scholarly journals The Impact of Routine Molecular Screening for SARS-CoV-2 in Patients Receiving Anti-Cancer Therapy: An Interim Analysis of the Observational COICA Study

Oncology ◽  
2021 ◽  
Author(s):  
Giuseppe Di Lorenzo ◽  
Mario Iervolino ◽  
Ferdinando Primiano ◽  
Maurizio D'Ambrosio ◽  
Concetta Ingenito ◽  
...  

Introduction: Cancer aggravates COVID-19 prognosis. Nosocomial transmission of SARS-CoV-2 is particularly frequent in cancer patients, who need to attend hospitals regularly. Since March, 2020, all cancer patients having access to the Oncology Unit at the “Andrea Tortora” Hospital (Pagani, Salerno - referred to as “the Hospital”) as inpatients or outpatients receiving intravenous therapy have been screened for SARS-CoV-2 using RT-PCR nasal swab. The ongoing COICA (COVID-19 Infection in Cancer Patients) study is an ambispective, multicenter, observational study designed to assess the prognosis of SARS-CoV-2 infection in cancer patients. The aim of the study presented here was to explore potential differences in COVID-19 related outcomes among screening-detected vs. non-screening detected SARS-CoV-2 infected patients. Methods: The COICA study enrolled cancer patients who had received any anti-cancer systemic therapy within 3 months since the day they tested positive for SARS-CoV-2 on RT-PCR. The target accrual is 128 patients, and the study was approved by the competent Ethics Committee. Only the sub-group of patients enrolled at the Hospital was considered in this unplanned interim analysis. Logistic regression analysis was used to evaluate the association of screening-based vs. non screening based diagnosis. Results: Since March, 15 2020 until August, 15 2021, a total of 931 outpatients and 230 inpatients were repeatedly screened for SARS-CoV-2 using RT-PCR nasal swab at the Hospital. Among these, 71 asymptomatic patients were positive on routine screening and five patients were positive for SARS-CoV-2 outside the institutional screening. Seven patients died because of COVID-19. At univariate analysis, non-screening vs. screening detected SARS-CoV-2 infection was associated with significantly higher odds of O2 Therapy (OR= 16.2; 95% CI =2.2 to 117.1; p =0.006),hospital admission (OR=31.5; 95% CI=3.1 to 317.8; p=0.003 ), admission to ICU (OR=23.0; 95% CI = 2.4 to 223.8; p= 0.007) and Death (OR=8.8; 95%CI= 1.2 to 65.5; p =0.034). Conclusion: Routine screening with RT-PCR may represent a feasible and effective strategy in reducing viral circulation and possibly COVID-19 mortality in patients with active cancer having repeated access to hospital facilities.

2020 ◽  
Author(s):  
Humaid Al-Shamsi ◽  
Ibrahim Abu-Gheida ◽  
Amr Hassan ◽  
Fathi Azribi ◽  
Hassan Jaafar ◽  
...  

BACKGROUND Cancer care during this pandemic is challenging given the competing risks of death from cancer versus death or serious complications from SARS- CoV-2 infection, and the likely higher lethality of COVID-19 in immunocompromised patients. Question remains on serial screening for SARS-CoV-2 in asymptomatic adult cancer patients prior to anti-cancer therapy during the COVID-19 pandemic. OBJECTIVE Formulate a consensus guideline statement to guide practicing physicians METHODS We conducted a systematic review to formulate a consensus statement to guide the practising oncologists RESULTS Most of the current guidelines recommend RT-PCR SARS-CoV-2 testing of asymptomatic patients prior to initiating and during the anti-cancer therapy despite the lack of robust evidence. We suggested the following: If screening is indicated in adult cancer patients, we recommend using RT-PCR over serum antibody or serum antigen for adult cancer patients; we also recommend assessing the risk of exposure to and infection from SARS-CoV-2 prior to each anti-cancer cycle, to consider SARS-CoV-2 in asymptomatic adult cancer patients prior to anti-cancer therapy in high risk groups : highly cytotoxic chemotherapy with potential profound neutropenia based on the physician’s risk assessment of the chemotherapy , stem cell transplantation. For asymptomatic intermediate-high risk cancer patients, we suggest performing RT-PCR 48-72 hours prior to initiating any anti-cancer therapy. For asymptomatic low-risk cancer patients, we suggest not to routinely screen prior to initiating any anti-cancer therapy (weak recommendation, low quality evidence). CONCLUSIONS SARS-CoV-2 screening might be indicated with higher certainty to certain cancer risk groups. There remains a need for prospective trials to assess this intervention, and the outcome of such intervention. Current recommendations may change based on new and emerging evidence.


Author(s):  
Ron M Kagan ◽  
Amy A Rogers ◽  
Gwynngelle A Borillo ◽  
Nigel J Clarke ◽  
Elizabeth M Marlowe

Abstract Background The use of a remote specimen collection strategy employing a kit designed for unobserved self-collection for SARS-CoV-2 RT-PCR can decrease the use of PPE and exposure risk. To assess the impact of unobserved specimen self-collection on test performance, we examined results from a SARS-CoV-2 qualitative RT-PCR test for self-collected specimens from participants in a return-to-work screening program and assessed the impact of a pooled testing strategy in this cohort. Methods Self-collected anterior nasal swabs from employee return to work programs were tested using the Quest Diagnostics SARS-CoV-2 RT-PCR EUA. The Ct values for the N1 and N3 N-gene targets and a human RNase P (RP) gene control target were tabulated. For comparison, we utilized Ct values from a cohort of HCP-collected specimens from patients with and without COVID-19 symptoms. Results Among 47,923 participants, 1.8% were positive. RP failed to amplify for 13/115,435 (0.011%) specimens. The median (IQR) Cts were 32.7 (25.0-35.7) for N1 and 31.3 (23.8-34.2) for N3. Median Ct values in the self-collected cohort were significantly higher than those of symptomatic, but not asymptomatic patients. Based on Ct values, pooled testing with 4 specimens would have yielded inconclusive results in 67/1,268 (5.2%) specimens but only a single false-negative result. Conclusions Unobserved self-collection of nasal swabs provides adequate sampling for SARS-CoV-2 RT-PCR testing. These findings alleviate concerns of increased false negatives in this context. Specimen pooling could be used for this population as the likelihood of false negative results is very low due when using a sensitive, dual-target methodology.


2021 ◽  
Author(s):  
Ahmed M Badheeb ◽  
Mohamed A Badheeb ◽  
Hamdi A Alhakimi

Abstract Background: The aim of this paper is to compare the patterns and determinants of cancer mortality in Najran region before and after the COVID-19 epidemics. The association between cancer mortality and each of age, sex, site of cancer, stage, and the 30-days survival rate after the last dose of chemotherapy were assessed.Materials & Methods: Adult cancer patients who died of cancer in King Khalid Hospital in Najran Saudi Arabia, were included in this retrospective observational study. We compared mortality patterns in a period of 6 months in 2020 (March to August) with the corresponding period of 2019.Results: 50 dead adult cancer patients were included, 24 in 2019 and 26 in 2020. Among them, 21% vs 42% were younger than 65 years of age; 61% vs 62% were males, for the years 2019 & 2020 respectively. The top three killers in 2019 were colorectal, gastro-esophageal cancers, and hepatocellular carcinoma, while in 2020 were colorectal, hepatocellular carcinoma, and lymphomas. About 16.7% of patients died within 30 days of receiving anti-cancer treatment in 2019 in comparison with 7.7% in 2020. The difference in the 30-days mortality after receiving anti-cancer treatment was not statistically significant between 2019 and 2020 (p = 0.329).Conclusion: The Year 2020, the time of the COVID-19pandemic, was not associated with a significant increase in short-term mortality among patients with malignancy in Najran, Saudi Arabia. Our results generally reflect the crucial role of strict preventive national measures in saving lives and warrants further exploration.


2021 ◽  
pp. 1-7
Author(s):  
Adriana Fonseca ◽  
Palma Solano ◽  
Vijay Ramaswamy ◽  
Uri Tabori ◽  
Annie Huang ◽  
...  

OBJECTIVE There is no consensus on the optimal clinical management of ventriculomegaly and hydrocephalus in patients with diffuse intrinsic pontine glioma (DIPG). To date, the impact on survival in patients with ventriculomegaly and CSF diversion for hydrocephalus in this population remains to be elucidated. Herein, the authors describe their institutional experience. METHODS Patients diagnosed with DIPG and treated with up-front radiation therapy (RT) at The Hospital for Sick Children between 2000 and 2019 were identified. Images at diagnosis and progression were used to determine the frontal/occipital horn ratio (FOR) as a method to measure ventricular size. Patients with ventriculomegaly (FOR ≥ 0.36) were stratified according to the presence of symptoms and categorized as follows: 1) asymptomatic ventriculomegaly and 2) symptomatic hydrocephalus. For patients with ventriculomegaly who did not require CSF diversion, post-RT imaging was also evaluated to assess changes in the FOR after RT. Proportional hazards analyses were used to identify clinical and treatment factors correlated with survival. The Kaplan-Meier method was used to perform survival estimates, and the log-rank method was used to identify survival differences between groups. RESULTS Eighty-two patients met the inclusion criteria. At diagnosis, 28% (n = 23) of patients presented with ventriculomegaly, including 8 patients who had symptomatic hydrocephalus and underwent CSF diversion. A ventriculoperitoneal shunt was placed in the majority of patients (6/8). Fifteen asymptomatic patients were managed without CSF diversion. Six patients had resolution of ventriculomegaly after RT. Of 66 patients with imaging at the time of progression, 36 (55%) had ventriculomegaly, and 9 of them required CSF diversion. The presence of ventriculomegaly at diagnosis did not correlate with survival on univariate analysis. However, patients with symptomatic hydrocephalus at the time of progression who underwent CSF diversion had a survival advantage (p = 0.0340) when compared to patients with ventriculomegaly managed with conservative approaches. CONCLUSIONS Although ventriculomegaly can be present in up to 55% of patients with DIPG, the majority of patients present with asymptomatic ventriculomegaly and do not require surgical interventions. In some cases ventriculomegaly improved after medical management with steroids and RT. CSF diversion for hydrocephalus at the time of diagnosis does not impact survival. In contrast, our results suggest a survival advantage in patients who undergo CSF diversion for hydrocephalus at the time of progression, albeit that advantage is likely to be confounded by biological and individual patient factors. Further research in this area is needed to understand the best timing and type of interventions in this population.


2021 ◽  
Author(s):  
Dilek Erdem ◽  
Irem Karaman

Aim: This study aimed to assess the impact of coronavirus disease 2019 (COVID-19) phobia and related factors on attitude towards COVID-19 vaccine in cancer patients. Methods: A prospective cross-sectional descriptive study was conducted with 300 adult patients using a validated COVID-19 Phobia Scale (C19P-S) and related survey to determine the factors affecting vaccine acceptance between May–June 2021. Results: Regarding the COVID-19 vaccine willingness, 86.7% accepted vaccination, 6.3% were hesitant and 7% refused vaccination. Patients that accepted vaccination had significantly higher C19P-S scores in general, and in psychological and psychosomatic subdivisions. Univariate analysis revealed that increased age, being retired, and being married were significantly associated with willingness to be vaccinated against COVID-19. Conclusion: The majority of patients had high coronophobia levels which were associated with increased willingness for the COVID-19 vaccines. Minimizing negative attitudes towards vaccines will most likely be achieved by raising awareness in the cancer population about COVID-19 vaccine.


2020 ◽  
Author(s):  
Samiul Hasan ◽  
Md Ayub Ali ◽  
Umama Huq

Abstract Background: COVID-19 has changed the practice of surgery vividly all over the world. This has already lead to a huge burden of rescheduled pediatric surgical cases worldwide. Though children are less likely to be infected and suffer less when infected, there is a growing fear among health care workers of being self-infected, which is limiting the surgical care of children globally. This study aims to share our experiences with the outcome of COVID-19 in children who had a co-existing surgical emergency, which might help the pediatric surgeons globally to mitigate the effect of COVID 19 on pediatric surgery.Methods: This is a retrospective observational study. We reviewed the epidemiological, clinical, and laboratory data of all patients admitted in our surgery department through the emergency department and later diagnosed to have COVID-19 by RT-PCR. During April 2020 – June 2020. A nasopharyngeal swab was taken from all patients irrespective of symptoms to detect SARS CoV 2 by RT-PCR to identify and isolate asymptomatic patients and patients with atypical symptoms. We divided the test positive patients into 4 age groups for the convenience of data analysis. Data were retrieved from hospital records and analyzed using SPSS (version 25) software. Ethical permission was taken from the hospital ethical review board.Results: Total patients were 32. Seven (21.9%) of them were neonates. Twenty-four (75%) patients were male. The predominant diagnosis was acute abdomen followed by infantile hypertrophic pyloric stenosis (IHPS), myelomeningocele, and intussusception. Only two patients had mild respiratory symptoms (dry cough). Fever was present in 13 (40.6%) patients. Fourteen (43.8%) patients required surgical treatment. The mean duration of hospital stay was 5.5 days. One neonate with ARM died in the post-operative ward due to cardiac arrest. No patient had hypoxemia or organ failure. Seven health care workers (5.51%) including doctors & nurses got infected with SARS Co V2 during this period.Conclusion: Our study has revealed a milder course of COVID-19 in children with minimal infectivity even when present in association with emergency surgical conditions. This might encourage a gradual restart to mitigate the impact of COVID-19 on children’s surgery.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 20110-20110
Author(s):  
Y. Jiang ◽  
Y. Zhang ◽  
T. Briggs ◽  
D. Talantov ◽  
A. Mazumder ◽  
...  

20110 Background: The 5-year survival rate of Dukes’ B colon cancer patients is approximately 75%. In our earlier genome-wide measurements of gene expression we have identified a 23-gene signature that sub-classifies Dukes’ B tumors and may provide better means of risk assessment on an individual basis for these colon cancer patients. The aim of this study is to validate this gene signature in an independent and more diverse group of patients, and further develop this prognostic signature into a clinical feasible test using formalin-fixed paraffin-embedded (FFPE) tissue samples. Methods: Using Affymetrix U133a GeneChip we analyzed the expression of the 23 genes in total RNA of frozen tumor samples from 123 Dukes’ B patients who did not receive adjuvant systemic treatment. Furthermore, we developed a quantitative RT-PCR assay for this gene signature in order to perform the test with standard clinical FFPE samples. Results: In the independent validation set of 123 patients, the gene signature proved to be informative in identifying patients who would develop distant metastasis (hazard ratio, HR 2.56; 95% confidence interval CI, 1.01–6.48), even when corrected for the traditional prognostic factors in multivariate analysis (HR, 2.73; 95% CI, 0.97–7.73). The RT-PCR assay developed for this gene signature was also validated in an independent set of 114 patients as a strong prognostic factor for the development of distant recurrence (HR, 6.38; 95% CI, 2.88–14.2) in univariate analysis and in multivariate analysis (HR, 13.3; 95% CI, 5.13–34.4). Conclusions: Our data provide not only a validation of the pre-defined prognostic gene signature for Dukes’ B colon cancer patients but also a clear feasibility of testing the gene signature using RT-PCR with standard FFPE specimens. The ability of such a test to identify patients that have an unfavorable outcome demonstrates potential clinical importance that could lead clinicians to choose a more aggressive therapeutic option for the high-risk patients. [Table: see text]


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20563-e20563
Author(s):  
Hans Tesch ◽  
DeLi Tilly Chang ◽  
Bertram Ottillinger

e20563 Background: G-CSF is frequently used to prevent/treat chemotherapy (CT)-induced neutropenia (CIN) in cancer patients. The non-interventional observational study HEXAFIL on the use of biosimilar filgrastim (EP-2006) was conducted to provide further insight into G-CSF usage with respect to guidelines (EORTC, ASCO) in Germany. Methods: Patients who signed informed consents were enrolled. Data were documented for up to 3 consecutive G-CSF-supported CT-cycles. Rates of modified CT-treatments (dose modification/discontinuation of drug) were calculated by the number and percentage of patients affected; data presented are based on the first CT-cycle. In/Exclusion criteria: www.germanctr.de . Results: A total of 709 breast cancer patients were included in this interim analysis (9/2012). Only 2.0% of all patients experienced febrile neutropenia (FN) and 8.7% neutropenic complications. A majority of patients received primary (49.4%, PP) or secondary prophylaxis (33.6%, SP) with the biosimilar G-CSF. However, 17.1% were treated interventional (TX). Median G-CSF treatment duration was 4d with median start on day 6 after CT. Of all documented patients, 96.3% received CT without modifications; in 3.0% of the patients dose of CT was modified and in 0.8% CT drug was discontinued. To investigate potential effects of guideline-concordant G-CSF treatment the following populations were selected: patients with FN-risk > 20% and (1) G-CSF initiation < day 5 after CT (ie, “guideline-concordant” GL; N=104) or (2) G-CSF initiation starting > day 6 after CT (ie, “individualized” IND; N=169). As expected, IND-patients experienced FN twice as often as GL-patients (4.1% vs 1.9%). Moreover, CT treatment had to be modified in 6.5% of IND-patients compared with only 1.0% of GL-patients. Conclusions: A total of 96.3% of all analyzed patients receiving biosimilar G-CSF-supported CT-cycles had no modification to their CT-regimen. Data indicate that IND-patients showed a higher rate of CT disturbances/FNs and, as a consequence, should “cross the bridge” to potentially benefit from guideline-concordant treatment. However, further data are required to detail the impact of individualized G-CSF treatment. Clinical trial information: DRKS00000313.


Cancers ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 2917
Author(s):  
Evgenii Shumilov ◽  
Petra Hoffknecht ◽  
Raphael Koch ◽  
Rudolf Peceny ◽  
Steffen Voigt ◽  
...  

Oncologists face challenges in the management of SARS-CoV-2 infections and post-SARS-CoV-2 cancer treatment. We analyzed diagnostic, clinical and post-SARS-CoV-2 scenarios in patients from three German cancer centers with RT-PCR confirmed SARS-CoV-2 infection. Sixty-three patients with SARS-CoV-2 and hematologic or solid neoplasms were included. Thirty patients were initially asymptomatic, 10 of whom developed COVID-19 symptoms subsequently. Altogether 20 (32%) patients were asymptomatic, 18 (29%) had mild, 12 (19%) severe and 13 (20%) critical courses. Lymphocytopenia increased risk of severe/critical COVID-19 three-fold (p = 0.015). Asymptomatic course was not associated with age, remission status, therapies or co-morbidities. Secondary bacterial infection accompanied more than one third of critical COVID-19 cases. Treatment was delayed post-SARS-CoV-2 in 46 patients, 9 of whom developed progressive disease (PD). Cancer therapy was modified in 8 SARS-CoV-2 survivors because of deteriorating performance or PD. At the last follow-up, 17 patients had died from COVID-19 (n = 8) or PD (n = 9) giving an estimated 73% four-month overall survival rate. SARS-CoV-2 infection has a heterogenous course in cancer patients. Lymphocytopenia carries a significant risk of severe/critical COVID-19. SARS-CoV-2 disruption of therapy is as serious as SARS-CoV-2 infection itself. Careful surveillance will allow early restart of the anti-cancer treatment.


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