bluuebunny/crossref_metadata_2025_split huggingface dataset:
Booster third dose of SARS-CoV-2 vaccine effectively lifts the waning immune response of solid cancer patients.
Authors: Janzic Urska , Bidovec-Stojkovic Urska , Katja Mohorcic , Fokter Dovnik Nina , Caks Marina , Debeljak Jerneja , Korosec Peter , Rijavec Matija 
Published: June 2022

e18791 Background: Since cancer patients (pts) are at increased risk of severe morbidity and mortality due to COVID-19, SARS-CoV-2 vaccination is crucial to prevent severe disease course. The efficacy and longevity of vaccine protection, however, is still in question. Methods: In this prospective observational study we assessed immunogenicity of cancers patients on active treatment for solid cancers in two Slovenian Oncology Centres receiving SARS-CoV-2 vaccine by detection of anti-SARS-CoV-2 S1 IgG antibodies in serum; before, after first and second dose, 3 and 6 months (mo) after complete primary course of vaccination and 1 mo after the 3rd booster dose. Samples with ≥ 175 ng/ml were considered positive. Results: There were 125 pts included in the study, 112 completed the primary course of vaccination with 2 vaccine doses and 34 received the booster 3rd dose. Out of 34 pts receiving booster 3rd dose, the majority received mRNA based vaccines (88%) for the primary course of vaccination and all patients received mRNA based vaccines for the booster 3rd dose. Median time from 2nd to booster 3rd dose of vaccine was 6.75 mo, median age of pts was 66 yrs and 59% were male. Patients were receiving chemotherapy (ChT), immune checkpoint inhibitors (IO) or targeted therapy (TT) in 9%, 56% and 35%, respectively. They achieved seroconversion in 94% after the 2nd and in 97% after the 3rd booster dose. Overall, the median anti-SARS-CoV-2 S1 IgG titer was 11,191 ng/ml (mean 25,394; range 0 – 100,000) after complete primary course of vaccination and 1892 ng/ml (mean 6413; range 0 – 72,000) 6 mo after, P < 0.0001. However anti-SARS-CoV-2 S1 IgG antibodies increased significantly after the 3rd booster dose with median antibody value 51,310 ng/ml (mean 51,787; range 0 – 100,000), P < 0.001. Only one pt in this group got infected with SARS-CoV-2 and had a mild disease course. Conclusions: Cancer pts treated for solid malignancies achieve a high rate of seroconversion through the primary course of vaccination. However, significant waning of immunity against SARS-CoV-2 is observed 6 months thereafter, which can be potentiated with additional 3rd booster dose of vaccine.
Prevalence and risk factors of preoperative anemia in patients undergoing hysterectomy for gynecologic cancer.
Authors: Chokshi Sagar Kamlesh , Leiser Aliza L. , Aikins James K. , Ananth Cande 
Published: June 2022

e18800 Background: Anemia is a common preoperative finding that is associated with increased morbidity and mortality in patients with gynecologic cancers. This study identified the prevalence and risk factors associated with anemia in women undergoing hysterectomy for gynecologic cancer. Methods: The National Surgical Quality Improvement Program (NSQIP) database was queried from 2014 to 2020 for women above the age of 18 who underwent an open or minimally invasive hysterectomy and had a postoperative diagnosis of endometrial, cervical, ovarian, or fallopian tube cancer. Prevalence rates of anemia (hematocrit less than 30%) were calculated, and odds ratio (OR) with 95% confidence interval (CI) were estimated from logistic regression models adjusted for comorbidities. Results: A total of 62,708 patients were included in the analysis and 3351 (5.3%) had anemia. Mean hematocrit was 38.9 (SD 4.9). Overall, endometrial cancer was the most common diagnosis (73.1%) and mean age for all patients was 61.2 years (SD 12.1). Patients were predominantly non-Hispanic White (74.4%). Non-Hispanic Black patients were 1.98 (95% CI, 1.76 – 2.22) times at increased odds of anemia compared to non-Hispanic White patients. Similarly, Hispanic ethnicity was associated with increased odds of anemia compared to non-Hispanic White women (OR, 1.31; 95% CI, 1.14 – 1.50). Underweight patients had 1.64 (95% CI, 1.27 – 2.12) increased odds of anemia compared to normal weight patients. Compared to patients that underwent minimally invasive surgery, those that had an open abdominal hysterectomy were at over 2.7-fold increased odds (OR, 2.77; 95% CI, 2.53 – 3.04) of anemia. Those who reported greater than 10% loss of body weight in the last 6 months were 2.33 (95% CI, 5.06 – 6.81) times at increased odds of anemia. Other clinical factors associated with increased odds of anemia included metastatic cancer, American Society of Anesthesiologists (ASA) physical status classification score of 3 or more, and 2 or more comorbid conditions. Conclusions: There are multiple risk factors associated with preoperative anemia in patients undergoing hysterectomy for cancer. Identification of high-risk patients may help clinicians appropriately screen for and treat anemia prior to surgery.
Assessing the immunomodulatory effect of testosterone on outcomes of patients with advanced solid tumors treated with immunotherapy using the National Cancer Database.
Authors: Jayakrishnan Thejus , Wei Wei , Sena Laura , Patil Pradnya Dinkar 
Published: June 2022

e18805 Background: Androgens have been described to suppress immune responses to various benign and pathogenic antigens, accounting in part for sex-based differences in incidence and severity of autoimmunity, infection, and malignancy. We hypothesized that testosterone exposure alters immune tolerance to solid tumors and outcomes to cancer immunotherapy. In an attempt to isolate the effect of testosterone exposure on outcomes to treatment with immunotherapy, we utilized age as a surrogate for testosterone level and sought to test whether younger men with higher testosterone would have different outcomes following immunotherapy than older men with lower testosterone, relative to women. Methods: National Cancer Database (NCDB) was queried for patients with advanced non-small-cell lung cancer (NSCLC), renal cell carcinoma (RCC), or melanoma, who received immunotherapy as first-line systemic treatment. These patients were divided by quartiles for age (Q1 (youngest) through Q4 (oldest)) and a Multivariate Cox proportional hazard model was used to test the interaction between sex and age on survival outcomes for each cancer type while adjusting for the Charlson-Deyo comorbidity index. Results: The study included 23,741 NSCLC (median age 66 years, interquartile range (IQR) 59 – 74), 1741 RCC (62 y, IQR 55 – 69), and 5825 melanoma (64 y, IQR 54 - 73) patients. The majority of patients were male – 52.3%, 71.3%, and 68.2% for each cancer type respectively. The median overall survival (OS) following first-line immunotherapy declined with increasing age in each cancer type (Q1 > Q4). No significant interaction between age group and sex for any of the cancer types was identified (table). Notably, male patients in any group and cancer type did not have statistically longer OS following immunotherapy than female patients. Conclusions: This study did not show that age altered sex-based differences in outcomes to immunotherapy in patients with advanced solid tumors. It is possible that age is a poor surrogate for testosterone level in this patient population, that additional confounding factors were present, or that testosterone exposure does not modify outcomes to immunotherapy. Future studies will directly correlate serum testosterone levels with outcomes to immunotherapy in patients with advanced cancer.[Table: see text]
The influence of EGFR mutation status and PD-L1 expression in stage III unresectable non-small cell lung cancer treated with chemoradiation and consolidation durvalumab.
Authors: Nindra Udit , Stevens Samuel Xavier , Shahnam Adel , Pal Abhijit , Adam Tamiem , Yip Po Yee , Lee Jenny HJ , Boyer Michael J. , Nagrial Adnan , Kao Steven Chuan-Hao , Bray Victoria Jane 
Published: June 2022

e18810 Background: The PACIFIC trial established concurrent chemoradiation followed by one year of consolidation durvalumab as the standard of care for unresectable stage III non-small cell lung cancer (NSCLC). However, the data to support the use of durvalumab in patients with EGFR mutations and low PD-L1 expression is less clear. This study adds to the available evidence by describing the survival outcomes for patients with stage III unresectable NSCLC treated with chemoradiation followed by durvalumab with a focus on their EGFR mutation and PD-L1 status. Methods: This retrospective observational study was conducted at six sites across Sydney, Australia. It included patients diagnosed with unresectable stage III NSCLC treated with chemoradiation and at least one cycle of durvalumab between January 2018 to September 2021. Patients were stratified into EGFR wild-type and mutated tumours and PD-L1 tumour proportional score (TPS) greater than or less than 1%. Survival analyses were supplemented with cox proportional hazards regression models which estimated HRs for PFS in treatment group comparisons. The proportional hazards assumption was confirmed for all cox models. All statistical analysis was done using R version 4.1.1. Results: 146 patients were included in the analysis. The median follow-up from the start of Durvalumab was 15.1 months. The median age was 66 years in the EGFR mutated and 65 years in the EGFR wild-type cohorts. 61% (n = 89) of patients were male. 10% (n = 15) of patients had EGFR mutation. 42% (n = 61) of patients had a PD-L1 TPS of < 1%. PD-L1 expression was similar in both cohorts with 47% (n = 7) of EGFR mutated patients having PD-L1 TPS of < 1% compared with 45% (n = 59) in the wild-type group. The median progression-free survival (PFS) was 7.5 months for EGFR mutated patients versus 33.9 months for EGFR wild- type patients (HR: 2.7; 95% CI: 1.2 – 5.7; p = 0.01). There was no statistically significant difference in either PFS (HR 0.7, 95% CI 0.4 – 1.7, p = 0.43) or OS (HR 0.5, 95% CI 0.4 – 4.7, p = 0.16) for patients with PD-L1 TPS of < 1% compared with PD-L1 TPS of > 1%. Conclusions: Our data adds to the growing evidence that suggests consolidation durvalumab after definitive chemoradiation may not be as efficacious in patients with EGFR-mutated tumours. PD-L1 TPS did not affect survival outcomes.
Burden of insomnia among cancer patients undergoing treatment: A retrospective claims database analysis.
Authors: Wickwire Emerson M , Juday Timothy R , Frech Feride H , Kelkar Mona Arti , Heo Jihaeng , Malhotra Manoj 
Published: June 2022

e18816 Background: Almost half of all cancer patients have trouble sleeping, usually insomnia or other sleep-wake disorders. Cancer treatment can exacerbate sleep problems. This study evaluated all-cause healthcare resource utilization (HCRU) and costs in cancer patients undergoing treatment who also have insomnia relative to a matched cohort of cancer patients undergoing treatment who do not have insomnia. Methods: This retrospective study used the IBM MarketScan Commercial and Medicare Supplemental Databases (Jan 2014-Dec 2019) to identify patients: (1) age ≥18 years; (2) with ≥1 ICD-9/ICD-10 codes for insomnia OR with ≥2 prescriptions for zolpidem immediate release (IR) OR trazodone ≤150mg OR benzodiazepine; (3) with ≥12 months of continuous enrollment pre-/post-index date (earliest diagnosis or medication fill date); (4) with ≥2 ICD-9/ICD-10 codes for any cancer; and (5) ≥1 claim for oncology treatment. Patients with sleep disorders other than insomnia were excluded. The resulting patients (“insomnia cohort”) were 1:1 matched on age, sex and Elixhauser Comorbidity Index (ECI) score to patients with cancer undergoing treatment without insomnia or other sleep disorders (“control cohort”). HCRU and costs were reported per patient per month (PPPM). Generalized linear models were used to compare adjusted outcomes between cohorts. Results: For each cohort, 7,132 patients (mean age 60.8 years, 69.5% female, 13.6 ECI score) were identified. In adjusted analyses, significantly more patients in the insomnia cohort had at least one inpatient visit per month, inpatient stays were significantly longer, and mean outpatient visits were significantly higher (all p < 0.001) relative to the control cohort. The insomnia cohort had higher mean number of emergency department (ED) visits (p < 0.05); however, mean number of inpatient visits was not significantly different between cohorts. Adjusted analyses also showed significantly higher mean total PPPM costs for the insomnia cohort than the control cohort ($4,864 and $3,302, respectively; mean ratio = 1.47; p < 0.0001). Mean PPPM costs for inpatient visits, ED visits, and outpatient costs were also higher for the insomnia cohort (p < 0.001). Conclusions: Cancer patients undergoing treatment who have insomnia had more intensive HCRU and higher costs relative to those without insomnia. These results suggest that better managing insomnia in this population may have a beneficial impact on both patients and payers.
Application of value framework to phase III trials of immune checkpoint inhibitors in esophageal and gastric cancer.
Authors: Thawani Rajat , Agrawal Neha , Taflin Nicholas , Kardosh Adel , Chen Emerson Yu-sheng 
Published: June 2022

e18817 Background: Recent clinical trials testing use of immune-checkpoint inhibitors in esophageal and gastric carcinomas have shown both positive and negative results. Given these mixed signals, we aimed to assess outcomes and tolerability of key subgroups using the ASCO Net Health Benefit Score (NHBS) and ESMO Magnitude of Clinical Benefit Scale (MCBS). Methods: A detailed search for phase III trials investigating use of FDA-approved anti PD-1 or anti PD-L1 drugs in esophageal and gastric cancer trials was completed using www.clinicaltrials.gov followed by primary literature identification on PubMed. These studies were then independently selected, reviewed, and scored using the ASCO NHBS and ESMO MCBS by two investigators, and any discrepancy was mutually resolved. The ASCO NGBS scores were compared by primary site of cancer (esophageal vs gastric) and PD-L1 expression using the Mann-Whitney test. The ESMO-MCBS grading were compared using Fisher's Exact test. Results: Of the 45 records identified, 15 clinical trials were included. Of them, six were primarily esophageal cancer trials, and nine were primarily gastric cancer trials. Of all 15, 10 stratified their analysis based on PD-L1 expression. The ASCO NHBS score was significantly higher for esophageal cancer than gastric cancer (mean 40, range 20  56.6 vs. mean 12, range -1.1  18.4, p < .01). No difference, however, was observed in survival and response rate outcome endpoints between the two groups. Similarly, the ESMO MCBS was also higher for esophageal cancer group than gastric cancer (p < .05). Additionally, the median scores were higher in the patients with high PD-L1 expression vs low PD-L1 expression (mean 37, range 11.2  66.6 vs. mean 14, range -19.5  43.6, p < .05). Conclusions: In this cohort of drug registration trials of immune checkpoint inhibitors for upper GI cancers, we showed the ASCO NHB scores and ESMO scores were consistently higher among esophageal cancer trials than gastric cancer trials and in those with high PD-L1 expression than those with low PD-L1 expression. Oncologists should carefully discuss overall clinical value and expectations of immunotherapy benefit with their patients per cancer histology and PDL1 expression, exercising caution in cases of gastric adenocarcinoma with low PD-L1 expression.[Table: see text]
Remote patient monitoring (RPM) through smartphone application in community oncology practice.
Authors: Kuthiala Rayna , Telivala Bijoy Pankaj , Karawadia Tejas 
Published: June 2022

e18828 Background: Patients with cancer receiving treatment can have symptoms related to their disease or treatment. Early recognition and appropriate intervention of these symptoms can lead to fewer emergency room visits and fewer hospitalizations with significant reduction in healthcare costs. Earlier treatment of symptoms leads to more adherence to treatment. We present data regarding reduction in healthcare costs after implementation of remote patient monitoring in our community oncology practice with 13 oncology practice sites and 29 medical oncologists in Jacksonville, Florida. Methods: We implemented RPM through a smartphone application at all our practice sites starting September 1,2021. We collected data regarding number of patients on active therapy who required inpatient admissions during the 3-month period from 9/1/2021 to 11/30/21 . We documented the number of admissions during this 3-month period in 2020, prior to implementation of RPM followed by number of admissions during the same period of time in 2021 after the implementation of RPM. The numerical difference in admissions was then multiplied by average cost of hospitalization for adult cancer patients to calculate the healthcare cost savings. Results: During the 3-month period in 2020 without RPM, there were 234 inpatient admissions. During the same time frame in 2021, after implementation of RPM, there were 199 admissions. The implementation of RPM, showed a 15 % reduction in number of inpatient admissions. Average cost of inpatient stay for a cancer patient is $22,100 as per the data from healthcare cost and utilization project. This would translate to $773,500 over 3-month period and approximately $3 million annual healthcare cost savings. The annual cost of implementation of RPM in our practice was $350,000 which includes cost of smartphone application and the required clinical staff. Conclusions: Remote patient monitoring through smartphone application can be effectively implemented in community oncology practice with significant reduction in healthcare costs. Not only does it save money, it helps improve patient experience and adherence to treatment. We will continue to collect data to see if the trend continues.
Total cost of care differences in National Comprehensive Cancer Center (NCCN) concordant and non-concordant breast cancer patients.
Authors: Sapkota Ujwal , Cavers William , Reddy Shirisha , Avalos-Reyes Elisea , Johnson Kjel Andrew 
Published: June 2022

e18833 Background: National Comprehensive Cancer Network (NCCN) treatment guideline non-concordance for breast cancer treatment has higher total costs. However, a significant knowledge gap exists regarding which cost components increase in non-concordant therapies. The purpose of this study is to evaluate the total cost of care (TCOC) and cost components for breast cancer patients who received NCCNconcordant versus non-concordant therapies. Methods: This is a retrospective study of patients throughout the United States with breast cancer at a large national Medicaid, Medicare, and commercial insurer from January 1, 2019, to December 31, 2020. NCCN regimen concordance was identified from pharmacy and medical claims and defined as concordant if the entire prescribed treatment regimen matched an NCCNregimen (Level 1 and 2a); patients not receiving an NCCN recommended regimen were deemed to be non-concordant. TCOC and its cost components were contrasted on a matched population of concordant and non-concordant patients with a ratio of 2:1. To eliminate possible selection bias and differences in baseline characteristics that could affect cost, propensity scores were developed using logistic regression and used to match patients on age, comorbidity, socioeconomic status (SES) index and treatment type (chemotherapy and radiation). Results: A total of 315 patients with breast cancer were matched. Beginning with and including the first treatment and for up to 180 days after, the TCOC in the concordant group was significantly less across all lines of business (p < 0.05). A reduction of 25%, 28% and 43% (a difference of $5,872, $6,946 and $3,542) in TCOC per member per month (PMPM) was observed in commercial fully insured (CFI), commercial self-insured (CSI) and Medicare patients, respectively. Provider administered chemotherapy spend was also significantly lower (p < 0.05) in the concordant group, a reduction of 34%, 50% and 43% (a difference of $3,615, $6,788 and $1,879) in CFI, CSI and Medicare patients, respectively. Outpatient spend was 28% lower (a difference of $4,268, p = 0.08) in CFI patients and significantly lower (p < 0.05) with reductions of 29% and 40% ($5,396 and $1,988) in CSI and Medicare patients, respectively. There were no significant differences in Inpatient and Emergency Room spend across all lines of business (p > 0.05). Conclusions: In this study, there is a correlation between breast cancer patients on NCCN concordant therapies and a lower TCOC. The savings due to medical spend highlight the importance of evidence-based guidelines in treatment determinations. Further evaluation will be needed to determine cost changes in hospitalizations and emergency room visits.
Choosing Wisely Africa: Insights from the front-lines of clinical care.
Authors: Rubagumya Fidel , Makori Kevin , Borges Hirondina , Mwanzi Sitna Ali , Karim Safiya , Msadabwe Susan Citonje , Dharsee Nazima Jaffer , Mutebi Miriam Claire , Hopman Wilma M. , Vanderpuye Verna D. , Ka Sidy , Ndlovu Ntokozo , Hammad Nazik , Booth Christopher M. 
Published: June 2022

e18835 Background: A multidisciplinary Task Force of African oncologists and patient representatives published the Choosing Wisely Africa (CWA) recommendations in 2020. These recommendations identified low-value, unnecessary, or harmful practices that are frequently used in Sub-Saharan Africa (SSA). We describe agreement and concordance with the recommendations from front-line oncologists across SSA. Methods: A self-administered electronic survey was distributed to members of the African Organization for Research & Training in Cancer and oncology groups within SSA using a hierarchical snowball method. The survey captured information about awareness of CWA, agreement with recommendations, and concordance with clinical practice. Descriptive statistics were used to summarize study results. Results: 49 individuals responded to the survey; 61% (30/49) were female and 59% (29/49) were clinical oncologists. Respondents represented 14 countries in SSA; 69% (34/49) practiced exclusively in the public system. Only 43% (21/49) were aware of the CWA list and 90% (44/49) agreed it would be helpful if the list was displayed in their clinic. There was generally high agreement (Table) with the recommendations (range 84-98%); highest agreement related to staging/defining treatment intent (98%). The proportion of oncologists who implemented these recommendations in routine practice was somewhat lower (range 68-100%). Lowest rates of concordance related to: use of shorter schedules of radiotherapy (68%). Conclusions: While most frontline SSA oncologists agree with CWA recommendations, efforts are needed to disseminate the list. Agreement with the recommendations is high but there are gaps in implementation in routine practice. Further work is required to understand barriers and enablers of implementation.[Table: see text]