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Background: Patients (pts) with thoracic cancers have a high rate of hospitalization and death from COVID-19. Smoking has been associated with increased risk for severe COVID-19. However, there is limited data evaluating the impact of smoking recency on COVID-19 severity in pts with cancer. We aimed to characterize the clinical outcomes of COVID-19 based on the recency of smoking in pts with thoracic cancers (TC) and all other cancers (OC). Methods: Adult pts with cancer and lab-confirmed SARS-CoV-2 and smoking history recorded in the CCC19 registry (NCT0435470) were included. Pts were stratified by cancer type (TC or OC) and further stratified into subgroups based on the recency of smoking cessation: current smoker;former smokers who quit < 1 yr. ago;1-5 yr. ago;6-10 yr. ago;quit > 10 yr. ago;and never smoker. 30-day all-cause mortality was the primary endpoint. Secondary endpoints were any hospitalization;hospitalization with supplemental O2;ICU admission;and mechanical ventilation. Results: From January 2020 to December 2021, 752 pts from TC group and 8,291 pts from OC group met the inclusion criteria. 78% of patients in TC group ever smoked compared to 36% patients in the OC group. In both groups, the majority of never-smokers were females (70% and 60% in TC and OC respectively). The burden of smoking and the rate of pulmonary comorbidities (PC) was higher in the TC group (PC 22-69%) compared to OC group (PC 12-26%) across all smoking strata. Overall, 30-day all-cause mortality was 21% and 11% in pts with TC and OC respectively. Former smokers who quit < 1 year ago in TC group had the highest rate of mortality and severe COVID-19 outcomes. However, in the OC group, there was no consistent trend of higher mortality or severe COVID-19 outcomes in specific subgroups based on smoking recency. Conclusions: To our knowledge this is the largest study evaluating the effect of granular phenotypes of smoking recency on COVID-19 outcomes in pts with cancer. Recent smokers who quit < 1 year ago in TC group had the highest rate of mortality and severe COVID-19. Further analysis exploring the factors (e.g., smoking pack years) associated with severe outcomes in this subgroup is planned.
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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.
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Background: Access to health care including clinical trials (CT) leading to paradigm-changing cancer treatments are critical for high quality cancer care and equity in society. In this report, we highlight methods in accruing to ETCTN wherein underrepresented rural, low-income, and racial minorities comprise >50% of enrollment. Methods: University of Kansas Cancer Center (KUCC) is one of eight National Cancer Institute (NCI) designated cancer centers awarded CATCH-UP.2020 (CATCH-UP), a congressionally mandated P30 supplement to enhance access for minority/underserved populations to ETCTN precision medicine CT. KUCC catchment area is 23% rural by Rural Urban Continuum Codes (RUCC);almost 90 % of counties are designated primary care HPSA's (Health Professional Shortage Areas). KUCC Early Phase and Masonic Cancer Alliance (rural outreach network) partnered to operationalize CATCH-UP. We engaged disease-focused champion investigators in disease working groups and MCA physicians who selected scientifically sound CT that fit catchment area needs. Patient and Investigator Voices Organizing Together, a patient research advocacy group provided practical feedback. MCA navigator coordinated recruitment. Telehealth was used for rural patients that would have a significant distance to travel just to be screened. Results: CATCH-UP was initiated in September 2020. Twenty-eight CT were activated, many in community sites. Average activation time was 81 days. Delays were mainly from CT amendments. KUCC enrolled the first patient in the CATCH-UP program. In 6 months, we met accrual requirements (24/year, 50% minorities). During first year, we enrolled 47 (>50% minorities), an increase of 680% from our average accrual of 6/year (>50% minorities) in ETCTN through Early Drug Development Opportunity Program (2016-2020). To date, we have enrolled 61, 54% from rural, HPSA, race and other minorities. Although the proportion of minorities did not change but remained high, this funding allowed us to substantially increase the number of patients from a catchment area with high proportion of geographically and socioeconomically underserved minorities given access to early phase CT through ETCTN. Conclusions: Amid COVID-19 pandemic, the NCI CATCH-UP program and methods we used allowed access to novel therapies for rural, medically underserved, and other minority groups.
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Background The SARS-CoV-2 pandemic has assaulted all aspects of daily life. Medical professionals in oncology face additional challenges with balancing prompt cancer diagnosis and urgent treatment against potential COVID-19 exposure risk in these high-risk patients. We designed this prospective freewill study to offer testing for SAR2-CoV-2 viral RNA and/or anti-COVID-19, respectively in asymptomatic medical and research staff who work in direct contact with cancer patients. The overall goal was to evaluate the prevalence of infection in this group of asymptomatic healthcare providers to reduce exposure of cancer patients to asymptomatic staff. Methods Asymptomatic medical and research staff who work in direct contact with cancer patients were asked to voluntarily be tested for either SARS-CoV-2 viral RNA or antibodies or both. Either NP swabs and/or blood samples (EDTA tube) were collected. Tests are performed at Sinochips Kansas LLC, Sinochips Diagnostics (CLIA number:17D2176068, CAP number: 8709463). The PCR test is performed with FDA authorized 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel EUA. The Elecsys® Anti-SARS-CoV-2 (Roche Diagnostics) immunoassay was used to qualitative detection of antibodies to SARS-CoV-2 in human plasma. Results From 06/18/2020 to 12/18/2020, 861 participated in the study. 1095 tests were completed for SAR2-CoV-2 virus infection, and 918 were completed for antibody. Amount participants, 530 had both virus and antibody tested. 235 were tested more than once for viral infection and 166 were tested more than once for the antibody. Median age of participants was 39 years (IQR 32-51 years). Among these 84.7% were females, 84.4% white, 6.7% African American, 4.8% Asian and 84.7% non-Hispanic. The cumulative incidence of a positive test for the virus was 2.2% (16/712), and for the antibody test was 3.8% (26/679). 5 had both viral and antibody tests positive, with an average time of 4.1 weeks from viral testing positivity to detectable antibody among 3 cases and 2 cases with both viral infection and antibody detected at same time. There were 3 cases virus was detected more than once after turning positive. 2 remained positive at 16 and 22 days after initial test and one turned negative at 36 days as of last follow up. There were 7 cases where the antibody was tested more than once after turning positive and all 7 remained positive as of last follow up (range 7-103 days). Conclusion Prospective voluntary testing in asymptomatic medical and research staff who work in direct contact with cancer patients was feasible and resulted in identification of asymptomatic carriers who then placed in quarantine, thereby limiting exposure to cancer patients. Medical and research staff who work with cancer patients are general very cautious and the frequency of infections were significantly lower than general society. In addition, it seems that 1) virus and antibody may co-exist in the same person after exposure, and 2) the antibody may last for a relatively long time.
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Background: Obesity is a bona fide risk factor for ICU admission, mechanical ventilation, and mortality in patients (pts) with COVID-19 in the general population. However, whether obesity is a risk factor in cancer pts remains unknown. Herein, we have conducted a systematic review/meta-analysis of obesity and all-cause mortality in cancer pts with COVID-19. Methods: Following PRISMA guidelines,a systematic search of PubMed and Embase as well as major conference proceedings (ASCO/ESMO/AACR) was conducted for publications from inception to 14 January 2020. Observational studies that reported all-cause mortality in cancer pts with lab confirmation or clinical diagnosis of COVID19 and BMI (obese (>30 kg/m2 ) vs. non-obese) were included in the analysis. The pooled odds ratio (OR) and 95% confidence interval (CI) were calculated with the fixed-effects model based on low heterogeneity. Small sample publication bias was evaluated using the Begg's Funnel Plot and Egger's test. Results: After reviewing 3387 studies,3 retrospective cohort studies of 419 obese and 1694 non-obese cancer pts (N=2117) with COVID-19 in both inpatient/outpatient settings that reported outcomes based on obesity were found. The 3 studies were conducted multi-nationally in North America, in France, and in the Netherlands respectively. The median ages of the cohorts ranged 66-68. All studies included various cancers of various stages and were of high quality per Newcastle Ottawa scale (scores 7-9). Fixed effects metaanalysis showed no association between obesity and all-cause mortality (OR 0.95, 95% CI 0.74- 1.23) in cancer pts with COVID-19. Heterogeneity was low (I2= 33%). No significant funnel plot asymmetry was detected per Egger's test (P=0.2273). The reported OR of each study is outlined in the table. Conclusions: In contrast to the general population, our analysis reveals that obesity is not associated with increased all-cause mortality in cancer pts with COVID-19. Limitations of this study include a limited number of included studies, reliance on retrospective studies, non-use of ethnicityspecific WHO BMI criteria, and limited granularity of the study-reported BMI. Future prospective studies are warranted to assess the complex interplay among anthropomorphic measures, cachexia/sarcopenia, comorbidities associated with the metabolic syndrome, and COVID-19 outcomes in the cancer pt population. (Table Presented).
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Background: Sarcoma pts often receive aggressive, highly immunosuppressive therapy and may be at high risk for severe COVID-19. Demographics, outcomes and risk factors for pts with sarcoma and COVID-19 are unknown. We aimed to describe the course of COVID-19 in sarcoma pts and to identify factors associated with adverse outcomes. Methods: The COVID-19 and Cancer Consortium (NCT04354701) is an international registry of pts with cancer and COVID-19. Adult pts (≥18 years old) with a diagnosis of sarcoma and laboratory confirmed SARS-CoV-2 were included from 50 participating institutions. Data including demographics, sarcoma diagnosis and treatment, and course of COVID-19 infection were analyzed. Primary outcome was the composite rate of hospitalization or death at 30 days from COVID-19 diagnosis. Secondary outcomes were 30 day all-cause mortality, rate of hospitalization, O2 need, and ICU admission. Descriptive statistics and univariate Fisher tests are reported. Results: From March 17, 2020 to February 6, 2021, N=204 pts were included. Median follow up was 42 days. Median age was 58 years (IQR 43-67). 97 (48%) were male. 30 (15%) had ECOG performance status ≥2. 104 (51%) received cancer treatment, including surgery or radiation, within 3 months of COVID-19 diagnosis. 153 (75%) had active cancer, of whom 34 (22%) had lung metastases. 100 (49%) pts met the composite primary endpoint;96 (47%) were hospitalized and 18 (9%) died within 30 days from COVID-19 diagnosis. 64 (31%) required oxygen, and 16 (8%) required ICU admission. Primary endpoint rates were similar for pts who received cytotoxic chemotherapy (38/58, 66%) or targeted therapy (16/28, 57%). Pts with higher rates of the primary endpoint included patients ≥60 years old (59% vs 40%, OR 2.04, 95% CI 1.12-3.74, p=0.016), pts with ECOG PS ≥2 vs 0-1 (90% vs 41%, OR 12.2, 95% CI 3.44-66.8, p<0.001), pts receiving any systemic therapy within 3 months of COVID-19 diagnosis (62% vs 39%, OR 2.65, 95% CI 1.43-4.97, p=0.001), and pts with lung metastases (68% vs 42%, OR 2.77, 95% CI 1.19- 6.79, p=0.013). Primary endpoint rates were similar across sarcoma subtypes (Table). Conclusions: This is the largest cohort study of pts with sarcoma and COVID-19 to date. Sarcoma pts have high rates of complications from COVID-19. Older patients, those with poor performance status, those recently receiving systemic cancer therapy, and those with lung metastases appear to have worse outcomes.
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Importance: There is strong evidence that COVID-19 is associated with higher morbidity and mortality in malescompared to females in the general population. However, whether the same sex bias exists in the cancer patientpopulation is unknown. Several published studies have examined this question, but the results are inconclusive andinconsistent and the association remains unclear. Objective: To evaluate the sex differences in the risk of severe illness and mortality attributable to COVID-19 in thecancer patient population. Data Sources: Published articles that evaluated clinical outcomes associated with severe illness or deathattributable to COVID-19 in the cancer patient population from inception to June 1, 2020, were identified bysearching PubMed and EMBASE, as well as the ASCO 2020 Virtual Annual Conference, ESMO conferences heldfrom January 2020 to June 1, 2020, and the preprint databases medRxiv and bioRxiv. Study Selection: Prospective or retrospective analyses, studies published in English, providing clinical outcomesdata with sex differences in the cancer patient population. Data Extraction and Synthesis: Author, date of publication, country, type of studies, median and range of age, cancer types included in the studies, definitions of clinical outcomes, and the odds ratios (OR) for severe illness ordeath attributable to COVID-19 were retrieved. Where OR data were not available, raw data were used to calculatethe OR in a univariate analysis model and included in the meta-analysis. Main Outcome(s) and Measure(s): The primary outcome of interest was OR of (1) severe illness, (2) death, and(3) composite outcome of severe illness and death attributable to COVID-19 in males versus females. Results: Overall, 2,764 patients (9 studies) were analyzed in retrospective study settings. Of the included studies, two studies were multinational whereas the rest were conducted in China (4), France (1), United Kingdom (1), andUnited States (1). Median ages were similar across studies (range 62-70). Three studies reported outcomes fordeath and six studies reported outcomes for severe illness. Of the seven studies, all but one defined severe illnessas illness requiring ICU admission or leading to death and attributable to COVID-19. Pooled ORs for the compositeoutcome was 1.68 (95% CI, 1.27-2.24), death was 1.98 (95% CI, 1.21-3.26), and severe illness was 1.48 (95% CI,1.05-2.10), all disfavoring males. Random effects model was used with the Dersimonian-Laird Model throughoutanalyses and significant heterogeneity was subsequently confirmed (I2, 48.1%;tau2, 0.0816). No significantbetween-study bias was detected per Begg's funnel plot. Conclusions and Relevance: The male sex was associated with higher risk of severe illness, death, and thecomposite outcome of both attributable to COVID-19. This finding has implications in informing the clinical prognosisand decision making regarding oncologic patients.
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Background: There is insufficient evidence to support clinical decision-making for oncology patients diagnosed withCOVID-19 due to the limited studies focusing on factors affecting COVID-19-associated disease severity/death incancer patients. Methods: We retrospectively analyzed data from KU Cancer Center to assess demographic/clinical characteristicsand ferritin levels of 40 cancer patients with a confirmed COVID19 diagnosis by viral RNA detection in anasopharyngeal swab between 3/1/20 through 6/9/20. Chi square test and Mann-Whitney U test were used toidentify whether demographic/clinical characteristics and ferritin were associated with COVID-19 severity/death. Results: Median age was 59.5 years, 16 (40%) were aged 65 years or older, and 18 (45%) patients were male. 31(77.5%) were non-Hispanic, 21 (52%) were Caucasians, 11 (27%) were African Americans, and 21 (52.5%) werecurrent/former smokers. 14 (35%) were obese. Breast cancer n=9 (22.5%) was the most prevalent malignancy. 28(70%) had ECOG of 0/1. 27 (67.5%) were on active anticancer treatment, and 13 (32.5%) had active (measurable)cancer. 12 (30%) had recent surgery. 6 (15%) were asymptomatic and 34 (85%) were symptomatic. Fever (47.5%), cough (57.5%), productive cough (50%), and shortness of breath (47.5%) were the most common symptoms. Atanalysis (June 9, 2020), 3 (7.5%) patients had died. 8 (38.1%) had mild/moderate COVID-19 illness and 13 (61.9%)had severe illness (ICU admission, intubation, death). Patients with mild/moderate illness were significantly younger(median age 56.5 years) vs. those with severe illness (median age 67.5 years), p=0.02. Sex, race and ethnicity, obesity, ECOG, cancer type, active cancer treatment, and recent surgery were not associated with COVID-19severity. However, productive cough (p=0.01) and shortness of breath (p=0.006) were associated with COVID-19severity. In 19 patients with available ferritin levels, asymptomatic patients (n=2) had a significantly lower ferritin(median 68.5 NG/ML) vs. symptomatic (n=17), who had higher ferritin (median 422 NG/ML) p=0.04. Conclusions: Age was associated with an increased risk of COVID-19-related disease severity/death in cancerpatients. This may possibly reflect the effects of more advanced malignant disease, anticancer treatment, andcomorbidities on the impact of this infection. Ferritin levels appear to have a role in screening and monitoring forCOVID-19 infection in cancer patients. Hence, our findings warrant validation in a larger cohort. A prospective studyis under way at the University of Kansas Cancer Center to validate the factors associated with COVID-19-relateddisease severity/death in cancer patients.
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Background: The oncology community faces unprecedented challenges in balancing a delay in cancer treatmentagainst the risk for a potential COVID-19 infection and associated complications. An early retrospective analysisreported that cancer patients with COVID-19 infection have a much higher death rate than those infected but withouta cancer diagnosis, likely because of their immunocompromised disease from cancer and treatment. Even thoughCOVID-19 is known to have a long incubation period (∼14 days), there were no clear guidelines for screeningasymptomatic cancer patients who are planning to have and having antitumor treatment as of April 2020. Methods: We developed a protocol to screen asymptomatic cancer patients for COVID-19 who are scheduled toreceive cancer-directed treatment (i.e., chemotherapy, targeted therapy, immunotherapy, anticancer monoclonalantibody, endocrine therapy, or investigational agent). The protocol was developed and activated within 2 weeksthrough the Cancer Center Investigator Initiated Trial Program. FDA-authorized CDC 2019-Novel Coronavirus(2019-nCoV) Real-Time RT-PCR Diagnostic Panel EUA kit was performed at Sinochips Diagnostics. The primaryobjective was to determine COVID-19 status in participants prior to initiating anticancer treatment. The secondaryobjective was to evaluate COVID-19 related adverse events (AEs) in recovered COVID-19-positive participants for30 days after initiation of anticancer therapy. Results: We enrolled 507 patients and tested for COVID-19 from 4/28/20 to 5/8/20 through coordinated efforts within the CTO and Biospecimen Repository Core Facility. The research study was stopped when the KU HealthSystem was able to test this population as standard of care. Median age was 65 years, 110 patients (22%) wereaged 75 years or older, and 274 (54%) patients were female. 387 patients (76.3%) were Caucasians, 35 (6.9%)African American, 7 (1.4%) Asian, and 437 (86.2%) non-Hispanic. Based on the catchment of zip codes, 7% oftested patients came from more than 60 miles and 1.6% from more than 100 miles. Zero patients had a positiveCOVID-19 test. Conclusions: The prevalence of COVID19 in asymptomatic cancer patients is low, likely because of goodcompliance with the social distance policy. Screening for COVID19 may help reduce AEs related to COVID-19 inpatients receiving cancer-directed treatment. Studying COVID-19 test results in a larger patient pool is warranted. Asimilar study to test asymptomatic patient-facing oncology staff is pending.