bluuebunny/crossref_metadata_2025 huggingface dataset:
Treatment patterns, social determinants of health, and functional outcomes for older adults in supportive oncology.
Authors: Armstrong Karen A. , Curseen Kimberly Angelia , Baldwin Dee M.
Published: June 2022

e18575

Background: Research suggests that disparities in all-cause cancer survival times include a dynamic interplay of social determinants of health (SDOH) and treatment decisions. The social environment and associated vulnerability to interpersonal factors, access to social resources and supports, socialization and socioecological experiences affect health outcomes. The purpose of this study was to examine the nexus of SDOH, treatment decisions, and functional outcomes for older adults in supportive oncology at a large academic medical center. Methods: After obtaining IRB approval, we conducted a retrospective chart review of supportive oncology older adults from 2014-2017 (n = 4495) using data restricted to ICD10 codes for solid tumors. We conducted a retrospective analysis to investigate SDOH and treatment decisions for the older adult cancer cohort. Demographic variables included patient age, race, sex, medical insurance, primary diagnosis, attending physician specialty, and comorbidities. Survival time was defined as time from admission to event of death or discharge. We used zip code median income as a surrogate for individual level social gradients. The data were analyzed using the Statistical Analysis Software (SAS) application version 9.4. We used logistics regression and Cox proportional hazards models to answer research questions. Results: The sample (n = 4495) of adult cancer patients was 50% female, 51% white, and mostly (81%) high SES position. The mean age was 66.24 years (SD = 15.23). Treatment patterns included 596 (14%) chemotherapy, 402 (9%) radiation, 415 (9%) both chemotherapy and radiation; and 3015 (68%) reported not having any treatment. Median survival time was 12.88 days. Over 95% of sample reported multiple comorbidities while 76% reported enrollment in government insurance. The crude association between treatment decisions and social position was 1.64 (CI 1.38,1.95) compared to the bias adjusted association which ranged from 2.60 to 4.54. However, the hazard of mortality between those with no cancer treatment was HR = 1.03 (0.96, 1.11) times the corresponding hazard among those receiving treatment. Conclusions: Although supportive oncology clinics may decrease symptom-burden, they may add to fragmentation of care if multiple personnel are involved. Our findings provided evidence that high socially positioned older adults were 4.54 times more likely to receive treatment compared to low socially positioned older adults although there was no meaningful difference in survival times. Clinicians need to create interventions to reduce treatment disparities. Further research is warranted to foster policy models to improve health equity and promote positive functional outcomes for older adults with cancer.
Racial disparities in the screening mammography continuum within a diverse healthcare system.
Authors: Ganguly Anisha , Baker Kelsey K. , Redman Mary Weber , McClintock Adelaide , Yung Rachel Lynn
Published: June 2022

e18580

Background: Racial disparities in breast cancer have been extensively characterized in the literature. Access to screening mammography is a significant contributor to breast cancer disparities. Decreased access to mammography translates into disparities in breast cancer through delayed presentation to care. The USPSTF recommends biannual screening mammography of women 50-74 with average risk for breast cancer. Methods: We conducted a cross-sectional analysis of encounter-level data for Black and white female primary care patients aged 50-74 in the University of Washington Medicine system who were due for mammogram in 2019. Completion of steps of the mammography continuum (referral, scheduling, and completion of mammogram) were compared among Black and white women. Multivariable logistic regression was used to explore race and mammogram completion, adjusting for age, language, referral, insurance, clinical site, wellness visit utilization, and history of prior mammogram. Results: The study population comprised 18,156 women of whom 2,059 (11.3%) were Black and 16,097 (88.7%) were white. Among Black women, 26.8% were referred to screening mammogram, 12.9% self-referred, 39.3% were scheduled, and 21.4% completed their mammogram, compared to 21.1%, 20.6%, 41.4%, and 26.9% among white women respectively. The greatest attrition among Black women was in the step of completing a mammogram after it was scheduled, which was higher seen in white women at the same step. Adjusted analyses demonstrated an association between Black race and lower rates of screening mammography completion (OR 0.85, [95% CI 0.78-0.98], p = 0.02). Conclusions: Our analysis assessed racial disparities in steps of the screening mammography continuum in a large, diverse health system. Black race was associated with lower screening mammography completion after adjustment for several covariates. Provider-initiated referral was higher for Black women, while self-referral was higher for white women. Both Black and white women experienced highest attrition from no-show rates for scheduled mammograms, though attrition was greater for Black women. These findings have systems implications for future interventions, such as patient navigators or system-driven nudges, to mitigate disparities in breast cancer screening. [Table: see text]
Standardization of toxicity related dose modification in oncology electronic health record (EHR).
Authors: Sanyal Amit , Wellner Daniel , Thomas James , Mattila Matthew
Published: June 2022

e18616

Background: Inappropriate antineoplastic drug dosing can cause excessive toxicities or impaired efficacy. Chemotherapy dose delays and reduced dose intensity are common in community oncology practices[1]. Electronic tools can improve quality and safety of chemotherapy. Methods: A quality improvement project to standardize toxicity related dose modifications was initiated in January 2021. A dose modification section was created in BEACON (Epic Systems, Verona, WI) chemotherapy protocols. Dose modifications used in primary source studies were added to the protocols (Table, illustrative). An embedded link to relevant section of the study protocol allowed detailed review. Similarly, a link to the relevant CTCAE grading was embedded for reference. A user experience survey was conducted in August 2021 to evaluate adoption and perceived utility. Results: Dose modifications recommendations have been introduced in 104 protocols to date. Of the 70 survey respondents, there were 18 physicians and 5 advance practice providers, remainder being oncology nurses and pharmacists. Pre-implementation, 29% (8/27) of respondents whose role required performing dose modifications indicated using personal clinical judgement for hematological toxicity related dose modifications. 34% (9/26) did the same for non-hematological toxicities. Post-implementation, 87% respondents indicated awareness of the recommendations. 47% indicated that recommendations saved timed and 60% found these useful. 7.2% felt recommendations were impractical for clinical use. Conclusions: Embedding evidence-based dose modification recommendations into EHR based treatment protocols is feasible with widespread user adoption. References Denduluri, N., et al., Dose Delays, Dose Reductions, and Relative Dose Intensity in Patients With Cancer Who Received Adjuvant or Neoadjuvant Chemotherapy in Community Oncology Practices. J Natl Compr Canc Netw, 2015. 13(11): p. 1383-93. Illustrative Dose Modification Table. Reference Links 1. Grothey et al. Dose Modifications 2. CTCAE Grading. Refer to Reference Link for Detailed Instructions. Decrease Oxaliplatin and 5 FU one dose level for ANC<1000, platelets <50,000, Grade 4 diarrhea Decrease 5 FU one dose level for Grade 3 diarrhea, Grade 3 or 4 mucositis Decrease Oxaliplatin one dose level for Grade 2 neurotoxicity persisting between treatments, Grade 3 neurotoxicity resolving to </= Grade 2 between treatments Discontinue Oxaliplatin for Grade 3 neurotoxicity persisting between treatments, Grade 4 neurotoxicity.[Table: see text]
Altered cancer care delivery during COVID-19: Evaluating the impact of virtual clinics and treatment changes on oncology patient outcomes, quality of life, and satisfaction.
Authors: Kachura Jacob , Hrycyshyn Adriyan , Abbruzzino Alexandria , Deruchie Tan Adam , Smith Janet , Brezden Christine
Published: June 2022

e18618

Background: The coronavirus disease (COVID-19) pandemic has created unprecedented strain on healthcare systems across the world. COVID-19 has thought to have significant impacts on the oncology patient population and has affected their care. Additional research is needed to ascertain the impact of the COVID-19 pandemic at the patient level. We sought to evaluate whether the delivery of cancer care, quality of life (QoL) and treatment outcomes of oncology patients at Mount Sinai Hospital (MSH), Toronto, Canada was impacted by the COVID-19 pandemic. Methods: A 3-part longitudinal questionnaire study including 138 oncology patients receiving active treatment or in active follow-up at MSH was conducted between June 15, 2020 and August 25, 2021. The questionnaire consisted of the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer QoL Questionnaire Version 3) and satisfaction with virtual healthcare questionnaire. The questionnaire was completed at baseline (Jun 15-Sep 8, 2020), 1 month follow-up (Jul 15-Oct 8, 2020), and 12 months follow-up (Aug 4-Aug 25, 2021). Repeated measures analysis of variance tests were performed to evaluate EORTC QLQ-C30 subscale score changes and satisfaction with virtual care question scores over time. Results: Overall, the mean EORTC QLQ-C30 QoL scores were seen to improve in oncology patients from 65.1 (SD±22.3) at baseline to 69.1 (SD±16.9) at 12 months follow-up (p = 0.2). Within the EORTC QLQ-C30 functional scales, mean role functioning and mean social functioning scores were observed to increase over 12 months of follow-up, 66.4 to 79.2 (p < 0.05) and 67.7 to 76.4 (p = 0.17), respectively. Little change was observed within other EORTC QLQ-C30 functional scales and individual symptom scales during follow-up. Over 12 months of follow-up, mean agreement (0 = strongly disagree to 6 = strongly agree) to the questionnaire statement regarding avoiding going to the hospital during COVID-19 pandemic had declined, from 4.6 (SD±2.0) at baseline to 3.9 (SD±2.2) at 12 months follow-up (p = 0.09). Although not significant, virtual care satisfaction generally decreased over the follow-up time period. 97% of 48 patients who completed the survey at 12 months of follow-up reported feeling more safe coming into the hospital when considering the current increased vaccination rates in Ontario. Conclusions: As the COVID-19 pandemic has evolved, there has been increased knowledge of disease transmission, along with the introduction of health care measures such as vaccination and treatment. During this time, cancer outpatients at MSH became more comfortable as demonstrated by improvements in both QoL and virtual care scores. Prospective studies should still be considered to assess the efficacy of different methods of improving oncology patient care and QoL during the COVID-19 pandemic.
Impact of personalized care discussions on advance care planning.
Authors: Hannan Emma , Collins Elizabeth , Wilde Lindsay , Worster Brooke , Hanson Molly , Csik Valerie Pracilio , Handley Nathan , VanSciver Jillian
Published: June 2022

e18619

Background: Advanced Care Planning (ACP) involves learning about decisions that may need to be made during care so they are known to family and providers. ACP has been associated with less aggressive medical care near death and improved quality of life.However, despite evidence for their benefit, ACP is inconsistent among patients with advanced cancer. At our institution, only 52% of patients with cancer undergoing palliative intent treatment had an ACP at the time of death. We sought to increase ACP through a quality improvement project intended to proactively identify and introduce patients to Personalized Care Discussions (PCDs). PCDs engage oncology patients and palliative care providers in ACP to articulate goals of care. Methods: A team of palliative care providers, medical oncologists, and administrative staff designed each phase of the intervention. Inclusion criteria to proactively identify patients eligible for a PCD were created along with a workflow to introduce PCDs and schedule a PCD appointment. A plan-do-study-act (PDSA) model was used to test impact of change to the PCD referral workflow and patient inclusion criteria. Each PDSA cycle lasted between 4 and 9 weeks between 6/1/2021 and 1/31/2022. PDSA 1: Oncologist referral to PCD for new patients. PDSA 2: Oncologist referral to PCD for Stage IV patients. PDSA 3: Automatic referral to PCD of Stage IV patients. PDSA 4: Pancreatic patients, any stage, added to PDSA 3 criteria. Results: During the measurement period, 68 patients completed a PCD. While changes to the inclusion criteria throughout PDSA cycles resulted in more total unique patients completing PCDs, the completion rate of eligible patients did not vary significantly across cycles. However, the proportion of patients completing PCDs for oncologists engaged in the project increased during the eight-month QI period (92%) from the previous eight-month period (86%). Conclusions: This project sought to identify and introduce patients to PCDs to improve ACP. We found that access to PCDs was not sufficient to increase completion of PCDs, since fewer than half completed the appointment. However, 68 patients who otherwise may not have completed a PCD did so because of this intervention. Misperceptions of palliative care may contribute to high cancellation rates of PCD appointments. This pattern is seen in the overall low completion rate of palliative care appointments (56% in same timeframe). Informal patient feedback often indicated a preference for care discussions to be with the primary oncologist, whereas our intervention introduced a new provider. These results demonstrate that a trigger to identify patients for PCDs without primary oncologist engagement falls short. Continued focus is needed to determine a proactive approach to identify patients who will benefit most from PCDs to complete ACP proactively.[Table: see text]
Screening for anxiety and depression in cancer patients using PHQ4.
Authors: Bhakta Pooja N. , Hunzeker Zachary E. , Gudipally Sindusha R , Willis Maurice , Venkatesan Rohit
Published: June 2022

e18629

Background: The prevalence of anxiety and depression disorder in patients with cancer is about 10% and 22%, respectively. Cancer patients were seven times more likely to have a psychiatric disorder than the normal population. Prior studies have used multiple questionnaires like GAD7, HADS, PHQ2 and PHQ9 which have been approved by national guidelines to assess severity of anxiety and depression in the cancer population. Patient Health Questionnaire-4 (PHQ4) questionnaire is a validated screening tool for anxiety and depression disorders. This study aimed to implement a concise screening tool, PHQ4, to identify the mental health status of cancer patients early and intervene with counseling, medications, and referral to PCP/Palliative care for symptoms control. Methods: Patients completed the 4-item PHQ4 during their clinic visits at University of Texas Medical Branch between December 1, 2021, and February 1, 2022. The patient was provided with a PHQ4 questionnaire at the beginning of their visit. The PHQ4 implements two screening questions for anxiety and depression each, with the frequency of symptoms determining the score on a scale of 0 (not at all) to 3 (nearly every day) for each item. When the total score was > or = 3, a presumptive diagnosis of anxiety, depression, or both was made. These patients were given information regarding support groups, resources for interventions, and provided with medications/referrals to primary care/palliative care/psychiatry for further management. Demographic factors (i.e., age, sex, race/ethnicity), type of cancer, and stage of cancer were other variables that were collected and analyzed as well. Results: Out of 70 total patients, 12 (17.1%) screened positive for anxiety, 14 (20%) screened positive for depression, and 9 (12.9%) screened positive for both depression and anxiety. 10 (14.3%) patients were diagnosed with mild symptoms (score 3-5), 10 (14.3%) with moderate symptoms (6-8), and 4 (5.7%) with severe symptoms. Median age of study population was 60, median age for positive screening was 54.5 years. While there were 35 males and females included in the study, 10 males (14.3%) and 7 females (10%) screened positive. Caucasian ethnicity (76.5%) and Colorectal cancer (24.3%) had the highest prevalence of patients who screened positive. All patients who screened positive were either stage 3 or 4 cancer patients. All patients (100%) who screened positive, received intervention. Conclusions: Based on our results, PHQ4 almost met the national average for depression screening. It possibly over diagnosed patients with anxiety and depression which may have been also contributed by other social/financial/personal stressors, warranting further attention with social worker support. PHQ4, is a quick, validated, effective screening tool that can regularly monitor cancer patients’ psychological health and enable timely intervention.
A lean-sprint approach to protocol development.
Authors: Paul Varun , Ferranti Lori , Dilts David M.
Published: June 2022

e18639

Background: With the ever-increasing complexity of protocols and their required approvals, there is a need to improve the time and reduce the effort required to create a Phase III protocol. The objective of this research was to reduce from months to weeks the time to create a Phase III protocol at a large global pharmaceutical organization, while maintaining or improving the quality and scientific merit of the protocol. Methods: The method required two phases: process redesign and process execution/performance. For the first phase, a continuous improvement methodology (Lean), was utilized. In a multi-team-based approach, the first stage (process-prep) focused on the development of the initial draft protocol. The second stage used the concept of a Sprint, a process to complete all protocol changes and approvals within a rapid time span, while simultaneously guaranteeing protocol quality. A set of policies, procedures, and information technology tools were developed to facilitate both efforts. The Process-prep stage was team-based, where a streamlined Clinical Study Team and a sub-group, the Protocol Working Group, identified all the key tasks, activities and their associated completion dates, and created an 80% complete draft protocol. The Sprint was a one-week, intensive effort by all those responsible for creation of the protocol, and for its final approval. Working virtually and internationally allowed for a continuous 24-hour effort during the Sprint. One key element of success was the use of a visualization tool for the creation, adaptation, and finalization of the protocol’s schedule of assessments (SOA) which both assured that all assessments were required by the protocol and that there was concordance between the protocol and the SOA. Results: Quantitative results were significant: a completed protocol was created with a 50% reduction of time compared to the last protocol written by the molecule group, reduction of avoidable amendments, reducing missed errors and potentially decreasing the number of protocol amendments and the near elimination of process loops and email-chains. Qualitatively, team members were trained on useful process tools and methods, while also increasing their comfort level in active participation in remote meetings. This resulted in faster time to create any amendments that may be required in the future for the protocol. Conclusions: It is possible to employ efficiency and effectiveness methods, such as Lean and Sprint, that have been used successfully in other industries in the pharmaceutical research & development process. While using such concepts requires a great deal of initial planning, the rewards of using them are significant. Likewise, the extensive use of interdisciplinary remote teams will be of increasing importance in a post-COVID environment of clinical research.
Beneficial role of customized intraoral stents in radiotherapy for nasopharyngeal carcinoma.
Authors: Yang Mi , Xie Huanhuan , Hou Zhen , Jiang Yuya , Wang Kongcheng , Sun Fangfang , Wang Juan , Li Shuangshuang , Liu Juan , Gao Shanbao , Yan Jing
Published: June 2022

e18642

Background: The intraoral stent is a mouth-opening device which may be used in nasopharyngeal carcinoma (NPC) patients during radiotherapy with the intention of preventing unnecessary irradiation in normal adjacent tissue. The purpose of this study was to investigate the effects of individualized intraoral stent on the intensity modulated radiation therapy(IMRT) by evaluation dose distribution and consequent radiobiological derived outcomes for NPC patients. Methods: Sixteen patients with NPC who used intraoral stent and 17 patients without intraoral stent were enrolled in this study. All patients underwent Helical Tomotherapy (HT) in our center. For the planning target volume (PTV), the conformity index (CI) and homogeneity index (HI) were used to compare two groups of HT plans (with or without intraoral stent). The mean dose of normal tissues were recorded for the two groups. Oral mucositis, gustatory sense, mouth opening and salivary function of each patients were weekly assessed at the beginning, during and after radiotherapy by clinical examination. Results: The mean dose metrics of oral cavity, mandible, left and right parotid gland in patients with intraoral stent was significantly decreased by 11.6%, 12.2%, 15.4%, and 8.7% on average, respectively (P < 0.05), while the conformity index (CI, P = 0.056) and homogeneity index (HI, P = 0.676) of the tumor target showed no statistically different. The rates of grade I，II, III of oral mucositis of patients with intraoral stent were 43.15%, 43.75%, 12.50% when radiotherapy was just over. While the rates of patients with intraoral stent were 23.53%, 17.65%, 58.82%. There were significantly different in two groups (p = 0.022). There was no significant difference in the decline of taste function among each groups. But the symptoms of xerostomia and mouth opening restriction in the group with intraoral stent had been relieved significantly compared the group without intraoral stent at 1 month and 6 months after radiation. Conclusions: The custom-made intraoral stents showed promising value at sparing normal tissue during radiotherapy for NPC without affecting target dose coverage or tumor control. Clinical trial information: No. NJSH-2021NL-041.
The clinical applicability of inpatient readmissions for cancer patients.
Authors: Garcia Sandra , Halm Ethan A , Lee Simon Craddock , Sweetenham John W. , Courtney D. Mark , Hong Arthur
Published: June 2022

e18661

Background: The 30-day rate of readmission, a standard metric for many common acute medical conditions, has also been proposed as a quality measure in cancer. However, hospitalizations for cancer patients are more heterogeneous than traditional groups (pneumonia, heart failure patients). We analyzed the pattern and timing of inpatient readmissions for a population-based sample of adults newly diagnosed with cancer. Methods: We identifiably linked adults diagnosed with cancer (2008-2018) from the UT Southwestern tumor registry to comprehensive hospital visits from a regional all-payer health exchange covering a 100-mile radius of Dallas, TX. Our primary outcome was first inpatient readmission within 30 days of discharge among patients hospitalized within 1 year of cancer diagnosis. Subsequent index periods began > 30 days from index discharge to create non-overlapping readmission windows. We grouped primary diagnosis codes into 15 clinically relevant conditions, noting concordance between index and readmission diagnosis. We separately grouped hospital diagnoses deemed preventable by Medicare’s systemic therapy (chemo or immunotherapy) quality measure. We defined early readmission as occurring on days 0-7 and late as days 8-30. Results: Our cohort of 19,608 patients (49.5% female, 71.0% commercial/Medicare insurance) were most diagnosed with gastrointestinal (14.7%), breast (13.9%), and lung cancer (13.6%), with 28.9% advanced stage at diagnosis. Of those, 53.3% had received systemic therapy for their initial treatment. Patients generated 15,066 index admissions and 1,783 readmissions (11.8% 30-day readmission rate). The reason for readmission was the same as index hospitalization in 22.9% of early readmissions and 15.3% of late readmissions. Neoplasm and infection were the most common conditions; their frequencies were similar in early readmissions (12.7% and 12.8% respectively), but infections were higher in late admissions (12.0% and 15.7%). The next most common were gastrointestinal symptoms - modestly more frequent in systemic therapy patients vs. non-systemic therapy (11.4% and 9.3%); and complications of medical care, modestly more frequent in early readmissions vs. late (9.8% and 7.5%). The proportion of early readmissions for preventable diagnoses was 21.7% following receipt of systemic therapy vs 18.0% not receiving systemic therapy, and 29.2% vs. 22.5% respectively for late readmissions. Conclusions: The 30-day readmission rate in patients with cancer was 11.8% (lower than many inpatient conditions) and was usually due to reasons different than the index admission. More work is needed to validate/refine the concept of readmissions to cancer patients as an indicator of quality of care due heterogeneity of patients with cancer, the reasons they are hospitalized and rehospitalized, and relatively low rates of potential preventability.
Assessment of early and late symptom toxicity in a real-world cancer treatment population using the PRO-CTCAE.
Authors: Galaznik Aaron , Trask Peter , Dudley William
Published: June 2022

e18663

Background: The FDA’s Draft Guidance for Core Patient-Reported Outcomes (PROs) in Cancer Clinical Trials, recommends assessment of disease-related symptoms, symptomatic adverse events, overall side effect impact, physical function, and role function. This guidance also recommends that core PROs be assessed more frequently within the first few treatment cycles. The NCI’s PRO Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a system to evaluate symptomatic toxicity. The objective of this study is to assess the utility of frequent assessment early in treatment, using PRO-CTCAE measures for symptom monitoring. Methods: The patient cohort (n = 248) was derived from users of PROmpt®, an application for remote patient reporting and provider symptom management, employed in routine care in 30+ integrated cancer treatment centers. Patients were enrolled (9/20-10/21) at treatment initiation. Baseline characteristics were assessed by survey and review of patient EMR records. PRO-CTCAE derived surveys of 14 core symptoms (pain, shortness-of-breath, nausea, diarrhea, sadness, anxiety, constipation, fever, neuropathy, insomnia, urinary problems, decreased appetite, fatigue and mouth sores) were administered weekly. Patients who completed surveys in weeks 1 – 3 AND weeks 9 – 11 were selected for analysis (n = 75), with weekly incidences calculated for these windows. Differences were tested using dependent measures T-test. Exploratory analysis of differences by gender, frailty status, and tumor type were also performed. Results: Overall cohort was predominantly female (86.7%), with mean age 59.6 yrs. Subjects with baseline multi-dimensional geriatric assessments (MGA), were 73% fit, 24.3% intermediate and 2.7% frail. The majority of symptoms (11 of 14) showed directional decline over time, with 6 trending towards significance (p < / = 0.10). Increases, however, were statistically significant for neuropathy(p = 0.01) and directional for shortness-of-breath (p = 0.10) and mouth sores (p = 0.32). Conclusions: Findings support recommendations for frequent, early assessment, with weekly surveys showing higher symptom incidence for most items compared with later assessment. Observation of late symptom increases support continued, regular monitoring for timely management of emerging symptoms with continued treatment.
Trading satisfaction for experience: Development of an oncology patient experience survey.
Authors: Gorham Rachel , Schear Rebekkah , Richardson Robin , Kvale Elizabeth Ann
Published: June 2022

e18667

Background: Patient-Reported Experience Measures (PREMs) are gaining favor over standard patient satisfaction surveys, providing a multidimensional approach to understand unique patients’ care experiences. However, while existing tools undergo robust creation and validation processes, many of these processes do not include input from patients themselves. The purpose of the present work was to describe the development of a patient experience survey to be distributed to oncology patients in an interdisciplinary care center, combining validated measures, site-specific considerations, and patient input. Methods: This questionnaire was designed through an iterative process over the course of 6 months. First, a focus group was conducted with advocates from our Patient Advisory Board to identify measures that mattered to them pertaining to their care experience. We then reviewed 12 measures of patient surveys to identify existing validated evaluation tools for patient experience. We critically examined these against core domains of the Cancer Life ReiMagined (CaLM) model of care: Whole Person Care, Care Coordination, Communication, Empowerment, Access to Care. Of 4 measures identified, 9 validated items were chosen and combined with team-generated items to produce an initial 19-question form of the Oncology Patient Experience Survey. Results: We held two 1-hour sessions with two groups of patient advocates to guide and narrow the survey from each dimension of the original scale. Overall response to the survey was positive, but results from these sessions prompted heavy modifications, including creation of a new section of the survey that re-classified ‘non-cancer needs’ as 7 distinct domains, and the addition of 3 open-ended questions. Conclusions: The end result was a complete 33-item Oncology Patient Experience Survey, ready for deployment. This methodology serves as a novel, low-cost and timely way to implement site-specific patient experience surveys without sacrificing quality.[Table: see text]
COVID-19 omicron variants demonstrated different virulence in infected patients with cancer: The real-world evidence from the National COVID Cohort Collaborative (N3C).
Authors: Song Qianqian , Bates Benjamin , Hsu Fang-Chi , Liu Feifan , Madhira Vithal , Mitra Amit Kumar , Bergquist Timothy , Li Xiaochun , Sharafeldin Noha , Topaloglu Umit , Su Jing
Published: June 2022

e18672

Background: Comprehensive real-world evidence of the virulence of COVID-19 Omicron, Delta, and Alpha variants as well as the effectiveness of booster vaccinations in patients with cancer are lacking. We aimed to fill in these gaps for cancer patients and provide essential insights on the management of the fast-evolving pandemic by leveraging the nationally-representative electronic medical records from the National COVID Cohort Collaborative (N3C) registry. Methods: The virulence of COVID-19 variants was examined according to severe outcomes of infected patients with cancer, compared with non-cancer patients, using the N3C data between 12/01/2020 and 02/03/2022. Variants were inferred according to the time periods of variant dominance at > 95% accuracy. The Cox proportional hazards model was employed to evaluate the effects of COVID-19 variants, adjusting for age, gender, race/ethnicity, geographic regions, vaccination status, cancer types, smoking status, cancer treatments, and adjusted Charlson Comorbidity Index (CCI). Results: Our study cohort included 114,195 COVID-19 patients with cancer and 160,493 without cancer as control. Among them, 52,539 (21%) were infected by Omicron, 82,579 (33%) by Delta, and 115,200 (46%) by Alpha variants. Prior to the COVID-19 breakthrough infection, 7%, 22%, 3%, and 69% were vaccinated with 1 dose, 2 doses, a booster, or unvaccinated respectively. The proportions of hospitalization and death among patients with vs without cancer were 40% and 7% vs 18% and 0.4%, respectively. Characteristics of the cancer subcohort are summarized in the Table. Our analysis showed dramatically lower risks of severe outcomes for patients who were infected by Omicron (HR 0.42, 95%CI: 0.38 – 0.46) and slightly lower risks for Delta (HR 0.93, 95%CI: 0.89 – 0.98) compared with those infected by Alpha, after adjusting for other demographic clinical risk factors, and vaccination status. This trend remained similar in subgroups of patients with solid tumors, hematologic malignancies, or without cancer. Similar associations were observed when virulence was evaluated in association with mortality. The effectiveness of booster vaccinations varied across sub-cohorts stratified by variants and cancer types. Booster shots reduced the risk of severe outcomes for patients with solid tumors infected by Omicron variant or hematologic malignancies infected by Delta variants. Conclusions: Our work provides up-to-date and comprehensive real-world evidence of the virulence of COVID-19 variants in patients with cancer. Omicron variant showed significantly reduced virulence for different cancer types.[Table: see text]
Delays in care following a COVID diagnosis.
Authors: Mullangi Samyukta , Aviki Emeline Mariam , Chen Yuan , Robson Mark E. , Hershman Dawn L.
Published: June 2022

e18675

Background: We sought to describe factors associated with treatment delay among cancer patients with COVID-19. Methods: We conducted a retrospective analysis of de-identified data from the ASCO COVID-19 Cancer Data Registry, a longitudinal cohort study launched in April 2020 with 60 community and academic practices. We evaluated all patients who were documented as having therapy (anticancer drug therapy, surgery or radiation therapy) scheduled at the time of entry into the registry due to a positive SARS-CoV-2 test result. Treatment delay were defined based on length of delay: on schedule or within 14 days, and delay > 14 days or discontinued entirely. The latter is defined as “delay in care”. We used univariate and multivariate logistic analyses to address these questions. Results: At the time of data analysis, 3028 patients were included in the registry, of which 2103 had scheduled drug therapy, 125 had scheduled surgery, and 202 had scheduled radiation. 46% of patients had a drug delay or discontinuation of care. A multivariable logistic regression found that delays were higher among Black patients relative to white patients (OR 1.73, 95%CI 1.27, 2.35), and Hispanic or Latino patients compared to non-Hispanic or Latino patients (OR 1.95, 95%CI 1.36, 2.80). Compared with patients with 0-1 comorbidities, having 2 or more comorbidities was associated with delay in treatment (OR 1.26, 95%CI 1.01, 1.56). Having metastatic disease, rather than local or regional disease (OR 1.61, 95%CI 1.28, 2.04), and having any COVID-19 complications compared to none (OR 1.49, 95%CI 1.22, 1.83) were associated with delay. Relative to the initial outbreak of the pandemic from March-June 2020, having a COVID-19 diagnosis later in the pandemic was associated with lower likelihood of delay (OR 0.45, 95%CI 0.26, 0.74). 47% (95/202) of patients had a radiation delay or discontinuation of care. Factors associated with radiation delay included having 2 or more comorbidities (OR 2.78, 95%CI 1.22, 6.53). 71% (89/125) of patients had a surgical delay or discontinuation care. Factors associated with surgical delay included female sex (OR 6.05, 95%CI 1.34, 34.6), being in the South compared with being in the Midwest (OR 9.00, 95%CI 1.97, 49.0). Counter-intuitively, having 2 or more comorbidities was associated with a lower likelihood of delay (OR 0.27, 95%CI 0.09, 0.90). Being diagnosed with COVID-19 in July-Sept 2020 was associated with lower likelihood of delay (OR 0.07, 95%CI 0.01, 0.49). Conclusions: Previous data has shown persistent disparities in COVID-19-related outcomes in subgroups of disadvantaged and minority patients and populations. Data from our study shows that another disparity borne of treatment delays for chronic disease in the setting of a positive SARS-CoV2 test may also contribute to overall poor outcomes in these vulnerable populations.
Real-world analysis of the impact of race on immunotherapy in non-small cell lung cancers.
Authors: Lee Matthew , Miao Emily , Wang Shuai , Zhang Frank , Wei John X , Chung Julie , Xue Xiaonan , Halmos Balazs , Cheng Haiying
Published: June 2022

e18692

Background: Immunotherapy (IO) has become an essential component in the treatment of NSCLC. However, there is limited data on the clinical impact of IO in distinct ethnic minorities who have been greatly under-represented in previous IO trials. It remains unclear whether Black patients carry similar characteristics and responses compared to Non-Black patients. Methods: Patients who were diagnosed with NSCLC from 1/1/2013 to 12/31/18 and confirmed to have received IO were identified from the Montefiore cancer network. Black and Non-Black patients’ characteristics were compared in patient clinical and socioeconomic variables by chi-squared, Mann-Whitney tests and two sample t-tests. Overall survival (OS) and progression free survival (PFS) were evaluated by Kaplan-Meier survival analysis and log-rank analysis using R 4.1.2 version. Results: Of the 108 patients that were analyzable, overall median age was 67 (range 45-86) years old, 35% were Black, 80% smokers/former smokers, 73% were metastatic, 53% treated with PD-l/PD-L1 inhibitor-based IO alone and 65% on first-line immunotherapy regimens. PD-L1 testing were performed in 88 (81%) of patients, including 33 (87%) Black and 55 (79%) Non-Blacks. PD-L1 TPS≥1% was found in 26 (68%) of Blacks and 42 (60%) of Non-Blacks but no significant difference between the two groups (p = 0.792). Overall, median follow-up time was 19.7 months, 50% of patients had disease control with either a complete/partial response or stable disease within 3 months of starting IO but again was not significantly different between Black and Non-Black patients (p = 0.591). Furthermore, there was no significant difference in PFS (8.2 vs. 6.2 months, p = 0.210) and OS (10.9 vs. 9.8 months, p = 0.438). Nevertheless, there was a significantly longer duration of IO in the Blacks (median 7.4 months) compared to the Non-Blacks (3.9 months) (p = 7.17E-07) (Table). Conclusions: Although the response and survival outcomes of IO were not significantly different between Black and Non-Black patients, the duration of IO is significantly longer in Black patients. This finding warrants further exploration on the reasoning behind this which may include different toxicity, tolerability or physiological characteristics.[Table: see text]
Clinical outcomes in COVID-19 patients with cancer who are treated with chemo- or immunotherapy.
Authors: Hatic Haris , Jung Jenny B , Hearld Kristine Ria , Deshane Jessy , Das Devika Govind
Published: June 2022

e18699

Background: Cancer patients infected with COVID-19 are very vulnerable to increased complications and mortality while actively being treated with chemotherapy or immune checkpoint inhibitors (ICIs). The full impact of COVID-19 infections on this subset of patients has not been fully defined. Our goal was to track clinical outcomes in patients with an underlying malignancy and COVID-19 infection who received chemotherapy or ICIs. Methods: We performed a retrospective chart review of 121 patients (age > 18 years) at the University of Alabama-Birmingham from January 2020 till November 2021 with an advanced solid malignancy that were treated with chemotherapy or ICIs within 12 months of their COVID-19 diagnosis. The aim of this study was to track clinical outcomes including: hospitalization rates, ICU admissions, treatments, and deaths of any cause. Results: A total of 121 patients were examined in this study and 61 received immunotherapy treatment within 12 months. The median age at diagnosis for the ICI group was 62.3 years and 54% were male while for the patients that receive chemotherapy the median age at diagnosis was 65.1 years and 53% were male (Table1). The 3 most common cancers represented in the ICI cohort were lung (30%, NSCLC), liver (13%, HCC) and renal (11%, RCC). While in the chemotherapy group, the 3 most cancers were NSCLC (40%), HCC (12%,), and head & neck (10%, H&N). 25% of patients on ICIs died while only 13% of patients died post chemotherapy. Of the ICI patients that died, 33% were admitted to the intensive care unit (ICU) and 53% received oxygen, steroids and antiviral therapy. For the chemotherapy patients that died, 25% were admitted to the ICU and 50% received oxygen, steroids and antiviral therapy. Patients with lower ECOG (0.98) had lower mortality compared to patients with worse functional status (0.98 vs 1.52; t = 3.20; p < 0.01). Factors associated with increased admission were higher ECOG (1.07 vs 1.67; f = 3.05; p = 0.05), higher AST (21.2 vs 40.9, f = 10.2; p < 0.001), lower absolute lymphocyte count (1122.8 vs 408.9, f = 5.99; p < 0.01) and higher oxygen needs (0.02 vs 1.11, f = 29.5; p < 0.001). Conclusions: ICI mortality was higher compared to patients receiving chemotherapy, especially for those with reduced functional status. Factors for hospitalization included: higher ECOG, higher AST, lower lymphocyte count and increased oxygen needs. However, further investigation still needs to be undertaken to understand if the PD-1-PD-L1 pathway with the subsequent inflammatory cascade post COVID-19 can impact overall survival.[Table: see text]
Short-term anthracyclines-induced cardiotoxicity in breast cancer patients.
Authors: Saidi Mohammed Alaeddine , Ghomari Soumeyya
Published: June 2022

e18703

Background: Anthracycline-containing regimens are effective treatment of early breast cancer; however, they can induce irreversible myocardial damage, leading to significant morbidity and mortality. The main aim of this study was to describe and evaluate early anthracycline cardiotoxicity. Methods: This was a prospective study including breast cancer patients who where candidates for adjuvant anthracycline-based chemotherapy. Patients were assessed at baseline with history, physical exam, standard 12-lead electrocardiography (ECG) and 2D echocardiography, and then shortly after completion of anthracycline-based chemotherapy. We reported the ECG parameters, LVEF calculated using Simpson's biplane method and global longitudinal strain (GLS). Cardiotoxicity was defined as a decline ≥ 5% in LVEF accompanied or not by clinical manifestations of heart failure, or a decline ≥ 10% in GLS. Statistical analysis was performed using SPSS version 26. For comparisons, we used two-tailed Student's t-test. Associations between risk factors and cardiotoxicity were assessed using linear and logistic regression; a p value < 0.05 was considered significant. Results: 171 patients with stage I (10.3%), stage II (81%) or stage III (8.7%) invasive ductal breast carcinoma, with a mean age of 48,1 ± 10 years. Obesity was found in 59 patients and 92 were overweight. Among comorbidities, hypertension was present in 11.7%, diabetes mellitus in 5.2%, and dyslipidemia in 4.6%. The most common concomitant medications were β-blockers in 6.4%, followed by angiotensin II receptor blockers in 5.2%, Statins in 4.6%, biguanides in 5.2%. Cardiac function was assessed 12 ± 7 days before and 19 ± 8 days post chemotherapy. 94 patients received Doxorubicin with a cumulative dose of 240 mg/m2, and 77 received Epirubicin with a cumulative dose of 300 mg/m2. Subclinical Cardiotoxicity was observed in 9 patients (5.2%), defined as a decline ≥ 5% in LVEF and in one patient (0.5%) defined by GLS decline ≥ 10%. This patient had the lowest post-therapy LVEF (40.2%) of the cohort. LVEF and GLS although reduced significantly after treatment, remained within the normal range. (LVEF: 62.8 ± 3% vs. 58 ± 6%, p = 0.03), (GLS: -19.0 ± 2.4% vs. -17.1 ± 1.0%, p = 0.01). Patients receiving Doxorubicin had lower LVEF compared to Epirubicin after therapy (57.1 ± 2% vs. 61.4 ± 2%, p = 0.03). Additionally, we found significant ECG changes in Heart Rate (72.6 ± 11,6 vs. 85.2 ± 14.4 bpm, p = 0.013) and QTc (410.1 ± 24.9 vs. 427.7 ± 26.5 ms, p = 0.032). Cardiotoxicity was not associated with any cardiovascular risk factors. Doxorubicin use was the only risk factor, confirmed on multivariate analysis (p = 0,02). Conclusions: Anthracycline-based chemotherapy has detrimental subclinical effect on electrical activity and left ventricle systolic function in the short term after adjuvant chemotherapy. We did not observe any significant effect of risk factors, it is therefore important to monitor all patients.
Triple negative breast cancer presentation in Afro-Caribbean women in New York City.
Authors: Ventura Ana M , Taiwo Evelyn , Leuva Harshraj , Chiu Edwin
Published: June 2022

e18726

Background: In the United States, triple negative breast cancer (TNBC) accounts for 10-15% of all breast cancers. It also has a higher incidence and worse prognosis in black women. There is paucity of information on the incidence and presentation of breast cancer in black women from the Caribbean. The clinical and pathologic profile of TNBC in this immigrant underrepresented patient group is described here. Methods: This is a retrospective study performed at Kings County Hospital (KCH), a safety net hospital in Central Brooklyn, New York City with a predominantly Afro-Caribbean patient population. Data from patients diagnosed with breast cancer from 2015-2018 were collected from the institution’s tumor registry and the clinical and pathologic data of these patients were collected and analyzed with descriptive statistics and chi square testing. Results: Of the total 299 female patients with a breast cancer diagnosis, 60 patients (20%) had TNBC with median age 57 and Nottingham grade 3 in 90% (54) of the patients. At presentation, 43% (26) presented with localized disease, 55% (33) with lymph node involvement (regional), and 2% (1) with distant metastasis. When stratified by menopausal status, 46 patients (77 %) were post-menopausal and remainder pre-menopausal. Premenopausal women presented with higher rates of regional disease at 64% with compared to 50% in the postmenopausal women (p = 0.5444). BMI was similar in both groups (p = 0.9879). Of the 37 patients with documented country of origin, 84% (31) were from the Caribbean, and 27% of these patients identified as medical tourists from the Caribbean. 25% (15) of all patients reported 1st or 2nd degree relative with breast cancer and 18% (11) reported a first degree relative with malignancy other that breast cancer. 100% of patients younger than 44 years reported a family history of cancer. Genetic testing information was unavailable to these patients. Of the twenty patients (33%) that received neoadjuvant chemotherapy with standard treatment, two achieved complete response, 15 partial response, and 3 without response to treatment. Conclusions: In our study of African-Caribbean patients with breast cancer, the incidence of TNBC was high at 20% with most presenting with high-grade tumors, regional lymph node involvement, and young age at diagnosis. Notably this represents a high-risk cohort with significant family history of breast and other cancers suggestive of inherited or familial cancers. Response to standard neoadjuvant chemotherapy was less than expected, encouraging the need to consider neoadjuvant immunotherapy in these patients.