ABSTRACT
Cutaneous squamous cell carcinoma (CSCC) is the second most common skin cancer with an incidence of 1 million cases per year in the US. While the surgical cure rate for CSCC is >95%, some patients have high risk of recurrence as assessed by immune status, primary disease stage, extent of nodal involvement, presence of extracapsular extension, and prior treatment. Postoperative radiation therapy (RT) is recommended for these patients, but relapse with locoregional recurrence or distant metastases may still occur. C-POST is evaluating the efficacy of cemiplimab as adjuvant therapy for patients with high-risk CSCC. Here, we provide a summary of the most recent study protocol amendment. C-POST is a randomized, placebo-controlled, double-blind, multicenter Phase 3 study to evaluate cemiplimab as adjuvant treatment for patients with high-risk CSCC, based on surgical and clinicopathologic findings, who completed surgery and postoperative RT (minimum total dose 50 Gy, within 10 weeks before randomization) (NCT03969004). Patients with at least one of the following high-risk features are eligible: (1) nodal disease with (a) extracapsular extension and at least one node ≥20 mm or (b) at least three lymph nodes positive on surgical pathology report, regardless of extracapsular extension;(2) in-transit metastases;(3) T4 lesion;(4) perineural invasion;and (5) recurrent CSCC with at least one other risk factor. Patients with CSCC involvement in at least three lymph nodes (feature 1b) were added to the eligibility criteria, as this group was found to be at similar risk of CSCC recurrence as the initially planned study population. Protocol amendment now allows patients with chronic lymphocytic leukemia (CLL) who are not on active treatment to be enrolled. The study has two parts. In Part 1 (blinded), patients are randomly assigned 1:1 to receive cemiplimab 350 mg or placebo intravenously every 3 weeks for 12 weeks, followed by cemiplimab 700 mg or placebo every 6 weeks for 36 weeks. In optional Part 2 (unblinded), patients in the placebo arm who experience disease recurrence and patients in the cemiplimab arm who experience disease recurrence ≥3 months after completion of 48-week treatment in Part 1 are eligible to receive open-label cemiplimab 350 mg Q3W for up to 96 weeks. The trial is expected to enroll 412 patients from about 100 sites in North and South America, Europe, and Asia-Pacific regions. Key primary objective is to compare disease-free survival;secondary objectives include evaluating overall survival, freedom from locoregional relapse, and distant relapse with adjuvant cemiplimab versus placebo in patients with high-risk CSCC. This study is once again open for enrolment following interruptions owing to the COVID-19 pandemic. Not applicable (trial in progress) Not applicable (trial in progress) [ FROM AUTHOR] Copyright of International Journal of Radiation Oncology, Biology, Physics is the property of Pergamon Press - An Imprint of Elsevier Science and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)
ABSTRACT
Background: CSCC is the second most common skin cancer with an estimated incidence of 1 million cases per year in the US. While the surgical cure rate for CSCC is > 95%, some pts have high risk of recurrence as assessed by immune status, primary disease stage, extent of nodal involvement, presence of extracapsular extension (ECE), and prior treatment. Postoperative RT is recommended for these pts but relapse with locoregional recurrence or distant metastases may still occur. C-POST is evaluating the efficacy of cemiplimab as adjuvant therapy for pts with high-risk CSCC. Here, we provide summary of the most recent study protocol amendment. Methods: C-POST is a randomized, placebo-controlled, double-blind, multicenter Phase 3 study to evaluate cemiplimab as adjuvant treatment for pts with high-risk CSCC, based on surgical and clinicopathologic findings, who completed surgery and postoperative RT (minimum total dose 50Gy, within 10 weeks before randomization) (NCT03969004). Pts with at least one of the following high-risk features are eligible: (1) nodal disease with (a) ECE and at least one node ≥20 mm or (b) at least three lymph nodes positive on surgical pathology report, regardless of ECE;(2) in-transit metastases;(3) T4 lesion;(4) perineural invasion;and (5) recurrent CSCC with at least one other risk factor. Pts with CSCC involvement in at least three lymph nodes (feature 1b) were added to the eligibility criteria, as this group was found to be at similar risk of CSCC recurrence as the initially planned study population. Protocol amendment now allows patients with chronic lymphocytic leukemia (CLL) who are not on active treatment to be enrolled. The study has two parts. In Part 1 (blinded), pts are randomly assigned 1:1 to receive cemiplimab 350 mg or placebo intravenously every 3 weeks for 12 weeks, followed by cemiplimab 700 mg or placebo every 6 weeks for 36 weeks. In optional Part 2 (unblinded), pts in the placebo arm who experience disease recurrence and pts in the cemiplimab arm who experience disease recurrence ≥3 months after completion of 48-week treatment in Part 1 are eligible to receive open-label cemiplimab for up to 96 weeks. The trial is expected to enrol 412 pts from about 100 sites in North and South America, Europe, and Asia-Pacific regions. Key primary objective is to compare disease-free survival;secondary objectives include evaluating overall survival, freedom from locoregional relapse, and distant relapse with adjuvant cemiplimab versus placebo in patients with high-risk CSCC. This study is once again open for enrolment following interruptions owing to the COVID-19 pandemic.
ABSTRACT
Introduction: The global scale of COVID-19 has been enormous, with the disease affecting 20 million people worldwide and resulting in 751,154 deaths by August 14, 2020. An increase in mental health problems is expected with an event of such scale, given past experience with epidemics such as severe acute respiratory syndrome and Ebola, among various vulnerable populations. One such population may be the family members of patients affected with COVID-19. Methods: This was a cross-sectional study. Five hundred and forty-one relatives of patients admitted in the COVID-19 wing of a tertiary care hospital were studied. Sociodemographic details were recorded and a Gujarati version of General Health Questionnaire-28 (GHQ-28) was applied. A total score of >= 4 on GHQ-28 was considered indicative of "caseness" or psychiatric morbidity and the population was divided into two groups based on whether the score was <4 or >= 4. The groups were analyzed for any differences with respect to variables like age, gender. Conclusion: 5.17% of the study population had a GHQ-28 total score of >= 4 indicative of "psychiatric morbidity." The most common symptoms were fatigue, stress, sleep disturbance, and anxiety. Male gender and advanced age were statistically significantly more likely to have a GHQ-28 total score >= 4.
ABSTRACT
Background: The high contagiousness of the COVID 19 disease, the uncertain course, and the high morbidity and mortality has led to unprecedented burden on the health care system, especially when the crisis has gone on for more than 5 months with no end in sight. The chronic high degree stress has made burnout in health care workers (HCWs) a reality that needs urgent attention which can otherwise lead to compromised patient care apart from their own suffering. Aims and Objectives: This study was planned to assess and compare the burnout in doctors and nurses of our dedicated COVID 19 hospital, to understand its correlates, and look for any implications on future policy decisions. Materials and Methods: Our study assessed and compared the burnout in 150 doctors and 150 nurses of our dedicated COVID 19 hospital using the Copenhagen Burnout Inventory (CBI). The CBI Scale is a 19 item scale including three domains of burnout in the form of personal (1-6), work related (7-13), and patient related burnout (14-19). More than 25% average score on these items is taken as the presence of burnout. Results: We found burnout in 58% of all HCWs with 78% in doctors (n = 150) and 38% in nurses (n = 150), the difference being statistically significant. Multiple linear regression analysis was performed to find common factors affecting burnout among both the groups, which were female gender, facing stigma due to COVID 19 duty, regular exercise/yoga, and dissatisfaction with administrative services. Our findings propose to emphasize the need to address the impact of working under pressure for sustained periods among HCWs.
ABSTRACT
Atopic Dermatitis (AD) is a systemic inflammatory disorder that not only affects the skin but is also associated with numerous other disorders. There is currently scant literature on the outcomes of COVID19 patients with atopic dermatitis and aim was to examine investigate the impact of AD on COVID complications. A retrospective cohort study was done using TriNetX, a national federated real time database of 63 million records. COVID patient cohorts were identified by validated ICD-10 and serology codes per CDC guidelines. An 1:1 matched propensity score analysis was conducted, adjusting for comorbidities and demographics, to calculate adjusted Risk Ratios (aRR) with 95% confidence intervals (CI). 45-day COVID complications were examined with severe COVID being defined as a composite of mortality and ventilation. Subgroup analyses were also performed for AD patients on systemic immunosuppressants. In a matched sample of 2408 patients in each cohort, there was no statistically significant difference between AD-COVID patients and non-AD COVID patients in any of the outcomes examined such as hospitalization (0.89[.075-1.04]), acute respiratory distress syndrome (1.05[0.55-2.1]), sepsis (0.98[0.66-1.46]), mechanical ventilation (0.73[0.43-1.23]), mortality (1.02[0.62-1.62]), and severe COVID (0.8[0.54-1.19]). Subgroup analysis also revealed that AD-COVID patients with a one-year history of immunosuppressant use had no significant difference in any of the listed outcomes as well compared to AD-COVID patients without history of immunosuppressants. AD patients who contract COVID are not at higher risk for more severe COVID outcomes compared to COVID patients without AD. Likewise, AD patients with a history of systemic immunosuppressants are also not at a higher risk for COVID complications compared to AD patients without a history of systemic immunosuppressants. More research may be needed to visit the longer term impacts of COVID on AD patients.
ABSTRACT
Dermatopolymyositis (DPM) is chronic inflammatory disorder that not only affects the skin and muscles but is also associated with malignancies and other disorders. There is currently scant literature on the outcomes of COVID19 patients with DPM and aim was to examine investigate the impact of AD on COVID complications. A retrospective cohort study was done using TriNetX, a national federated real time database of 63 million records. COVID patient cohorts were identified by validated ICD-10 and serology codes per CDC guidelines. An 1:1 matched propensity score analysis was conducted, adjusting for comorbidities and demographics, to calculate adjusted Risk Ratios (aRR) with 95% confidence intervals (CI). 45-day COVID complications were examined with severe COVID being defined as a composite of mortality and ventilation. Subgroup analyses were also performed for Dermatopolymyositis patients on systemic immunosuppressants. In a matched sample of 177 patients in each cohort, there was no statistically significant difference between DPM-COVID patients and non-DPM COVID patients in any of the outcomes examined such as hospitalization (0.97[0.63-1.49]), acute respiratory distress syndrome (1.01[0.42-2.34]), sepsis (1.1[0.48-2.52]), mechanical ventilation (1.01[0.43-2.34]), mortality (1.2[0.53-2.71]), and severe COVID (1.5[0.69-3.25]). Subgroup analysis also revealed that DPM-COVID patients with a one-year history of immunosuppressant use had no significant difference in any of the listed outcomes compared to DPM-COVID patients without history of immunosuppressants. DPM patients who contract COVID are not at higher risk for more severe COVID outcomes compared to COVID patients without DPM. Systemic immunosuppressants in DPM-COVID patients also did not lead higher risk for COVID complications compared to DPM-COVID patients without a history of systemic immunosuppressants. Continuing research on the long term impacts of COVID on DPM patients is needed.
ABSTRACT
This investigation aimed to assess the pandemic impact on the incidence of newly prescribed dermatological agents compared to the pre-pandemic period. TrinetX is a real-time, federated healthcare database that was used in the retrospective review comprised of 61 million patient records at the time of the analysis. This database was used to identify the incidence of newly prescribed drugs each month for two periods of the pandemic. Medications were categorized by LOINC codes and categorized into groups. The first period was from April-July 2020, and the second was from August-November 2020. The mean for each drug group was then compared with the pooled monthly incidence from similar periods between 2018-2019 before the pandemic. Descriptive analyses were performed, and comparisons were made using a student's t-test. 11 groups of dermatological agents were analyzed in both periods. In the early pandemic period, 7 of 11 groups of agents showed a statistically significant reduction of up to 32.1% in prescription. These agents included anti-psoriatic, anti-acne, topical anti-neoplastic, topical anti-viral, topical anti-inflammatory, topical anti-fungal, and all dermatological agents as a whole. Newly prescribed topical analgesics, keratolytic, anti-perspirant, and anti-bacterial agents did not show a statistically significant decrease in prescription. During the later pandemic, five of the dermatological agents showed a statistically significant decrease in prescription. Anti-psoriatic, topical analgesics, topical antineoplastics, topical keratolytic, topical anti-perspirant, and topical anti-bacterial agents did not show a significant reduction. This study shows that there has been a significant reduction in incidence of prescribed dermatological agents during the COVID19 pandemic. Further research is needed to determine the future impact of this disruption in the dermatological care.
ABSTRACT
The COVID19 pandemic has caused a major disruption in healthcare delivery as restrictions have limited the ability to seek elective procedures. This investigation aimed to assess the pandemic impact on the incidence of dermatology procedures compared to the pre-pandemic period. TrinetX, a national federated healthcare database comprised of 61 million patient records, was used to identify the incidence of new dermatology procedures performed each month for two periods of the pandemic. The first period was from Apr-July 2020, and the second was from Aug-Nov 2020. The mean for each variable was then compared with the pooled monthly incidence from similar periods between 2018-2019 before the pandemic. Descriptive analyses were performed, and comparisons were made using a student's t-test. Procedures were identified by CPT codes and categorized into groups. In the Apr-July 2020 period, 11 groups of procedures showed a significant statistical decrease in incidence by up to 47.3%. They included: Excision of benign lesions, shaving of epidermal/dermal lesions, skin tag removal, skin biopsy, paring/cutting procedures, surgical procedures on nails, surgical procedures on pilonidal cyst, destruction of malignant lesions, destruction of benign/premalignant lesions, Mohs surgery, and incision and drainage procedures. The incidence of debridement procedures during the initial COVID period was similar to overlapping months in 2018 and 2019. In the late pandemic period, 10 procedure groups demonstrated a significant statistical decrease in incidence. The incidence of debridement procedures and surgical procedures on pilonidal cysts during the later COVID period was similar to overlapping months in 2018 and 2019. The statistically significant decrease in dermatology procedures during the COVID-19 pandemic may suggest that the general public is postponing skin care placing a greater burden on healthcare.
ABSTRACT
During the COVID19 pandemic, research has shown that many patients have decided to delay elective procedures, even if available, to reduce COVID exposure. There is scant literature that demonstrated the risk of COVID after dermatological procedures and whether these risks are higher compared to other medical procedures. This study aims to investigate these risks. A retrospective cohort study was done using TriNetX, a federated real time database of 63 million patient records. Patients undergoing any procedure were identified by CPT codes from Jan 2020-Nov 2020. ICD-10 and serology codes were used to identify 30-day risk of post-procedural COVID diagnosis per CDC guidelines. A 1:1 matched propensity score analysis was conducted, adjusting for comorbidities and demographics, to calculate adjusted Risk Ratios (aRR) with 95% CI. 224,536 dermatological procedures were conducted during the timeframe. Overall, there was a 2% risk of 30 day COVID diagnosis after a dermatological procedure. After matching, patients had a lower risk of contracting COVID after undergoing dermatological procedures when compared to urinary procedures (aRR[95%CI])=(0.56[0.54-0.58]), gastrointestinal procedures (0.61[0.59-0.63]), cardiovascular procedures (0.56[0.55-0.58]), respiratory procedures (0.42[0.40-0.43]), hemic/lymphatic procedures (0.49[0.46-0.53]), musculoskeletal procedures (0.75[0.73-0.78]), and nervous procedures (0.86[0.83-0.89]). There was no difference in COVID risk compared with reproductive procedures. Dermatological procedures presented a higher COVID risk when compared with endocrine procedures (1.46[1.17-1.82]), ophthalmic procedures (1.23[1.15-1.32]), and auditory procedures [1.52[1.41-1.64]). There is a minimal risk of contracting COVID after dermatological procedures, even when compared to other medical procedures. Risks can be further mitigated by following proper guidelines by public health officials.
ABSTRACT
Psoriasis is a systemic chronic inflammatory disorder that affects the skin and is associated with other disorders. There is scan literature on outcomes of COVID19 patients with Psoriasis (Pso) and Psoriasis Arthritis (PsoA), especially from multicenter data. Therefore, the aim was to examine investigate the risk of COVID complications in these two groups. A retrospective cohort study was done using TriNetX, a federated real time database of 63 million records. COVID patient cohorts were identified by validated ICD-10/serology codes per CDC guidelines. An 1:1 matched propensity score analysis was conducted, adjusting for comorbidities and demographics, to calculate adjusted Risk Ratios (aRR) with 95% CI. 45-day COVID complications were examined with severe COVID defined as a composite of mortality and ventilation. Subgroup analyses were also performed for Pso and PsoA patients on systemic immunosuppressants. In a matched sample of 2288 patients in each cohort, there was no differences between Pso-COVID patients and non-Pso COVID patients in hospitalization (0.90[0.78-1.03]), sepsis (0.78[0.54-1.14]), mortality (0.82[0.57-1.19]), and severe COVID (0.77[0.58-1.03]). Pso-COVID patients had statistically significant lower risk of acute respiratory distress syndrome (0.51[0.30-0.90]) and mechanical ventilation (0.65[0.45-0.95]). In a matched sample of 502 patients in each cohort, PsoA-COVID patients had no differences in any of the listed outcomes. A subgroup analysis revealed that Pso-COVID and PsoA-COVID patients with a one-year history of systemic immunosuppressant use also had no differences in COVID outcomes compared to Pso-COVID patients and PsoA-COVID patients without immunosuppressants respectively. Pso-COVID and PsoA-COVID patients were not at higher risk for severe COVID complications. History of immunosuppressant use in both cohorts also revealed no higher risk in COVID complications. Additional studies are warranted to visit the longer-term impacts of COVID on Pso and PsoA patients.
ABSTRACT
Varicella Zoster Virus (VZV) causes shingles in adults and may be reactivated in stress related states such as inflammation. There is minimal literature on whether patients with VZV who contract COVID19 are at higher risks of complications and therefore the aim was to examine this. A retrospective cohort study was done using TriNetX, a national federated real time database of 63 million records. COVID patients were identified by validated ICD-10 and serology codes per CDC guidelines. An 1:1 matched propensity score analysis was conducted, adjusting for comorbidities and demographics, to calculate adjusted Risk Ratios (aRR) with 95% CI. 45-day COVID complications were examined with severe COVID being defined as a composite of mortality and ventilation. Subgroup analyses were also performed for VZV patients with a one-year history of antivirals. In a matched sample of 3493 patients in each cohort, there was no statistically significant difference between VZV-COVID patients and non-VZV COVID patients in outcomes such as hospitalization (1.01[0.83-1.22]), acute respiratory distress syndrome (ARDS) (1.41[0.96-2.07]), mechanical ventilation (0.98[0.75-1.28]), mortality (1.04[0.82-1.31]), and severe COVID (1.01[0.83-1.22]). VZV-COVID patients were at a statistically significant higher risk for sepsis (1.64[1.25-2.16]). Subgroup analysis revealed that VZV-COVID patients with a history of antiviral use were at statistically significant higher risks for hospitalization (1.37[1.07-1.74]) and severe COVID (1.65[1.01-2.75]) than VZV-COVID patients not on antivirals. No differences between the cohorts were seen in ARDS, sepsis, mechanical ventilation, and morality. VZV patients with COVID are not at higher risk for COVID complications compared to COVID patients without VZV. However, history of antiviral use in VZV-COVID patients has a higher risk for severe COVID compared those without antivirals. Additional research is needed to visit the longer term impacts of COVID on VZV patients.