplan–Meier curves, log-rank test and multivariable Cox’s models were used and adjusted for age, histology, previous renal surgery, International Metastatic RCC Database Consortium score and pazopanib initial dose. Results Among 474 patients, 87.3% had clear cell metastatic renal cell cancer histology. Most of them (84.6%) had upfront renal surgery. Median progression-free survival and overall survival were 15.8 and 34.4 months, respectively, significantly correlating with International Metastatic RCC Database Consortium’s good prognosis (P < 0.001), ECOG PS 0 (P < 0.001), age (<75 years, P = 0.005), surgery (P < 0.001) and response to pazopanib (P < 0.001). After 3 months of pazopanib, overall disease control rate have been observed in 76.6% patients. Among International Metastatic RCC Database Consortium’s favorable group patients, 57/121 (47%) showed complete/partial response. No unexpected AEs emerged. Conclusions In this real-world study, metastatic renal cell cancer patients treated with first-line pazopanib reached greater progression-free survival and overall survival than in pivotal studies and had high response rates when belonging to International Metastatic RCC Database Consortium’s favorable group, without new toxicities. Pazopanib has been confirmed a valid first-line option for International Metastatic RCC Database Consortium’s good prognosis metastatic renal cell cancer patients who cannot be submitted to immunotherapy.

scholarly journals Real-World Experience of the One-Year Efficacy of Rifaximin Add-On to Lactulose Is Superior to Lactulose Alone in Patients with Cirrhosis Complicated with Recurrent Hepatic Encephalopathy in Taiwan

2021 ◽  
Vol 11 (6) ◽  
pp. 478
Author(s):  
Ching Chang ◽  
Chien-Hao Huang ◽  
Hsiao-Jung Tseng ◽  
Fang-Chen Yang ◽  
Rong-Nan Chien
Keyword(s):  
Hepatic Encephalopathy ◽  
Real World ◽  
Ammonia Level ◽  
Decompensated Cirrhosis ◽  
Control Group ◽  
Multivariable Logistic Regression Model ◽  
Before And After ◽  
One Year ◽  
The One ◽  
Serum Ammonia

Background: Hepatic encephalopathy (HE), a neuropsychiatric complication of decompensated cirrhosis, is associated with high mortality and high risk of recurrence. Rifaximin add-on to lactulose for 3 to 6 months is recommended for the prevention of recurrent episodes of HE after the second episode. However, whether the combination for more than 6 months is superior to lactulose alone in the maintenance of HE remission is less evident. Therefore, the aim of this study is to evaluate the one-year efficacy of rifaximin add-on to lactulose for the maintenance of HE remission in Taiwan. Methods: We conducted a real-world single-center retrospective cohort study to compare the long-term efficacy of rifaximin add-on to lactulose (group R + L) versus lactulose alone (group L, control group). Furthermore, the treatment efficacy before and after rifaximin add-on to lactulose was also analyzed. The primary endpoint of our study was time to first HE recurrence (Conn score ≥ 2). All patients were followed up every three months until death, and censored at one year if still alive. Results and Conclusions: 12 patients were enrolled in group R + L. Another 31 patients were stratified into group L. Sex, comorbidity, ammonia level, and ascites grade were matched while age, HE grade, and model for end-stage liver disease (MELD) score were adjusted in the multivariable logistic regression model. Compared with group L, significant improvement in the maintenance of HE remission and decreased episodes and days of HE-related hospitalizations were demonstrated in group R + L. The serum ammonia levels were significantly lower at the 3rd and 6th month in group 1. Concerning changes before and after rifaximin add-on in group R + L, mini-mental status examination (MMSE), episodes of hospitalization, and variceal bleeding also improved at 6 and 12 months. Days of hospitalization, serum ammonia levels also improved at 6th month. Except for concern over price, no patients discontinued rifaximin due to adverse events or complications. The above results provide evidence for the one-year use of rifaximin add-on to lactulose in reducing HE recurrence and HE-related hospitalization for patients with decompensated cirrhosis.

scholarly journals Estimating the consequences of a COVID-19 super spreader: A stochastic model of a night on the town

2021 ◽  
pp. 140349482110314
Author(s):  
Nils Henrik Kolnes ◽  
Snorre Nilsen Eikeland ◽  
Tor Albert Ersdal ◽  
Geir Sverre Braut
Keyword(s):  
Infection Control ◽  
Stochastic Model ◽  
Control Measures ◽  
Social Distancing ◽  
Infection Control Measures ◽  
Local Municipality ◽  
The Town

A stochastic model estimated the consequences of a COVID-19 super spreader event occurring in the local municipality of Stavanger, Norway as a result of a night on the town. The model imposed different infection control regulations and compared these different scenarios. For Stavanger’s 161 locations of service, secondary transmissions from a super spreader event was estimated to infect a median of 37, requiring the quarantining of 200 guests given no infection control regulations, 23 and 167 when imposing social distancing regulations and other hygienic infection control measures, 7 infected and 63 quarantined guests with restrictions placed on the guest capacity, and 4 infected and 57 quarantined guests with both forms of restriction in use.

Efficacy and Safety of Lipegfilgrastim in Lung Cancer Patients Receiving Myelosuppressive Chemotherapy in a Real-World Setting: Results of an Analysis of Pooled Data from Two Non-Interventional European Studies

2021 ◽  
pp. 1-9
Author(s):  
Christian Gessner ◽  
Karin Potthoff ◽  
Nikolaj Frost
Keyword(s):  
Lung Cancer ◽  
Clinical Practice ◽  
Cancer Patients ◽  
Adverse Drug Reactions ◽  
Real World ◽  
Secondary Prophylaxis ◽  
Drug Reactions ◽  
Myelosuppressive Chemotherapy ◽  
Lung Cancer Patients ◽  
Chemotherapy Induced Neutropenia

<b><i>Background/Aim:</i></b> Chemotherapy-induced neutropenia is a common and serious complication in cancer patients receiving myelosuppressive chemotherapy. This analysis was undertaken to evaluate the effectiveness and safety of prophylaxis with lipegfilgrastim, a glycoPEGylated granulocyte colony-stimulating factor, in lung cancer patients undergoing chemotherapy in real-world clinical practice. <b><i>Methods:</i></b> Data from two European non-interventional studies (NIS NADIR and NIS LEOS) investigating lipegfilgrastim for primary and secondary prophylaxis were pooled. Outcomes included the incidence of chemotherapy-induced neutropenia and febrile neutropenia (FN), use of anti-infectives and antimycotics, and adverse events and their relationship to lipegfilgrastim. <b><i>Results:</i></b> The safety population included 361 patients with lung cancer (median age, 66 years [range, 36–88]), of whom 322 had received 2 or more consecutive cycles of lipegfilgrastim (efficacy population [primary prophylaxis, 75.5%; secondary prophylaxis, 16.5%]). Almost 40% of the patients were considered to have a high risk (&#x3e;20%) of FN, and around 60% had an intermediate risk (10–20%). For all cycles, FN was reported in 3 patients (0.9%), neutropenia in 14 (4.3%), and grade 4 neutropenia in 9 (2.8%). Anti-infectives were used in 27 patients (8.4%) and antimycotics in 6 (1.9%). The incidence rates were lower for the patients’ first cycle (FN, 0.4%; neutropenia, 0.8%; grade 4 neutropenia, 0.8%; anti-infectives, 0.6%; antimycotics, 0.6%). Adverse drug reactions considered lipegfilgrastim related were reported in 35 patients (9.7%), and serious adverse drug reactions in 10 (2.8%). None of the fatal events reported in 28 patients (7.8%) were lipegfilgrastim related. <b><i>Conclusion:</i></b> Lipegfilgrastim administered to patients with lung cancer undergoing chemotherapy in real-world clinical practice showed similar effectiveness and safety to that reported in published pivotal trials.

PP469 From Theory To Practice: Which Value Framework Is Applied For Onco-Hematology Therapies In Italy? A 5-year Retrospective Analysis

2020 ◽  
Vol 36 (S1) ◽  
pp. 37-37
Author(s):  
Americo Cicchetti ◽  
Rossella Di Bidino ◽  
Entela Xoxi ◽  
Irene Luccarini ◽  
Alessia Brigido
Keyword(s):  
Real World ◽  
Ad Hoc ◽  
Grey Literature ◽  
National Level ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
The Real ◽  
R Process ◽  
The One ◽  
The Impact

IntroductionDifferent value frameworks (VFs) have been proposed in order to translate available evidence on risk-benefit profiles of new treatments into Pricing & Reimbursement (P&R) decisions. However limited evidence is available on the impact of their implementation. It's relevant to distinguish among VFs proposed by scientific societies and providers, which usually are applicable to all treatments, and VFs elaborated by regulatory agencies and health technology assessment (HTA), which focused on specific therapeutic areas. Such heterogeneity in VFs has significant implications in terms of value dimension considered and criteria adopted to define or support a price decision.MethodsA literature research was conducted to identify already proposed or adopted VF for onco-hematology treatments. Both scientific and grey literature were investigated. Then, an ad hoc data collection was conducted for multiple myeloma; breast, prostate and urothelial cancer; and Non Small Cell Lung Cancer (NSCLC) therapies. Pharmaceutical products authorized by European Medicines Agency from January 2014 till December 2019 were identified. Primary sources of data were European Public Assessment Reports and P&R decision taken by the Italian Medicines Agency (AIFA) till September 2019.ResultsThe analysis allowed to define a taxonomy to distinguish categories of VF relevant to onco-hematological treatments. We identified the “real-world” VF that emerged given past P&R decisions taken at the Italian level. Data was collected both for clinical and economical outcomes/indicators, as well as decisions taken on innovativeness of therapies. Relevant differences emerge between the real world value framework and the one that should be applied given the normative framework of the Italian Health System.ConclusionsThe value framework that emerged from the analysis addressed issues of specific aspects of onco-hematological treatments which emerged during an ad hoc analysis conducted on treatment authorized in the last 5 years. The perspective adopted to elaborate the VF was the one of an HTA agency responsible for P&R decisions at a national level. Furthermore, comparing a real-world value framework with the one based on the general criteria defined by the national legislation, our analysis allowed identification of the most critical point of the current national P&R process in terms ofsustainability of current and future therapies as advance therapies and agnostic-tumor therapies.

scholarly journals Why Do Our Cancer Patients Sleep So Badly? Sleep Disorders in Cancer Patients: A Frequent Symptom with Multiple Causes

2021 ◽  
pp. 1-7
Author(s):  
Herwig Strik ◽  
Werner Cassel ◽  
Michael Teepker ◽  
Thomas Schulte ◽  
Jorge Riera-Knorrenschild ◽  
...  
Keyword(s):  
Sleep Disorders ◽  
Cancer Patients ◽  
Treatment Options ◽  
Ethics Committee ◽  
Breathing Disorders ◽  
The One ◽  
Diagnosis Therapy ◽  
The University ◽  
Insomnia Symptoms

<b><i>Introduction:</i></b> On the one hand, sleep disorders in cancer patients are reported in 30–50% of cancer patients. On the other hand, specific causes for these sleep disorders are little known. This study was done to evaluate factors which may affect sleep of cancer patients. To our knowledge, this is the first study which includes return to work as one factor of sleep disturbance. <b><i>Methods:</i></b> 107 patients with various types of cancer treated in 2 hospitals were interviewed with a battery of questionnaires after having given informed consent. The questionnaires intended to detect abnormalities of sleep and related pain, breathing disorders, restless legs syndrome, depression, rumination, medication, and psychosocial distress. The study was approved by the ethics committee of the University of Marburg. <b><i>Results:</i></b> The analysis of the 6 sleep-related questionnaires indicated a sleep disorder of any kind in 68% of all patients. Insomnia symptoms were present in 48 patients (44.9%). Pain, depression, anxiety, and worries about the workplace were significantly related to sleep disorders. <b><i>Conclusion:</i></b> Sleep disorders are common in cancer patients. The causes are manifold and should be considered by caregivers during diagnosis, therapy, and aftercare of cancer patients. Tumour patients should actively be asked about sleep disorders. If these are present, they should be addressed, and as they have a large impact on quality of life, treatment options should be offered in cooperation with sleep specialists.

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