bluuebunny/crossref_metadata_2025 huggingface dataset:
Comparison of tongue cancer survival among White and Black cancer patients: An exploratory analysis of the SEER database.
Authors: Shah Jaffer , Shah Asghar , Shah Aarati , Aiash Hani
Published: June 2021

e18053

Background: Despite the relatively rare incidence of tongue cancer in the United States, 2,830 people were estimated to have died from it in 2020. Research has indicated disparities in oral cancer screenings among minority and low-income patients. The aim of the present study is to characterize the incidence of tongue cancer across in the US population and to determine mediators of survival months. Methods: SEER 18 regions database (November 2019 submission) was queried to obtain data on tongue cancer incidence, patient demographics, and clinical variables for patients (n=51,622) from 2000-2017 using SEER*Stat 8.3.8. Data analysis were performed using R and RStudio version 4.02, and 1.3.1073, respectively. For comparison between groups, Chi-squared test for independence, Fisher’s exact test, and Wilcoxon signed-rank test were applied where applicable. Univariate and multivariate regression models characterized the relationship between survival months and sex, race, primary site, and additional patient characteristics. Results: Several significant group differences were determined in the incidence of tongue cancer. Patient sex was significantly associated (P<0.001), with survival months in White patients, with median survival months 33 (IQR 11,85) and 35 (IQR 12,82) for females and males respectively. Regression analysis found multiple patient level characteristics significantly mediating survival months. The odds ratio (OR) for reported patient race of Black were OR 0.78 (95% CI 0.68, 0.89; P<.001) and OR 0.75 (95% CI 0.66, 0.86; P<.001) for univariate and multivariate regression, respectively. Conclusions: The study indicates that health disparities vis-à-vis social determinants of health play a role in mediating differences in tongue cancer survival months for patients in the US. Further research should characterize and address persisting health inequities and potential solutions in oral cancer incidence and mortality.[Table: see text]
Social disparities in Southeastern Brazil and the burden of cervical cancer.
Authors: Aleixo Sabina B. , Pulido Jose Zago , Parmanhane Narelle , Sogame Luciana
Published: June 2021

e18511

Background: Cervical cancer (CC) is the fourth most common malignancy in women worldwide and around 85% of the cases currently diagnosed are in underdeveloped countries. According to the National Cancer Institute of Brazil (INCA), in the year 2021, 16.590 new cases are expected with an estimated risk of 15.43 cases per 100,000 women and unfortunately numbers are not decreasing. Low socioeconomic status is been known to be associated with inferior cancer survival. Although Brazil’s publicly funded Unified Health System (SUS) increased access to health care, the universal access is still a problem. Brazil is a country of continental dimensions with widespread regional and social inequalities. The CC differs enormously by regions in the Brazilian country. Here, we use a population-based cancer registry to explore sociodemographic characteristics and CC in Southeastern Brazil. Methods: We collected retrospective data of patients with CC registered in the regional cancer reference center from the south of Espirito Santo (ES) the Hospital Evangélico de Cachoeiro de Itapemirim (HECI). We used the brazilian Health Information System - SISRHC from 2010 to 2017. Characteristics such as educational level (years of study), age, race, type of health insurance for treatment (SUS or private) and disease stage at diagnosis were recorded. Results: Among 3272 women diagnosed with cancer in the period analyzed, 286 had a diagnosis of CC.The educational level of 44,61% was less than 9 years, 16,43% between 10 and 12 years and 3,15% more than 12 years (36,01% without information).Mean age at diagnosis was 49 years, and 50 % were younger than 50 years. As for race, 50% of the women self-declared as non-white and 40,91% as white (9,09% without information), and 89,9% were treated by SUS and 10,1% treated by private health system. The distribution of CC stages at diagnosis was 0 (13,99%), I (15,03%), II (23,08%), III (18,53%) and IV (3,5%). Stage status was missing for 35,87% of CC cases. Conclusions: The majority of the women in the study where non-white, had low education level , used public health system (SUS) for treatment and had advanced disease. We also found that Brazilian SISRHC needs more attention to be a reliable cancer source data. These findings reinforce that social determinants affects access to diagnosis and treatment of CC patients in Southeastern Brazil. Future health awareness and preventive interventions must target less-educated communities to reduce delays in seeking medical care for cancer.
A cross-sectional study on global disparities in information experiences of patients with lymphoma/CLL.
Authors: Bamigbola Olufunmilayo , Dren Natalie , Warwick Lorna
Published: June 2021

e18517

Background: Patient-centricity remains a cornerstone in the care of patients with lymphoma and CLL, as informed patients are consistently associated with better outcomes and experiences. This study uses the Lymphoma Coalition (LC) 2020 Global Patient Survey (GPS) on Lymphomas and CLL to describe the global differences in the top choices for medical information among patients with lymphoma, as well as differences in their understanding of this information relating to various aspects of their care. Methods: Globally, 9,179 patients from 89 countries took part in the LC 2020 GPS. The countries were grouped into regions, and the regions with greater than 200 patients were included in the analysis (Table). The demographics of the regions were examined, and descriptive analyses of questions relating to information source preferences, information provision at diagnosis (addressing treatment options; process and stages of care; managing treatment side effects), and corresponding levels of patient understanding were performed in IBM SPSS v27. Results: Doctors were the first choice for medical information for patients in each region (SA-82%, AS- 75%, EU-69%, OC-63%, NA-61%). In EU, NA and SA, websites were the most prevalent second and third choice for information (27% and 28%; 30% and 32%; 35% and 27%, respectively). In AS, patient advocacy organisations were the most prevalent second and third choices for information (32% and 40%, respectively), while in OC, the most prevalent second and third choices were nurses (27%) and patient advocacy groups (32%) respectively. Over a fifth of NA patients were not given information on the process and stages of care and how to manage side effects of treatment (21% and 29%, respectively). About a third of patients from SA (32%) reported not getting information on treatment options. Over half of OC patients reported being given information on and completely understanding the different treatment options (51%), processes and stages of care (53%) and how to manage treatment side-effects (58%). Patients from AS were the most prevalent in reporting across the three categories, that they were given information but did not understand it (10%, 7%, 5%, respectively). Conclusions: Globally, patients with lymphoma use various avenues to source the medical information they need, and they differ in their information experiences. Access to appropriate and adequate medical information remains an essential aspect of a successful patient experience and LC advocates that this information be contextual and accessible to all patients with lymphoma. [Table: see text]
A trial-level correlation analysis of progression-free survival as a surrogate for overall survival in the immunotherapy era.
Authors: Yekeduz Emre , Koksoy Elif Berna , Akbulut Hakan , Utkan Gungor , Urun Yuksel
Published: June 2021

e18580

Background: Progression-free survival (PFS) is accepted as a surrogate endpoint for cancer drugs approval by the Food and Drug Association. In the expanding immunotherapy era, there is no convincing data for reliable surrogacy of PFS. Methods: We systematically searched PubMed and included all phase III trials of ICIs. Besides, we manually included phase III trials of ICIs presented in congresses. Trials including non-metastatic patients and hematologic malignancies were excluded. The primary endpoint was the relationship between treatment effects (i.e., hazard ratio (HR) of PFS and overall survival (OS)). The secondary endpoint was the relationship between the median PFS (mPFS) and median OS (mOS). We also performed subgroup analyses by ICIs subtypes (i.e., anti-programmed death-1 (PD-1) and anti-programmed death ligand-1 (PD-L1)), treatment lines (i.e., the first-line and subsequent treatments), ICI plus CT combination, and ICI monotherapy. To ensure parametric assumptions, we addressed logarithmic conversion to HRs by using log10. We used Pearson’s correlationand weighted linear regression for parametric variables and Spearman’s rank-order correlation for non-parametric variables. We assessed the relationship between variables by using correlation coefficient (r) and coefficient of determination (R2). Results: We included 57 phase III clinical trials with 39,525 patients. A total of 67 outcomes were compared. There was a good correlation between the logarithmic HR of PFS (log HRPFS) and OS (log HROS) (r=0.71, R2=0.50 p<0.001). In subgroup analyses, there was a weak or moderate correlation between the log HRPFS and log HROS in anti-PD-L1, ICI plus CT, and the first-line treatment subgroups (r=0.61, R2=0.38 p=0.004 for anti-PD-L1; r=0.65, R2=0.43 p=0.008 for ICI plus CT; r=0.70, R2=0.49 p<0.001 for the first-line treatment). Conversely, there was a good correlation between the log HRPFS and log HROS in the anti-PD-1, ICI monotherapy, and subsequent treatment line subgroups (r=0.81, R2=0.66 p<0.001 for anti-PD-1; r=0.71, R2=0.51 p<0.001 for ICI monotherapy; r=0.78, R2=0.62 p<0.001 for subsequent treatment line). Correlations between the mPFS and mOS were good or strong in all subgroups. (Table). Conclusions: PFS might be considered a reliable surrogate endpoint for OS, particularly in anti-PD-1 ICIs, ICI monotherapy, and subsequent metastatic cancer treatment lines.[Table: see text]
In-hospital outcomes of transcatheter aortic valve replacement (TAVR) in patients with localized and metastatic malignancy.
Authors: Macchi Hugo , Salazar Miguel , Del Cid Fratti Juan , Gauto Estefania , Baral Binav , Shrivastava Trilok , Upadhyay Banskota Shristi Upadhyay , Zia Maryam , Khanal Nabin
Published: June 2021

e18602

Background: There is limited use of transcatheter aortic valve replacement (TAVR) in patients with malignancy, given that current guidelines do not recommend TAVR in patients with a life expectancy of less than 1 year. Data that compare short-term outcomes after TAVR in cancer and metastasis is scarce. Methods: Using the national inpatient sample (NIS) database, we identified patients who underwent TAVR from 2016-2017 using ICD10-PCS codes. Patients were subsequently divided based on local malignancy and metastatic malignancy. In-hospital mortality, total hospital cost, length of hospital stays, and post-procedural complications were evaluated. Multivariate logistic regression analysis was conducted to adjust for confounders. Results: A total of 91, 624 TAVR hospitalizations were identified, 4, 995 (4.7%) with malignancy. Patients with malignancy were most likely to be women, have a higher Charlson comorbidity index, to use private insurance, and being admitted to a teaching hospital. The most common malignancy was hematological, head and neck, prostate, digestive, and breast cancer of these patients 15.6% had metastatic disease at the time of TAVR. After adjusting for confounders there was no difference in mortality, LOS, healthcare utilization, and post-procedural complications. Conclusions: TAVR seems to have a safe short-term outcome in patients with active malignancy and metastatic disease. In this population, we recommend having an oncological evaluation to perform a risk assessment to aid in the decision when to not proceed with TAVR.[Table: see text]
How to choose your surgeon for colorectal cancer: The influence of fellowship training on outcomes.
Authors: Aquina Christopher Thomas , Becerra Adan Z. , Ejaz Aslam , Monson John R.T. , Fleming Fergal J.
Published: June 2021

e18603

Background: Rectal cancer has a well-established volume-outcome relationship. However, the impact of fellowship training on outcomes following colorectal cancer resection is unknown. Methods: Patients who underwent stage I-III colorectal adenocarcinoma resection (2004-2014) were identified in the New York State Cancer Registry and Statewide Planning & Research Cooperative System. Hierarchical analyses assessed the association between surgeon American Board of Colorectal Surgery (ABCRS) certification and postoperative outcomes and survival. Derived from volume tertiles, surgeons who performed ≥15 annual colon cancer resections or ≥10 annual rectal cancer resections were characterized as high-volume colon (HVCSs) or rectal (HVRSs) surgeons, respectively. Results: 47,491 colorectal cancer resections (right colon = 23,824, 50.2%; left colon = 18,154, 38.2%; rectal cancer = 5,513, 11.6%) met inclusion criteria. ABCRS-certified HVCSs (N = 92) comprised only 5.5% of the surgeon cohort but performed 20.6% of the colon cancer resections. Similarly, ABCRS-certified HVRSs (N = 31) comprised only 3.8% of the surgeon cohort but performed 16.5% of the rectal cancer resections. Despite no significant difference in complications, ABCRS-certified HVCS/HVRSs overall had better postoperative outcomes and were associated with improved survival following colorectal cancer resection. Conclusions: These results suggest that for the best outcomes and long-term survival following colon and rectal cancer resection, referral to high-volume, ABCRS-certified surgeons may be the best choice.[Table: see text]
Outcomes with COVID-19 in patients with hematopoietic stem cell transplant and cellular therapy: A systemic review and meta-analysis.
Authors: Chaudhary Sibgha Gull , Zafar Muhammad Usman , Hassan Maha Awaiz , Shahzad Moazzam , Hussain Ali , Ali Fatima , Riaz Yumna , Khalid Fatima , Khurana Sharad , Balusu Ramesh , Ahmed Nausheen , Singh Anurag K , Anwer Faiz , Abhyankar Sunil H. , McGuirk Joseph , Mushtaq Muhammad Umair
Published: June 2021

e18611

Background: Coronavirus Disease 2019 (COVID-19) was declared a pandemic on March 11, 2020. COVID-19 has caused over 100 million infections and over 2 million deaths globally. Patients who have received a hematogenic stem cell transplant or cellular therapy (HCT) have a high risk of mortality and morbidity with COVID-19 due to severe immune dysregulation. We conducted a systematic review and meta-analysis aimed to evaluate the outcomes of COVID-19 in HCT patients. Methods: A literature search following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines (PRISMA) guidelines was performed on 3 databases (PubMed, Cochrane, and Clinical trials.gov) from the date of inception to Jan 2021. MeSH terms included ‘hematological malignancies’, ‘hematopoietic stem cell transplantation’, ‘SARS-CoV-2’, and ‘COVID 19’. We screened 99 articles and 6 studies (4 retrospective studies, 2 prospective) were included after excluding review, duplicate, and non-relevant articles. Quality evaluation was done using the NIH quality assessment tool. The Inter-study heterogeneity among the studies was assessed using the Q statistic proposed by Cochrane and the I2 index introduced by Higgins and Thompson. Pooled analysis was done using the ‘metaXL’, and the random effects model was used to estimate the pooled prevalence with 95% CI. Results: Of 1619 patients in 6studies, 646 HCT patients were analyzed (Table ). The median age of patients was 63 years and 59% were males. Median days since HCT for autologous (auto) HCT and allogeneic (allo) HCT patients were 690 and 450 days respectively. The average follow-up duration after COVID-19 was 24 days. COVID-19 mortality in HCT patients was 20% (95%CI 0.17 to 0.23, I2=0). Roedl et al (n=6) reported a mortality of 83% and was excluded from the pooled analysis. The mortality rate was 19% (95% CI 0.15 to 0.24, I2=0%) in auto HCT patients and 21% (95% CI 0.17 to 0.25, I2=0%) in allo HCT patients. Conclusions: The HCT patients are at significant risk of increased mortality and morbidity due to COVID-19. There is a need to prioritize HCT patients for COVID-19 vaccination, close surveillance, and aggressive management.[Table: see text]
Patient-reported outcomes in clinical trials for multiple myeloma: Where we are.
Authors: Andreas Marike , Salek Sam , Kreuzberger Nina , Piechotta Vanessa , Oliva Esther Natalie , Ionova Tatyana , Monsef Ina , Skoetz Nicole , Laane Edward
Published: June 2021

e18615

Background: It is recommended to include patient-reported outcomes (PROs) in cancer trials to ensure clinical benefit based on patients’ perceptions. For multiple myeloma patients, PRO measurement is essential to understand the impact of treatment on their physical and psychosocial functional behaviour. However, it is unclear which PRO instruments are utilized in multiple myeloma trials, how often they are used and whether results are consistently reported. The aim of this project was to explore the use and frequency of PRO instruments in randomized controlled trials for multiple myeloma and to assess the consistency of their reporting. Methods: Within the European Hematology Association (EHA) project to develop guidelines for the use of PROs in adult patients with hematological malignancies, MEDLINE and CENTRAL were systematically searched for randomized controlled trials investigating multiple myeloma between 2015 and 2020. Study design, disease and treatment characteristics, the primary outcome and used PRO instrument(s) were extracted using a pre-defined template. To assess the consistency of PRO reporting, study registries were compared with publications, study protocol and Health Technology Assessment (HTA) reports where available. Results: Overall, 10,707 records were found. Following screening for randomized-controlled trials, 283 ongoing, completed or published studies were included for review. 118 studies planned the use of PROs. The most frequently used PRO instrument (92 studies) was the EORTC QLQ-30, an instrument that measures health-related quality-of-life (HRQoL) in cancer patients. The disease-specific questionnaire EORTC-MY20 was also frequently used (50 studies). Likewise, the HRQoL instrument EQ-5D was used in 50 studies. Overall, 38 different PRO instruments were reported. In 39 studies for which a study protocol was found, only 19 reported PRO instruments consistently with the trial registry for the study. In addition, in 30 studies, for which a publication reported PRO results (58 overall), the information on PRO instruments differed between publication and the trial registry. For example, PRO instruments mentioned in the registry were omitted in the respective publications. Additionally, information on PRO in HTA reports was available for 26 studies, of which 18 reports were consistent with the trial registries. Conclusions: The results show that measurement of PROs still remain under-utilized in multiple myeloma research. While most PRO instruments identified in this review comply with the recommendations for incorporating PROs into clinical research in adult oncology, they are often inconsistently reported. Thus, reporting standards for the use of PROs are needed to ensure consistency in the use and reporting of PROs.
Characterizing unplanned resource utilization associated with cancer-related diarrhea.
Authors: Schwartzberg Lee S. , Roeland Eric , Okhuysen Pablo C. , Anupindi Ruthwik , Hull M , Yeaw Jason , Sun Lucille , Tam Iris M. , Franklin Gina , Chaturvedi Pravin
Published: June 2021

e18625

Background: In clinical oncology practice, diarrhea is a very common and severe side effect of cancer treatments including from radiotherapy, chemotherapy, and targeted therapies. Cancer-related diarrhea (CRD) leads to increased healthcare resource consumption due to unscheduled outpatient visits, and , increased hospital stays requiring intensive supportive care measures. We evaluated CRD patients receiving chemotherapy, targeted therapy, or both, requiring emergency department (ED), physician office visits, hospitalizations, and length of stay (LOS) compared to a matched cohort of non-CRD patients. Methods: We performed a longitudinal study among adult patients ( > 18 yrs) with CRD identified by diagnosis codes or pharmacy claims compared to matched non-CRD patients using claims data derived from the IQVIA PharMetrics Plus database. Index date was the first cancer claim date and patients were re-indexed based on their CRD claim. Each patient had a 6-month pre-index period, a minimum 3-month post-index period and had ≥12 months of continuous enrollment following the CRD index date. To adjust for selection bias and baseline differences, we matched CRD patients to non-CRD patients (1:1) by age, gender, geography and payer type. Patients were stratified by cancer therapy type (chemotherapy, targeted therapy or both treatments). We reported proportion of patients with hospitalizations, average length of stay (LOS), and ED visits. A generalized estimating equation model with log link and binomial distribution adjusted for type of cancer, therapy, and Charlson Comorbidity Index (CCI) was built to estimate the difference in occurrence of hospitalization between CRD and non-CRD cohorts. Results: We evaluated a total of 104,135 matched pairs of CRD and non-CRD adult patients with solid or hematologic cancer with 12-month continuous enrollment. The proportion of patients with ED visits (36.2% vs 18.9%, p < 0.0001) and hospitalizations (29.6% vs 12.8%, p < 0.0001) were significantly higher among CRD versus non-CRD cohort. When compared to non-CRD patients, CRD patients were more likely to be hospitalized (adjusted OR 2.28. 95% CI of 2.23-2.33). Mean CRD-specific office/hospital visits were significantly higher in the CRD cohort compared to the non-CRD cohort over the 12-month post-index period and patients had more CRD-specific visits to ED (7.5% vs 1.8%); physician’s offices (14.7% vs 3.8%); laboratory testing (11.6% vs 3.2%) and outpatient ancillary services (10.9% vs 2.6%) (all p < 0.0001). Mean hospital LOS among patients with CRD was higher than non-CRD patients (6.6±8.9 vs 5.8±10.5 days, p < 0.0001). Conclusions: Patients with CRD used significantly more resources, including outpatient services, ED visits, and hospitalizations. Effective prevention of CRD remains an unmet strategy to reduce the overall cost of cancer care.
Can online patient reviews be used to assess oncologist competency? RateMD as a cancer care evaluation tool.
Authors: Morena Nina , Zelt Nicholas , Nguyen Diana , Rentschler Carrie A. , Greyson Devon , Meguerditchian Ari N.
Published: June 2021

e18656

Background: Medical oncology (MEDONC) requires a combination of skills in collaboration, communication, and professionalism, ultimately delivering technical and clinical knowledge in practice. Standard assessment tools (e.g. written examination, OSCE) are not effective in evaluating competencies beyond technical skills and fail to define the cancer care experience holistically. This explorative, descriptive study aims to identify the potential of unstructured, unsolicited, open access online patient reviews (OPRs) as a tool to assess physician competency. Methods: University-affiliated MEDONCs in Ontario (Canada) were selected. All OPRs were identified on RateMD using every name permutation; physician names and institutional affiliations were removed from comments. A descriptive analysis of the cohort was completed. The CanMEDS Framework, defining physician standards, was used with its hierarchy of roles, concepts, and competencies. Two reviewers, a communication studies researcher and a healthcare professional, independently assessed comments and identified common themes. Competency-level assessments were evaluated using kappa with linear weights. Results: 473 OPRs were identified for 49 MEDONCs (71% male, 29% female). Of these, 23% were written by care providers. Competencies defining roles of Medical Expert, Communicator, and Professional were most prevalent (64%, 38%, and 27% respectively). Agreement levels were high in all roles (wK = 0.71 - 1.00). Themes identified were similar in positive and negative evaluations. Most commonly discussed positive themes were knowledge translation and compassionate interpersonal skills. Most common negative themes centered on lack of humility, compassion, and communication skills. 38% of comments were marked helpful, indicating engagement with other OPRs as a key characteristic of rating tools. In addition to the physician in question, 21% of OPRs reported on healthcare delivery by staff. Conclusions: OPRs emphasize experiential competencies related to interpersonal skills and suggest an alternative format to evaluating such aspects of MEDONC competencies.[Table: see text]
Multi-level QI interventions in a safety-net academic oncology clinic.
Authors: Jotwani Aparna Chakravarti , Miller-Chism Courtney Nicole , Crawford Margaret Griffin , Mach Claire , Woods LaToya , Zhang Jessica , Godwin Kyler , Murphy Daniel
Published: June 2021

e18665

Background: Clinic cycle time is a performance metric and prolonged wait times may impact patient satisfaction and/or treatment outcomes. In primary care clinics, studies show prolonged cycle times detract from patient satisfaction. Fewer studies examine specialty clinics such as oncology which require multi-faceted care. Our Harris Health System (HHS) serves a diverse county with high patient volume with physician learners and limited providers due to limited resources. Our patient satisfaction assessments previously identified prolonged wait times as an area for improvement. Our team studied and process mapped operations with the goal of improving clinic efficiency. Our primary objective is to streamline the process for our outpatient oncology appointments measured through patient cycle times. We aimed to decrease the cycle time by 25% and improve patient satisfaction. Methods: From January 2018 through December 2019, the cycle time processes for Smith Thursday Oncology Clinics in the HHS were mapped and analyzed, and sequential PDSA (Plan-Do-Study-Act) cycles were completed to reduce non-value-added time. Six-month cycle times before and after implementation of three process changes implemented were compared with t-test analysis. Next, NRC (National Research Corporation) Health patient satisfaction data for the corresponding time frames was compared with both t-test and chi-square analyses. Results: Patient cycle time from July 2018 – December 2018 was compared to July 2019 – December 2019 with a t-test analysis. Our results showed a significant (p = 0.036) reduction in cycle time. The average percent decrease in cycle time was 19%. NRC patient satisfaction data inquiries, including overall satisfaction, informed regarding appointment delays, and waiting for more than 15 minutes were reviewed for this same time frame. We found trends in all three categories showing improvements in scores with p-values of 0.483, 0.821 and 0.282 respectively. Conclusions: Through multi-level interventions we were able to significantly reduce clinic cycle times. Trends towards improvement were seen as the population assessed was in the hundreds and not thousands needed for significance. Our academic teaching model is meaningful to study as it serves a high patient volume and educates future oncologists, especially pertinent when a shortage of oncologists in anticipated in the future. Additionally, our patients receive high quality care with nursing, education and infusion services. An area for improvement is communication with patients during their cycle times and other early QI work in our clinics show patients are interested in further education. Our underserved patient population is multi-ethnic, has unassessed health literacy, and frequent language barriers. Better efficiency in the clinics and utilization of cycle time can have multiple patient benefits that warrant further work in QI.
Impact of clonal hematopoiesis to tumor-targeted liquid biopsy in a Chinese pan-cancer cohort.
Authors: Xu Enwu , Zhou Yang , Yi Zhao , Gong Longlong
Published: June 2021

e18700

Background: Somatic mutations through detecting circulating cell-free DNA (cfDNA) in plasma samples have been used to diagnose tumor, administer drugs and monitor tumor recurrence. However, cfDNA is not only derived from tumor, but also from clonal hematopoiesis. Thus, the mutations from clonal hematopoiesis impact accuracy of somatic mutation detection using plasma cfDNA in tumor patients. Methods: We screened clonal hematopoiesis using a bioinformatics pipeline in 11,725 Chinese pan-cancer cohort. To evaluate the impact of clonal hematopoiesis for somatic mutations, Fisher’s exact test was used. Results: In this study, we identified clonal hematopoiesis mutations using a bioinformatics pipeline in a Chinese cohort included 11,725 pan-cancer patients. In order to enhance the detection accuracy of clonal hematopoiesis mutations, we performed a statistical framework to compare the distribution of alteration-supporting reads in cfDNA and matched peripheral blood lymphocyte (PBL) samples. The result indicated that 5,933 clonal hematopoiesis mutations in 301 genes for 5,100 patients. In particularly, 48 of 5,933 clonal hematopoiesis mutations carried by 92 of 5,100 tumor patients were actionable somatic mutations. Seven oncogenes (including EGFR, ERBB2, FGFR3, IDH1, KIT, KRAS and NRAS) and 10 tumor suppressor genes (including BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, PTEN, RB1, SMAD4 and TP53) were contained in the 48 clonal hematopoiesis mutations. The frequency of TP53 gene was 32.6% (30 of 92 tumor patients) and KRAS which was considered as targeted therapy was 16.3% (15 of 92 tumor patients). Conclusions: Taken together, we exhibited characteristic of clonal hematopoiesis mutations in a Chinese pan-cancer cohort and explored effect of clonal hematopoiesis mutations on liquid biopsy for tumor patients.
Patterns and costs of hospital-based cancer care in the last year of life: A national data linkage study in Scotland.
Authors: Diernberger Katharina , Bowden Joanna , Fallon Marie T. , Luta Xhyljeta , Droney Joanne , Lemmon Elizabeth , Gray Ewan , Ennis Holly , Marti Joachim , Hall Peter S
Published: June 2021

e18732

Background: Approximately thirty thousand people in Scotland are diagnosed with cancer each year, of whom 10,000 live less than one year. Hospital is the most common place of death for people with cancer, despite most expressing a preference for community-based care. There is inadequate understanding of the nature and value of hospital-based care for people with advanced cancer. This study aimed to describe patterns of hospital-based healthcare use and associated costs for cancer decedents in their last year of life. Methods: A population-wide administrative data linkage study of hospital-based healthcare use for cancer decedents aged 60+ at death who died between 2012 and 2017 was conducted in Scotland. Linkage was established between the Scottish Morbidity Record, Scottish Cancer Registry and the National Records of Scotland. Hospital admissions, length of stay (LoS), number and nature of outpatient and day case appointments were extracted. Associated costs were estimated using generalised linear models, adjusted for age, gender, primary cause of death, socioeconomic deprivation status, rural-urban (RU) status and comorbidity. Results: The study population included 85,732 decedents with a cancer diagnosis, for whom 64,553 (75.3%) cancer was the underlying cause of death. Mean age at death was 84 years. The mean number of inpatient stays in the last year of life was 5.88 (SD 5.68), with a mean LoS of 7 days. Mean total 1-year inpatient, outpatient and day-case costs per patient were £10,261, £1,275 and £977 respectively. People who died of haematological cancers had the most hospital admissions (mean 11.8). Admission rates rose sharply in the last month of life and were most common in those who died of haematological and lung cancers. One year adjusted and unadjusted costs decreased with increasing age. Unadjusted costs for the youngest group (60-64) were £15,895, double the cost for those aged 90+. People dying of haematological cancers had the highest hospital-based costs (mean £24,772) followed by those with ovarian cancer (mean £17,556). The largest single contributor to hospital-based costs in the last year of life was unscheduled admissions. Conclusions: People in Scotland in their last year of life with cancer use substantial hospital-based care. Unscheduled admission rates are high, particularly in the last month of life when the value of acute intervention may be uncertain. Further research is needed to examine triggers for hospitalisation and to assess the value of hospital-based care to people living with advanced cancer.
Do differences in baseline clinical severity of ovarian cancer patients with thrombosis predict treatment with rivaroxaban versus low molecular-weight heparin?
Authors: Kohn Christine G. , Caranfa Jonathan T. , Brewer Molly , Singh Meghana , Coleman Craig I. , Costa Olivia S.
Published: June 2021

e18748

Background: Prescribers use direct oral anticoagulants and low molecular-weight heparin (LMWH) for the acute treatment and secondary prevention of cancer-associated thrombosis (CAT). We sought to identify predictors impacting the use rivaroxaban versus LMWH for CAT in patients with ovarian cancer. Methods: Using US Surveillance, Epidemiology and End Result-Medicare linked data from 2013-2016, we evaluated adults with ovarian cancer, undergoing hospitalization/emergency department admission for CAT and prescribed rivaroxaban or LMWH for outpatient anticoagulation. Univariate analysis was performed to examine the association between covariates and clinicians’ choice to use rivaroxaban or LMWH. Variables with a p-value < 0.20 upon univariate analysis were deemed significant and subsequently included into a stepwise, backwards multivariable logistic regression model to obtain adjusted odd ratios (ORs) of treatment assignment. Results: Of the 125 ovarian cancer patients included in our analysis, 26% received rivaroxaban and 74% LMWH. All patients had stage 3 or 4 ovarian cancer, 36% were ≥75 years-of-age, 78% were white, and 18% were below the poverty line (p ≥ 0.25). Upon univariate analysis, rural community, time between cancer diagnosis and VTE ≥ 1 year, index VTE without evidence of pulmonary embolism, and CKD ≥ stage 3 were found to be significant predictors of rivaroxaban use when compared to LMWH (p ≤ 0.14 for all). Upon multivariable regression, CKD ≥ stage 3 (OR = 3.13) was shown to be independently associated with rivaroxaban versus LMWH use (p≤0.01). Conclusions: In routine practice, patients were more likely to receive rivaroxaban if they had CKD and lived in a rural area. These differences in prescribing practices may be due to less availability of LMWH in rural areas and less tolerance of injections in CKD patients. Univariate analysis also suggest that low VTE burden (i.e., DVT only) and VTE event ≥ 1 year after cancer diagnosis were also associated with rivaroxaban use over LMWH, which may be due to LMWH therapy as the long-established standard of care for patients with cancer. Large observational studies are needed to confirm these results. [Table: see text]
Effect of influenza vaccination on immune-related adverse events in patients receiving single-agent immune checkpoint inhibitors for the treatment of cancer.
Authors: Vutukuri Naga Malleswari , Corcoran Calette , Comeau Jill , Stephenson Elizabeth , Beedupalli Kavitha , Shi Runhua
Published: June 2021

e18763

Background: Recent single-center, retrospective reviews have evaluated the effect of influenza vaccinations on the incidence and severity of immune-related adverse events (irAEs) in patients receiving immune checkpoint inhibitors (ICI). Methods and outcomes in these studies vary. The most common medication investigated was ipilimumab, an Anti-CTLA-4 monoclonal antibody. There is limited data evaluating the incidence of irAEs in those receiving the specific ICIs, program death-1 (PD-1) and program death ligand-1 (PD-L1) inhibitors. Methods: A retrospective chart review was conducted including patients 18 to 89 years old who received single-agent pembrolizumab, nivolumab, atezolizumab, or durvalumab at an academic medical center from August 2015 to August 2019. The primary objective was to evaluate the incidence of irAEs in those who received an influenza vaccine compared to those who did not. Electronic health records, and the Louisiana Immunization Network for Kids (LINKS), which now collects adult information, were utilized for data collection. Chi-square tests were used to evaluate all endpoints. Results: Of the 217 charts screened, 133 were included in this study Fifty-three patients were included in the influenza vaccination group and 80 patients in the group that did not receive influenza vaccinations. The median age in those who received an influenza vaccine and in those who did not were 61 years and 62 years, respectively. The most common cancer diagnoses were lung cancer and melanoma. Ninety-one percent of patients in the vaccination group versus 81% in the group who did not receive an influenza vaccine received either nivolumab or pembrolizumab (PD-1 inhibitors). There was no statistical difference in irAEs in those who received an influenza vaccine versus those who did not (30% versus 45%, p = 0.15). The only significant secondary outcome found was the rate of irAEs in patients receiving a PD-1 inhibitor versus a PD-L1 inhibitor regardless of vaccination (42.2% versus 11.1%, p = 0.03). The majority of irAEs were grade 1 or 2. Conclusions: Based on this study, receiving an influenza vaccine does not have an influence on the risk of irAEs in those receiving ICI, specifically PD-1 and PD-L1 inhibitors. These outcomes may have been affected by adherence issues with yearly influenza vaccinations, inaccurate vaccine records, and receiving vaccines out of state. The statistically significant secondary outcome may have been affected by the disproportionate number of patients who were receiving a PD-1 inhibitor in this study. Larger population studies are needed to validate these findings and identify both the risk and benefit of patients receiving their yearly influenza vaccine while receiving ICI.
The impact of COVID-19 pandemic on access to new patient cancer care as evaluated in the Integra Connect Database (ICD).
Authors: Gart Mike , Varughese Prateesh , Gordan Lucio N. , Heritage Trevor , Brown Greg , Botts Elizabeth , Keni Dakshesh , Blanc Simon , Scott Jeffrey A. , Smith Robert E.
Published: June 2021

e18792

Background: The Covid-19 pandemic has affected all aspects of life. Integra Connect sought to assess its impact on new visits for cancer care by querying its Electronic Medical Record and Claims database as a surrogate for understanding Covid’s impact on cancer care in the larger United States population. Methods: Using Real World Data (RWD) from over 1200 oncology providers in 14 large practice settings, comprising 250 plus care sites in the ICD, we measured new patient (Pt) and established Pt visits from 2018 through 2020. Centers for Medicare & Medicaid Services (CMS) codes for new and established Pt’s were applied to define cohorts. Disease states were defined using CMS Oncology Care Model (OCM) mapping to diagnosis codes. Because the ICD is heavily based in the Eastern US, we conducted a geographic analysis by segmenting providers by Northeast (NE) with 506 providers from NY, NJ, PA, and VA and Southeast (SE) with 578 providers from FL, GA, SC, and AL. We looked at visits across all tumor types and identified breast cancer (BC) and colorectal cancer (CC) as likely to be most affected by decreased screening, and multiple myeloma (MM) and advanced prostate cancer (APC) as likely to be vulnerable to delay in initiation of first treatment since treatment often trails diagnosis. Results: We found a decline in new patient volume (NPV) in ‘20 of -1% compared to ‘19; this compared to an anticipated increase of +7% based on growth in NPV in the ICD from ‘18 to ‘19. In the NE we saw NPV decrease in ‘20 by -7% vs. ‘19 but increase by +6% in the SE compared to ‘19. In comparing NPV ‘20 to ’19 and ’19 to ‘18, we saw a smaller increase for BC of +4% vs. +6% and for CC of +5% vs. +7%, respectively. Whereas in MM it was -7% vs. +3% and APC -6% vs. +8%. (See Table). Conclusions: Covid-19 has negatively impacted cancer care access. This RWD shows the number of both newly diagnosed Pts and those with initial oncologic intervention in established Pts, where symptoms traditionally have determined initiation of treatment, has declined year-over-year. The American Cancer Society projected new Pt cases to increase +2% in ‘20 to 1.806 million ( ACS, Cancer Facts and Figures 2020), whereas in the ICD, that figure was projected +7% but resulted in -1%. This suggests a major expected reduction of new Pt cases in the US at large. The drop in cases during Covid-19 in our data was greater in the NE compared to the SE. In addition, the drop in the NE in our data was earlier and more prolonged than SE. While recovery occurred in both regions, after an initial overshoot following lockdowns, volumes plateaued at levels lower than pre-pandemic.[Table: see text]
Real-world trends in costs of next generation sequencing (NGS) testing in U.S. setting.
Authors: Desai Kaushal , Hooker Gillian , Gilbert Katri , Cropper Caiqian , Metcalf Rob , Kachroo Sumesh
Published: June 2021

e18824

Background: Recent advances in NGS testing have revolutionized the scope for personalized medicine. The goal of this study was to describe historic trends in the average allowed cost for NGS testing. Methods: This was a retrospective database study evaluating biomarker testing claims in patients undergoing tumor and/or germline sequencing tests between 2016-2019. Molecular testing claims data and marketplace data of tests currently sold in the U.S. were analyzed in the proprietary Concert Genetics Medical Claims Data Warehouse. Results: Analysis of data highlighted high variability in utilization rates as well as allowed amounts for NGS testing. The average allowed amounts for NGS Tests varied from $1269 to $2058 per test during the study period. Higher variability in billing codes and price was also observed when analysis was done for subgroups, which included region, age, gender and cancer type. Similar trends were also observed for panels containing NGS-derived tests such as Tumor Mutation Burden (TMB), an upcoming biomarker. Average allowed amounts for NGS tests that included TMB testing varied from $438 to $3700 per test. To gain a better perspective on evolution of coding, utilization and pricing trends, additional analyses were done in hereditary cancer, given longer availability of these tests in the US Market. For Hereditary cancers, the average allowed amounts varied from $1722 to $2249 per test during the study period. Greater consistency in price was observed in hereditary cancer. Utilization is also more consistent over time and price showed a gradual decreasing trend over time. Coding was also less variable per claim for hereditary cancer and showed a converging trend. Conclusions: Understanding and quantifying the trends in cost of NGS testing for novel biomarkers is critical to predict evolution of testing costs and provide insights essential for minimizing barriers to availability and affordability of these tests. NGS testing can play an important role in improving quality of care and making the clinical decision-making process more efficient. Currently, coverage and reimbursement of NGS tests is one of the key policy challenges that needs to be addressed. Hence, development and adoption of policies is needed to ensure efficient integration of NGS testing in the US health care system.
Comprehensive genomic profiling in advanced/metastatic colorectal cancer: Number needed to test and budget impact of expanded first-line use.
Authors: Proudman David , DeVito Nicholas C. , Belinson Suzanne , Alsaraf Allo Mina , Morris Eric D. , Signorovitch James , Patel Anuj K.
Published: June 2021

e18834

Background: A growing number of genomic alterations inform treatment of advanced/metastatic colorectal cancer (mCRC). However, use of comprehensive genomic profiling (CGP) is limited in the first-line (1L) setting. Based on the Tempus xT next-generation sequencing assay, we estimated the impact of expanded 1L CGP on the detection of currently actionable alterations in mCRC and associated diagnostic testing costs in a modeled US health plan setting. Methods: A decision analytic model was used to compare testing scenarios over a two-year time horizon: current 1L testing with a mix of CGP and non-CGP diagnostics vs. replacing 20% of usual testing with Tempus CGP. The incidence of 1L mCRC, current testing rates, prevalence of actionable alterations, and test sensitivity were drawn from a literature review and clinical expert input. Currently actionable alterations included KRAS, NRAS, RAF, BRAF, dMMR/MSI, NTRK, RET, EGFR, HER2, MET, PIK3CA and POLE1. Cost components included initial and repeat testing, physician-associated and administrative costs. Opportunities for genomically-informed therapy or clinical trials were assessed under each testing scenario. A forward looking scenario, with additional informative alterations, was also explored. Results: In a hypothetical five million-member health plan, with 50% Medicare and 50% commercial insurance, 1,112 incident cases of mCRC (22 per 100,000 patients) are expected in a typical year. Among these cases, 566 (51%) are expected to undergo 1L molecular diagnostic testing, with 55 projected to undergo repeat testing upon progression within the next year. Based on current real-world testing rates, there are an expected 521 missed opportunities for genomically informed treatment (47% of the incident mCRC population), with 442 missed due to lack of testing and 79 due to testing without CGP. Replacing 20% of usual testing with Tempus CGP in the modeled scenario was associated with up to a $0.003 per member per month (PMPM) testing cost increase and an additional 15.5 patients with an opportunity for genomically-informed care (12.7 patients for guideline-recommended treatment and 2.8 for a clinical trial). The number needed to test (NNT) with Tempus CGP versus the usual mix of testing was 7.8 1L patients to identify one actionable alteration. Scenario analyses projecting the advent of additional genomically-informed treatments and clinical trials resulted in smaller numbers needed to test. Conclusions: Replacing 20% of usual testing with Tempus CGP is associated with a small incremental testing cost but can identify actionable alterations for a meaningful number of patients. For every eight 1L mCRC patients tested with Tempus CGP rather than the usual mix of molecular testing, one additional patient is expected to be identified as having currently actionable alterations.