bluuebunny/crossref_metadata_2025 huggingface dataset:
Effects of housing quality, housing stability, and contemporary mortgage lending bias on breast cancer stage at diagnosis among older women in the United States.
Authors: Rademacher Nicole , Zhou Yuhong M. , McGinley Emily L. , Laud Purushottam W. , Yen Tina W.F. , Beltran Ponce Sara , Nattinger Ann B. , Beyer Kirsten M. M.
Published: June 2022

e18557

Background: The purpose of this study was to examine the association between measures of housing quality, stability, and access on breast cancer stage at diagnosis among older women living in the United States. Methods: This study included 67,588 women aged 66-90 with data from the SEER-Medicare linked database. The primary outcome was breast cancer stage at diagnosis. Multinomial regression models were performed using a three-category outcome (stage 0, early-stage (I-II), late-stage (III-IV)). The key independent variables were median housing value, percentage living in the same house as the previous year, percentage owner occupied homes, and an index of contemporary mortgage lending bias (redlining). Results: In adjusted models, higher contemporary mortgage lending bias was significantly associated with later-stage diagnosis (RR = 1.10 1.02-1.20; RR = 1.31, 95% CI 1.16-1.49; RR = 1.41, 95% CI 1.24-1.60 for Least to High, respectively). Median housing value was inversely associated with later-stage diagnosis, but to a lesser degree than mortgage lending bias (RR = 0.88, 95%CI 0.80-0.96; RR = 0.77, 95% CI 0.68-0.88 for second and third tertiles, respectively). Owner occupancy and tenure were not significantly associated with late-stage diagnosis in adjusted models. Conclusions: Contemporary mortgage lending bias demonstrated a significant dose-response relationship with later stage at diagnosis of breast cancer in this cohort of elderly women. Policy interventions aimed at reducing the effects of redlining with the goal of decreasing late-stage breast cancer diagnosis to improve prognosis should be considered. Table. Relative risk of late stage breast cancer diagnosis based on measures of housing quality and stability, as well as redlining. Risk is relative to the base outcome, stage 0. Values for the first tertile of housing quality and stability as well as the “least” category for redlining are not shown in this table as they are the base outcome which the other values are compared to. Standard error was adjusted for MSA clustering effects in all models.[Table: see text]
Discovering disparities in diffuse large B-cell lymphoma (DLBCL): A hispanic population comparison between Florida and Texas.
Authors: Orellana Ysaith , Velez-Mejia Carolina , Ananth Snegha , Liu Qianqian , Michalek Joel , Diaz Duque Adolfo Enrique
Published: June 2022

e18562

Background: DLBCL is the most common type of non-Hodgkin lymphoma worldwide. Hispanics (H) in Texas (TX) and Florida (FL) represent 39.7% and 26.4% of the population of each state, respectively. This is the first population-based two statewide study looking at demographics, treatment patterns, and survival outcomes, in years (y), comparing those two Hispanic enriched states. We hope that identifying differences among state populations and provide interventions for the future. Methods: A retrospective cohort study of patients diagnosed with DLBCL between 2006-2017 using the Texas Cancer Registry and the Florida Cancer Data System. Standard demographic, socioeconomic, clinical, survival variables were reviewed. The Fisher's Exact tests and Chi-Square tests were assessed for categorical outcomes by ethnicity; Survival distributions were depicted using Kaplan-Meier curves. Results: From 2006 to 2017, 16,529 patients from TX and 18,641 patients from FL were diagnosed with DLBCL. At 20-100% poverty index, H in FL and TX had higher poverty percentages than non-Hispanic (NH), with TX H having the higher percentage (55%) compared to FL H (33%). Median survival time in FL was 5.4y for H compared to TX 3.7y H. Overall survival probability at 10y did show a statistically significant difference for H vs. NH when comparing FL (p < 0.001) and TX (p = 0.95). Conclusions: In patients with DLBCL, two statistically significant differences were survival probability at 10y and median survival time comparing H populations in FL and TX. While most demographic variables were homogenous, one difference was observed; poverty index at 20-100% was higher for H in TX than FL. Higher poverty rates in TX to FL among the H population may explain why the median survival time and probability are higher and can provide further opportunities for structured interventions.[Table: see text] [Table: see text]
Impact of socioeconomic and medical factors on racial disparities in time to treatment initiation and survival in breast cancer patients.
Authors: Basali Diana , Zabor Emily Craig , Lindberg Jacob , Peterre Brittany , Tomer Jacqulyn , Moore Halle C. F.
Published: June 2022

e18583

Background: Delays in breast cancer treatment have been associated with adverse outcomes. Previously, we observed longer time to treatment initiation (TTT) and inferior overall survival (OS) among Black versus White patients with breast cancer. We aim to examine the extent to which social, and medical factors influence these outcomes. Methods: Women over age 18 who identified as Black or White and diagnosed with stage I-IV breast cancer between 2015 and 2020 at the Cleveland Clinic were identified. Variables included were age, race, type of insurance, receptor status, hypertension, type 2 diabetes, CKD stage 3/4, obesity, and tobacco use. Characteristics according to race were analyzed by the Chi-squared test for categorical variables and the Wilcoxon rank sum test for continuous variables. The primary outcomes were TTT and OS. TTT was analyzed using multivariable linear regression and OS was analyzed using multivariable Cox regression. Results: Patient characteristics by race are shown in Table. Black patients were older, more frequently had triple-negative (TN) receptor status and comorbidities, and less frequently had private insurance. On multivariable linear regression Black race and increased age were associated with longer TTT (both p < 0.001) whereas TN vs HR+/HER2- was associated with shorter TTT (p = 0.007). On multivariable Cox regression Black race (HR 1.39; p = 0.009), increased age (HR 1.02; p < 0.001), Medicaid/Medicare (HR 1.91) or other insurance (HR 1.68) vs private insurance (p < 0.001), type 2 diabetes (HR 1.55; p = 0.001), CKD stage 3/4 (HR 1.93; p < 0.001), and HER2+ (HR 1.44) or TN (HR 2.41) vs HR+/HER2- (p < 0.001) were associated with increased hazard of death .Obesity (HR 0.73; p <0.025) was associated with decreased hazard of death. Conclusions: Our study highlights racial disparities in breast cancer outcomes including the potential contribution of medical and socioeconomic factors. Further investigation will identify the relative contribution of patient related factors on TTT and OS and explore their impact on breast cancer recurrence. It is critically important for providers to attempt to understand factors contributing to disparities in order to implement interventions that can attempt to limit them.[Table: see text]
Ensuring equal access: Language as exclusion criteria among clinical trials in gynecologic oncology.
Authors: Lee Sarah S. , Dinicu Andreea , Arthurs Likolani , Seda Danielle , Pothuri Bhavana , Lightfoot Michelle DS
Published: June 2022

e18587

Background: Enrolling a diverse patient population into clinical trials may help mitigate disparities and ensure generalizability of results. We aimed to assess clinical trial eligibility criteria that may adversely impact enrollment of underrepresented groups. Methods: We searched clinicaltrials.gov for gynecologic cancer studies between 1997 and 2021. Studies were excluded if they included non-gynecologic or multiple sites of disease; hereditary gynecologic cancer syndromes were included. The inclusion and exclusion criteria of each study were reviewed to determine if demographic factors were used for enrollment screening. Our outcome of interest was the characterization of inclusion and exclusion factors that may adversely impact enrollment of historically underrepresented groups. Data were analyzed using chi-square tests, logistic regression, and Cochrane-Armitage test of trends. Results: A total of 1614 studies were included; 902 (56%) were ovarian, 357 (22%) were cervical, and 355 (22%) were uterine cancer studies. The majority (86%, n = 1394) were therapeutic trials, 38% (n = 608) were phase 2, and 8% (n = 123) were phase 3. Ovarian cancer trials were most likely to be industry-sponsored (252, 28%), compared to only 12% of cervical and endometrial cancers (n = 44 each, p < 0.001). Overall, 190 gynecologic cancer studies (12%, n = 190) excluded patients based on language. Cervical cancer studies were the most likely to exclude patients based on language (n = 67, 19%), compared to endometrial cancer (n = 45, 13%) and ovarian cancer (n = 78, 9%, p < 0.001). Compared to investigator-initiated trials, industry-sponsored trials (adjusted OR [aOR] 0.07, 95% confidence interval [CI] 0.02-0.29) and organizational/government-sponsored trials (aOR 0.37, CI 0.21-0.66) were less likely to exclude based on language. Compared to drug/device trials, behavior/quality of life studies (aOR 31.63, CI 18.50-54.09) and prevention/diagnosis trials (aOR 5.14, 2.81-9.41) were more likely to exclude based on language. During the study period, the number of studies using language as exclusion criteria increased over time (p < 0.001). Conclusions: Over the last three decades, one in ten gynecologic cancer trials excluded patients based on language. Studies focused on cervical cancer, investigator-initiated, and behavior/quality of life studies were most likely to exclude on the basis of language. Eliminating language as an exclusion criterion in clinical trial eligibility could improve understanding of the health-related quality of life among all patients with gynecologic cancer and help achieve equity in clinical trial enrollment.
Rapid adoption of immunotherapy in community health systems, associated with changing treatment guidelines.
Authors: Winzeler-Cotton Alissa , Subramanian Akila , Kane Kaitlyn , Zhang Chenan , Rioth Matthew J. , Berry Anna B. , Brown Thomas D.
Published: June 2022

e18610

Background: In the quickly evolving landscape of developmental therapeutics, uptake of new standards of care is a critical issue. Community health systems (CHS) provide > 50% of cancer care in the US. Rapidly changing immunotherapy (IO) guidelines provide a window into changing practice patterns. This analysis describes how IO use has evolved within CHS. Methods: Patients (pts) selected were ≥ 18 years, diagnosed with advanced or metastatic NSCLC 2015-2020, with 2+ EHR encounters before 4/1/2021. Two sub cohorts were analyzed. Cohort 1: pts receiving IO in any line of therapy (L); first use of IO by L was assessed over time. Cohort 2: pts receiving any first L (1L) therapy; 1L use of IO, alone or with chemotherapy (IO combo), was assessed over time. Results: In cohort 1, IO use in 1L grew from 24% of all IO pts in 2016 to 93% in 2020, increasing from 33% in Q4 2016 to 62% in Q1 2017. In cohort 2, 1L therapy shifted from 4% of all pts receiving IO in 1L in 2016 to 59% in 2020, increasing from 6% in Q4 2016 to 24% in Q1 2017. Within IO 1L pts, IO combo use grew from 29% to 68% in 2020, increasing from 35% in Q1 2018 to 53% in Q2 2018. Conclusions: We observed two rapid shifts in care patterns. First, 1L IO use grew rapidly from Q4 2016 to Q1 2017, following 1L IO approval (10/2016). Second, 1L IO use shifted rapidly toward IO combo use from Q1 2018 to Q2 2018, coinciding with pivotal trial results and FDA priority review (4/2018), but preceding label expansion (8/2018). Two RWD analyses from independent oncology practices observed less substantial shifts during similar periods of time. These results demonstrate that CHS can rapidly adjust to evolving clinical evidence and associated changes in standards of care.[Table: see text]
Applying Lean Kaizen to improve timely CT scan appointments for oncology patients in a safety-net hospital.
Authors: Ho Brian , Epistola Raisa , Leong Sally , Ali Sana , Germono Rachel , Ranada Denise , Kummerfeldt Christopher , Patel Vrunda , Berbano Annette , Berbano Annette , Kannampuzha Minni , Celles Larissa , Pena Adriana , Balderas Leslie , Ellis Sharon , Martinez Abarca Brenda , Gutierrez Griselda , Shim John , Lee Jennifer Minkyoung , Yeh James Jen-Chi
Published: June 2022

e18627

Background: Timely radiographic studies are essential to oncology care. At our institution, a safety net hospital in a large metropolitan area, baseline assessment determined that the overwhelming majority of outpatient computed tomographic (CT) scans for oncology patients were overdue for scheduling. We applied the Lean Kaizen quality improvement model to improve on-time scheduling of CT scans in our hematology-oncology clinic. Lean Kaizen is centered around eliminating waste, improving productivity, and maintaining sustained improvement through collaborative efforts from multiple departments to analyze system workflow inefficiencies in a stepwise fashion. Methods: In collaboration with our Kaizen Promotion Office, we conducted a series of interdisciplinary meetings including staff from radiology, oncology, scheduling, and administration. All aspects of the scheduling workflow were critically reviewed and barriers to scheduling were identified using an Ishikawa root-cause diagram and the Kaizen principle of gemba (“go and see the work”). A new workflow was developed in which clinic staff scheduled patients for CT scans prior to clinic discharge. To implement the new workflow, we employed the principles of shojinka (“create flow”) and nagara (“eliminate waste”). We developed and distributed workflow guides, conducted simulation events, and provided one-on-one training to ensure a successful rollout. Three months after our initial meeting, the new workflow was launched. The workflow was refined based on feedback from daily pre-clinic team meetings. Results: Preliminary data were gathered approximately 3 weeks following implementation of our new workflow. Since our intervention, the percentage of CT scans overdue for scheduling decreased from 87% (65 of 75 CT scans) to 17% (9 of 53 CT scans). Conclusions: Our study showed that the Lean Kaizen QI model was successful in improving the rate of oncology patients scheduled for CT scans in a timely fashion. This study demonstrated the importance of interdepartmental collaboration and continuous monitoring for improvement. Given the success of this project, this workflow will be expanded to other services within our institution following the Kaizen principle of yokoten (“sharing knowledge”).
Malnutrition screening in cancer patients on chemotherapy.
Authors: Gudipally Sindusha R , Tayyem Ala'a , Venkatesan Rohit , Willis Maurice
Published: June 2022

e18640

Background: Malnutrition occurs in 40-80% of cancer patients and has great impact on quality of life and treatment outcomes. The essential elements of malnutrition for patients with cancer are early identification of patients at greatest risk, nutrition assessment to determine the level of deficit, and appropriate nutrition intervention. Currently we don’t have a standard tool to identify patients who are malnourished on chemotherapy and nutrition referrals were placed based on provider's subjective assessment. Methods: From March 2020 to August 2020, 41 patients on chemotherapy were reviewed, of which 29% were referred to nutrition. To assess the patients at risk early on, a validated Malnutrition Screening Tool(MST) was implemented from September 2020 to February 2021 in the Medical Oncology fellow's clinic notes. Although the original MST was implemented mostly for inpatient elderly patient population, the idea of this study was to apply this tool to assess acute nutrition issues for patients receiving cancer therapy in the outpatient setting. This tool used two simple questions, Have you lost weight recently without trying? (If lost 1-6lbs = 1points, 7-13lbs = 2points and > 13 = 3points), and have you been eating poorly because of decreased appetite? (Yes = 1 point; No = 0 points).A smart phrase which included these questions was used in the notes and if patients scored greater than or equal to 2, were considered malnourished and qualified for nutrition referrals. Other variables included were age, sex, and type of cancer. Results: Of the 41 charts that implemented MST, 21 patients(49%) screened positive and all 100% of them were referred to nutrition. After implementing this tool, there was a 20% increase in identifying and referring the malnourished patients who were receiving cancer therapy during the clinic visits. Median age for patients who screened positive was 60 years, more males screened positive than females(60% vs 40%). Gastro-intestinal malignancies and head and neck cancers were the highest who screened positive in the MST group(14% each out of the 49%). Conclusions: Malnutrition is a major cause of morbidity and mortality in patients with any stage cancer and especially worse in advanced stage cancer. By simply using this two-step questionnaire, we were able to identify 20% more patients who were at risk for malnutrition. Older age, Males and Gastro-intestinal and Head and Neck cancer patients are more at risk and needs to be more closely screened. The study concludes that using a simple tool in the outpatient clinics can assess patient's at risk and provide early qualitative support throughout course of therapy.
Patient-reported distress at a cancer center during the COVID-19 pandemic.
Authors: Shah Manan P , Rosenthal Sarah , Roy Mohana , Khaki Ali Raza , Hernandez-Boussard Tina , Ramchandran Kavitha
Published: June 2022

e18644

Background: Assessments of health-related quality of life (HRQOL) are conducted by health systems to analyze and improve patient-centered care. Numerous studies have shown that the COVID-19 pandemic poses unique stressors for patients with cancer. However, the impact of the pandemic on HRQOL in patients with cancer is unknown. This study investigates change in self-reported global health scores in patients with cancer before and during the COVID-19 pandemic. Methods: In this single-institution retrospective cohort study, patients who completed the Patient-Reported Outcomes Measurement Information System (PROMIS) at a comprehensive cancer center before and during the COVID-19 pandemic were identified. Surveys were analyzed to assess change in the PROMIS global mental health (GMH) and global physical health (GPH) scores at different time periods (pre-COVID: 3/1/5/2019-3/15/2020, surge1: 6/17/2020-9/7/2020, valley1: 9/8/2020-11/16/2020, surge2: 11/17/2020-3/2/2021, and valley2: 3/3/2021-6/15/2021). Results: A total of 29,983 surveys among 7,209 patients were included in the study. Mean GMH scores for patients before the COVID-19 pandemic (50.57) were similar to that during various periods during the pandemic: surge1 (48.82), valley1 (48.93), surge2 (48.68), valley2 (49.19). Mean GPH score was significantly higher pre-COVID (42.46) than during surge1 (36.88), valley1 (36.90), surge2 (37.33) and valley2 (37.14) (Table). During the pandemic, mean GMH (49.00) and GPH (37.37) scores obtained through in-person were similar to mean GMH (48.53) and GPH (36.94) scores obtained through telehealth. Conclusions: In this single institution study, patients with cancer reported stable mental health and deteriorating physical health during the COVID-19 pandemic as indicated by the PROMIS survey. Modality of the survey (in-person versus telehealth) did not affect scores. [Table: see text]
Smoking cessation counseling in patients with active malignancy.
Authors: Avigan Zachary M , Boussi Leora S , Mukamal Kenneth J.
Published: June 2022

e18655

Background: Tobacco smoking increases risk of multiple malignancies, most notably lung cancer, and is a leading cause of premature morbidity and mortality. Tobacco cessation counseling is effective in assisting patients to quit smoking and improving health outcomes, but over one third of smokers report receiving no counseling by healthcare providers. In this study, we investigated rates of tobacco cessation education at ambulatory visits among patients with active malignancy. Methods: We identified ambulatory visits among current smokers with a diagnosis of malignancy using the National Ambulatory Medical Care Survey (NAMCS), a nationally representative sample of ambulatory visits in the US, from 2008 to 2018. We first determined weighted rates of documented smoking cessation counseling. We next evaluated sociodemographic characteristics, provider and visit type, and chronic conditions as determinants of counseling in this population using logistic regression. Results: We identified 2,437 total visits during the study period, representing an estimated 48.9 million such visits in the US. In this cohort, smoking cessation counseling was provided at 14.2% (95% confidence interval [CI] 12.1-16.7%) of visits. Patients were significantly less likely to receive counseling with older age (adjusted OR 0.97 per year of age; 95% CI 0.96-0.98) and less likely in surgical (OR 0.49; 95% CI 0.32-0.75) or medical subspecialties (OR 0.60; 95% CI 0.36-0.99) compared to primary care visits. Sex, race, year of visit, insurance type, and previous visit to the same provider were not significantly related to receipt of counseling. Patients with concomitant COPD were substantially more likely to receive counseling (OR 3.50; 95% CI 2.21-5.53), with 28.4% (95% CI 21.5-36.4%) of such visits including tobacco cessation education. Conclusions: Tobacco smoking is a modifiable risk factor associated with multiple malignancies and substantial non-neoplastic morbidity and mortality. Nonetheless, smokers with current malignancy receive smoking cessation counseling at only about one in seven outpatient visits, with lower frequency with advanced age and at subspecialty visits. As more effective treatments improve survival for cancer patients, further work is needed to improve tobacco cessation efforts that could improve survival and quality of life.[Table: see text]
Insomnia in cancer patients.
Authors: Mensah-Osman Edith J.
Published: June 2022

e18657

Background: As new treatments extend patient survival, the quality of their lives (QoL) grows in importance. QoL may differentiate alternative treatments, and QoL assessment has become a standard component of treatment evaluations. Sleep is a key component of QoL. Insomnia can worsen pain, fatigue, depression and cognitive impairments in cancer patients. Inappropriate treatments for insomnia can further worsen these and interact with chemotherapy medications. Recognizing this, in 2019 the American Society of Clinical Oncology identified Insomnia as a key patient-reported outcome performance measure (PRO-PM) for the National Quality Forum to consider. Methods: Through review of the scientific literature the project identified specific cancers and their treatments where treating Insomnia can have a significant impact on patient QoL. PubMed, Pharmapendium, and Science Direct databases were used. Search terms included “insomnia demographics, epidemiology of insomnia in cancer, insomnia in tumor types, cancer insomnia, insomnia associated hormonal treatment, insomnia in patients awaiting cancer diagnosis; insomnia in cancer care-givers, insomnia in cancer survivors, cancers treated with corticosteriods”. Original research articles in English that used human subjects between January 1, 1993 and January 31, 2020 were included. Results: Insomnia is associated with specific tumor types: brain tumors, breast cancer, gastrointestinal cancer, leukemia, lymphoma, multiple myelomaand terminal cancer. Autoimmune causes of insomnia in paraneoplastic syndromes. Insomnia is prevalent in oncology patients being evaluated, awaiting diagnosis and treatment. Age and gender are demographic factors associated with oncology insomnia. Insomnia is associated with specific antineoplastic agents. Corticosteroid use is associated with insomnia, before, during and after cancer treatment. Insomnia in cancer survivors starts during their treatment and may persist for years. Conclusions: Specific demographics, cancers and treatments are associated with insomnia. Insomnia often occurs in patients undergoing evaluations for cancer. Insomnia is often not recognized and not treated in oncology patients. Insomnia that is not addressed during cancer treatment often persists in cancer survivors. There is the need to investigate whether treating insomnia early in cancer patients during their course of treatment can reduce symptoms such as fatigue and improve their QOL.
Does perceived stigma or shame affect stage of presentation in Iraqi Kurdish women diagnosed with breast cancer?
Authors: Chagpar Anees B. , Qader Suzann , Baqri Mehdi , Khoshnood Kaveh , Ahmed Hamdia
Published: June 2022

e18680

Background: The concept of breast cancer related stigma and its effect on stage at presentation has been understudied in the Iraqi context. We sought to determine the extent to which perceived stigma or shame affected stage at presentation in Iraqi women diagnosed with breast cancer. Methods: A survey was conducted of 100 cancer patients seen at the Breast Center in Erbil, Kurdistan. Patients were asked subjectively whether they felt a sense of shame with the diagnosis of breast cancer and whether this delayed them in being diagnosed. In addition, a breast cancer stigma scale (BCSS) that has been validated in Arab women was fielded, and objective data regarding stage at presentation was collected. The BCSS has a possible score of 12-60, with lower scores indicating higher levels of stigma. Results: : Of the 100 women surveyed; only 7% were diagnosed at stage 1. While only 6% of women stated that they felt shame when diagnosed with breast cancer, 48% felt that some sense of shame delayed them getting diagnosed. The median BCSS score was 43 (range; 16-60). While marital status (p = 0.360), rural vs. urban setting (p = 0.380), working outside the home (p = 0.669), educational level (p = 0.203) and monthly household income (p = 0.642) were not associated with whether women presented with stage 1 breast cancer at diagnosis, there was a trend towards higher BCSS among those with stage 1 disease (p = 0.076). Further, patients who reported that feelings of shame either “somewhat” or “very much” delayed them being diagnosed were more likely to present with higher stage disease than those who felt this did “not at all” cause a delay (100% vs. 87.8%, p = 0.016). Indeed, all six patients diagnosed with stage 1 disease reported that feelings of shame did “not at all” delay them from being diagnosed. Conclusions: Most patients in the Iraqi Kurdistan context are diagnosed with later stage disease. Feelings of stigma or shame may contribute to later diagnosis in this context.
Clinical effectiveness of SARS-CoV-2 vaccines and booster doses in patients with cancer: An analysis from the European OnCovid registry.
Authors: Pinato David J. James , Aguilar-Company Juan , Ferrante Daniela , Hanbury Georgina Helen , Bower Mark , Salazar Ramon , Lambertini Matteo , Pedrazzoli Paolo , Lee Alvin Jun Xing , Sinclair Alasdair , Townsed Sarah , Plaja Andrea , Tucci Marco , Sita-Lumsden Ailsa , Mukherjee Uma , Mazzoni Francesca , Aujayeb Avinash , Gennari Alessandra , Tabernero Josep , Cortellini Alessio
Published: June 2022

e18725

Background: Immunogenicity and safety of SARS-CoV-2 vaccines have been widely investigated in patients (pts) with cancer. However, their effectiveness against Coronavirus disease 2019 (COVID-19) and the additional protective effect of a booster dose in this population are yet to be defined. Methods: Using OnCovid study data (NCT04393974), a European registry enrolling consecutive pts with cancer and COVID-19, we evaluated morbidity and 14 days case fatality rates (CFR14) from COVID-19 in pts who were unvaccinated, vaccinated (either partially/full vaccinated but not boosted) and those who had received a third dose. Analyses were restricted to pts diagnosed between 17/11/2021 (first breakthrough infection in a boosted pt) and the 31/01/2022. Pts with unknown vaccination status were excluded. Results: By the data lock of 22/02/2022, out of 3820 consecutive pts from 36 institutions, 415 pts from 3 countries (UK, Spain, Italy) were eligible for analysis. Among them, 51 (12.3%) were unvaccinated, 178 (42.9%) were vaccinated and 186 (44.8%) were boosted. Among vaccinated pts, 26 (14.6%) were partially vaccinated (1 dose). Pts with haematological malignancies had more likely received a booster dose prior to infection (25.4% vs 13.6% and 11.8%, p = 0.02). We found no other associations between vaccination status and pts’ characteristics including sex, age, comorbidities, smoking history, tumour stage, tumour status and receipt of systemic anticancer therapy. Compared to unvaccinated pts, boosted and vaccinated pts achieved improved CFR14 (6.8% and 7.0% vs 22.4%, p = 0.01), COVID-19-related hospitalization rates (26.1% and 20.6% vs 41.2%, p = 0.01) and COVID-19-related complications rates (14.5% and 15.7% vs 31.4%). Using multivariable Inverse Probability of Treatment Weighting (IPTW) models adjusted for sex, comorbidities, tumour status and country of origin we confirmed that boosted (OR 0.21, 95%CI: 0.05-0.89) and vaccinated pts (OR 0.19, 95%CI: 0.04-0.81) achieved improved CFR14 compared to unvaccinated pts, whilst a significantly reduced risk of COVID-19 complications (OR 0.26, 95%CI: 0.07-0.93) was reported for vaccinated pts only. Conclusions: SARS-CoV-2 vaccines protect from COVID-19 morbidity and mortality in pts with cancer. Accounting for the enrichment of haematologic pts in the boosted group, the observation of comparable mortality outcomes between boosted and vaccinated pts is reassuring and suggests boosting to be associated with reduced mortality in more vulnerable subjects, despite evidence of adverse features in this group.
Real-world biomarker testing trends in metastatic non-small cell lung cancer (NSCLC).
Authors: Clinton Natasha , Patel Manish R. , Ayars Michael
Published: June 2022

e18728

Background: NSCLC is now recognized as not one disease, but many—differentiated by an increasing number of molecular targets. About 50% of patients with advanced nonsquamous NSCLC have a targetable driver mutation. We retrospectively assessed biomarker testing trends in a large community oncology practice to identify evolving real-world testing rates and patterns in the areas of methodology, specimen types, and vendors. Methods: Natural-language processing queries were used to extract data from biomarker testing reports of patients diagnosed with stage IV NSCLC in 2015-2019. Tests were included if done within 1 year of diagnosis and were classified as NGS panels (20+ genes) or targeted single-gene tests. Results: Records of 587 patients were included. Over the 5-year study window, testing rates increased for all 6 mutations analyzed (Table). In 2015, only ALK, ROS1, and EGFR were profiled in our data (n = 20 patients), all using targeted single-gene tests. The use of multigene panels increased steadily over time, constituting the majority by 2019. MET, RET, and NTRK were tested almost exclusively using NGS panels (data beginning in 2016). Tissue-only specimens were used for 93.8% of patients diagnosed in 2015, while tissue plus blood were used in 6.3%. Blood-only samples began appearing in our data in 2016, making up 7% of patients. By 2019, the use of blood tests had increased substantially, to 47% of patients, although tissue-only remained the most common type (54%). While blood testing has become more popular, it is often still performed with tissue tests. The primary testing methods used in 2015-2017 were FISH for ALK and ROS1; NGS for MET, NTRK, and RET; and Sanger or NGS for EGFR. By 2018, NGS had become the predominant test method across all 6 biomarkers. During 2015-2016, several vendors were used for testing, with a very segmented market for ALK and EGFR tests. By 2019, the market had aligned to a few key vendors for the majority of tests. In 2016, the top 5 vendors did 76% of 180 total tests, which increased to 93% of 1880 tests in 2019. Almost all blood testing in our data was performed by a single vendor. Conclusions: Testing rates for ALK, ROS1, and EGFR were more consistent than those for MET, RET, and NTRK throughout the study window, possibly because of earlier availability of tests and treatments for these biomarkers. NGS was more available by the time MET, RET, and NTRK became established as actionable biomarkers, explaining the earlier use of panels. A limitation is that nearly 75% of the data are from the final 2 years. These results, however, represent notable testing trends from a large practice and illustrate the expanding application of molecular testing in community oncology.[Table: see text]
Outpatient cancer rehabilitation services for gynecologic cancer survivors: Who participates, and do they benefit?
Authors: Pergolotti Mackenzi , Wood Kelley C , Bertram Jessica , Kendig Tiffany , Hidde Mary , Leiser Aliza L. , Buckley De Meritens Alexandre
Published: June 2022

e18793

Background: Women with gynecologic cancers are likely to experience acute, late, or lasting functional impairments that impact ability to complete activities of daily living and quality of life. While cancer rehabilitation interventions (physical or occupational therapy, PT/OT) treat functional impairment, the use, impact, and acceptability of these services in community-based settings is unknown. We describe outpatient PT/OT services used by gynecologic cancer survivors and evaluate the impact and acceptability of these services using patient-reported outcome measures (PROM). Methods: This retrospective study included women with history of gynecologic cancer (via ICD-10 code) who: (1) received community-based outpatient cancer PT/OT services provided by a single institution in 5 geographic regions of the United States in 2019, and (2) completed a PROM at evaluation and discharge. Data was extracted from PT/OT medical charts. We calculated descriptive statistics for all available patient and rehabilitation characteristics (including age, cancer type, complexity-level of rehabilitation, interventions provided and number of visits). To evaluate pre-post rehabilitation change for each PROM, we used paired samples t-tests, then calculated pre-post effect size (Hedge’s g) and the proportion who achieved the minimal detectable change (MDC). We calculated median Net Promotor Score (NPS, 0-10) to determine acceptability. Results: Women who received rehabilitation (N = 84) were 64.63 ± 11.04 (range = 40.82 – 90.82) years old with predominant diagnoses of ovarian (n = 35, 41.7%) or endometrial (n = 27, 32.1%) cancer. Most attended PT (vs. OT) and completed 13 sessions ( IQR= 8.0 – 19.0). Seventeen different PROM were used. From pre- to post- rehabilitation, a significant improvement was seen in four PROM: Lower Extremity Functional Scale (LEFS; n= 20, M∆ = 12.88 ± 12.31, t(19) = 4.68, p = .00), Modified Fatigue Impact Scale (MFIS; n= 14, M∆ = 6.55 ± 9.69, t(13) = 2.53, p = .03), Patient-Specific Functional Scale (PSFS; n= 14, M∆ = 2.93 ± 2.31, t(13) = 4.72, p = .00), and Lymphedema Life Impact Scale (LLIS; n= 12, M∆ = 20.50 ± 20.61, t(11) = 3.45, p = .01). A large pre-post effect size (g ≥ 0.80) was observed for three PROM (17.6%), including: The PSFS ( n= 14, g = 1.47), LLIS, ( n= 12, g = 1.18), and Activities-specific Balance Confidence (ABC6; n= 3, g = 1.77). Overall, 54.8% (n = 46) patients achieved the PROM MDC. Median acceptability was 10.0 out of 10.0 ( n= 64, IQR = 9.75 – 10.0). Conclusions: For women with gynecologic cancers and functional impairment, cancer rehabilitation improved patient-reported function and was highly acceptable. Future research is needed to understand diagnosis-specific considerations and to optimize timing of rehabilitation.
Treatment patterns and outcomes in resectable early stage NSCLC: Interim analysis of a global real-world study.
Authors: Lin Steven H. , Ahn Myung-Ju , Nagar Saurabh P. , Affi Raafet , Agulnik Jason , Shih Jin-Yuan , Hochmair Maximilian J. , Tufman Amanda , Debieuvre Didier , Jimenez Maria , Davis Keith , Kahangire Doreen A. , Servidio Leslie Ann , Veluswamy Rajwanth
Published: June 2022

e18803

Background: Complete surgical resection is the preferred treatment for early stage NSCLC, with adjuvant chemotherapy as the standard of care in resected stage II/III and select stage IB NSCLC. Osimertinib, an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), is approved as adjuvant therapy in patients (pts) with resected stage IB–IIIA EGFR mutation-positive (EGFRm) NSCLC following results from the Phase III ADAURA trial. Understanding real-world clinical outcomes in early stage NSCLC, including EGFRm prevalence, will help inform unmet needs and further development of new treatment strategies in this population. We report interim results from a global non-interventional retrospective study of pts with resectable NSCLC using clinical data from medical records. Methods: Eligible pts (aged ≥18 yrs) had completely resected stage IA–IIIA NSCLC diagnosed between Jan 1, 2014 and Dec 31, 2017 with EGFR test results available and were followed to at least Dec 31, 2020. Primary endpoints included EGFRm prevalence, treatment patterns, and overall survival (OS); disease-free survival (DFS) was an exploratory endpoint estimated by Kaplan-Meier at predefined landmark timepoints. Results: Of 463 pts from 6 countries (31% from Taiwan, 21% Canada, 17% US, 13% Austria, 10% South Korea, 9% France), median age was 66 yrs (range: 33–86); 172 pts (37%) had stage IA NSCLC at initial diagnosis and 291 (63%) had stage IB–IIIA (22% IB, 13% IIA, 10% IIB, 18% IIIA). 213/463 pts (46%) were EGFRm (43% stage IA, 61% IB, 43% IIA, 26% IIB, 47% IIIA), of who 46% were from Taiwan, 21% South Korea, 14% Austria, 8% Canada, 7% US, and 4% France. In pts with EGFRm vs EGFR wild-type (wt) NSCLC, 84/213 (39%) and 83/250 (33%), respectively, received (neo)adjuvant therapy, of who 156/167 pts (93%) had stage IB–IIIA NSCLC. 106/156 pts (68%) had disease recurrence or death from time of surgery; recurrence rates were similar in pts with EGFRm vs EGFRwt NSCLC, though median DFS was longer in the EGFRm group (Table). Recurrence rates were high in both EGFRm and EGFTwt groups, with landmark DFS probability of 72% vs 77% at 12 mo and 29% vs 32% at 60 mo, respectively. Conclusions: In this real-world global study of surgically resected stage IA–IIIA NSCLC in pts who received an EGFR test, nearly half of the study cohort were EGFRm positive, of who 70% were treated in Taiwan/South Korea. The high rate of recurrence in pts with stage IB–IIIA NSCLC despite receiving (neo)adjuvant therapy reinforces the need for early diagnosis and EGFR testing to identify pts who might benefit from EGFR-targeted therapy, helping optimize clinical outcomes.[Table: see text]
Cost-effectiveness of mt-sDNA versus mailed FIT outreach for Medicare Advantage enrollees using the CRC-AIM microsimulation model.
Authors: Bhatt Jay , Chen Jing Voon , Vahdat Vahab , Fendrick A. , Lieberman David A. , Brooks Durado , Ozbay A. Burak , Karlitz Jordan J.
Published: June 2022

e18827

Background: Despite proven effectiveness in reducing colorectal cancer (CRC) cases, screening for CRC remains underutilized, including those enrolled in Medicare Advantage. A mailed fecal immunochemical test (FIT) outreach program may increase CRC screening adherence. This study examined the cost-effectiveness of stool-based tests (FIT and multi-target stool DNA [mt-sDNA]), with FIT offered via a mailed outreach program, in a Medicare Advantage population. Methods: The validated CRC-AIM microsimulation model was used to simulate the costs and clinical outcomes of 2 million average-risk individuals, free of diagnosed CRC at age 40, who initiated CRC screening at age 65. Annual mailed FIT outreach and triennial mt-sDNA were assessed. Test sensitivity and specificity inputs were based on the 2021 United States Preventative Services Task Force modeling study. FIT outreach program cost ($25.92) and direct costs for screening tests, colonoscopies (COLs), complications, and CRC care were included. The model employed a lifetime horizon, 3% discount rates, and a Medicare Advantage perspective. The primary analysis used published real-world adherence rates for stool-based tests and follow-up COLs (FIT/COL: 29%/53%; mt-sDNA/COL: 69.8%/71.5%). Secondary analyses assumed 100% adherence for stool-based tests and/or follow-up COLs and 20% higher than primary analysis for FIT and the corresponding follow-up COLs. Results: In the primary analysis, mt-sDNA had the greatest life-years gained (LYG), incidence reduction (IR), and mortality reduction (MR) and was cost-effective at a willingness-to-pay threshold of $50,000/QALY compared to mailed FIT outreach (Table). This was true when 100% adherence was assumed for follow-up COL and when FIT had 20% higher adherence than the primary analysis. mt-sDNA had 64-129% greater LYG, 79-150% greater IR, and 68-146% greater MR than mailed FIT outreach. When assuming 100% adherence for both screening test and follow-up COL, mt-sDNA was dominated by mailed FIT outreach. Conclusions: Adherence to CRC screening modality and follow-up COL greatly impacts clinical and cost-effectiveness outcomes. Future analysis should consider evidence-based, health plan-specific data to accurately reflect outcomes that aid in payer decision making.[Table: see text]
Novel ways to fund cost-efficiency studies of expensive drugs: Efforts to maintain sustainable healthcare expenditure in the Netherlands.
Authors: Barjesteh van Waalwijk van Doorn-Khosrovani Sahar , van der Flier Silvia , van den Berg Denise
Published: June 2022

e18831

Background: The rising costs of new cancer drugs is a major burden for healthcare system. Healthcare providers and payers constantly look for solutions to reduce inefficient use of these drugs. Methods: These solutions may involve dose-rounding, dose-banding or vial-sharing to minimise the quantity of discarded pharmaceuticals. Alternative dosing strategies, such as tapering and/or increasing the dose-interval, shortening treatment duration, or boosting potency of the drugs may also be applied. Another approach is the development of predictive/monitoring biomarkers that can prevent mis-prescribing and overuse of therapies to patients who will not benefit from such a therapy. Provided that the therapeutic benefit is retained, a lower drug exposure evidently not only results in savings for the national healthcare budget but may also limit (off-target) toxicity, reduce hospitalisation and improve quality-of-life for patients. Results: Once compelling evidence of non-inferiority is available, the roll-out one of the strategies mentioned above is justified. Parties providing financial support for cost-efficiency initiatives are then often eager to support implementation and generate potential shared savings. However, when (additional) research is required to generate adequate evidence, fund raising and finding support can be quite challenging. In the Netherlands a dedicated national fund was recently established. Treatmeds, a foundation under Dutch law, is tasked to support cost-efficiency studies and to secure and manage (part of) the funding needed for those initiatives. Treatmeds is backed by Dutch healthcare insurers. Its governance provides for decisions based on the advice of an independent Scientific Advisory Board, an Intervention Board and a Financial Board. The Scientific Advisory Board aides with selecting studies for support on a pure scientific basis, the Intervention Board considers aspects as efficiency, the possibility of reimbursement under the Dutch compulsory healthcare insurance, the cost-benefit ratio of a study and the Financial Board ultimately decides on the financial aspects of supporting a study. Although Treatmeds only has just started its activities, it is expected that it can have a pivotal role in acceleration of efficiency tools in clinical practice. Conclusions: From our own experience we can state that a dedicated national fund supporting research on improved efficiency and quality of care can be of great value to accelerate study start-up and roll-out.
Projected impact of oncology biosimilar substitution from the perspective of provider risk in value-based oncology payment models.
Authors: Yang Jingyan , Chaudhry Basit Iqbal , Yue Andrew , Kelton John M. , Shelbaya Ahmed , Tran Lisa , Li Meng
Published: June 2022

e18836

Background: Oncology biosimilars may play an important role in managing risk for providers participating in value-based payment (VBP) models. The impact of biosimilar substitution on risk to providers remains unclear, as prior researchers have adopted a generic budget impact approach. Methods: We estimated the impact of biosimilar substitution on financial risk to providers in oncology VBPs by applying simulation approaches to model the quantitative methodology (e.g. episode framing, pricing, risk adjustment) of Medicare’s Oncology Care Model (OCM). Patient demographic and utilization data to fit the models were drawn from the Medicare Limited Data Set (LDS). Risk was defined as total cost of care (TCOC) relative to target price for an episode per the OCM methodology. Target prices were estimated using the most recently available OCM risk adjustment coefficients (2020). Biosimilars for six oncology agents were examined: bevacizumab, rituximab, trastuzumab, epoetin alfa, filgrastim, and pegfilgrastim (hereafter biosimilar investigation agents – BIAs). Episode TCOC was computed under the assumption of the use of reference BIAs and was then recomputed after biosimilar substitution. The study population consisted of 1620 episodes framed per the OCM methodology using the most recently available LDS data (2019-2020) that had use of a BIA. The impact to provider groups was estimated by computing the change in OCM risk bands (incentive payment earned/ neutral/ payment owed back to Medicare) associated with biosimilar substitution in panels of 100 randomly selected episodes from the study population over 10000 simulation runs. In our base model, we assumed that substitution for antineoplastics would occur only in treatment naïve patients and that substitution for supportive therapies would occur for all eligible patients. Treatment naïve status was assessed by examining longitudinal LDS data from 2016-2020 for beneficiaries from the study population. Results: Biosimilar substitution resulted in a mean reduction in cost relative to target of approximately $1,200 per eligible episode and reduced the proportion of practices that were above benchmark for eligible episodes by 33% and increased the number of practices below target for eligible episodes by 42%. Additional scenario analyses suggested that adoption strategy was a major determinant of potential impact. If assumptions of antineoplastic substitution requiring treatment naïve status were relaxed, costs savings relative to target would go from $1200 per eligible episode to $2700. Conclusions: Biosimilar substitution significantly reduces aggregate provider risk in OCM, representing a significant potential intervention for providers to mitigate risk in oncology VBPs both in terms of absolute costs saved relative to target and reduction in risk band relative to payer projections.