bluuebunny/crossref_metadata_2025 huggingface dataset:
The single center experience with the war-related Ukrainian patients with various cancer diagnoses treated in clinical trials between 2022-2024.
Authors: Gudewicz Izabela
Published: June 2024

e23040

Background: According to the WHO, 32% of active combat areas residents have been unable to obtain essential medicines since the beginning of the war in Ukraine. Clinical trials conducted in Poland have proven to assist oncological patients greatly. Many Ukrainian residents have Polish ancestors and are fluent in the Polish language. We decided to check whether the highest ethical standards of clinical trials make the ordinary intention to include a patient from Ukraine insufficient. Conducting a complete risk-benefit analysis allows choosing the best interest and safety of the clinical trial participant. Methods: The study aimed to evaluate the most frequent standards of oncological treatment of Ukrainian patients. We retrospectively verified the number of patients of Ukrainian nationality, in the age above 18 years treated at our center since the start of the invasion of Ukraine in February 2022 compared to the Polish patients. Results: Based on the National Health Fund data, Polish cancer centers in 2022 treated overall 994,767 patients including 8,000 patients from Ukraine. In the Pomeranian region, 3,815 patients received oncological therapies (data from the Central Statistical Office - of national). At our center in Gdansk between 01.01.2022 and 31.12.2023, therapy received 38,574 patients, including 34 Ukrainians. Clinical trials participants included 3,968 Polish and four Ukrainian patients (2 cases of malignant melanoma, one breast cancer, one lung cancer). Ukrainian patients represented 28.5%, 10%, and 8% of all patients included, respectively. Conclusions: Not prepared for the rapid influx of migrants Polish healthcare system encountered many problems like the language barrier, the need for a translator or approved documents by the Bioethics Committee, and the legal side of the informed consent form (ICF). At our center, all Ukrainian patients signed ICF in Polish. Regarding clinical trials participation, our study shows the unmet need of Ukrainian patients. The decision to include a patient has to be mutual (sponsor and investigator) and as soon as possible to ensure the required safety of each patient.
Clinical trial diversity (CTD) scorecards.
Authors: Horton Sara L. , Lewis Stanley , Olmstead Kay , Fassberg Elizabeth , Komelasky Chris , Fitzsimmons Bill
Published: June 2024

e23042

Background: To ensure safety and efficacy, oncology clinical trials must include adequate participation by age, gender, race, and ethnicity subgroups. In November 2020, the US FDA issued Guidance for Industry to increase clinical trial diversity in pivotal clinical trial programs. CARER Group developed the CTD Scorecard to evaluate demographic diversity in registration trial programs for new drugs. Methods: Based on publicly available data, CTD Scorecard assigns each drug a letter grade (A, B, C, D, F) for demographic subgroups-age, race and ethnicity, as well as an overall grade. Scoring includes percentage of subgroup enrolled relative to US population, number of subgroup receiving study drug, and prevalence of disease in each subgroup. Results: From January 2022 to December 2023, US FDA approved 26 new oncology drugs. In this period, 8 trial programs were rated Grade B, 18 received Grade C. Notably, elderly, and female participation was better represented with 23 (88%) and 19 (90%) with Grade A or B respectively. Two trial programs each received Grade C for these subgroups. Asian representation was high, with 54% of programs scoring Grades A or B. Only one drug received Grade D for this demographic and no programs received Graded F. In contrast, Black and Hispanic populations showed significant underrepresentation. Fourteen (54%) of trial programs for Black and thirteen (50%) for Hispanic populations received Grades D or F. Notably, 20 (77% ) of trial programs had ≤10 Black participants receive study drug, with 6 programs having no Black participants receive study drug. Similarly, 14 (54%) of trial programs included ≤ 10 Hispanic participants receiving study drug, and 3 (12%) programs with no Hispanics receiving study drug. During this time, FDA issued Post-Market Requirements or Commitments (PMR/PMC) for 9(35% ) of oncology drugs due to premarket trial diversity shortfalls. However, by CTDs, 20 (77%) of the 26 approved drugs lacked adequate representation, yet did not receive Post-Marketing Requirements or Commitments. Conclusions: Oncology drug safety and efficacy can vary by age, race, sex, and ethnicity, necessitating diverse demographic participation in clinical trials. Alongside US FDA industry guidance, entities like the National Academy of Sciences, Engineering and Medicine and the GAO Report emphasize the need for trial diversity, bolstered by Federal Clinical Diversity Provision H.R. 2617 enacted in 2022. CARER’s scoring system evaluates clinical diversity age, sex, race and ethnicity, based on FDA data since January 2022. Age ≥65, female gender, and Asian race subgroups were generally well represented in clinical trial programs. Black and Hispanic groups show the lowest representation. Consistent use of PMC and PMR to new drugs may improve demographic inclusivity in trials lacking initial diversity.
Hematologic parameters as predictors of overall survival in metastatic solid tumor and aggressive lymphoma.
Authors: Morgenstern Kaplan Dan , Trabolsi Asaad , Plate Thomas , Hevroni Gil , Campoverde Leticia , Kronenfeld Rachel , Mercadel Alyssa , Zhao Wei , Soff Gerald A.
Published: June 2024

e23053

Background: Aggressive cancer is associated with an increased rate of thrombosis. In addition to body mass index (BMI), the Khorana score has identified several hematologic parameters associated with an increased risk of thrombosis. In this study, we assessed the relationship of these parameters with overall survival. Methods: Using data from our tumor registry, we selected patients with aggressive lymphomas (AL), glioblastoma multiforme (GBM), metastatic prostate (MP), metastatic lung (ML), and metastatic colorectal (MCRC) cancer from 2018 to 2023. Laboratory data were extracted from our electronic medical record, with a timeframe of 90 days before and 30 days after first contact, but prior to initiating treatment. We analyzed the relationship of hemoglobin (Hgb), white blood cell (WBC) count, platelet (Plt) count, and body mass index (BMI), with overall survival (OS). Each cancer type was analyzed as a separate group and multivariable analysis was controlled by sex and age at diagnosis. Dichotomizing the variables from categories of the Khorana score, we evaluated the relationship of such variables and OS using Kaplan-Meier Analysis and Cox Proportional Hazards Models. Patients were censored at two years of follow-up. Data analysis was done using R (version 4.3). Results: Of 2,362 patients, 55% were male, and median age was 63 years. (Cancer types: 622 ML, 604 AL, 453 GBM, 281 MCRC, 203 MP, and 199 MB). An initial, pre-treatment Hgb < 10 g/dL was associated with a shorter OS in patients with ML, MCRC, MP, and AL patients. Plt ≥350 x 109/L was associated with a shorter OS in ML and MCRC patients. WBC > 11 x 109/L was associated with a shorter OS in ML, AL, and MCRC, and a BMI ≥35 was associated with a shorter OS only in GBM patients (Table). Conclusions: While not in all cancer types, the hematologic parameters of the Khorana score that predict thrombosis correlate with a reduced overall survival. This effect was significant for different parameters in different cancers. The increased hazard ratio is beyond that which would be expected from thrombosis-related mortality. Our study is limited to data from our single institution and the retrospective nature of the study. [Table: see text]
Inpatient outcomes of patients with new solid tumors admitted to a comprehensive cancer center.
Authors: Nguyen Son V. , Stephen Bobyna A. , Curry Shauna L. , Halm Josiah , Kheder Ed
Published: June 2024

e23056

Background: Hospitalized cancer patients demonstrate multiple challenges including management of acute illnesses, establishment of the cancer diagnosis, creation of a goal concordant care plan, and post-hospital disposition. Yet, there has been limited research regarding characteristics and outcomes of new to hospital oncology patients. Methods: We performed a retrospective chart review of patients with suspicion or confirmed solid tumor cancer diagnosis who were admitted without an established MD Anderson Cancer Center oncologist. We assessed length of stay, ICU utilization, 30-day readmission rate, inpatient mortality, and discharge disposition. We compared the results to our group’s established oncology patients. Statistical analysis was performed using Chi-squared testing. Results: Between November 2022 and January 2023, 201 unique new patients were reviewed out of 1635 admissions. Of those 103 (51.2%) were males, median age of 60 (range: 22-79), White including Hispanics 118 (59%), African Americans 46 (23%), others 33 (18%). Of the study population, 88 (43.8%) did not have a confirmed cancer diagnosis, of which we established a cancer diagnosis in 68 (77.3%) and ruled out cancer in 8 (4%). Of the 113 (56.2%) diagnosed at outside facilities, 63 (55.8%) were treatment naive and 22 (19.4%) had their cancer diagnosis revised. Of 175 patients which had staging information, 150 (85.7%) were stage 4. During the index admission, 45 (22.4%) patients had cancer-directed therapy. The average and geometric mean length of stay (days) for new patients was 12.1 and 8.8, respectively, compared to the established group of 8.2 and 6.1 (p < 0.001). Inpatient mortality was higher in new patients (10.5% vs 6.8%, p < 0.001) and they were more likely to be referred to hospice services (17.4% vs 8.3%, p < 0.001). Furthermore, hospice referral was higher in the unestablished, previously treated group compared to treatment naive patients (28% vs 13.9%, p = 0.003), however inpatient mortality was similar (12% vs 9.9%, p = 0.63). ICU stay, 30-day readmission rate, discharge to home vs placement were similar in new and established patients (Table 1). Conclusions: Admitted new oncology patients typically present with advanced disease and had longer length of stay, mortality rates, and hospice referrals compared to established patients. Further research is needed to identify and improve care barriers to new inpatients, focusing on improving workflow process and timely goal concordant care discussions. [Table: see text]
Adapting a prescreening program from VHIO to match molecular alterations in over 10,000 patients' tumors with targeted agents and immunotherapies in early clinical trials.
Authors: Aguilar Susana , Vivancos Ana , Nuciforo Paolo , Gonzalez-Zorelle Jenifer , Pedrola Anna , Viaplana Cristina , Felip Enriqueta , Tabernero Josep , Garralda Elena , Dienstmann Rodrigo
Published: June 2024

e23071

Background: VHIO's Molecular Prescreening Program (MPP) began in 2010 to catalyze precision medicine at the institution. Over the last decade, this program has provided access to advanced molecular diagnostics to more than 10,000 cancer patients (pts) and is critical in matching targeted therapeutic approaches to clinical trials (CTs). Here we report the clinical utility of our program given the evolving molecular testing landscape and trends in drug development. Methods: We assess the adoption and impact of the VHIO’s MPP in CTs recruitment. All tests were developed in-house: a. from 2010 to 2014 we used formalin fixed paraffin embedded tumor samples to test for hotspot mutations (Sequenom, 20 oncogenes) plus FISH/IHC of selected markers; b. from 2015 to 2017 we moved to a amplicon-based NGS panel (MiSeq, 61 genes), a copy number alteration (CNA) panel (Nanostring, 44 genes) and a fusion + gene expression assay (Nanostring, 26 genes) with additional FISH/IHC in selected cases, including PDL1 and MSI status; c. since 2019, we use a custom capture-based NGS assay for mutations (mut), CNA and Tumor Mutation Burden (TMB) estimation (NextSeq, 435 genes); d. since 2022, we run a liquid biopsy panel in-house (Guardant360, technology transfer). Results: We found a stepwise increase in the MPP adoption, from 207 pts in 2010 to 1,965 pts in 2023, representing almost a tenfold increase. Most common tumours analysed were colorectal, lung, breast, gynaecologic, pancreato-biliary, and gastric. The number of CTs requiring biomarker match has increased from 13 in 2010 to more than 201 in 2023, the most frequent in the last year being HER2 (33), PDL1 (20), EGFR (17), RAS (15) and FGFR (9), MSI (9) and ALK (7). In 2023, 1,230 patients had broad tissue NGS panel, 1,235 were tested with IHC, 373 with fusions + expression assay and 991 with liquid biopsy. Inclusion rate in CTs with biomarker match has fluctuated between 13% and 19% in the past 5 years. Overall, close to 50% of these trial recruitments are with genomically-informed enrichment strategies and not mandatory inclusion criteria. On average, 20% of the patients were still enrolled in unmatched trials after molecular testing. Conclusions: The success of VHIO's MPP is related to agile innovation and clinical deployment of new technologies in a timely manner, critical for the development of new drugs in CTs. Biomarker matched trials evolved from a “few targets/ large populations” scenario to a complex situation with “many targets/ small populations”. Many pts benefit from enrichment strategies in Phase 1 CTs. The impact of the recent implementation of liquid biopsy and ongoing development of genomic + transcriptomic signatures will be closely monitored.
Outcomes of pericardial complications among patients with solid and liquid cancer: Analysis of National Inpatient Sample database.
Authors: Shah Nagma , Hajiabbasi Maryam , Bhatt Navin , Song David
Published: June 2024

e23073

Background: Pericardial complications (PC) are common in malignancy as sequelae of metastasis, direct toxicity of radiation or chemotherapy, or pericardial infection/inflammation due to malignancy. The goal of this study was to assess the cardiovascular outcomes of pericardial complications among patients with solid and liquid cancer. Methods: The National Inpatient Sample from the years 2015 to 2018 was queried to assess cardiovascular outcomes in the setting of pericardial complications (acute pericarditis, chronic constrictive pericarditis, chronic adhesive pericarditis, hemopericardium, cardiac tamponade and other unspecified pericarditis) for patients that have any solid or liquid malignancy. Outcomes included in-hospital mortality, acute kidney injury (AKI), heart failure (HF), cardiogenic shock (CS), myocardial infarction (MI), sudden cardiac arrest (SCA), mechanical circulatory support (MCS), major adverse cardiovascular and cerebrovascular events (MACCE), and stroke. Outcomes were assessed using chi-square analysis using STATA. Results: A total of 1,183,619 cancer patients with PC (n = 20,410.00; 1.7%) and without PC (n = 1,163,209.60; 98.3%) were included. The mean age of patients with and without PC was 58 and 59 years, respectively. The average length of stay in the hospital was 14 and eight days in patients with and without PC, respectively. The most common complications were electrolyte disorders (51.2%, p = 0.000) and arrhythmias (40.4 %, p = 0.000) for patients with and without PC. Patients with PC had higher incidence of in-hospital mortality (11.7% vs 5.1%, p = 0.000), AKI (37.8% vs 22.1%, p = 0.000), HF (25.7% vs 15.5%, p = 0.000), CS (2.7% vs 0.4%, p = 0.000), MI (3.6% vs 2.0%, p = 0.000), SCA (3.2% vs 1.0%, p = 0.000), MCS (0.7% vs 0.1%, p = 0.000), and MACCE (17% vs 7.9%, p = 0.000) compared to cancer patients without PC. There was no difference in outcomes in terms of stroke (1.2% vs 1.2%, p = 0.879). The yearly trend was stable for length of stay among both groups while adjusted total hospital cost was progressively increasing from 2015 to 2018, with a greater net increase in those with PC. Yearly trends of complications were stable among both cohorts. Conclusions: Pericardial complications are prevalent in up to 1.7% of cancer patients, and they are associated with worse cardiovascular outcomes as compared to patients without pericardial complications. Patients with PC also have a higher incidence of in-hospital mortality.
Overestimation of survival in individuals with cancer treated in the real world with new cancer drugs: A population-based cohort study.
Authors: Niraula Saroj
Published: June 2024

e23076

Background: Oncologists and individuals with cancer often rely on outcomes from pivotal randomized controlled trials (RCTs) for real-world treatment decisions. However, stringent inclusions and standardized protocols limit their applicability. This study quantifies overall survival (OS) disparities for novel cancer drugs between real-world and pivotal RCTs. Methods: Ethics approvals were secured, and data on frequently used targeted cancer drugs for solid cancer treatment in all individuals with cancer in Manitoba, Canada from inception to June 30, 2023, collected using pharmacy database and the Manitoba Cancer Registry. Evidence consistently indicates similar cancer outcomes in Manitoba to most high-resource countries. This analysis includes six common immunotherapies and monoclonal antibodies. Kaplan-Meier Method was used to plot survival probabilities, and descriptive statistics to elucidate variable differences. Comparison between survival outcomes in pivotal RCTs and real-world scenarios was expressed as "Overestimation Quotient or OQ" (OS in RCT over OS in the real world for same indication). Results: A total of 941 individuals diagnosed with cancer were evaluated across eight indications. The observed median OS in the real world for included indications was 11.9 months, ranging from 6.6 to 37.6 months— a duration significantly shorter than the median OS reported in pivotal Randomized Controlled Trials (RCTs) (31.35 months, range 9.2 to 72.1) (P < 0.001). This translated to a median difference of 15.6 months (range 2.6 to 59.9) per indication and an "Overestimation Quotient" ranging from 1.5 to 5.9. Notably, the observed OS was even inferior in the real-world setting compared to the control group used in pivotal RCTs in half of the indications (Table 1). Conclusions: In routine practice, new cancer drugs offer starkly inferior survival compared to that reported in pivotal RCTs used for approval of those drugs, with the difference in survival ranging from a few months to several years, translating up to six-fold difference. Our results highlight potential for alarming misinformation influencing treatment decisions in clinics. We trust that oncologists will consider our findings during treatment discussions in clinics. [Table: see text]
The integration of big data analytics in examining the effects of mental illness screening on mortality and burden of illness among patients with cancer.
Authors: Mohan Minu , Epstein Joel Brian , Alam Naheed , Haniff Shaniza , Pili Roberto , Poolakkad Sankaran Satheesh Kumar
Published: June 2024

e23083

Background: Cancer patients receiving cancer care in US hospitals undergo notable psychological suffering, characterized by manifestations of multiple psychiatric disorders and a further doubling of healthcare spending each year. The psychological burden of illness (BOI) frequently accompanies the physical obstacles of the disease, hence increasing the intricacy of cancer care. Analysis was conducted on cancer patients admitted to hospitals in the US in 2017 for the treatment of prostate (PC), cancers of the lip, oral cavity, and pharynx (CLOP), lung (LC), and leukemia. The aim was to understand better and compare the differences in mental illness screening (MIS) and its impact on these patients. Methods: We employed generalized linear models to examine the association between MIS and outcomes––BOI, such as cost, total charge, length of stay (LOS), and in-hospital mortality after controlling for clinical and patient variables. Results: Among 224,540 LC, 178,470 patients underwent MIS. This was 151,285 vs. 58,125 among PC; among CLOP, 35,770 vs. 18,495; for leukemia, this was 53,019 vs.18,759. In the adjusted analysis, MIS among the LC cohort was associated with lower length of stay—(coefficient, 0.96, 95% CI, 0.92-0.98), lower total charges, (0.94, 0.92-0.96), and lower mortality (aOR, 0.77, 95% CI, 0.73-0.82). In the LC cohort, when compared to Whites, Blacks (1.11, 1.05-1.17) and Others (Native Americans, Asians, and Others (1.1, 1.02-1.20) had longer LOS. Compared to high-income neighborhoods, low-income neighborhoods showed higher LOS (1.09, 1.03-1.153), and compared to "Central" counties of metro areas of ≥ 1 million population, Not metropolitan or micropolitan counties had a lower LOS (0.86, 0.80-0.92). Private insurance holders had lower total charges than Medicare beneficiaries (0.84, 0.81-0.88). Females, when compared to males, had a lower total charge (0.96, 0.94-0.98), and when compared to Whites, Hispanics (1.35, 1.25-1.45), and Others (1.28, 1.19-1.37) had a higher total-charges. And compared to Whites, Others had a higher in-hospital mortality (aOR, 1.16, 95% CI, 1.03-1.31). Further, the analysis was stratified into surgical and non-surgical cohorts in the LC cohort. Compared to LC, none of the other solid or liquid cancer cohorts, MIS showed no beneficial association with BOI or mortality. Conclusions: The LC cohort showed a positive association between MIS and BOI and in-hospital mortality. To provide holistic treatment for all cancer patients, including MIS as a standard practice is advantageous. This study can offer helpful information for future research on the impacts and implementation of routine mental illness screening among patients with cancer.
National Comprehensive Cancer Network guideline compliance in an oncology value-based care program serving Medicare members.
Authors: Thompson Edward , Hastings Kevin , Cullum Robert , Reddy Shirisha , Brito Rogelio Alberto , Byrd Brooke , Avalos-Reyes Elisea , Johnson Kjel Andrew
Published: June 2024

e23095

Background: Value-based care (VBC) focuses on improving patient health outcomes while reducing the overall cost of healthcare. National Comprehensive Cancer Network (NCCN) cancer treatment guidelines standardize and improve quality of care. While studies have shown that compliance to NCCN guidelines improves survival, little information exists regarding the impact of compliance in VBC arrangements. This study aimed to evaluate compliance to NCCN regimen guidelines in Medicare members being treated for cancer under a VBC arrangement. Methods: This is a cohort study of individuals receiving care, in a single state, enrolled in a VBC contract within a large national insurer from February 2023 to October 2023. Medicare members with bladder, colon, lung, melanoma, breast, hepatocellular, rectal, pancreatic, multiple myeloma, gastric, ovarian, esophageal, lymphoma, kidney, leukemia, head and neck, biliary tract and uterine cancer with at least one oncology claim within the contract year were included. NCCN compliance was a quality measure of the VBC. NCCN regimen compliance was identified from pharmacy and medical claims and defined as concordant if the entire prescribed treatment regimen matched an NCCN regimen (Level 1 and 2a); members not receiving an NCCN recommended regimen were deemed to be non-concordant. Results: This study included 561 patients, the mean [SD] age was 75.7 [8.2] years and 286 [51.0%] members identified as male. The total population captured through the automated prior authorization platform yielded 100% NCCN compliance. Conclusions: In this study, individuals receiving chemotherapy participating in a shared savings VBC demonstrated 100% compliance to NCCN guidelines.
Childhood Cancer in Cameroon and Kenya: Preliminary findings of an implementation effectiveness study for early detection of childhood cancer.
Authors: Noh Hayle , Denburg Avram , Gupta Sumit , Barwick Melanie , Githanga Jessie Nyokabi , Pondy Ongotsoyi Angele Hermine , Afungchwi Glenn Mbah , King'e Maureen , Landis Fongang Che , Ward Nathan
Published: June 2024

e23096

Background: Early childhood cancer detection reduces mortality, particularly in LMIC contexts where an improved understanding of early warning signs and symptoms (EWSS) and integration of vital referral pathways into existing health systems are crucial to improved childhood cancer outcomes. Our project seeks to adapt and implement a Ghanaian-developed EWSS intervention for Kenya and Cameroon using implementation science frameworks to move beyond the common but ineffective train-and-hope approach. Cameroon operates on a three-tiered sub-sector health system, with the intermediate level consisting of regional delegations that support districts1. In Kenya a six-tiered health system delivers primary care (1-2), mid-level care (3-4), advanced care with centers of excellence (5-6) 2. Health system contexts will inform implementation planning and execution. Methods: Health system stakeholders convened in each country to launch their EWSS initiative. Two-day meetings were collaboratively led by local stakeholders and the research team, guided by The Implementation Roadmap3, a multi-implementation framework resource. They discussed l) local barriers to childhood cancer detection, 2) referral pathways, 3) leadership and operational implementation teams, 4) sustainable EWSS training, and 4) target settings. Results: Stakeholders endorsed the EWSS program and identified individuals to form implementation teams to plan and execute implementation reflective of health system organization and realities. Both countries engaged in an evidence-based implementation planning process, reviewed EWSS core components and training logistics, and endorsed a sustainable tiered training model targeting clinicians and oncologists across system levels and institutional providers. Training content will be adapted for country, region, and county contexts. Both countries endorsed and identified district childhood cancer champions to facilitate training and coordinate timely referrals. Common implementation barriers identified included high healthcare worker turnover, transportation logistics for in-person training, and remuneration options for trainees. Conclusions: Health system leaders in Kenya and Cameroon endorsed an evidence-based EWSS implementation and sustainment approach and identified adaptations responsive to the health system contexts. Implementation will be locally led to ensure effectiveness, sustainability, and appropriate cultural EWSS adaptation. Moving forward, local implementation teams will work with researcher-facilitators to implement EWSS toward improved cancer detection rates.
A comparative analysis of needs and role of patient navigation among early-phase cancer clinical trial participants and non-participants at a single cancer center.
Authors: Doroshow Deborah Blythe , Sheng Tianxiang , Aryeh Brittany , Conner Robert , Loehle Julia , Lucas Natalie , Padilla Melissa , Pappalardo Rachel , Fromm Katherine , Smith Cardinale B.
Published: June 2024

e23127

Background: Early phase clinical trials (EPCTs) assess the safety and toxicity of novel anticancer agents and represent opportunities for patients (pts) to try novel therapies when standard therapies have become ineffective. However, EPCT participants represent a vulnerable population with high financial toxicity and symptoms related to their cancer and previous treatments. EPCTs often require frequent visits and additional procedures which may be burdensome. Pt navigators perform needs assessments and provide guidance to pts as they move through the health care system. Navigation, which has a high level of acceptance among pts with cancer, can improve time from diagnosis to treatment, decrease pt anxiety, and improve participation of minoritized individuals in clinical trials. We hypothesized that EPCT participants would have higher navigation needs than those of non-EPCT participants with cancer. Methods: Utilizing a needs assessment conducted in person or by telephone, pts with cancer treated at Mount Sinai are assessed for 26 individual and systemic social drivers of health (SDoH) barriers by pt navigators at their trial screening visit. EPCT participants were defined as pts participating in a study in the Early Phase Trials Unit. Descriptive characteristics were assessed for all participants regarding demographic characteristics and SDoH barriers. Welch's T-test was used to compare differences in navigation encounters, SDoH barriers and navigator interventions between the EPCT and non-EPCT pt groups. Results: From February to December 2023, 31 EPCT pts and 1145 non-EPCT pts completed the assessment. Median age was 58.9 and 62.4 years, respectively. Racial and ethnic self-identification included 13% vs. 20% Black pts and 19% vs. 20% Hispanic pts. EPCT pts had a mean 5.29 navigation encounters per pt compared to 4.11 in non-EPCT pts (p = 0.27). Pts in the EPCT group were found to have an average of 3.81 SDoH barriers identified, in contrast to 1.7 in the non-EPCT group (p < 0.001). The most common barriers identified in EPCT pts were institutional, knowledge, and psychosocial; in non-EPCT pts, transportation barriers were most common. Furthermore, based on the identified barriers, EPCT pts required an average of 17.23 interventions, compared to 4.57 among those not in the EPCT group (p < 0.001). Interventions most frequently involved coordination with the primary team and education for pts in both groups. Conclusions: EPCT pts had more navigation encounters, SDoH barriers identified, and resultant interventions than non-EPCT pts. Participants in EPCTs are a vulnerable pt population for whom navigation is particularly warranted. [Table: see text]
Molecular and genomic testing in Native American patients with metastatic lung and colorectal cancers: A retrospective chart review.
Authors: Popuri Niveditha , Phan Minh Duc , Nipp Ryan David , Doescher Mark Philip , Janitz Amanda , Dvorak Justin , Buckner Sheryl , Anderson-Buettner Amber , Rhoades Dorothy Alison
Published: June 2024

e23136

Background: The Native American (NA) population has the poorest cancer survival of all racial groups in the U.S. A long history of research misconduct has caused many tribal communities to hold unfavorable views toward genomic data collection. Routine molecular and genomic testing is standard of care for most metastatic lung and colorectal cancers but the frequency of such testing in NA patients is unknown. Many NA patients have limited financial resources and must rely on coverage for health care from an Indian Health Service, Tribal Health Service, or Urban Indian Health (ITU) program. However, ITU programs do not operate their own cancer treatment services and must refer their patients elsewhere for such care. Methods: A Native American Navigation program (NANP) was established at the Stephenson Cancer Center (SCC) in Oklahoma to promote cancer health equity and provide high-quality cancer care by facilitating access to care for ITU patients from across the state. The NANP interfaces with ITU programs to obtain approvals for care as well as to coordinate clinical and supportive services, such as transportation or food assistance. We conducted a retrospective chart review of patients referred from an ITU program to the SCC NANP in Oklahoma from 1/2014 to 6/2023. Among patients with metastatic colorectal cancer (CRC), we investigated the frequency of testing for KRAS, NRAS, BRAF as well as MSS/MSI. In patients with metastatic non-small cell lung cancer (NSCLC), we identified the frequency of EGFR, ALK, ROS1, and PD-L1 testing. Results: A total of 305 NA patients were referred to SCC for colorectal and lung cancers. Of these, 68 patients had metastatic disease and qualified for molecular and genomic testing per National Comprehensive Cancer Network guidelines. The mean age of our cohort was 63 with a male-to-female ratio of 1.6:1. Most (85.3%) patients eligible for testing had testing for at least one biomarker. In patients with metastatic CRC, 100% received MSS/MSI as well as KRAS testing and the frequency of NRAS and BRAF testing was 69.6% and 84.8% respectively. In patients with metastatic NSCLC, the frequency of EGFR, ALK, and ROS1 testing was 95.8%, 87.5%, and 79.1%, with PD-L1 testing frequency being 83.3%. Conclusions: The overall frequency of molecular and genomic testing in these navigated NA patients (85.3%) was comparable to the range reported in the general population (66-90%). By facilitating access to cancer care, programs such as the NANP may help NA patients receive appropriate testing to guide treatment. Larger studies are needed to further assess the role of navigation programs in reducing cancer disparities by facilitating access to appropriate molecular and genomic testing for NA patients with metastatic cancers.
Safety and acceptance of nirmatrelvir/ritonavir in early SARS-CoV-2 treatment in Greek patients with solid cancer.
Authors: Pappas Georgios , Tsoukalas Nikolaos , Boutis Anastasios L. , Saloustros Emmanouil S. , Gazouli Ioanna , Gkoura Stefania , Zakopoulou Roubini , Aidarinis Chrysovalantis , Boukovinas Ioannis , Koumarianou Anna , Kokkali Stefania , Gkoumas Georgios , Vlachostergios Panagiotis J. , Assi Avraam , Karampeazis Athanasios , Nikolaidi Adamantia , Fountzilas Elena , Chatzifoti Natalia , Saridaki Zacharenia (Zenia)
Published: June 2024

e23139

Background: Oncologic patients are at risk of developing severe SARS-CoV-2 infection. Nirmatrelvir/ ritonavir (N/R) is an oral antiviral combination effective in minimizing risk of hospital/ ICU admission/ death, if administered early. Adverse events are rare, but significant drug-drug interactions may necessitate modification of other therapies. We aimed to evaluate implementation, safety, and outcomes in Greek patients with solid tumors and SARS-CoV-2 infection, treated with N/R. Methods: The study was designed by the Hellenic Society of Medical Oncology; 11 Greek oncology centers participated. We retrospectively, prior to February 2023, or prospectively thereafter, recorded the use or not of N/R in oncologic patients, patient characteristics and infection course/ outcomes, post patient consent. No ethical issues exist, since this is the official early therapy recommended by the Greek Ministry of Health. Results: Data from182 patients were collected (55.5% women), aged 24-89 years (median 63). Most (64.8%) had stage IV or metastatic disease. 87.4% were on treatment (66% chemotherapy, 32% immunotherapy, 7.5% hormone therapy). Co-morbidities were present in 45%. This was the primary infection for 89.6%. Most (61.1%) were vaccinated ≥ 3 doses, with 85.2% receiving ≥ 1 dose. N/R was administered to 92.3%; for the non-recipients, patient refusal was the major cause. Symptomatic/ positivity relapse were rarely noted. Adverse reactions were reported by 5.9%, all mild/ moderate, mainly dysgeusia. Temporary adjustment or postponement of oncologic treatment course was needed in 33.9%. Hospitalization was needed in 1.1%, and ICU admission in 0.55%. No deaths were recorded in a 30-day period post diagnosis, but 2 deaths with possible SARS-CoV-2 contribution on them were reported in the 1-3 month follow-up period. The small number of patients not administered N/R precludes extraction of statistically significant comparisons. Conclusions: There is limited experience on efficacy/ safety of early N/R therapy for SARS-CoV-2 infection in oncologic patients; our series is the largest at present. The study demonstrates wide oncologic patient use of N/R with minimal side effects. Although 1/3 of the patients had to adjust their oncologic therapeutic course, this may have been due to the infection per se rather than drug-drug interactions. Most patients exhibited full recovery, with 1.1% in need of hospitalization and no deaths recorded during the first post-infection month. N/R is a convenient, effective early treatment for SARS-CoV-2 infection in solid cancer patients.
Can systematic dental examinations or treatments in addition to routine multidisciplinary treatment in a palliative care unit (PCU) improve the quality of life (QoL) and symptom burden (SB) of patients (Pt) receiving palliative care (PC)?
Authors: Uhlig Sarah , Doberschütz Florian , Munzert Philipp , Hallmann Franziska , Rahm Johannes , Salm Hanna , Pink Daniel
Published: June 2024

e23163

Background: Pt with advanced cancer who require PC often experience not only common symptoms such as pain, shortness of breath, or nausea, but also oral health and dental problems. In many PC teams, and even in dedicated PCUs, the inclusion of dentists in the Pt care team is rare, resulting in a lack of routine dental screening or treatment. Objectives:To investigate the extent to which Pt admitted to a PCU suffer from oral health or dental problems and to explore the impact of incorporating dentists into inpatient PC, with a focus on improving QoL and reducing SB. Methods: In this monocentric study, data were collected in one PCU over a period of eight months. At admission, T0, Pt underwent both a dental examination and interviews using established questionnaires, the EORTC QLQ-C30 (core, general) and OH 15 (oral health). One week later, at T1, Pt underwent a follow-up examination and interview. The QLQ-C30 is a widely accepted instrument developed to assess health-related QoL in cancer Pt. Results: A total of n = 103 Pt (48.5% women) were enrolled. The median time since the last dental visit was 1 year. The dental status at T0 was worse (Table 1). At T1, statistically and clinically significant changes in oral QoL and SB were observed. Notable changes were observed in OH-QoL score (mean 60.60 vs. 88.40, p < 0.001), sticky saliva (mean 38.10 vs. 11.28, p < 0.001), sensitivity to food and drink (mean 35.25 vs. 8.16, p < 0.001), sore mouth (mean 23.87 vs. 4.98, p > 0.001), and poorly fitting dentures (mean 38.63 vs. 8.07, p < 0.001). Improvements in xerostomia, candidiasis and mucositis were also observed. A confidential survey was administered to both Pt and palliative care staff to assess their satisfaction with the addition of systematic dental care to routine multidisciplinary PC. 97% of respondents indicated a high level of satisfaction with this treatment program. Conclusions: The study underscores the powerful contribution of integrating a dentist into the PC, e.g. in a PCU, resulting in a notable reduction in oral symptom burden. This contributes to improved care status, alleviation of distressing symptoms and ultimately an improvement in QoL. The results strongly support the consideration of dental support (e.g. routine dental screening) as an integral part of PC. [Table: see text]
Coping strategies and patient-reported outcomes (PROs) in early-phase cancer clinical trial (EP-CT) participants.
Authors: Lundquist Debra , Lam Anh B. , Pelletier Andrea , Durbin Sienna , Petrillo Laura A. , Jimenez Rachel , Turbini Victoria , Bame Viola , Lynch Kaitlyn , Yalala Vaishnavi Reddy , Ollila Nicholas , Malowitz Benjamin , McIntyre Casandra , Juric Dejan , Nipp Ryan David
Published: June 2024

e23194

Background: Individuals with cancer often rely on various coping strategies as they navigate their cancer course. Little is known about coping strategies among patients enrolled on EP-CTs or associations of these coping strategies with other PROs. Methods: We prospectively enrolled adults with cancer participating in EP-CTs at Massachusetts General Hospital from 4/2021-1/2023. Participants completed baseline surveys prior to EP-CT initiation that assessed coping strategies (Brief COPE), quality of life (QOL; Functional Assessment of Cancer Therapy-General), hope (Herth Hope Index), depression/anxiety symptoms (Patient Health Questionnaire-4), and financial wellbeing (COST tool). We used regression models to explore associations of coping strategies with patient characteristics and PROs (QOL, hope, depression/anxiety symptoms, financial wellbeing). Results: Among 205 participants (median age = 63.3 [range: 31.8-88.6], 57% female), the most common cancer types were gastrointestinal (35%) and breast (20%). Patients in this cohort utilized the following coping strategies (range 0-6): acceptance (mean = 4.81), emotional support (mean = 4.63), active (mean = 4.30), positive reframing (mean = 3.13), religion (mean = 2.77), self-blame (mean = .87), denial (mean = .59), and behavioral disengagement (mean = .36). Older age was associated with decreased use of self-blame coping (B = -0.02, p = .025). Female sex was associated with higher scores for denial (B = 0.42, p = .009), emotional support (B = 0.50, p = .037), positive reframing (B = 0.57, p = .036), and religion (B = 1.02, p = .001) coping compared with males. See table for associations of coping strategies with PROs (QOL, hope, depression/anxiety symptoms, financial wellbeing). Conclusions: In this cohort of EP-CT participants, we demonstrated that patients use multiple coping strategies and identified differences by age and sex. Notably, we found that some coping behaviors (acceptance, emotional support, positive reframing) were more favorably associated with QOL, hope, depression/anxiety symptoms, and financial wellbeing than others (denial, self-blame, behavioral disengagement). Interventions seeking to enhance PROs in this population should address patients’ use of coping strategies. [Table: see text]
Maximizing efficiency and patient outcomes to meet the demands of a rapidly growing cancer institute.
Authors: Brazee Tyler , Ogbonna Stella , Dominick Anthony
Published: June 2024

e23203

Background: In 2023, the US is projected to have 1.96 million new cancer diagnoses with a 33% decline in cancer-related deaths. The prevalence of cancer is increasing at a rate that is difficult for oncology practices across the country to manage. Improvement processes must be evaluated to address these demands and create a practice with a foundation for long-term growth, scalability, and structure. The main target of this research was to standardize practice procedures to improve communication leading to reduced variation in order entry practices that resulted in confusion for staff, interruptions for providers, and chair time delays for patients. Methods: A QI project was undertaken at a rapidly expanding community oncology practice to meet patient volume demands. Three separate areas were identified to create standardization of procedures to improve care including referral guidelines, infusion center orders, and handoffs on patient care. New patient referral guidelines were created to determine if patients met criteria for urgent referrals or needed a referral at all. In addition, infusion center guidelines were standardized to require providers to sign all orders prior to an infusion clinic appointment time. The last area addressed was creating a means of safe and effective handoff between staff members at the end of a patient appointment through required utilization of the "Wrap-Up" section in Epic. Data was collected both before and after implementation of routine practice standards in all three areas mentioned. Utilizing the data gathered over a 6-month period, comparisons were made to identify if the changes had any measurable benefit. Results: Standardization of practice procedures had a significant positive impact. Through standardization of referral guidelines, 500 patients being referred to as urgent were determined not to meet criteria for an urgent evaluation in addition to over 300 patients that did not even need to be seen. By identifying these unnecessary referrals, patients that needed to be seen could be seen sooner. In addition, improved infusion center guidelines requiring providers to sign orders prior to appointment times increased infusion volumes that had a direct margin improvement upwards of $3 million dollars over a 6-month period. The last area addressed was streamlining patient handoff that directly correlated to an average reduction of 100 monthly in-basket messages across all providers. Conclusions: By standardizing daily practices across multiple areas within the practice, there were direct measurable benefits related to each intervention. These were simple, manageable changes that most practices could easily implement to increase productivity, improve patient care, and decrease the work burden on the staff. Ultimately, these improvements led to increased patient and employee satisfaction with decreased staff turnover as observed in this study.
Oncologic outpatient specialty palliative care referral utilization: A single institution quality improvement project.
Authors: Ratnaparkhi Rubina , Pope Elaine , Cook Ian , Javellana Melissa , Jewell Andrea , Sinclair Christian T. , Spoozak Lori Ann
Published: June 2024

e23205

Background: ASCO recommends that late-stage and/or recurrent disease patients with a prognosis of 6-24 months receive specialty palliative care within eight weeks of diagnosis. Prior studies suggest only 30% of eligible patients are referred to outpatient palliative care. Little is known about existing referral patterns to direct quality improvement initiatives. Our aim was to characterize outpatient palliative care referral sources, timeliness, and completion rates across our cancer center. More broadly, this investigation may serve as a model for outpatient palliative care utilization improvement at other cancer centers. Methods: A single institution retrospective quality improvement study was conducted of patients in the seven oncology subspecialties with the most palliative care referrals from 2019 – 2022. Data collected included demographics, referral source, and utilization metrics. Outcomes were rate of referral completion and time from referral to first palliative care visit, hospice enrollment, and/or death. Descriptive statistics were performed. Results: 1671 outpatient specialty palliative care referrals were placed. 57% were initiated by medical oncologists, 21% by inpatient palliative care consulting service at hospital discharge, and 14% by surgical oncology. 27% of referred patients did not schedule an appointment. Gynecologic and breast cancer patients had the highest rates of being scheduled. Median time from referral to appointment was 20 days (interquartile range 9 – 30 days). Reasons patients did not utilize palliative care included transition to hospice (41%), lack of interest (41%), or death prior to visit (7%). 79% of patients seen by palliative care who died were enrolled in hospice. Median time from palliative care referral to hospice enrollment was 66 days (IQR 22 – 164 days), and median time from hospice enrollment to death was 13 days (IQR 5 – 31 days). Conclusions: In a single institution self-evaluation, most patients referred to outpatient specialty palliative care completed referral within thirty days. Within the context of this institution, relevant goals for quality improvement interventions include increasing palliative care referrals among surgical oncologists and shifting palliative care referrals earlier in the disease course and prior to need for inpatient hospital admission. Understanding the elements of the creation of our palliative care referral database and relevant data tracking may serve as a method for other institutions to target interventions that may improve uptake of outpatient palliative care referrals at cancer centers more broadly.