Analysis of social and psychological factors influencing the treatment of patients with chronic kidney disease under the regular epidemic prevention and control of coronavirus disease 2019.

Objective To explore the sociodemographic and psychological factors influencing the continuity of treatment of patients with chronic kidney disease under the regular epidemic prevention and control of coronavirus disease 2019 (COVID-19). Methods A total of 277 patients with chronic kidney disease who were admitted to Department of Nephrology, The First Affiliated Hospital of Naval Medical University (Second Military Medical University) from Apr. 2020 to Mar. 2021 were enrolled and divided into 3 groups: non-dialysis group (n=102), hemodialysis (HD) group (n=108), and peritoneal dialysis (PD) group (n=67). All patients were investigated by online and offline questionnaires, including self-designed basic situation questionnaire, self-rating anxiety scale (SAS), and self-rating depression scale (SDS). The general sociodemographic data, anxiety and depression of the 3 groups were compared, and the influence of sociodemographic and psychological factors on the interruption or delay of treatment was analyzed by binary logistic regression model. Results There were significant differences in age distribution, marital status, occupation, medical insurance type, caregiver type, whether there was an urgent need for hospitalization and whether treatment was delayed or interrupted among the 3 groups (all P0.05). The average SAS score of 65 PD patients was 38.15+/-15.83, including 53 (81.5%) patients without anxiety, 7 (10.8%) patients with mild anxiety, and 5 (7.7%) patients with moderate to severe anxiety. The average SAS score of 104 patients in the HD group was 36.86+/-14.03, including 81 (77.9%) patients without anxiety, 18 (17.3%) patients with mild anxiety, and 5 (4.8%) patients with moderate to severe anxiety. There were no significant differences in the mean score of SAS or anxiety severity grading between the 2 groups (both P0.05). The mean SDS scores of 65 PD patients were 53.42+/-13.30, including 22 (33.8%) patients without depression, 21 (32.3%) patients with mild depression, and 22 (33.8%) patients with moderate to severe depression. The mean SDS scores of 104 patients in the HD group were 50.79+/-10.76, including 36 (34.6%) patients without depression, 56 (53.8%) patients with mild depression, and 12 (11.6%) patients with moderate to severe depression. There were no significant differences in mean SDS scores or depression severity grading between the 2 groups (both P0.05). The results of intra-group comparison showed that the incidence and severity of depression were higher than those of anxiety in both groups. Multivariate binary logistic regression analysis showed that high school education level (odds ratio OR=5.618, 95% confidence interval CI) 2.136-14.776, P0.01), and unmarried (OR=6.916, 95% CI 1.441-33.185, P=0.016), divorced (OR= 5.588, 95% CI 1.442-21.664, P=0.013), urgent need for hospitalization (OR=8.655, 95% CI 3.847-19.476, P0.01) could positively promote the continuity of treatment in maintenance dialysis patients under the regular epidemic prevention and control of COVID-19. In the non-dialysis group, no sociodemographic and psychological factors were found to be associated with the interruption or delay of treatment (P0.05). Conclusion Education, marital status, and urgent need for hospitalization are correlated with the continuity of treatment in patients with chronic kidney disease on maintenance dialysis.Copyright © 2022, Second Military Medical University Press. All rights reserved.

Identifying factors that affect barriers to lymphoma treatment during the COVID - 19 pandemic

Introduction: Barriers to therapy for patients with lymphoma are an essential topic. The Lymphoma Coalition biennial global patient survey collects data on patient experiences, including challenges or limitations patients face in seeking medical attention or access to treatment. Due to Covid-19, patients with lymphoma have experienced high barriers. This study aims to rank the influence of core demographic variables in their ability to predict barriers to lymphoma treatment in 2020 and 2022. Method(s): The survey was deployed globally to lymphoma patients and caregivers in 2020 & 2022. The outcome variable was the identification of any barrier to receiving lymphoma treatment. Logit regression was used to model the outcome against core demographics. Variable importance was quantified with independent Monte Carlo resampling. Result(s): Barriers were significantly elevated in all regions in 2022 (p<0.0001). Those who are of older age were found to have fewer barriers to treatment: Unit OR = 0.965;95%CI [0.962 - 0.968]. Age was consistently a variable of high importance across most regions in both survey years (Table 1). In 2022, treatment delay due to concerns over COVID-19 was the second-ranked variable of importance in three regions. Conclusion(s): Barriers to treatment for patients with lymphoma increased dramatically across all regions from 2020-2022. Increased barriers to treatment in those of younger age were an unexpected finding. Heterogeneity in the impact of variables that influence access to treatment appears to be enhanced by participants' psychosocial impacts due to the pandemic. Policymakers and providers should actively rectify access disparities in their respective regions.

Developing Multidisciplinary Models of Care in Rheumatology at University College London Hospital: 18 Months of Learning from Conception to Delivery and Beyond

Background/Aims The COVID-19 pandemic has placed unprecedented pressures on NHS departments, with demand rapidly outstripping capacity. The British Society for Rheumatology 'Rheumatology Workforce: a crisis in numbers (2021)' highlighted the need to provide innovative ways of delivering rheumatology specialist care. At University College London Hospitals (UCLH) we created a rheumatology multidisciplinary team (MDT) clinic to meet rising demands on our service. The aims of the Rheumatology MDT clinic were to: reduce new appointment/follow-up waiting times, increase clinic capacity, incorporate musculoskeletal (MSK) point of care ultrasound, reduce number of hospital visits and add value to each clinic encounter. Methods We ran a 6-month pilot, supported by our outpatient transformation team, incorporating a Rheumatology Advanced Practice Physiotherapist (APP), Clinical Nurse Specialist (CNS) and MSK ultrasound within a Consultant clinic. The success of the pilot helped secure funding for a further 12 months. Over 18 months we have implemented: APP/Consultant enhanced triage - up to 40% of referrals were appropriate for APP assessment, including regional MSK problems and back pain. This increased capacity for consultant-led appointments. Standardisation of time-lapse between CNS and consultant follow-up appointments to ensure appropriate spacing between patient encounters. Facilitated overbooking of urgent cases afforded by additional capacity provided by the APP. MSK ultrasound embedded in the clinic template. 'Zoom' patient education webinars facilitated by MDT members and wider disciplines e.g. dietetics, to empower self-management and reduce the administrative burden of patient emails/phone calls occurring outside the clinic. Patient participation sessions and feedback to help shape the service. Results During the 6-month pilot we reduced our waiting time for follow-up appointments from 9 months to 2. We now have capacity to book 1-2 urgent cases each week. Pre-MDT the average wait from consultant referral to physiotherapist appointment was 55 days. The MDT allows for same day assessment (reducing 2-3 patient journeys a clinic) and where suitable, facilitates discharge or onwards referral to the appropriate service. A dedicated MDT CNS has shortened treatment times, reduced email traffic between CNS and consultant and allows for same day, joint decision-making resulting in fewer appointments. Zoom webinar feedback has been positive. Patients value the broad expertise of allied health professionals which supports self-management. Embedding ultrasound allows for same day diagnostics, decreased referrals to radiology and reduced hospital visits. Conclusion Our MDT model has reduced waiting lists, decreased treatment delays and cut hospital attendances. Point of care ultrasound allows for same day decision making and abolishes the cost and diagnostic delay associated with referrals to radiology or outsourced providers. Shared decision-making adds value to outpatient attendances, which is reflected in patients' positive feedback. The MDT model maximises the existing workforce skill set by enhancing the APP and CNS role, allowing patients immediate access to their expertise.

Evaluation of Factors Causing a Delay in Management and Hospital Stay in Diabetic Foot Amputation Patients: A Prospective Cohort Study

OBJECTIVE: To determine the rate of different amputation levels in diabetic foot patients and the incidence of repetitive foot surgeries and evaluate the factors causing a delay in hospital stay and amputation of patients. METHODOLOGY: This prospective cohort study was conducted in Dr. Ruth K.M. Pfau, Civil Hospital Karachi, Pakistan. The study selected 375 participants from the clinic's daily patient inflow from October 2021 to March 2022 using a non-probability consecutive sampling technique. Those who had a delay in hospital stay and amputation were further followed up from May-October 2022. The chi-square test and Kruskal Wallis test (p-value <0.05) were used to correlate the effect of the level of lower limb amputation and the cause of delay in amputation using SPSS version 24.0. RESULT(S): Total 246(65.60%) were males and 129(34.40%) were females. Toe amputation was the most commonly seen amputation in 173(46.1%) participants. About 168(44.8%) patients had some in-hospital delay stay during their treatment. Preoperative hurdles (Uncontrolled RBS, Osteomyelitis, etc.) were the most common factor causing an in-hospital delay in 92(24.5%) patients. The level of amputation performed was found to be statistically significant with factors causing a delay in hospital stay through chi-square (p=0.003*) and Kruskal Wallis test H (2) statistic= 13.3, df = 3, H (2), P=0.004*). CONCLUSION(S): Diabetic foot is a frequent cause of amputation globally, majorly in developing countries like Pakistan. On-time provision of treatment to these patients can decline the global amputation rate due to diabetic foot ulcers.Copyright © 2023 Syeda Anjala Tahir.

Impact of COVID-19 pandemic on oral and maxillofacial surgery in Japan: A report from a questionnaire survey during the different phases of the pandemic

COVID-19 pandemic has provided a new challenge to healthcare systems and medical care providers. In the current study, we describe the challenges faced and actions taken to provide optimum healthcare in Japan during the COVID-19 pandemic based on the results of a questionnaire survey that was conducted by oral and maxillofacial surgeons. A total of 24 Japanese institutions participated in the study. The first survey was conducted between June 22, 2020 and June 26, 2020, and the second survey was conducted between October 23, 2020 and November 8, 2020. The questionnaire focused on the practical situation in the respondent's hospital, personal protective equipment (PPE) availability, and what alterations had occurred compared to the situation before the COVID-19 pandemic. The commonest reported duration of restrictions to the outpatient clinic was 1-2 months. All of the institutions had lifted their restrictions on outpatient services by September 2020. Surgical procedures in the operating room were restricted in 74% of hospitals in the first wave of the pandemic;however, 88% lifted their restrictions and restarted their regular surgical services by November 2020. Although, non-urgent or elective procedures were delayed, surgeries for malignant tumors, maxillofacial infections, and trauma were performed at almost all hospitals during the pandemic. Health care institutions will require a new approach to maintain patient volume and recover from the pandemic. Going forward, it is also necessary to minimize the risk of exposure and transmission to health care personnel as well as patients.Copyright © 2021 The Authors

The impact of the COVID19 pandemic on treatment practices for patients diagnosed with early breast cancer: a cross-sectional study from a large comprehensive cancer centre in Italy

The impact of the COVID19 pandemic on treatment practices for patients diagnosed with early breast cancer: a cross-sectional study from a large comprehensive cancer centre in Italy. Introduction: The Coronavirus Disease 2019 (COVID19) has disrupted health services worldwide. The evidence on the impact of the pandemic on cancer care provision, however, is conflicting. Some reports found that management for patients diagnosed with early breast cancer (EBC) during the pandemic did not differ from pre-pandemic practices;other reports suggested that delays in breast cancer surgery may have occurred. We aimed to audit the management of patients diagnosed with EBC during the pandemic in a large, tertiary-level cancer centre in Italy. Method(s): We conducted a cross-sectional study to track the route to first treatment for patients diagnosed with EBC during 2019, 2020, and 2021. We ed data for all consecutive patients referred to the Veneto Institute of Oncology (Padua, Italy). We defined as point of contact (POC) the date of the first consultation with a breast cancer specialist of the breast unit. We considered patients with a first POC in the 6 months preceding the multidisciplinary (MDT) meeting and initiating a treatment within 6 months from the POC. We chose the 3-month period April-June because in 2020 it was when health services were first acutely disrupted. We analysed the same period for 2019 and 2021. First treatment was defined as either upfront surgery or neoadjuvant chemotherapy (NACT). The time to first treatment was defined as the interval between the first POC and the first treatment. We used the median time to first treatment in 2019 to define the threshold for treatment delay. Result(s): We reviewed medical records for 878 patients for whom an MDT report during 2019-2021 (April through June) was available. Of these, 431 (49%) were eligible: 144 in 2019, 127 in 2020 and 150 in 2021. Median age at first POC was 61 years. The proportion of screen-detected tumours was larger in 2019 and 2021 than in 2020 (59%). Conversely, the proportion of screen-detected tumours was offset by the proportion of palpable tumours in 2020 (44% versus 56%). These differences were statistically significant (chi-square test 11.12, p=0.004). Distribution of tumour and nodal stage was unchanged over time, but in-situ tumours were slightly fewer in 2020 than in 2019 or 2021. The odds ratio for treatment delay (45 days or more) was 0.87 for 2020 versus 2019 (95% CI, 0.5-1.53) and 0.9 for 2021 versus 2019 (95% CI, 0.52-1.55), after adjusting for type of POC, presentation with symptoms, treatment type, tumour stage, nodal stage, and EBC subtype (i.e., luminal, HER2positive, triple-negative). Conclusion(s): There was no evidence for major changes in the management of EBC patients during 2019-2021 and no treatment delays were observed. However, our results show a slight decrease in the absolute number of patients being treated in 2020, offset by an increase in 2021 to levels comparable to 2019. Our findings suggest that disruption of breast cancer screening programmes may have impacted on the characteristics of the patient population, with a larger proportion of women presenting with palpable nodules. Validation on a larger, population-based cohort of patients is warranted to robustly assess the impact of the COVID19 pandemic on treatment practices and outcome for EBC patients.

Head and neck cancer management in the Covid-19 era: Our experience

Introduction: In March 2020 a new viral pandemic was declared. As etiological factor a virus belonging to the coronavirus family was isolated. This virus was named SARS-CoV-2 or COVID-19. This virus can cause different clinical frames, variating from mild symptomatology to cases of ARDS or death. Although the pandemic outbroke in China, COVID-19 had one of first hotspots in Italy, where the Public Health System needed a re-arrangement to face the disease. The incidence of oncological disease doesn't suffer any variation in relation to pandemics or emergency period, but need to be managed as soon as possible in every situation. In our maxillo-facial surgery Unit we continued our regular activities to treat all oncological patient that needed surgery during the pandemic. Because of the absence of knowledge about the COVID-19, first periods were very difficult to manage, due to the risk of infection of patients and health professionals. We decided to share our experience. Material(s) and Method(s): Between March and June 2020, 34 patients affected by head and neck cancer were admitted at our Unit. All patients underwent surgical treatment and were hospitalized until their situation guaranteed a safe discharge. Result(s): All patients treated for head and neck cancer underwent surgery. All the medical and nurse post-operative management was performed by health operators by using all the personal protective equipment (PPE) to prevent any possible infection. All contacts between patients and their family were suspended. During phase 1, all patients were submitted to a short verbal triage, measurements of physiological parameters and qualitative COVID-19 test. They were also screened by imaging to guarantee there were not any bronchopulmonary diseases referable to viral infections. During phase 2, patients were also screened by serological tests. During phase 3, all patients practiced oropharyngeal swap before being hospitalized. Discussion(s): During lockdown a re-arrangement of the management of oncological patients was mandatory. The difficulties were caused by the restriction of several activities that guarantee a normal health care system function. To date there is not a standardized therapeutic protocol to face the infection. Main therapies are symptomatic and a lot of patients need to be treated in ICUs. To prevent any possible infections, surgical activities were reserved only for urgent disease that cannot be delayed. In our Unit we continued to manage oncological patients. Social distancing and confinement measures were necessary and mandatory, in order to manage our patients. During first phases we had not any valid instrument to totally exclude COVID-19 infection. During phase 3, when oropharyngeal swaps were introduced in the screening of our patients, we could start to work in a safer way. Conclusion(s): There are still a lot of difficulties in the management of patients during COVID 19 pandemic. Because of the important consequences deriving from the delay of oncological patients their management must to be clearly defined.Copyright © 2021

The Psychological Impacts of COVID-19 on Breast Cancer Patients in China

Background: Approximately 30% to 50% of breast cancer patients experienced mental distress prior to the advent of COVID.The delayed access to cancer treatment due to the outbreak of COVID -19 pandemic posed a unique challenge to breast cancer patients and caused a significant level of mental distress among them. In the current research, we examined the psychological impacts of COVID on breast cancer patients in China using Symptom Checklist-90-R (SCL-90-R). Method(s): Participants were breast cancer patients at the outpatient clinic of Xijing hospital. The study was conducted virtually, and the questionnaires were distributed via Wenjuanxing, the Chinese alternative of Qualtrics. The researchers were healthcare workers affiliated with Xijing hospital, and the survey was sent to a breast cancer patient support group which included 1399 cancer patients and 6 healthcare workers. The initial sample consisted of 199 participants who signed an informed consent form to participate in the study. The inclusion criteria were as follows: 1) diagnosed with breast cancer, 2) aged 18 years or above, and 3) had no history of cognitive impairment or previous diagnosis of psychiatric disorders. The validated Mandarin version of the SCL-90-R (Wang, 1984) was then given to the participants to evaluate their psychological status.Categorical variables were summarized as numbers and percentages;continuous variables were described as mean (M) +/- standard deviation (SD). Data were analyzed using IBM SPSS Statistics Version 26. Result(s): Participants (N = 195) filled out the SCL-90 questionnaire in February, 2020. All participants were female breast cancer patients treated at Xijing hospital, among which 16.41%, 36.41%, 19.49%, and 28.21% had respectively received treatment for less than a year, 1-3 years, 3-5 years, and 5 years or more. 64.62% of the patients were at stage I;0.77% were at stage II and III;4.62% were at stage IV according to TNM classification. The molecular type of participants is as follows: 47.2% of ER+ HER2-, 31.8% of HER2+, and 21.0% of Triple negative.Participants whose treatments continued to be delayed, on average, reported an elevated general psychopathology score (M = 1.48, SD = 0.47) compared to participants whose treatments were resumed (M = 1.30, SD = 0.34), and the difference was statistically significant, t(193) = 2.96, p = .003, d = 0.44, 95%Cl [0.06, 0.30]. The one-way ANOVA revealed a marginally significant effect of length of treatment delay on general psychopathology score, F(4, 190) = 2.09, p = .08, eta2 = .04. Follow-up multiple comparison analysis showed that participants who had their treatment delayed for 3 weeks to 1 month (M = 1.70, SD = 0.70) reported significantly higher general psychopathology scores than participants whose delay in treatment was less than 1 week (M = 1.34, SD = 0.40), p = .05. General health status (p < .001) and current treatment status (p = .02) are the only two variables that were statistically associated with general psychopathology score.Poorer perceived health status and current delay in treatment were associated with higher general psychopathology score, Additionally, younger age was associated with higher interpersonal sensitivity (p = .01) and hostility (p = .006). Conclusion(s): We found that breast cancer patients at an advanced stage were more likely to experience psychological symptoms with longer treatment delay, and whose treatments continued to be delayed reported elevated psychological symptoms than individuals whose treatment were resumed, regardless of treatment type. Additionally, a treatment delay of more than three weeks might have exacerbated breast cancer patients' psychological symptoms, whereas a short-term delay of less than three weeks was less likely to have a significant effect on one's mental wellbeing.

COVID-19 testing trends: pre-radiation and throughout cancer care

Introduction: Patients presenting for radiation therapy (RT) at a single institution were analysed regarding treatment delays and disparities during the coronavirus disease 2019 (COVID-19) pandemic. Methods: The study was conducted at an urban multidisciplinary cancer centre. In April 2020, the institution's radiation oncology department implemented universal COVID-19 screening protocols prior to RT initiation. COVID-19 testing information on cancer patients planned for RT from 04/2020 to 01/2021 was reviewed. Trends of other lifetime COVID-19 testing and overall care delays were also studied. Results: Two hundred and fifty-four consecutive cancer patients received RT. Median age was 63 years (range 24-94) and 57·9% (n = 147) were Black. Most (n = 107, 42·1%) patients were insured through Medicare. 42·9% (n = 109) presented with stage IV disease. One (0·4%) asymptomatic patient tested positive for COVID-19 pre-RT. The cohort received 975 lifetime COVID-19 tests (median 3 per patient, range 1-18) resulting in 29 positive test results across 21 patients. Sixteen patients had RT delays. Identifying as Hispanic/Latino was associated with testing positive for COVID-19 (p = 0·015) and RT delay (p = 0·029). Conclusion: Most patients with cancer planned for RT tested negative for COVID-19 and proceeded to RT without delay. However, increased testing burden, delays in diagnostic workup and testing positive for COVID-19 may intensify disparities affecting this urban patient population. © The Author(s), 2022. Published by Cambridge University Press.

The impact of pandemic of COVID-19 on routine immunization: A cross-sectional study in tertiary care centre at Pune

Background: Due to COVID-19 pandemic there was implementation of preventive measures like lockdown, mobility restriction and fear had an impact on routine immunization of children. There are significantly increases the susceptibility window for vaccine preventable diseases due to delayed vaccination in under five children. The objective of study is to know the trend of routine immunization of previous five year and to assess the impact of COVID-19 pandemic on routine immunization of children of age group up to 7 years at tertiary care hospital at Pune. Method(s): A hospital-based cross-sectional study was conducted in a tertiary care hospital of Pune city from the month of January 2017 to December 2021. All the data of immunization from age group 0 to 7 years present at tertiary care center Pune, was compared and analysed. Data is expressed as numbers and percentages and means. Chi-square test was used to compare observed results with expected results. Result(s): In year 2020, there was a declining trend of all vaccines among children compared to previous 3 years. In year 2019, 2020, 2021, number of children vaccinated are 6547, 4052, and 5062 respectively. Out of this 1078(16%), 1089(26.9%), 1165(23%) children had delayed vaccination in year 2019, 2020, 2021 respectively. There was highly significant increase in delayed vaccination of children in COVID-19 period. Conclusion(s): The routine immunization of children was decreased and delayed due to COVID-19 pandemic. This is an alarming finding to prevent reappearance of new epidemics of vaccine preventable diseases.Actions should be taken to avoid delayed routine immunization in future. Copyright © 2022 Ubiquity Press. All rights reserved.

COVID-19 VACCINATION-ASSOCIATED LYMPHADENOPATHY: A DIAGNOSTIC CONUNDRUM IN LUNG CANCER STAGING

SESSION TITLE: Lung Cancer Imaging Case Report Posters 2 SESSION TYPE: Case Report Posters PRESENTED ON: 10/19/2022 12:45 pm - 01:45 pm INTRODUCTION: The Coronavirus disease 2019 (COVID-19) pandemic affected millions of people globally, prompting the emergent need for an effective vaccine. Lymphadenopathy associated with COVID-19 vaccine is a recognized phenomenon that can present a diagnostic dilemma for staging thoracic malignancies. We present a case of post COVID-19 vaccination axillary lymphadenopathy complicating the staging process for a patient with newly diagnosed lung adenocarcinoma. CASE PRESENTATION: A 64-year-old-male with chronic obstructive pulmonary disease, former smoker with a 20-pack-year smoking history was found to have a 1.7 cm solid nodule in the left upper lobe with irregular margins on low dose computed tomography (CT) scan of the chest for lung cancer screening. Fine needle aspiration of the nodule was done, and histopathology results were consistent with the diagnosis of adenocarcinoma. Patient then underwent fluorodeoxyglucose-positron emission tomography (FDG-PET) scan that showed a 16 mm nodule in the left upper pulmonary lobe with maximum standardized uptake value (SUVmax) of 5.3 and left axillary nodes measuring up to 8 mm with SUVmax of 4.4 concerning for metastatic disease. On further history, patient had received the Pfizer mRNA vaccination booster three days prior to undergoing the FDG-PET scan. Patient was evaluated by oncology and decision was made to treat with a 7-day course of prednisone 20 mg daily and to repeat FDG-PET scan. FDG-PET scan done four weeks later showed resolution of axillary lymphadenopathy. Patient was clinically staged as T1bN0M0 stage 1A and underwent robotic left upper lobe lingular-sparing lobectomy. DISCUSSION: In patients with thoracic malignancies, lymphadenopathy related to COVID-19 vaccination with avid FDG uptake on PET scan was reported in 29% of patients (2). The presentation of FDG avid lymphadenopathy creates a clinical challenge by confounding accurate cancer staging and leading to unnecessary workup (3). More importantly, detection of lymphadenopathy while staging lung cancer has crucial implications in the process of triaging patients to oncologic management in terms of candidacy for surgical resection (3). Currently, no consensus is available to guide management for incidental lymphadenopathy associated with COVID-19 vaccination in lung cancer patients. For this patient, we chose to treat with steroids and to obtain repeat imaging within 4 weeks of the original FDG-PET to not delay treatment planning. Repeat imaging showed resolution of the axillary lymphadenopathy and patient was able to undergo definitive treatment promptly. CONCLUSIONS: This case highlights the diagnostic challenge posed by COVID-19 lymphadenopathy in patients with newly diagnosed lung cancer and delineates our approach to navigating this challenge to avoid malignancy up-staging and treatment delay. Reference #1: Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020;383(27):2603-2615. doi:10.1056/NEJMoa2034577 Reference #2: Nishino M, Hatabu H, Ricciuti B, Vaz V, Michael K, Awad MM. Axillary Lymphadenopathy After Coronavirus Disease 2019 Vaccinations in Patients with Thoracic Malignancy: Incidence, Predisposing Factors, and Imaging Characteristics. J Thorac Oncol. 2022;17(1):154-159. doi:10.1016/j.jthoCH.2021.08.761 Reference #3: Lehman CD, D'Alessandro HA, Mendoza DP, Succi MD, Kambadakone A, Lamb LR. Unilateral Lymphadenopathy After COVID-19 Vaccination: A Practical Management Plan for Radiologists Across Specialties. J Am Coll Radiol. 2021;18(6):843-852. doi: 10.1016/j.jacr.2021.03.001 DISCLOSURES: No relevant relationships by Hadya Elshakh No relevant relationships by Stephen Karbowitz No relevant relationships by Gina Villani

Real impact and reasons for anti-VEGF treatment delay during Covid-19 pandemic lockdown in neovascular age-related macular degeneration: A national study

Purpose : To assess the visual impact and reasons for treatment delay during the COVID-19 pandemic lockdown in neovascular age-related macular degeneration (nAMD) patients in ongoing anti-VEGF therapy. Methods : Retrospective, national, multicentre, observational study in nAMD patients treated with anti-VEGF therapy and registered in the Fight Retinal Blindness (FRB) Spain platform prior to lockdown. Study cohort was divided in timely treated patients (TTP) and delayed treatment patients (DTP). Mean change in best corrected visual acuity (BCVA, in ETDRS letters) from the last follow-up visit (FUV) before lockdown (BLD) (baseline [BL] visit) to the first FUV after lockdown (ALD) was assessed. A specific questionnaire was distributed to the participant centers to investigate further the reasons for treatment delay in all individual cases. Results : A total of 245 eyes fulfilled the eligibility criteria, from which 39.6% were TTP (n=97) and 60.4% were DTP (n=148). TTP presented greater baseline and final BCVA compared to DTP (64.1 vs 58.7 letters, p=0.023, and 63.6 vs 57.1, p=0.004). BCVA loss was significantly greater for DTP vs TTP (-2.0 vs -0.6 letters, p=0.016). For DTP cohort, the primary reason for visit delay was patient decision (48.2%) followed by limited hospital clinic capacity (42.7%). When patients decided not to attend scheduled visits, the main reason was fear to Covid-19 infection (49.4%). Conclusions : This study provides relevant data about the impact on visual outcomes of Covid-19 pandemic lockdown on nAMD patients and specifically provides new additional information regarding the main reasons for treatment and visits delay from both patients and healthcare service delivery perspectives.

Telehealth utilization in gynecologic oncology clinical trials (295)

Objectives: In light of the COVID-19 pandemic, the Society of Gynecologic Oncology (SGO), National Cancer Institute, and Food and Drug Administration published clinical practice statements encouraging the use of telemedicine in clinical trials, which had previously been prohibited. Our study aimed to assess the feasibility and safety of telehealth utilization in clinical trials for gynecologic malignancies. Methods: A retrospective cohort study was performed. Patients who were enrolled in a gynecologic oncology clinical trial at the University of Pennsylvania Health System from March 16, 2020, to August 30, 2020, were included. Receipt of care during the telehealth period (March 16, 2020, to August 30, 2020) was compared to the pre-telehealth period (September 30, 2019, to March 15, 2020). Pairwise comparisons of clinical trial outcomes were performed between the two time periods, using paired t-test, Wilcoxon signed-rank test, simple linear regression, Chi-square, and ANOVA. Results: Thirty-one patients met the inclusion criteria. The mean age was 63.7 years (SD 10.3);84% were non-Hispanic White. The median distance from home zip code to study center was 25.2 miles (IQR: 16-46, range: 1.9-170). Most patients had high-grade serous ovarian carcinoma (84%) and had the disease at an advanced stage (Stage III 48%, Stage IV 38.7%). Trial drugs included 22.6% (n=7) intravenous only, 29% (n=9) oral only, and 48.4% (n=15) combination oral/intravenous therapies. The median duration of enrollment was similar between pre-telehealth (5.2 months, IQR: 3.2-5.6) and telehealth periods (5.6 months, IQR: 3.8-5.6), (p=0.682). During the TELEHEALTH period, significantly more virtual provider visits (p <0.001) and remote laboratory testing (p=0.015) occurred, with similar rates of remote imaging (p=0.551). Delayed provider visits (p = 0.965), laboratory testing (p = 0.989) and imaging (p = 0.999) occurred infrequently in both timeframes. The number of patient touchpoints (portal messages and phone calls) per month did not increase (p = 0.147). Patients who lived farther from the study center were more likely to use remote imaging (p = 0.013);however, the distance was not associated with the use of virtual provider visits (p = 0.309) or remote laboratory testing (p = 0.821). Number of dose reductions (p = 0.112) and toxicity-related treatment delays (p = 0.888) were similar. Increased need for extra imaging was noted in the telehealth period (p=0.007) and was not associated with disease progression (p=0.614). Extra provider visits, emergency department visits, and hospital admissions were infrequent and similar in both timeframes (Table 1). The total number of deviations was increased (p=0.010);however, when adjusted for minor deviations documenting telehealth use or deferment of research-related laboratory testing given the pandemic precautions, there was no difference between timeframes (p = 0.468). The total number of adverse events and severe adverse events did not increase in the telehealth period (p=0.494 and p=0.601, respectively). Conclusions: Utilizing telehealth in clinical trials for gynecologic oncology patients did not increase clinical workload or adverse patient outcomes. Documentation of telehealth use and pause of research-related laboratory collections resulted in a higher number of protocol deviations during the telehealth period. Telehealth should be incorporated into future clinical trials as it appears safe and feasible and may facilitate access for remote, rural, and under-served populations.

A Phase II Study of Metformin with Pemetrexed/Carboplatin in Patients with Metastatic Non-Squamous Non-Small Cell Lung Cancer

Introduction: There is a subset of NSCLC patients ineligible for benefit from TKIs/Immunotherapy (e.g. STK11 mutation conferring resistance to Immunotherapy). Besides, many patients cannot afford these therapies. Metformin has anticancer properties acting both on glycolytic metabolism and tumor microenvironment. In vitro studies suggest synergism between metformin and pemetrexed. STK11 deficient cell lines are more sensitive to metformin. Clinical studies combining metformin with chemotherapy are limited by small sample size. We conducted an exploratory phase-2 clinical trial of metformin with pemetrexed/carboplatin in advanced non-squamous NSCLC. Methods: This was a single center, open label, single arm phase 2 clinical trial with a Simon’s two stage design. The null hypothesis was that the combination would not improve the 6-month PFS rate by 15%, from 50%. Treatment-naive, non-diabetic patients aged 18-75 years with NSCLC (adenocarcinoma/not-otherwise-specified) with stage IV disease having ECOG PS 0-2 with unmutated EGFR/ALK and without brain metastasis or with asymptomatic brain metastases were treated with pemetrexed-carboplatin chemotherapy and metformin for six months. The primary outcome was 6-month progression free survival (PFS) rate. Secondary outcomes were safety, overall survival (OS), overall response rate (ORR), proportion of STK 11 mutation and effect of STK 11 mutation on 6-month PFS rate. PFS and OS were estimated using the Kaplan-Meier method. Targeted sequencing was attempted for available tissue specimens. Results: The first interim analysis was performed after enrollment of 26 patients for the first stage (before the target accrual of first stage was reached) due to slow accrual, in view of COVID pandemic. The study was terminated after first stage for futility. The median age of patients in the study was 52 years (range, 30 to 68) and 18 patients (69.0%) were males. Half of the patients had ECOG-PS 2. Brain metastases were present in eight (31%) patients and among these four (50%) were symptomatic at presentation. The median follow-up time was 25 months. The median PFS was four months. 6-month PFS rate was 28% (95% CI - 0.12 to 0.46). Of the 25 evaluable patients, five (20%) had a partial response, and eight (32%) had stable disease;13 (52%) of the patients had disease control. The median OS was 16 months. During combined therapy, 14 (54%) and 3 (11%) patients had any grade and grade 3 anemia respectively. One patient had grade 3 neutropenia. Among non-hematological toxicities, gastrointestinal toxicities (nausea, vomiting and diarrhea) were the most common. No grade 4 toxicities were reported. There were no treatment discontinuations, however treatment delay due to grade three toxicities was present in two patients. Dose modification for Metformin was required in four patients. Targeted Sequencing was possible in nine cases. Two of these patients had STK11 mutation and an associated bad outcome (PFS < 2 months). Conclusions: We could not demonstrate the benefit of combination of Metformin with pemetrexed-carboplatin in terms of improvement in 6-month PFS rate. The addition of metformin to pemetrexed-carboplatin has an acceptable safety profile. Future trials should test metformin in specific subsets (STK11 mutated) and in combination with immunotherapy and TKIs. Keywords: Metformin, NSCLC, STK11

Delays in care following a COVID diagnosis

Background: We sought to describe factors associated with treatment delay among cancer patients with COVID-19. Methods: We conducted a retrospective analysis of de-identified data from the ASCO COVID-19 Cancer Data Registry, a longitudinal cohort study launched in April 2020 with 60 community and academic practices. We evaluated all patients who were documented as having therapy (anticancer drug therapy, surgery or radiation therapy) scheduled at the time of entry into the registry due to a positive SARS-CoV-2 test result. Treatment delay were defined based on length of delay: on schedule or within 14 days, and delay > 14 days or discontinued entirely. The latter is defined as “delay in care”. We used univariate and multivariate logistic analyses to address these questions. Results: At the time of data analysis, 3028 patients were included in the registry, of which 2103 had scheduled drug therapy, 125 had scheduled surgery, and 202 had scheduled radiation. 46% of patients had a drug delay or discontinuation of care. A multivariable logistic regression found that delays were higher among Black patients relative to white patients (OR 1.73, 95%CI 1.27, 2.35), and Hispanic or Latino patients compared to non-Hispanic or Latino patients (OR 1.95, 95%CI 1.36, 2.80). Compared with patients with 0-1 comorbidities, having 2 or more comorbidities was associated with delay in treatment (OR 1.26, 95%CI 1.01, 1.56). Having metastatic disease, rather than local or regional disease (OR 1.61, 95%CI 1.28, 2.04), and having any COVID-19 complications compared to none (OR 1.49, 95%CI 1.22, 1.83) were associated with delay. Relative to the initial outbreak of the pandemic from March-June 2020, having a COVID-19 diagnosis later in the pandemic was associated with lower likelihood of delay (OR 0.45, 95%CI 0.26, 0.74). 47% (95/202) of patients had a radiation delay or discontinuation of care. Factors associated with radiation delay included having 2 or more comorbidities (OR 2.78, 95%CI 1.22, 6.53). 71% (89/125) of patients had a surgical delay or discontinuation care. Factors associated with surgical delay included female sex (OR 6.05, 95%CI 1.34, 34.6), being in the South compared with being in the Midwest (OR 9.00, 95%CI 1.97, 49.0). Counter-intuitively, having 2 or more comorbidities was associated with a lower likelihood of delay (OR 0.27, 95%CI 0.09, 0.90). Being diagnosed with COVID-19 in July-Sept 2020 was associated with lower likelihood of delay (OR 0.07, 95%CI 0.01, 0.49). Conclusions: Previous data has shown persistent disparities in COVID-19-related outcomes in subgroups of disadvantaged and minority patients and populations. Data from our study shows that another disparity borne of treatment delays for chronic disease in the setting of a positive SARS-CoV2 test may also contribute to overall poor outcomes in these vulnerable populations.

Impact of the COVID-19 pandemic on cervical cancer diagnosis and treatment in Botswana

Background: The COVID-19 pandemic rapidly altered cancer care delivery globally, providing a compelling opportunity to empirically study how these changes impacted persistent disparities in care. Cervical cancer is one of the most common female cancers worldwide, with approximately 90% of cases and deaths occurring in low- and middle-income countries (LMICs). In Botswana, a LMIC with a particularly high prevalence of HIV and cervical cancer, delays in cervical cancer diagnosis and treatment have been documented but is unknown how these delays may have been mitigated or exacerbated since the pandemic. Methods: The objective of this analysis is to evaluate patterns of cervical cancer diagnosis and treatment initiation before (January 2015-March 2020) and during the pandemic (April 2020-July 2021) using longitudinal clinical and patient-reported data from a cohort of over 1,000 patients receiving care for gynecologic cancers in Botswana. The primary outcome is timeliness of treatment defined by the number of days between first clinical visit and initiation of first-line treatment and categorized dichotomously (> 30 days classified as delay). Primary exposure is the time period (prepandemic and pandemic) defined by the month of first visit. We calculated unadjusted proportion of delays and covariates stratified by time period and used bivariate analysis to examine factors associated with each time period. We used multivariable logistic regression models to examine the association between delay and time period, adjusting for all covariates (age, stage, HIV status, rurality, screening history, and partner status). Results are presented as unadjusted proportions, adjusted odds ratios (AOR), and 95% confidence intervals. Results: Of the 1,200 patients treated for cervical cancer at the multidisciplinary clinic, 990 (82.5%) were diagnosed pre-pandemic and 210 (17.5%) during the pandemic. Among all patients with gynecologic cancers (n = 1,568), the proportion of patients with cervical cancer significantly decreased from 78.6% pre-pandemic to 68.0% during the pandemic (p < 0.001). In comparison to pre-pandemic, patients with cervical cancer during the pandemic were significantly less likely to have attended a screening clinic prior to their treatment (57.6% vs 15.3%;p < 0.001) and significantly more likely to experience treatment delays (61.6% vs 92.9%;p < 0.001). In the multivariable model, patients diagnosed during the pandemic had a 7-fold higher likelihood of treatment delays than those patients diagnosed pre-pandemic (AOR: 7.95;95% CI: 4.45-14.19). Conclusions: The pandemic significantly increased delays in treatment for nearly all patients with cervical cancer in Botswana. Given persistent global disparities in cervical cancer, there is a great need to implement evidence-based strategies for improving screening and timeliness of care in Botswana and other LMICs.

Racial/ethnic disparities of cancer treatment disruptions among patients with breast cancer with SARS-CoV-2 infection: An analysis of the ASCO Survey on COVID-19 in Oncology Registry

Background: The COVID-19 pandemic has led to disruptions in cancer treatment delivery among breast cancer patients in the U.S. However, it is currently unknown whether racial/ethnic disparities exist in cancer treatment disruptions among patients with breast cancer and SARS-CoV-2 infection. Methods: We obtained data from the ASCO Survey on COVID-19 in Oncology Registry (March 2020-July 2021) describing breast cancer patients diagnosed with SARS-CoV-2 during their care treated at 46 practices across the US. Data included patient demographics, SARS-CoV-2 diagnosis and treatment, breast cancer characteristics, and modifications to cancer treatment plans. Breast cancer treatment delay or discontinuation (TDD) was defined as any treatment postponed more than two weeks from the originally scheduled date. We computed adjusted odds ratios (aOR) using multivariable logistic regression, accounting for non-independence of patients within hospitals to evaluate racial/ethnic disparities of TDD. Multivariable models were adjusted for age, sex, number of comorbidities, cancer extent, ECOG performance score, pandemic period based on case peaks (< 06/2020, 06-12/2020, 01-07/2021), and COVID-19 severity (death/hospitalization/ICU admission/mechanical ventilation). Results: Breast cancer patients (n = 804) with SARS-CoV-2 were mostly aged 50 years and above (75%) and urban residents (83%). The racial/ethnic makeup of the sample included: 13.3% non-Hispanic Black/African American (NH-Black), 11.7% Hispanic/Latinx, 4.9% American Indian/Alaskan Native (NH-AI/ AN), 4.6% NH-Asian, and 65% NH-White. At SARS-CoV-2 diagnosis, 736 patients (91%) were scheduled to receive drug-based therapy (78%), radiation therapy (8%), or surgery (6%), of whom 39% experienced TDD. Across treatment modalities, the most commonly reported TDD reason from the clinic perspective was the patient's COVID-19 disease (∼90%). Overall, NH-Black (62%), Hispanic/Latinx (44%), and NH-Asian (42%) adults with breast cancer and SARS-CoV-2 were more likely to experience TDD versus NH-White adults (34%) (p < 0.001). In multivariable analyses, NH-Black cancer patients were more likely to experience TDD compared to NH-White patients (aOR: 3.12, 95% CI: 1.96-5.47). The data suggest Hispanic/Latinx (aOR: 1.34, 95% CI: 0.78-2.30) breast cancer patients may also experience TDD, although not statistically significant. No association was observed among NH-Asian (aOR: 1.16, 95% CI: 0.50-2.73) or NH-AI/AN (aOR: 0.64, 95% CI: 0.28-1.52) breast cancer patients with TDD. Conclusions: Black or African American breast cancer patients are more likely to experience cancer care disruptions during the pandemic. Future research should evaluate the long-term impacts of care disruptions on breast cancer outcomes among minoritized US communities.

The role of rurality in cancer treatment disruptions among patients with cancer diagnosed with SARS-CoV-2: An analysis of the ASCO Survey on COVID-19 in Oncology Registry

Background: U.S. rural cancer patients experience multifactorial barriers to cancer treatment;however, little is known about the impact of the pandemic on cancer treatment delays or discontinuations (TDD) in the rural context. Our objective was to evaluate the role of rurality at both the patient and clinic level on cancer TDD among patients living with cancer with SARS-CoV-2 infection. Methods: We used data from the ASCO Survey on COVID-19 in Oncology Registry (March 2020-July 2021), which includes cancer patients diagnosed with SARS-CoV-2 (n = 3193). Data included patient demographics, SARSCoV- 2 treatment, cancer characteristics, and modifications to cancer treatment plans. Cancer-related TDD was defined as any treatment postponed > two weeks from the original scheduled date. Rurality was defined using the USDA Rural-Urban Commuting Area schema. We compared cancer characteristics, COVID-19 outcomes, and TDD by rurality of cancer patients, and TDD by rurality of oncology practices. We computed adjusted odds ratios (aOR) using multivariable logistic regression to evaluate rurality with TDD adjusting for age, race/ethnicity, sex, comorbidities, ECOG score, cancer extent, pandemic time period based on case peaks (< 06/2020, 06-12/2020, 01-07/2021), and COVID-19 severity. Results: Rural cancer patients (n = 499, 16%) with SARS-CoV-2 were mostly over 50 years (87%), female (57%), and NH-White (81%) with solid tumors (76%). Most rural patients received oncology treatment in urban areas (65%, p < 0.001). Rural patients were less likely to receive care through telemedicine (18%) compared to urban patients (26%) (p < 0.001). At SARS-CoV-2 diagnosis, rural patients were scheduled to receive drug-based therapy (72%), radiation therapy (8%), surgery (4%), or transplant (1%). Rural versus urban cancer patients with SARS-CoV-2 were less likely to experience TDD (41% vs. 51%) (p < 0.001). Among patients treated at rural oncology clinics, urban cancer patients were more likely to experience TDD (65%) compared with rural patients (47%) (p < 0.001). Similarly, among patients treated at urban oncology clinics, urban cancer patients were also more likely to experience TDD (51%) compared with rural patients (38%) (p < 0.001). In multivariable analyses, rural cancer patients were 28% less likely to experience TDD (aOR:0.72, 95% CI: 0.55- 0.94) than urban cancer patients. Oncology practice rurality was not associated with TDD (aOR: 1.19, 95% CI: 0.81-1.76). Conclusions: Rural cancer patients were less likely to experience TDD than urban patients supporting the urban-rural paradox i.e., geographic distance to cancer care facilities is not consistently associated with treatment delivery in expected ways. Future work should focus on area-level factors of the rural cancer patient experience to disentangle potential reasons for TDD during the pandemic.

Complications and severity of COVID-19 in patients with (HNC): A COVID-19 and Cancer Consortium (CCC19) registry analysis

Background: Patients with cancer have worse outcomes from COVID-19 infection. However, the specific impact of COVID-19 on patients with (HNC) is largely unknown. The COVID-19 and Cancer Consortium (CCC19) maintains an international registry (NCT04354701) aimed to investigate the clinical course and complications of COVID-19 in patients with cancer. Here, we report severity of COVID-19 and its complications among HNC patients. Methods: The CCC19 registry was queried for patients with HNC and laboratory confirmed SARS-CoV-2 infection. The co-primary outcomes were severity of COVID-19 illness on an ordinal scale (0: no complications;1: hospitalized, no oxygen (O2);2: hospitalized, required O2;3: ICU admission;4: mechanical ventilation (MV);5: death), and severity of complications (mild, moderate, serious). The outcomes were further stratified by demographics, recent treatment (systemic vs local;surgery, radiation (RT) vs systemic), treatment intent (palliative vs curative), and cancer status (remission, responding, stable, progressing). Results: From March 2020 to December 2021, 356 HNC patients were identified. Median age was 65 (interquartile range 58-74), 29% were female, 56% were white, 67% were former or current smokers, 20% had a BMI >30, 15% had an ECOG performance status >2, and 57% had >2 comorbidities. 154 (43%) had no complications, 61 (17%) were hospitalized without O2, 135 (38%) were hospitalized with O2, 50 (14%) required ICU, 32 (9%) required MV, and 74 (21%) died. 88 (25%) had mild, 59 (17%) had moderate, and 132 (37%) had serious complications. 33% of patients who received systemic therapy and 30% who received RT within 3 mo prior to COVID-19 diagnosis died. Mortality was higher in patients receiving palliative when compared to curative intent treatment (44% vs 16%). In addition, 50% of patients with actively progressing cancer, and 45% who had serious complications died. Importantly, 37 (n=12 palliative systemic therapy and n=25 local therapy) patients had a treatment delay due to COVID-19 diagnosis. Conclusions: Our study is the largest cohort to date describing COVID-19 outcomes in HNC patients and suggest a high rate of mortality even in those receiving local and curative intent treatment. Variables stratified by COVID-19 severity. Note: Ordinal levels 3 and 4 not shown due to small case numbers.