bluuebunny/crossref_metadata_2025_split huggingface dataset:
Real-world effectiveness of prophylactic tixagevimab-cilgavimab monoclonal antibodies on incidence and severity of COVID-19 infection in patients with cancer.
Authors: Naser Maryam , Bhardwaj Prarthna V , Warriach Fatima Zahid , Jadoon Yamna , Gupta Kush , Rastegar Vida , Loke Chandravathi , Siddappa Malleshappa Sudeep Kumar 
Published: June 2023

e18843 Background: Mortality rate secondary to COVID-19 in patients with cancer is estimated to be > 10% after vaccination, with an increased risk of infection and hospitalization The FDA granted emergency use approval for pre-exposure prophylaxis with tixagevimab-cilgavimab (Evusheld)based on preliminary results from the PROVENT trial conducted before the emergence of the Omicron variant. However, there are limited real-world studies investigating the impact of Evusheld on COVID-19 in patients with cancer, especially after Omicron became the most common circulating variant in the US in Nov 2021. We assessed the impact of Evusheld on the incidence and severity of COVID-19 at our institution. Methods: We conducted a retrospective descriptive study in our institution on patients with cancer who received Evusheld between Dec 2021 and Mar 2022 with a 6 month follow-up. Primary outcome was incidence of COVID-19. Secondary outcomes included rate of hospitalization related to COVID-19 and associated mortality. Results: Of the 228 patients included in this study, 90% were White with a median age of 67 years, 67% had a hematologic malignancy, 98% were vaccinated against COVID-19, and 72.8% received the recommended 300mg dosing during the study period. Thirty-one patients (13.6%) developed COVID-19, with an average time to diagnosis of 43 days from receiving Evusheld, of whom 26 (83%) were symptomatic. Infected patients were of an average age of 60 years with a BMI of 26, and only a minority (3.2%) had prior COVID-19. Most had hematologic malignancies (77.4%), with the most common being non-Hodgkin lymphoma. Most were receiving chemotherapy (68%) at the time of diagnosis. Third of the affected patients received ani-CD20 treatment (32%). Most received only 150 mg dose (80.6%) of Evusheld. 8(33%) patients with hematological malignancy and 3 (42%) with solid malignancy received Paxlovid after diagnosis. All patients who had COVID-19 were previously vaccinated, with the majority receiving 3 doses (64.5%). Five (16%) patients were hospitalized for COVID-19, of whom 4 had hematological malignancy; one with hematological malignancy required mechanical ventilation and died. Conclusions: Overall, the incidence of COVID-19 following Evusheld was higher than in the PROVENT trial. This could be attributed to the ineffectiveness of Evusheld against new variants. Infections appeared to be more common and severe in patients with hematologic malignancies. [Table: see text]
Utilization and dispensing patterns of medical cannabis products in a state with legalized medical cannabis.
Authors: Olson Amanda Leigh , Lai Stephen Yenzen , Shete Sanjay , Harbison Kevin , Scheid Jennifer , Jankowski Mika , Tanco Kimberson Cochien 
Published: June 2023

e18844 Background: The medical uses of cannabis-based products have been proposed to include treatment of pain, various neurological, gastrointestinal and psychological conditions. Cancer patients are some of the highest utilizers of medical cannabis-based products. To understand real world use and impact of cannabis-based products, we analyzed the database from 4 dispensaries of a cannabis company licensed in New York state. We aim to evaluate the dose, average THC/CBD ratios, association of various medical conditions to THC/CBD dose and cost of products to individuals receiving cannabis-based products. Methods: A retrospective analysis of anonymized data was conducted on 422,201 dispensed products from 32,845 unique individuals aged 18 years and older between 1/1/2016 and 12/31/2020. The database included patients age, gender, qualifying medical condition, type of product, medication directions and amount of product dispensed. Results: Median age was 53 years old and 52% were females. Cancer and non-cancer related pain (85%) were the most common medical condition and inhalation (57%) the most common route. Individuals received a median of 6 prescriptions with median cost of $50/product. Average THC:CBD ratios were 28:0.5mg/day and 12:0.25mg/dose. Highest average cost [mean (95% CI): $73 ($71-$75)] and average CBD/dose per product [mean (95% CI):5.89 (5.38-6.40)] were dispensed for neurological conditions. Highest average THC/dose [mean (95% CI): 14.25 (13.36-15.14)] were found as use as alternative products for those with substance use disorders. Table 1 shows the comparison of gender and route to medical condition. Conclusions: More females received medical cannabis prescriptions while males used more products. Pain was the most common reason for medical cannabis prescriptions. Neurological conditions demonstrated highest average cost and CBD/dose and prescriptions for substance use disorder demonstrated highest THC/dose for products dispensed. Products prescribed had more THC as compared to CBD and inhalation was preferred. As cancer patients increasingly utilize medical cannabis products in conjunction with tumor directed and symptom therapy it will be important to have randomized studies to help guide oncologists. [Table: see text]
Real world assessment of clinical benefit with consolidation durvalumab following chemoradiotherapy in stage III unresectable non-small cell lung cancer.
Authors: Marur Shanthi , Mangurian Mark , Wise Corey , Pozotrigo Melissa , Marur Shika , Norden Andrew D. , Toler Andrew , Bobolts Laura Rose 
Published: June 2023

e18853 Background: The phase III PACIFIC trial compared the efficacy of consolidation durvalumab to placebo in newly diagnosed, unresectable stage III non-small cell lung cancer (NSCLC) who had not progressed after chemoradiotherapy (CRT). With a median follow-up of 34.2 months, the median progression free survival (PFS) was 16.9 months (13.0-23.9) compared to 5.6 months (4.6-7.7) for placebo (HR = 0.55, 95% CI,0.45-0.68). We report a real-world study that utilizes surrogate endpoints to assess duration of clinical benefit with consolidation durvalumab. Methods: OncoHealth, a digital health company, conducted a retrospective observational real-world study to assess time to treatment failure in patients with unresectable Stage III NSCLC who received consolidation durvalumab after completion of CRT between June 2018-June 2021. Data sources included electronic medical records (EMR) submitted with prior authorization (PA) requests to OncoHealth and medical claims data. With a data cut-off of 12/22/2022, real-world Time to Progression (rwTTP), and real-world Time to Next Treatment (rwTTNT) were evaluated to assess time to treatment failure. All end points were measured from durvalumab administration dates, rwTTP spanned until earliest date of clinician-assessed progression, and rwTTNT spanned until initiation of subsequent treatment. Results: Total of 281 patients with unresectable Stage III NSCLC who received durvalumab after completion of definitive CRT were identified. Median age was 71 years (range: 53 to 88), 57% male, 53% former smokers, 47% Stage IIIA, 52% non-squamous histology and 98% received concomitant platinum-based chemotherapy prior to durvalumab. Median time between completing CRT and initiating durvalumab was 41 days. With a cutoff date of 12/22/2022, and a median follow up of 28.4 months, 34% (n = 95) experienced disease progression. Sites of progression included lung, lymph nodes, adrenal, liver, bone and brain. The median rwTTP was 10.6 months (range: 2.0-38.1 months) and median rwTTNT was 12.4 months (range: 2.5-39.6 months). Conclusions: In this real-world study, the patient and disease characteristics available in EMR were comparable to those reported in the PACIFIC trial. The rwTTP and rwTTNT reported here suggest treatment failure occurred within one year of exposure to durvalumab and subsequent line of treatment was initiated shortly thereafter. Variables such as co-morbidities, performance status, treatment compliance, change of payers and barriers to treatment in real world will be further explored.
Outcomes of stage IV non-small cell lung cancer patients after failure of platinum-based chemotherapy in clinical trials and real-world settings: A literature review.
Authors: Soon Yu Yang , Furnback Wesley , Kim Jin , Chuang Jenny , Chavez Gordon , Proescholdt Christina , Koh Cloe Ying Chee 
Published: June 2023

e18859 Background: To report the outcomes of therapeutic regimens being evaluated for patients with stage IV non-small cell lung cancer (NSCLC) that has progressed on or after platinum-based chemotherapy in clinical trial and real-world settings. Methods: A systematic literature review was undertaken to identify clinical trials and real-world studies evaluating treatments for stage IV NSCLC after progression with platinum-based chemotherapy. Studies were included in the review if they were published between September 2017 and September 2021, in English, and included an outcome of interest. The outcomes of interest were overall response rate, progression-free survival, overall survival, the incidence of grade 3-4 adverse events, and discontinuation due to adverse events. Results: A total of 23 studies were identified, comprising of 17 clinical trials and six real-world studies. The total sample size ranged from 12 to 1,253 patients in clinical trials and 11 to 383 patients in real-world studies. A total of 28 and six treatment regimens were evaluated within the clinical trials and real-world studies respectively. Six clinical trials evaluated outcomes in the second-line setting, one in the third-line, three in a mix of second-line and above, and seven did not report the specific treatment line(s). There were no real-world studies exclusively in the second-line setting, one in the third-line, three in a mix of second-line and above, and two did not report the specific treatment line(s). Ramucirumab + docetaxel was the only treatment regimen evaluated in both the clinical trial and real-world studies. In the real-world studies, nivolumab was the most common treatment evaluated (n = 3). The real-world studies were conducted in India (n = 2), China, Colombia, Germany, and the United States. The overall response rate (ORR) ranged from 3% to 66% and a rate of > 15% was reported for one or more treatment regimens in 86% (12/14) of clinical trials. ORR ranged from 10% to 36% in real-world studies. Median progression-free survival ranged from 1 to 5 months in clinical trials and 3 to 8 months in real-world studies. In clinical trials, a median PFS of > 6 months was observed in 71% (10/14) of studies. Median overall survival (OS) ranged from 5 to 15 months in clinical trials and 3 to 18 months in real-world studies. Discontinuation due to adverse events ranged from 3-15% in clinical trials and 9-20% in real-world studies. Conclusions: Patients with stage IV NSCLC that has progressed on or after platinum-based chemotherapy experienced a limited response and a high burden of adverse events with the treatment regimens evaluated in both the clinical trial and real-world settings.
A population-level analysis of survival in patients with ALK+ anaplastic large cell lymphoma (ALCL) in the era of novel therapies.
Authors: Mishra Rahul , Dima Danai , Durmaz Arda , Mian Agrima , Mukherjee Sudipto , Caimi Paolo Fabrizio , Jagadeesh Deepa 
Published: June 2023

e18863 Background: The introduction of novel therapies such as brentuximab vedotin (BV), has changed the treatment paradigm of ALK+ALCL in both upfront and relapsed/refractory settings. We sought to compare differences in the survival trends of patients with ALK+ ALCL in the routine clinical practice, before and after approval of BV (year 2011). Methods: We used SEER-17 registry to identify adult patients using international classification of disease code for oncology assigned to ALK+ ALCL (9714/3) between 2000-2019.We excluded patients (pts) with diagnosis on autopsy or from death certificate, unknown survival time, any other malignancy, cause of death other than non-Hodgkin lymphoma, or survival of < 2 months from diagnosis. Follow-up period was until December 2019. Demographics and treatment details were extracted using SEER Stat v8.4.0.1. Comparisons were made between pts diagnosed in 2000-2010 (pre-BV) vs 2011-2019 (post-BV) using R v4.0. 2. Chi-squared test was used to calculate difference between categorical variables. Kaplan-Meier method and log-rank test were used to estimate overall survival (OS). A multivariate cox proportional hazard (CPH) model, adjusted for sex, radiation, and time-dependent covariates was used to estimate impact of time-period on survival. Results: A total of 1794 pts (n = 956 pre-BV, and 838 post BV) with ALK+ ALCL were identified. The majority were male (1099, 61%), white (78%), and had median age of 49 (IQR: 34-62) years at diagnosis. The baseline characteristics of pts diagnosed during the two time periods were similar (Table). 3-year (y) and 5y OS (95%CI) were 81% (78.1-83.7) and 79% (75.9-81.9) in post-BV vs 61% (58.0-64.2) and 58% (55.5-61.7) during pre-BV period (P < 0.0001, log rank test). Multivariate model showed increased risk of death in the pre-BV vs post-BV period particularly among those surviving > 6 months after diagnosis [log(HR), (95%CI)] = [1.12 (0.86-1.38)]. Conclusions: Using data from nationwide cohort, we demonstrated an improvement in the OS trend of pts with ALK+ ALCL treated in the era of novel targeted therapies, compared to those treated in pre-BV era. [Table: see text]
The same outcome of cancer patients treated with radiotherapy or chemoradiotherapy regardless COVID-19 status.
Authors: Zhang Zhenyu , Li Ping , Zhou Juan , Lin Qinghai , Peng Xun , Meng Xue , Hu Man , Zhao Miaoqing , Ru Kun 
Published: June 2023

e18866 Background: COVID-19 has spread all over the world and infects people including cancer patients. The aim of this study is to explore the influence of COVID-19 infection on various cancer patients in China. Methods: A total of 167 cancer patients receiving radiotherapy or chemoradiotherapy from July 2022 to February 2023 were included in this study. Tumor types included lung, breast, esophageal, nasopharyngeal, cervical, pancreatic, thymus, rectal, bladder, testicular cancers, and glioblastoma, etc. The patients were divided into three groups: no COVID-19 infection during the therapy cycle (group A, n = 52), therapy beginning at least 10 days after the first positive COVID-19 tests (group B, n = 43), and therapy beginning less than 10 days after the first positive COVID-19 tests (group C, n = 72). The COVID-19 variants in this study were BA5.5.6, BA.5.2, and BF.7. Results: Some infection-related parameters were increased in COVID-19 positive cancer patients, such as SAA (group A vs group B, p= 0.0006; group A vs group C, p= 0.0004), hsCRP (group A vs group B, p= 0.0043; group A vs group C, p= 0.0144), ferritin (group A vs group B, p= 0.0417; group A vs group C, p= 0.0319) and PA (group A vs group C, p= 0.011), yet IL-6 and PCT were of no difference among three groups. Similarly, the serum markers for the myocardial and hepatic lesions, such as LDH (group A vs group B, p= 0.0064; group A vs group C, p= 0.0369), HBDH (group A vs group B, p= 0.0116; group A vs group C, p= 0.0414), and CHE (group A vs group B, p= 0.0303; group A vs group C, p= 0.0256), were raised in both group B and group C, but AST, CK, CK-MB, ADA, GGT, cTnT, and proBNP showed no difference between COVID-19 positive and negative cancer patients. The cancer patients receiving radiotherapy or chemoradiotherapy showed no differences in the lowest WBC, Hgb, platelets, NLR (Neutrophil to Lymphocyte Ratio), and lymphocyte subtype counts among three groups. Nevertheless, the leukopenia was apparent in group C (group A vs group C, p= 0.0031; group B vs group C, p= 0.0194), and no obvious difference between group A and group B. Finally, the dropout rates in three groups were nearly the same (group A, 4/52; group B, 6/43; group C, 6/72), and the causes of treatment interruption varied, including pneumonia, deep venous thrombosis, mucosal damage, headache, diarrhea, agranulocytosis, esophageal fistula, etc. Moreover, the completion rate of treatment was not affected by the radiation dose or antitumor drugs in COVID-19 infected cancer patients. Conclusions: This study found that COVID-19 infection did not change the completion rate of radiotherapy or chemoradiotherapy in cancer patients, although some hematological and serum parameters altered during the treatment and infection. In contrast to NCCN guidelines, cancer patients positive for COVID-19 could be treated safely by radiotherapy or chemoradiotherapy.
The broader impact of specialized outpatient cancer rehabilitation on health and quality of life among breast cancer survivors.
Authors: Pergolotti Mackenzi , Wood Kelley C , Kendig Tiffany 
Published: June 2023

e18881 Background: After diagnosis and treatment, women with cancer often experience significant functional decline from which most do not recover. Functional deficits, especially when persistent, are related to poorer health and quality of life (QOL). Interventions to mitigate declines in function, health and QOL are necessary given their known associations with morbidity and mortality yet are understudied and underutilized. While there is evidence supporting cancer rehabilitation’s (Physical or Occupational therapy, PT/OT) ability to improve physical function and upper extremity disability among breast cancer survivors (BCS), the impact of cancer PT or OT on health and QOL is unknown. To understand this broader impact, we examined the rehabilitation needs and outcomes of BCS who attended specialized, community-based cancer PT/OT. Methods: In this retrospective study, we extracted case characteristics and patient-reported outcomes (PRO) measures of health, function and QOL from a national sample of BCS who attended cancer-specialized outpatient PT or OT. We examined ICD-10 codes to identify rehabilitation needs. PROs collected at baseline and discharge from rehabilitation included: Patient Reported Outcome Measuring System (PROMIS) global physical health, global mental health, physical function, and ability to participate in social roles and activities. To examine change from baseline to discharge we used paired t-tests ( p< .05) and calculated effect size (Cohen’s d). Results: PT/OT patients (N = 2,706; PT, n = 2,245; OT, n = 461) were 99.6% female, 58.33±12.50 years old and attended approximately 10 (IQR: 7.0 – 17.0) sessions. Needs included: muscle atrophy, weakness or ataxia (PT: 44%, OT: 32%); lymphedema (PT: 40%, OT: 56%); upper extremity impairment (PT: 44%, OT: 28%); pain (PT: 44%, OT: 25%); and scar tissue or fibrosis (PT: 15%, OT: 16%). At discharge, all health, function and QOL-related outcomes improved significantly (p < .001) in both PT and OT. Specifically, significant gains in PROMIS global physical health (PT: M∆ = 3.56±7.21, d= 0.49; OT: M∆ = 2.26±7.03, d= 0.32), global mental health (PT: M∆ = 2.01±6.91, d= 0.29; OT: M∆ = 1.34±7.20, d= 0.19), physical function (PT: M∆ = 2.81±7.45, d= .38, M∆ = 1.91±7.39, d= .26), and participation in social roles & activities (PT: M∆ = 3.24±9.09, d= .36; OT: M∆ = 1.91±8.41, d= .23) were observed. Conclusions: BCS presented to community-based outpatient rehabilitation with a variety of needs yet, despite this variety, demonstrated significant improvement in self-perceived health, physical function and QOL. Significant gains were reported for both PT and OT interventions. For providers working with BCS, these results can be used to increase awareness of the role of cancer rehabilitation and support referral to these services. Future research should evaluate the impact of specialized PT/OT on individuals with other cancer types.
Healthcare resource utilization (HCRU) and costs among adult patients with lung cancer with broad panel genomic testing and clinically relevant or non-clinically relevant genomic variants.
Authors: Moore Kristin , Diessner Brandon , Le Lisa , Yuan Tze-An , Cao Feng , Horstman Thomas , Landis Christina , Johnson Michael P , Sainski-Nguyen Amy 
Published: June 2023

e18889 Background: Lung cancer is the second most common cancer diagnosed in the United States. An estimated 236,740 new cases of lung cancer were diagnosed in 2022. Use of genomic testing to drive treatment decisions can lead to improvements in patient survival. However, the HCRU and costs of genomic testing are just being understood and little is known about the impact of the clinical relevance of those genomic findings. Methods: This retrospective analysis utilized administrative claims and enrollment information with linked genomic sequencing results from Optum’s de-identified Market Clarity Data and Clinicogenomics Database. Adult lung cancer patients newly diagnosed between 01 January 2016 – 30 June 2021 with evidence of treatment and genomic sequencing results post diagnosis were eligible for the study. Patients were required to have at least 6 months of continuous enrollment prior to and after their diagnosis date, unless death occurred, and were followed until death, disenrollment, or study end. Cohorts were created based on presence of clinically relevant variants with an FDA-approved treatment for lung cancer. Unadjusted all-cause HCRU and costs during follow-up were reported as per-patient per-month (PPPM). Results: This study identified 2,190 patients, of which 999 (45.6%) had clinically relevant variants. Age, insurance type, and geographic region did not appear to differ substantially between groups, though those with clinically relevant variants were more likely to be female (57.4% vs. 46.0%). During follow-up, the average number of PPPM ambulatory visits was similar between groups (5.89 vs. 5.58, p = 0.08), but the average number of emergency room visits (0.29 vs. 0.23, p < 0.01) and inpatient stays (0.12 vs. 0.11, p = 0.03) were higher among those with clinically relevant variants. Additionally, those with clinically relevant variants had higher average PPPM all-cause medical costs ($20,948 vs. $19,097; p = 0.02) and pharmacy costs ($3,073 vs. $2,083, p = 0.02). Conclusions: Average PPPM emergency room visits, inpatient stays, medical costs and pharmacy costs were higher among lung cancer patients with clinically relevant variants compared to those with non-clinically relevant variants. Future research should evaluate HCRU and costs attributable to targeted therapy. [Table: see text]