Deviation from standard cancer treatment during the first wave of the COVID-19 pandemic in India: A cross-sectional study

Background: During the coronavirus disease 2019 (COVID-19) pandemic, established best practices in cancer care were modified to diminish the risk of COVID-19 infection among patients and health-care workers. Objective(s): We aimed to study the modifications in cancer-directed therapy during the first wave of the COVID-19 pandemic. Material(s) and Method(s): A cross-sectional study of patients with cancers of the head and neck, thoracic, urologic, and central nervous systems who visited the medical oncology department of the Tata Memorial Hospital, Mumbai, India, between April 22, 2020 and June 01, 2020, was conducted. Data were prospectively collected in an online pro forma and supplemented from the electronic medical records. Result(s): Of a total of 514 patients, 363 (71%) were men. The most common malignancy was lung cancer in 234 patients (46%). Cancer-directed therapy was modified in 83 patients (16%). Deviations consisted of modification of the chemotherapy regimen (48%), temporary discontinuation of chemotherapy in 37%, and interim chemotherapy to delay surgery in 5%. Changes in the chemotherapy regimen included a shift to a less intensive regimen in 45%, changing from intravenous to oral in 40%, and less frequent dosing of immunotherapy in 7%. Considering missed appointments as a deviation from planned cancer therapy, 68% of patients had a deviation in the standard planned cancer care. Conclusion(s): Almost two-thirds of the patients could not reach the hospital during the COVID-19 pandemic lockdown in India. Of those who could reach the hospital, one of out every six patients with cancer had a change in their cancer-directed treatment, half of which consisted of a modification in the standard chemotherapy regimens. The effects of these therapy deviations are likely to be long-lasting. (Clinical Trials Registry-India, CTRI/2020/07/026533).Copyright © 2023 Neurology India, Neurological Society of India Published by Wolters Kluwer - Medknow.

COVID-19 vaccine uptake and vaccine hesitancy in Indian patients with cancer: A questionnaire-based survey

Background: Patients with cancer are at a higher risk of severe forms of coronavirus disease 2019 (COVID-19) and mortality. Therefore, widespread COVID-19 vaccination is required to attain herd immunity. Objective(s): We aimed to evaluate the uptake of the COVID-19 vaccine in Indian patients with cancer and to collect information regarding vaccine hesitancy and factors that contributed to vaccine hesitancy. Material(s) and Method(s): This was a questionnaire-based survey conducted between May 7, 2021 and June 10, 2021 in patients aged 45 years and over, with solid tumors. The primary end points of the study were the proportion of Indian patients with cancer aged 45 years and older who had not received the COVID-19 vaccine, and the reasons why these patients had not received the COVID-19 vaccine. Our secondary end points were the proportion of patients with a history of COVID-19 infection, and the proportion of the patients who had vaccine hesitancy. Additionally, we attempted to assess the factors that could impact vaccine hesitancy. Result(s): A total of 435 patients were included in the study. Of these, 348 (80%) patients had not received even a single dose of the COVID-19 vaccine;66 (15.2%) patients had received the first dose, and 21 (4.8%) had received both the doses. Approximately half (47.1%) of the patients reported that they took the COVID-19 vaccine based on the advice from a doctor. The reasons for not taking the COVID-19 vaccine could be considered as vaccine hesitancy in 259 (77%) patients. The two most common reasons were fear in 124 (38%) patients (fear of side-effects and of the impact of the vaccine on the cancer/therapy) and lack of information in 87 (26.7%) patients. On the multivariate analysis, the two factors found to be significantly associated with vaccine hesitancy were a lower educational level (OR, 1.78;95% CI, 1-3.17;P = 0.048) and a lack of prior advice regarding the COVID-19 vaccine (OR, 2.80;95% CI, 1.73-4.53;P < 0.001). Conclusion(s): Vaccine hesitancy is present in over half of our patients, and the most common reasons are a fear of the vaccine impacting the cancer therapy, fear of side-effects, and lack of information. Widespread vaccination can only be attained if systematic programs for education and dissemination of information regarding the safety and efficacy of the COVID-19 vaccine are given as much importance as fortification of the vaccination supply and distribution system.Copyright © 2021 Cancer Research, Statistics, and Treatment Published by Wolters Kluwer - Medknow.

mHealth and social mediation: Mobile support among stigmatized people living with HIV and substance use disorder

The social mediation role of mobile technology is typified by mHealth apps designed to connect individuals to others and support substance use disorder (SUD) recovery. In this study, we examined the use and utility of one such app designed to support people living with HIV (PLWH) and SUD. Drawing on Ling's emphasis on reciprocity and micro-coordination in mobile telephony as a social mediation technology, we gathered digital trace data from app logs to construct two metrics, initiation (i.e. whether a particular feature is engaged on a given day) and intensity (i.e. degree of involvement in the activity when engaged on that day), at three levels of communication—networked (one-to-many), dyadic (one-to-one), and intraindividual (self-to-self). We consider these affordances alongside use of information resources, games and relaxation links, a meeting and events calendar, and support tools to address use urges. We found few differences in patterns of use by race, sex, and age, though African Americans were less likely to engage in intraindividual expression, whereas women and older users were more likely to make use of this affordance. The initiation and intensity of network and dyadic reception, as well as the intensity of network expression, predicts recovery outcomes as measured on a weekly "check-in” survey, suggesting the utility of mobile log data for digital phenotyping in mHealth. By implementing this app during the COVID-19 pandemic, the study also found the disruption caused by national lockdown was negatively related to the app use. © The Author(s) 2023.

Hepatic manifestations of COVID-19 in the obstetric population

COVID-19 has and continues to affect healthcare across the world. Pregnant women have been identified as a moderate-risk group with regards to clinical susceptibility to COVID-19. Acute liver injury in pregnancy secondary to COVID-19 has been documented sparsely across the world. In this report, we describe the case of a pregnant women who presented with COVID-19 liver injury. A second women with a similar presentation and outcome also presented during the same COVID-19 wave but contact details were lost and consent not gained. Description The cases occurred in December 2020 during which time the predominant reported variant was the alpha strain of COVID-19. Patient A was a multiparous woman, who presented to the labour ward at 37 weeks, a few days after a positive COVID-19 test with vomiting. Investigations revealed significant derangement of liver function tests (LFTs) but with normal bilirubin and clotting. On a working diagnosis of acute fatty liver of pregnancy and with breech presentation, she underwent a caesarean section. Liver enzymes continued to deteriorate with a mild coagulopathy. A non-invasive liver screen and ultrasound did not reveal any significant abnormalities. She was discussed with the tertiary liver centre and started on a Nacetylcysteine infusion with some additional vitamin K. A few days later LFTs began to improve and she was discharged home with follow-up in the community. Her baby was treated with antibiotics for 5 days empirically due to the unknown nature of the transaminitis but remained well. Following further discussion with the tertiary centre, a diagnosis of acute liver injury secondary to COVID-19 was made. Discussion Extra-pulmonary features of COVID-19 have been reported in the literature. A number of theories have been postulated to describe the hepatic effects. This has mainly manifested itself as a transaminitis with varying outcomes. The prevalence in the obstetric population has been more sparsely reported but most isolated cases have been relatively self-limiting with positive outcomes [1]. This case also highlighted the diagnostic difficulties with other severe hepatic diseases of pregnancy. A handful of case reports have already described some of the crossover and difficulty in decisionmaking when these patients present acutely unwell to hospital [2]. The severity and rapid progression of some hepatic disorders in pregnancy not only warrants decisive decision-making but also involvement of the multidisciplinary team.

Societal Spillovers of TV Advertising: Social Distancing During a Public Health Crisis

Can TV advertising affect societal outcomes beyond traditional marketing outcomes such as sales and brand awareness? The authors address this question in the context of the COVID-19 pandemic by analyzing daily advertising and mobility data for 2,194 counties across 204 designated market areas in the United States. By employing a border identification strategy that exploits discontinuities across television markets, the authors find a significant positive causal relationship between TV ads from brands containing COVID-19 narratives and people's social distancing behavior, while controlling for government policy interventions (e.g., shelter-in-place, mask mandates). The estimated effects are almost 11 times larger in counties without government policy interventions compared with counties with policy interventions. Notably, while the overall impact of government ads on social distancing behavior is nonsignificant, the effect becomes significantly negative (positive) in the presence (absence) of policy interventions. The results are robust to alternative model specifications, variable operationalizations, and other data considerations. The findings underscore the critical role that spillover effects from brand-sponsored TV ads can play during major public crises, including mitigating the lack of local governments' policy interventions. The findings bear substantive implications for managers and policy makers regarding how advertising strategies may help improve public health outcomes or advance social good.

Vaccination During Acute COVID-19 Infection Protects Against 30 Day Adverse Outcomes

Background. Therapeutic vaccination following SARS-CoV-2 infection might stimulate anti-viral immunity and improve patient outcomes. We investigated, amongst previously unvaccinated patients, whether vaccination with the Pfizer, Moderna, or Johnson & Johnson vaccines within 14 days of a positive SARS-CoV-2 test affected 30-day patient outcomes. Methods. Using a deidentified national electronic health record dataset (Optum, Inc.), we identified previously unvaccinated patients who tested positive forCOVID-19 between 12/11/2020 and 12/19/2021. Among this cohort, 1,909 patients received a first vaccine dose within 14 days (vaccinated) while 446,309 did not receive a first dose of vaccine within 30 days of their first positive test (unvaccinated). We performed 1:1 propensity score matching based on age, gender, race, ethnicity, region, BMI, insurance, and comorbidities from the Charlson Comorbidity Index. Next, we compared odds of severe outcomes within 30 days between vaccinated and unvaccinated groups using a partial proportional odds model with the following ordinal severity outcome: no hospitalization, hospitalization, ICU stay, or death (Stata version 17.0, alpha = 0.05). Results. 1,909 vaccinated patients were propensity score-matched to 1,909 unvaccinated patients. The final matched cohort was statistically indistinguishable (p > 0.05) for all metrics used in propensity score calculation. This matched cohort (n = 3,818) was 58.6% female, 67.7% white, 12.6% Hispanic, and 56.4% commercially insured, with a mean age of 50.6 years and a similar comorbidity profile. A partial proportional odds model showed that unvaccinated patients were at increased risk for hospitalization and higher ordered outcomes (OR = 1.19, 95% CI: 1.02-1.39), ICU stay and higher ordered outcomes (OR 1.63, 95% CI: 1.21-2.20), and death (OR 4.57, 95% CI: 2.50-8.37). Conclusion. Among previously unvaccinated patients, those who received a first dose vaccine within 14 days of a positive COVID-19 test were less likely to experience hospitalization, ICU stay, or death compared to matched peers who did not receive a first dose in the acute phase of infection. The sample size of patients vaccinated during the acute phase is limited, so further studies are indicated to evaluate the safety and efficacy of this practice.

Calcifying Epithelial Odontogenic Tumour - A Diagnostic Challenge

Introduction/Aims: Calcifying epithelial odontogenic tumour (CEOT) or Pindborg's tumour is a rare, benign, slow-growing dental neoplasm which is locally aggressive and can invade dentoalveolar bone with possible displacement of teeth and soft tissue. We present a case of CEOT, which was initially managed as cemento-osseous dysplasia (COD). Material(s) and Method(s): A 52-year-old Afro-Caribbean female presented with a two-month history of a left anterior maxillary swelling and examination revealed a firm, buccal mass from upper left central incisor to first premolar. Plain radiograph and computed tomography (CT) imaging revealed a dense calcified body with a lucent capsule measuring 19 x 24 x 23 mm causing displacement of adjacent teeth and expansion of the maxillary cortex, and concluded the diagnosis of COD. Biopsy was offered to the patient but she was reluctant to proceed, so she was managed conservatively according to the radiological diagnosis. Results/Statistics: During the 18-month surveillance period, the patient developed signs of infection of her anterior left maxilla and COD. CT scans showed a slight increase in the tumour size and surgical excision was postponed due to COVID-19 pandemic and resolution after oral antibiotics. After another 12 months, a biopsy of the bony mass was carried out due to overlying mucosal erythematous and nodular changes. The histology confirmed CEOT. Conclusions/Clinical Relevance: Radiological diagnosis is often helpful and tissue biopsy is key when adverse signs are detected. Clinicians should be aware of CEOT as a differential diagnosis for any slow-growing bony lesion which appears mixed radiolucent and radiopaque on imaging. Copyright © 2022

COVID-19 impact on multiple myeloma prescribing

Background: COVID-19 has impacted several areas of oncology patient care, most notably the reduction of patient visits for treatments. Standard treatment of multiple myeloma (MM) involves a combination of intravenous (IV) and oral therapies. Objective(s): The purpose of this study is to assess the impact COVID-19 had on IV and oral medication prescribing patterns pre and during the COVID-19 pandemic among MM patients. Method(s): This is a retrospective review of adult MM patients insured by a large commercial and Medicare health plan in the United States who started a new IV or oral MM agent during the study period. To assess the impact of COVID-19 on IV and oral medication prescribing patterns, we compared a pre-COVID period (1 March-31 August 2019) to a COVID period (1 March-31 August 2020). We utilized medical and pharmacy claims to identify patients and calculated new therapy starts per newly diagnosed patient (defined as the number of patients starting a new IV or oral medication for MM divided by the total number of patients with a first indication date of MM within the study timeframe). We compared rates using a Chi-square test;p-values <=.05 were considered statistically significant. Result(s): 1754 patients were enrolled in the study;there were no significant differences in demographic characteristics pre and during COVID-19 between the two groups with respect to age (67.05 vs. 66.64;p=.45), gender (p=.80), insurance plan type (p=.17), geographical region (p=.26) and medication (p=.59). During COVID-19, the number of newly diagnosed MM patients decreased by 22% (9657-7560) and the total number of new therapy starts decreased by 11% (930-824). When looking at rates of new therapy starts per newly diagnosed patient, both IV (11%;p=.03) and oral (51%;p=.03) medication rates significantly increased. Additionally, there were significant increases in new therapy start rates by region in the Northeast for oral (157%;p=.08). Conclusion(s): While the total count of new therapy starts, a proxy for new diagnoses, decreased during COVID-19, the rate of new starts for both IV and oral therapies for patients diagnosed with MM significantly increased. These increased start rates may be explained by a remarkable 22% drop in the total number of newly diagnosed MM patients during COVID-19. As the pandemic continues, further study is warranted to understand how COVID-19 may impact IV vs. oral usage in MM.

Impact of COVID-19 on oral oncolytic adherence

Background: CVS Health recently developed a best-in-class mobile app and website that enables oncology patients to start and stay on therapy. While digital patient engagement is relatively new, identifying and estimating the frequency of its use and the impact of COVID-19 on adherence are critical for planning strategies to mitigate the effects of the pandemic on cancer patient outcomes. Objective(s): This study examined the impact of COVID-19 on adherence to oral oncolytic agents in a large health plan with a significant digital health platform. Method(s): This retrospective cohort study included adult patients with chronic myelogenous leukemia (CML), ovarian cancer or prostate cancer initiating oral oncolytics between 3/1/19 and 3/ 1/2021. Patients were divided into two groups: pre-COVID oral oncolytic initiators before 3/1/20 and COVID initiators after 3/1/ 20 and were followed for 1 year after therapy initiation. The primary outcome was optimal adherence to oral oncolytic agents as defined by a medication possession ratio (MPR)>=0.8. Percent of digital engagement, defined as the number of times a patient interacted with the CVS digital platform, was examined as a secondary endpoint and was considered as a binary and categorical endpoint (none, low (<28), moderate (28-105) and high (>105)). Descriptive statistics and logistic regression modeling were performed;p-values <.05 were significant. Result(s): In total, 15,494 patients were included in the study, with 8067 (52.07%) in the pre-COVID initiator group. Patient demographics were similar across study groups, with the exception of pre-COVID initiators who were less likely to be male (75.32 vs. 77.34%;p<.01) and receive copay assistance (38.37 vs. 41.70%;p<.01). No difference in digital engagement pre and during COVID was noted (74.55 vs. 73.60%;p=.18). Pre-COVID initiators were less likely to be optimally adherent than COVID initiators (84.75 vs. 85.96%;p=.04). Therapy persistence was more common among COVID initiators, with greater number of fills (Median [quartile (Q) Q1-Q3]: 10 [4-12] vs. 9[4-12];p<.01) and less changes to therapy (8.87 vs. 9.95%;p=.02). After regression, COVID initiation of oral oncolytics was not associated with optimal adherence (odds ratio (OR) = 1.06 [95% (confidence interval (CI) 0.96-1.16]). Adherence increased as digital engagement increased (low: OR 0.64 [95% CI 0.56-0.72];moderate: OR 0.67 [95% CI 0.56-0.76];high: OR 1.71 [95% CI 1.48-1.99]). Other factors associated with increased adherence were copay assistance, male gender and age between 65 and 84 (all p<.05). Factors associated with decreased adherence were therapy change, CML and age <50 years (all p<.05). Conclusion(s): The onset of the COVID-19 pandemic did not significantly impact optimal adherence for new-to-therapy oral oncology patients. Patients with high digital engagement during the pandemic experienced significantly improved adherence than those not engaged. Additionally, persistence and number of fills were slightly improved in COVID initiators, suggesting that the current pandemic may have influenced adherence behaviors.

COMPARISON OF HIGHER VERSUS LOWER DOSE STEROID ADMINISTRATION IN PATIENTS WITH COVID-19 AND ACUTE HYPOXEMIC RESPIRATORY FAILURE ON INHALED EPOPROSTENOL

SESSION TITLE: Critical Care Management of COVID-19 SESSION TYPE: Original Investigations PRESENTED ON: 10/17/2022 01:30 pm - 02:30 pm PURPOSE: Superimposed bacterial co-infection is common among patients with Coronavirus disease-19 (COVID-19) pneumonia. Incidence of any superimposed infection ranges from 0% to 40%. Up to 50% of COVID-19 patients who died, had concomitant bacterial or fungal infection. Steroids are recommended for the treatment of acute hypoxemic respiratory failure (AHRF) due to COVID-19 and are thought to mitigate inflammatory organ injury. This retrospective study explores a subset of COVID-19 patients receiving Epoprostenol (iEPO) for AHRF and compared two different steroid treatment strategies and the impact on patient outcomes. METHODS: This is a retrospective study of 101 COVID-19 patients with AHRF receiving iEPO and systemic steroids. Patients in the high dose steroid group (n=59) received a minimum of dexamethasone 20mg daily or solumedrol 100mg daily while the standard dose steroid group (n=52) were those who received any lower dose. Patients that were DNR/I were excluded from the study. The primary outcome of the study was the rate of bacterial co-infection defined by positive cultures. Secondary outcome was mortality. RESULTS: Results showed that patients treated with high dose steroids were older (66.77±11.17 vs 60.33±14.49, p0.006) and received a longer treatment course (18 days (12-25) vs 12.5 days (10-17), p 0.004). Univariate and Multivariate analysis showed that higher dose steroids were not associated with increased risk of superimposed bacterial infection (OR 0.96, CI (0.34-2.66), p0.93). The duration of steroids, regardless of the dose, was associated with increased risk of superimposed bacterial infection (OR 1.06, CI (1.01-1.13), p0.033). When adjusted for comorbidities and inflammatory state, there was no significant difference in mortality between patients treated with high dose compared to standard dose steroids (OR 3.60, CI (0.65-19.93), p0.14). A longer duration of steroids was associated with a trend towards improved mortality (OR 0.93, CI (0.87-1.00), p0.072). CONCLUSIONS: Our study suggests that the duration of steroids, rather than dosage, had an effect on patient outcomes. There was no difference in bacterial co-infection rates between the two groups, but infection rates were increased among those who received a longer course of steroid treatment. There was a trend towards lower mortality with increased steroid duration, however, this did not reach statistical significance. Given this trend towards lower mortality, future prospective studies should investigate steroid duration to determine if a longer course of treatment leads to better outcomes in patients with COVID-19 pneumonia and refractory AHRF. CLINICAL IMPLICATIONS: Based on our study, patients should not receive a higher dose or longer duration of steroid treatment given the increased risk of bacterial infection with no definitive improvement in mortality. DISCLOSURES: No relevant relationships by Natasha Garg No relevant relationships by Abhinav Hoskote No relevant relationships by Raymonde Jean No relevant relationships by Arpanjeet Kaur No relevant relationships by Sara Luby No relevant relationships by Omar Mahmoud No relevant relationships by Maria Athena Riego No relevant relationships by Edith Robin No relevant relationships by James Salonia No relevant relationships by DISHANT SHAH No relevant relationships by Venus Sharma No relevant relationships by Elizabeth Zipf

POST-COVID-19 EOSINOPHILIC PNEUMONIA

SESSION TITLE: Post-COVID-19 Infection Complications SESSION TYPE: Case Report Posters PRESENTED ON: 10/17/2022 12:15 pm - 01:15 pm INTRODUCTION: We present two cases of symptomatic post-COVID eosinophilic pneumonia responsive to steroids. CASE PRESENTATION: Case 1: A 73-year-old gentleman with underlying asymptomatic rheumatoid arthritis (RA), was admitted with COVID pneumonia for which he received tocilizumab, remdesivir, and 12 days of dexamethasone. His course was complicated by MRSA pneumonia and bacteremia, so was discharged on IV Vancomycin. Six days post discharge, he redeveloped respiratory distress. Labs showed a WBC 18,000 and proBNP 2828. A chest CT revealed bilateral ground-glass opacities, worsening right upper lung airspace disease and bilateral pleural effusions. Despite receiving Furosemide, Vancomycin, and Ceftazidime, he required high-flow nasal cannula oxygenation (HFNC). Bronchoscopy demonstrated thick right bronchial secretions. BAL fluid revealed 7% eosinophils and grew MRSA. Case 2: A 70-year-old gentleman with extensive smoking history, emphysema, psoriasis, Guillain-Barré syndrome and a recent hospitalization for COVID pneumonia was discharged on a steroid taper. He returned 23 days post discharge in respiratory distress requiring HFNC, 5 days after discontinuing steroids. The chest CT revealed worsening fibrosis and bronchiectasis. Intravenous Levofloxacin and Vancomycin resulted in no clinical improvement. Bronchoscopy showed inflamed bronchi with secretions and BAL analysis revealed 6% eosinophils. For both patients, BAL was negative for fungi and PJP and CTA ruled out PE. Both patients were started on Prednisone with a prolonged taper. They improved clinically with decreased oxygen requirements to 4L nasal cannula and dramatic decrease in subjective dyspnea within 48 hours of starting steroids. DISCUSSION: The differential diagnosis for the clinical deterioration and worsening radiographs in both patients includes bacterial/fungal superinfection, PE, post-COVID-ILD and eosinophilic pneumonia. For the first patient, his RA was inactive. His BAL was positive for MRSA but did not improve until steroids were initiated. Neither of the patients were stable for VATS biopsy. Eosinophilic pneumonia is defined as pulmonary infiltrates with peripheral blood eosinophilia =500/ml, BAL eosinophils > 5% or eosinophilic infiltration on lung biopsy [1]. Both of our patients had >5% BAL eosinophils. Potentially, prolonged COVID-ILD stimulates T-Helper-2 cells, causing the release of IL-4/5/13 with recruitment of eosinophils. Studies report post-COVID-ILD biopsies show organizing pneumonia and fibrosis but have not yet been associated with eosinophilia. In both patients, we observed eosinophilia on BAL. It can be hypothesized that a delayed inflammatory response mediated by eosinophils play a role. CONCLUSIONS: Pulmonary eosinophilic pneumonia is a complication of post-COVID-ILD and can be successfully managed with steroids. Reference #1: De Giacomi F, Vassallo R, Yi ES, Ryu JH. Acute Eosinophilic Pneumonia. Causes, Diagnosis, and Management. Am J Respir Crit Care Med. 2018 Mar 15;197(6):728-736. doi: 10.1164/rccm.201710-1967CI. PMID: 29206477. DISCLOSURES: No relevant relationships by farrukh ahmad No relevant relationships by Deborah Markowitz No relevant relationships by Dhiraj Shah No relevant relationships by Garima Singh No relevant relationships by Aakriti Soni

Post-acute sequelae of SARS-CoV-2 infection in patients with cancer

Background: Most patients with cancer and COVID-19 will survive the acute illness. The longer-term impacts of COVID-19 on patients with cancer remain incompletely described. Methods: Using COVID-19 and Cancer Consortium registry data thru 12/31/2021, we examined outcomes of long-term COVID-19 survivors with post-acute sequelae of SARS-CoV-2 infection (PASC aka “long COVID”). PASC was defined as having recovered w/ complications or having died w/ ongoing infection 90+ days from original diagnosis;absence of PASC was defined as having fully recovered by 90 days, with 90+ days of follow-up. Patients with SARS-CoV-2 re-infection and records with low quality data were excluded. Results: 858 of 3710 of included patients (23%) met PASC criteria. Median follow-up (IQR) for PASC and recovered patients was 180 (98-217) and 180 (90-180) days, respectively. The PASC group had a higher rate of baseline comorbidities and poor performance status (Table). Cancer types, status, and recent anticancer treatment were similar between the groups. The PASC group experienced a higher illness burden, with more hospitalized (83% vs 48%);requiring ICU (29% vs 6%);requiring mechanical ventilation (17% vs 2%);and experiencing co-infections (19% vs 8%). There were more deaths in the PASC vs recovered group (8% vs 3%), with median (IQR) days to death of 158 (120-272) and 180 (130-228), respectively. Of these, 9% were attributed to COVID-19;15% to both COVID-19 and cancer;15% to cancer;and 23% to other causes. Conversely, no deaths in the recovered group were attributed to COVID-19;57% were attributed to cancer;and 24% to other causes (proximal cause of death unknown/missing in 38% and 19%, respectively). Cancer treatment modification was more common in the recovered group (23% vs 18%). Conclusions: Patients with underlying comorbidities, worse ECOG PS, and more severe acute SARS-CoV-2 infection had higher rates of PASC. These patients suffered more severe complications and incurred worse outcomes. There was an appreciable rate of death in both PASC and non-PASC, with cancer the dominant but not only cause in fully recovered patients. Further study is needed to understand what factors drive PASC, and whether longer-term cancer-specific outcomes will be affected.

An update on the overall epidemiology, clinical characteristics, and outcomes from the COVID-19 and Cancer Consortium (CCC19)

Background: Despite mitigation and treatment strategies, COVID-19 continues to negatively impact patients (pts) with cancer. Identifying factors that remain consistently associated with morbidity and mortality is critical for risk identification and care delivery. Methods: Using CCC19 registry data through 12/31/2021 we report clinical outcomes (30-day case fatality rate [CFR], mechanical ventilation use (MV), intensive care unit admission (ICU), and hospitalization) in adult pts with cancer and laboratory confirmed SARS-CoV-2, stratified by patient, cancer, and treatment-related factors. Results: In this cohort of 11,417 pts (with 4% reported vaccination prior to COVID-19), 55% required hospitalization, 15% ICU, 9% MV, and 12% died. Overall outcome rates remained similar for 2020 and 2021 (Table). Hydroxychloroquine was utilized in 11% and other anti-COVID-19 drugs (remdesivir, tocilizumab, convalescent plasma, and/or steroids) in 30%. Higher CFRs were observed in older age, males, Black race, smoking (14%), comorbidities (pulmonary [17%], diabetes mellitus [16%], cardiovascular [19%], renal [21%]), ECOG performance status 2+ (31%), co-infection (25%), especially fungal (35%), and initial presentation with severe COVID-19 (48%). Pts with hematologic malignancy, active/ progressing cancer status, or receiving systemic anti-cancer therapy within 1-3 months prior to COVID-19 also had worse CFRs. CFRs were similar across anti-cancer modalities. Other outcomes (ICU, MV, hospitalization) followed similar distributions by pt characteristics. Conclusions: Unfavorable outcome rates continue to remain high over 2 years, despite fewer case reports in 2021 owing to multiple factors (e.g., pandemic dynamics, respondent fatigue, overwhelmed healthcare systems). Pts with specific socio-demographics, performance status, comorbidities, type and status of cancer, immunosuppressive therapies, and COVID-19 severity at presentation experienced worse COVID-19 severity;and these factors should be further examined through multivariable modeling. Understanding epidemiological features, patient and cancer-related factors, and impact of anti-COVID-19 interventions can help inform risk stratification and interpretation of results from clinical trials.

COVID-19 impact on multiple myeloma prescribing patterns

Background: COVID-19 has impacted several areas of oncology patient care, most notably the reduction of patient visits for treatments. Standard treatment of multiple myeloma (MM) involves a combination of intravenous (IV) and oral therapies. The purpose of this study is to assess the impact COVID-19 had on IV and oral medication prescribing patterns pre and during the COVID-19 pandemic among MM patients. Methods: This is a retrospective review of adult MM patients insured by a large commercial and Medicare health plan in the United States who started a new IV or oral MM agent during the study period. To assess the impact of COVID-19 on IV and oral medication prescribing patterns, we compareda pre-COVID period (March 1-August 31, 2019) to a COVID period (March 1-August 31, 2020). We utilized medical and pharmacy claims to identify patients and calculated new therapy starts per newly diagnosed patient (defined as the number of patients starting a new IV or oral medication for MM divided by the total number of patients with a first indication date of MM within the study timeframe). We compared rates using a Chi-square test;p-values ≤ 0.05 were considered statistically significant. Results: 1,754 patients were enrolled in the study;there were no significant differences in demographic characteristics pre and during COVID-19 between the two groups with respect to age (67.05 vs. 66.64;p=0.45), gender (p=0.80), insurance plan type (p=0.17), geographical region (p=0.26) and medication (p=0.59). During COVID-19, the number of newly diagnosed MM patients decreased by 22% (9,657 to 7,560) and the total number of new therapy starts decreased by 11% (930 to 824). When looking at rates of new therapy starts per newly diagnosed patient, both IV (11%;p=0.03) and oral (51%;p=0.03) medication rates significantly increased. Additionally, there were significant increases in new therapy start rates by region in the Northeast for oral (157%;p<0.01) and West for IV (32%;p=0.02) medications. There were no significant differences in new start rates by insurance plan type (all p>0.08). Conclusions: While the total count of new therapy starts, a proxy for new diagnoses, decreased during COVID-19, the rate of new starts for both IV and oral therapies for patients diagnosed with MM significantly increased. These increased start rates may be explained by a remarkable 22% drop in the total number of newly diagnosed MM patients during COVID-19. As the pandemic continues, further study is warranted to understand how COVID-19 may impact IV vs. oral usage in MM.

Impact of the COVID-19 pandemic on oral oncolytic adherence

Background: COVID-19 has substantially decreased cancer screening, management visits and surgeries. CVS Health recently developed a best-in-class mobile app and website that enables oncology patients to start and stay on therapy. This study examined the impact of COVID-19 on adherence to oral oncolytic agents in a large health plan with a significant digital health platform. Methods: This retrospective cohort study included adult patients with chronic myelogenous leukemia (CML), ovarian cancer or prostate cancer initiating oral oncolytics between 3/1/19 and 3/1/2021. Patients were divided into two groups: pre-COVID oral oncolytic initiators before 3/1/20 and COVID initiators after 3/1/20 and were followed for 1 year after therapy initiation. The primary outcome was optimal adherence to oral oncolytic agents as defined by a medication possession ratio (MPR) ≥ 0.8. Percent of digital engagement, defined as the number of times a patient interacted with the CVS digital platform, was examined as a secondary endpoint and was considered as a binary and categorical endpoint (none, low (< 28), moderate (28-105) and high (> 105)). Descriptive statistics and logistic regression modeling were performed;p-values < 0.05 were significant. Results: In total, 15,494 patients were included in the study, with 8,067 (52.07%) in the pre-COVID initiator group. Patient demographics were similar across study groups, with the exception of pre-COVID initiators who were less likely to be male (75.32% vs. 77.34%;p < 0.01) and receive copay assistance (38.37% vs. 41.70%;p < 0.01). No difference in digital engagement pre and during COVID was noted (74.55% vs. 73.60%;p = 0.18). Pre-COVID initiators were less likely to be optimally adherent than COVID initiators (84.75% vs. 85.96%;p = 0.04). Therapy persistence was more common among COVID initiators, with greater number of fills (Median [quartile (Q) Q1-Q3]: 10 [4-12] vs. 9[4-12];p < 0.01) and less changes to therapy (8.87% vs. 9.95%;p = 0.02). After regression, COVID initiation of oral oncolytics was not associated with optimal adherence (odds ratio (OR) = 1.06 [95% (confidence interval (CI) 0.96-1.16]). Adherence increased as digital engagement increased (low: OR 0.64 [95% CI 0.56-0.72];moderate: OR 0.67 [95% CI 0.56-0.76];high: OR 1.71 [95% CI 1.48-1.99]). Other factors associated with increased adherence were copay assistance, male gender and age between 65 and 84 (all p < 0.05). Factors associated with decreased adherence were therapy change, CML and age < 50 years (all p < 0.05). Conclusions: The onset of the COVID-19 pandemic did not significantly impact optimal adherence for new-to-therapy oral oncology patients. Patients with high digital engagement during the pandemic experienced significantly improved adherence than those not engaged. Additionally, persistence and number of fills were slightly improved in COVID initiators, suggesting that the current pandemic may have influenced adherence behaviors.

BRIDGING TECHNOLOGY AND HEALTH: A COMMUNITYBASED TELEHEALTH PROGRAM FOR LOW-INCOME OLDER ADULTS

STATEMENT OF PROBLEM/QUESTION: The COVID-19 pandemic prompted a rapid shift to telemedicine as both a replacement and adjunct to usual in-person care, but in a recent estimate using 2018 data from the National Health and Aging Trends Study, 13 million, or roughly 38% of older adults in the US, are not ready to participate in video visits primarily due to inexperience with technology. DESCRIPTION OF PROGRAM/INTERVENTION: The purpose of this community-based partnered program between Denver Health and Denver Housing Authority (DHA) is to provide the supports needed to engage older adults in telehealth. DHA manages approximately 3900 subsidized housing units across Denver with buildings designated specifically for low-income older adults (65+) and persons with disabilities. Up to 467 of these individuals already receive primary care at Denver Health which offers a unique opportunity to establish targeted supports for the equitable delivery of virtual health. These supports may include technology and digital health education, equipment deployment, and facilitated telehealth appointments. We conducted a formative evaluation of DHA resident interest and capability to participate in video visits. MEASURES OF SUCCESS: Outcomes for the formative survey include interest in video visits, perceived barriers to in-person care, comfort levels with technology, barriers to use of technology, healthcare topics of interest, and selfreported health status. The results of the survey helped to shape the key interventions proposed: 1) digital health literacy workshops and 2) facilitated on-site video visits. FINDINGS TO DATE: Survey responses were compiled for all participants across six participating sites. 115 participants provided responses to program interest and baseline comfort levels with technology. Of participants surveyed, 89% have a mobile phone, 46% have had experience with videoconferencing, and 53% have someone to help them with technology. Challenges accessing healthcare included scheduling an appointment 20%, getting a ride to clinic 23%, and difficulty walking 15%. Of the 76 participants who indicated their learning interests, 51% were interested in learning how to use the online patient portal, 465 in participating in a video visit, and 59% in understanding and managing chronic medical conditions. KEY LESSONS FOR DISSEMINATION: At baseline there were both barriers to seeking in person medical care and interest in technology as a tool for health. The survey participants showed a strong interest in sessions about using the online patient portal, how to have a video visit, and understanding chronic medical conditions. Video visits and technology have become an increasingly common and useful part of the primary care system, yet a portion of the population is not equipped with the knowledge or resources to utilize this resource. Older adults may also find transportation and mobility in getting to the doctor's office a significant challenge. This program is designed to outreach those individuals and give them the skills and resources to utilize technology to reduce barriers to health.

Respiratory Safety of Lemborexant in Adult and Elderly Subjects with Moderate to Severe Obstructive Sleep Apnea: A Randomized, Double-blind, Placebo-controlled, Crossover study

Introduction: A safety risk of some commonly prescribed sleep-promoting drugs, including benzodiazepines and nonbenzodiazepine receptor agonists, is central respiratory depression. Subjects with coexisting respiratory disease such as obstructive sleep apnea (OSA), and/or the elderly, are particularly at risk. Lemborexant (LEM) is a dual orexin receptor antagonist (DORA) approved in multiple countries for the treatment of adults with insomnia. In study 102 (E2006-A001-102;NCT03471871), no differences between LEM 10 mg (LEM10) and placebo (PBO) were found on peripheral oxygen saturation (SpO2) and the apnea-hypopnea index (AHI) in adult and elderly subjects with mild OSA following a single dose and multiple doses. Study 113 (E2006-A001-113;NCT04647383) is the first to investigate the effect of LEM on respiratory safety in adults and elderly subjects with moderate to severe OSA. Materials and Methods: This was a multicenter, multiple-dose, randomized, double-blind, PBO-controlled, 2-period crossover study in adult (age ≥45 to <65y) and elderly (age ≥65 to ≤90y) subjects with moderate (15≤AHI<30) to severe (AHI≥30) OSA. Subjects were randomized to two 8-night treatment periods (separated by a washout ≥14d) with either LEM10 or PBO. In-lab polysomnography and transmissive pulse oximetry were performed at screening, on Day 1 (after a single dose) and Day 8 of study drug during both treatment periods. Treatment-emergent adverse events (TEAEs) were recorded throughout the study. Results: Forty-eight subjects were screened;33 (68.8%) were randomized;of these n=13 had moderate OSA and n=20 had severe OSA. Mean age was 60.6y;22/33 subjects (66.7%) were age ≥45 to <65y and 11/33 (33.3%) were ≥65 to ≤90y. During total sleep time, mean baseline SpO2 was 93.5% and mean AHI for moderate OSA and severe OSA groups together (n=33) was 44.2. No significant difference was found in AHI (least squares mean [LSM]) after a single dose or multiple doses of LEM10 versus PBO in subjects with moderate (single: LEM10, 31.49;PBO, 32.41, P=0.818;multiple: LEM10, 34.66;PBO, 37.16, P=0.442) or severe (single: LEM10, 48.22;PBO, 52.69, P=0.172;multiple: LEM10, 51.48;PBO, 51.15, P=0.902) OSA. LEM10 versus PBO was also not significantly different for SpO2 (LSM with moderate [single: LEM10, 93.68;PBO, 93.86, P=0.696;multiple: LEM10, 93.74;PBO, 93.86%, P=0.784] or severe [single: LEM10, 92.57;PBO, 92.65, P=0.841;multiple: LEM10, 92.63;PBO, 93.02, P=0.283] OSA). Furthermore, no significant difference was found in percentage of total sleep time during which SpO2 was below the thresholds of <90%, <85%, <80% for LEM10 vs PBO following a single dose (P=0.694, P=0.134, P=0.195, respectively) or multiple doses (P=0.481, P=0.711, P=0.699, respectively) in subjects with moderate or severe OSA. TEAEs were higher with LEM10 (18.2%) versus PBO (9.1%). One subject did not complete treatment due to an adverse event unrelated to LEM10 (COVID-19). Overall, LEM was well tolerated, and most TEAEs were mild. Conclusion: As objectively measured by AHI and SpO2 during TST, LEM, a DORA, demonstrated respiratory safety with single and multiple dosing in subjects with moderate and severe OSA, and was well tolerated. Acknowledgements: Supported by Eisai, Inc.