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Morie Gertz,1,* Rafat Abonour,2,* Sarah N Gibbs,3,* Muriel Finkel,4,* Heather Landau,5,* Suzanne Lentzsch,6,* Grace Lin,7,* Anuj Mahindra,8,* Tiffany Quock,9,* Cara Rosenbaum,10,* Michael Rosenzweig,11,* Surbhi Sidana,12,* Sascha A Tuchman,13,* Ronald Witteles,12,* Irina Yermilov,3,* Michael S Broder3,* 1Department of Medicine, Mayo Clinic, Rochester, MN, USA; 2Department of Medicine, Indiana University School of Medicine; Director, Multiple Myeloma, Waldenstrom’s Disease and Amyloidosis Program, Indianapolis, IN, USA; 3PHAR (Partnership for Health Analytic Research), Beverly Hills, CA, USA; 4Amyloidosis Support Groups Inc, Wood Dale, IL, USA; 5Memorial Sloan-Kettering Cancer Center, New York, NY, USA; 6Multiple Myeloma and Amyloidosis Program, Columbia University Medical Center, New York, NY, USA; 7Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA; 8Malignant Hematology, Scripps Clinic MD Anderson Cancer Center, La Jolla, CA, USA; 9Health Economics and Outcomes Research, Prothena Biosciences Ltd., South San Francisco, CA, USA; 10Department of Medicine, Hematology/Oncology, Weill Cornell Medical College, New York, NY, USA; 11Division of Multiple Myeloma, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, CA, USA; 12Division of Cardiovascular Medicine, Stanford School of Medicine, Palo Alto, CA, USA; 13Division of Hematology, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA*These authors contributed equally to this workCorrespondence: Michael S Broder, PHAR (Partnership for Health Analytic Research), 280 S Beverly Drive, Suite 404, Beverly Hills, CA, 90212, USA, Tel +1 310 858 9555, Email mbroder@pharllc.comPurpose: Patients with diagnosed with systemic light chain (AL) amyloidosis at advanced Mayo stages have greater morbidity and mortality than those diagnosed at non-advanced stages. Estimating service use by severity is difficult because Mayo stage is not available in many secondary databases. We used an expert panel to estimate healthcare utilization among advanced and non-advanced AL amyloidosis patients.Patients and Methods: Using the RAND/UCLA modified Delphi method, expert panelists completed 180 healthcare utilization estimates, consisting of inpatient and outpatient visits, testing, chemotherapy, and procedures by disease severity and organ involvement during two treatment phases (the 1 year after starting first line [1L] therapy and 1 year following treatment [post-1L]). Estimates were also provided for post-1L by hematologic treatment response (complete or very good partial response [CR/VGPR], partial, no response or relapse [PR/NR/R]). Areas of disagreement were discussed during a meeting, after which ratings were completed a second time.Results: During 1L therapy, 55% of advanced patients had ≥ 1 hospitalization and 38% had ≥ 2 admissions. Rates of hematopoietic stem cell transplant (HSCT) in advanced patients were 5%, while pacemaker or implantable cardioverter defibrillator (ICD) placement were 15%. During post-1L therapy, rates of hospitalization in advanced patients remained high (≥ 1 hospitalization: 20-43%, ≥ 2 hospitalizations: 10-20%), and up to 10% of advanced patients had a HSCT. Ten percent of these patients underwent pacemaker/ICD placement.Conclusion: Experts estimated advanced patients, who would not be good candidates for HSCT, would have high rates of hospitalization (traditionally the most expensive type of healthcare utilization) and other health service use. The development of new treatment options that can facilitate organ recovery and improve function may lead to decreased utilization.Keywords: consensus, hematology, outcomes research, mayo stage, cardiac failure

Charlotte Thor Petersen,1,2 Kristoffer Jarlov Jensen,1 Mary Rosenzweig,2 Benedikte Irene von Osmanski,1,2 Mikkel Zöllner Ankarfeldt,1 Janne Petersen1,3 1Copenhagen Phase IV Unit (Phase4CPH), Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark; 2Life Science Insights Centre, DLI Market Intelligence, Copenhagen, Denmark; 3Section of Biostatistics, University of Copenhagen, Copenhagen, DenmarkCorrespondence: Charlotte Thor Petersen, Life Science Insights Centre, DLI Market Intelligence, Copenhagen, Denmark, Tel +45 30 35 20 43, Email ctp@dlimi.comPurpose: There is an increasing need for national and international pharmacoepidemiological studies based on high-quality real-world data of which the Danish registries are a valuable source. In lack of a complete overview of which data are used to assess real-world drug safety and effectiveness outcomes, we aimed to map the outcomes, data sources, and the reporting of outcome quality in recent pharmacoepidemiological studies.Methods: We conducted a systematic mapping review of pharmacoepidemiological studies based on Danish registries investigating drug safety and/or effectiveness, published in the period 2018– 2019, identified in PubMed and Scopus. Extraction included: Anatomical Therapeutic Chemical level 2 code for drug exposures, outcomes, outcome data sources, and quality of outcomes.Results: Of the 210 included studies, 96% used outcomes categorized as Clinical, 4% utilized outcomes categorized as Society-related, 5% used outcomes categorized as Healthcare cost and utilization, and 3% of the studies applied outcomes categorized as Patient-reported in which the percentages are not mutually exclusive. Diagnosis (66%) and Mortality (38%) were the two most utilized subcategories among those categorized as Clinical outcomes. Danish Health Data Authority and Statistics Denmark registries were the most reported outcome data sources (90%). Ninety-six studies (46%) reported one or more quality parameters related to their outcomes of interest with accuracy/validity being the most reported parameter (22%).Conclusion: The Danish registries support a wide range of outcomes. Across therapeutic areas, most studies investigate traditional clinical outcomes of disease and mortality based on data from a small number of available registries. In contrast, clinical and biochemical databases, despite potentially offering outcomes with high responsiveness, and the high-quality social and healthcare cost registries were rarely used as outcome data sources.Keywords: pharmacoepidemiology, registries, review, Denmark, drugs

Background and Objectives: Mixed success with primary palliative care delivery models may be related to inadequate communication between members of the care team. We sought to describe the previously unexamined role of oncologists in an oncology nurse-led primary palliative care intervention study. Design, Setting, and Subjects: We conducted a secondary analysis of data from Care Management by Oncology Nurses to Address Supportive Care Needs, a cluster-randomized controlled trial of a nurse-led primary palliative care intervention for adults with advanced cancer conducted at 17 community oncology clinics in Western Pennsylvania from 2016 to 2020. Nurses conducted three monthly study visits during which they developed care plans (CPs) with the patient and after which they updated the patient's oncologist. We characterized the level of oncologist involvement with the intervention. Results: Of the 336 patients randomized to receive primary palliative care, 266 completed at least one study visit and 233 (88%) had at least one visit where the oncologist was updated afterward. Across 674 total study visits, the oncologist was updated in 553 (82%) of the visits, signifying the oncologist awareness of the intervention. Of the times the nurse updated the oncologist, a CP was presented 29% of the time (163/553). Conclusion: In a large trial of oncology nurse-led primary palliative care, oncologists were often aware of but infrequently involved with the intervention. Future primary palliative care interventions should consider communication and engagement among team members.

Problem Statement: To define the Oncology Nursing Society Research Agenda for 2024-2027., Design: An iterative, multiple data sources consolidation through the Research Agenda Project Team., Data Sources: Previous research priorities, literature review, stakeholder survey, and research priorities from other cancer care organizations and funding agencies., Findings: 10 evergreen statements articulated foundational values for oncology nurse scientists, and 5 topics emerged as research priorities for the upcoming three years: Advance patient-centric, precision symptom science; provide evidence for safe and effective cancer care delivery models and support of the oncology nursing workforce; describe the impact of the environment on cancer care outcomes; integrate patient navigation into cancer care across the trajectory; and advance the use of innovative methodologies in oncology nursing research., Implications for Nursing: The Oncology Nursing Society Research Agenda is an effective resource for directing the organization's research vision. This foundational document directs funding awards and requests, mentorship, and policy initiatives.

We report on a patient with ciltacabtagene autoleucel-induced movement and neurocognitive toxicity, which was refractory to immunosuppression but responsive to combination dopaminergic therapy (carbidopa/levodopa, ropinirole, amantadine). Response was seen upon both initial treatment and rechallenge after unintended withdrawal. This is the first report of a successful symptomatic treatment of this well-described neurotoxic syndrome., Competing Interests: MJ: consultancy: Jansen, Bristol-Myers Squibb; research funding: Bristol-Myers Squibb. SG: consultancy: Bristol-Myers Squibb, Janssen, Sanofi; research funding: Bristol-Myers Squibb, Ipsen; speaker bureau: Adaptive Biotechnologies, Janssen. XM: consultancy: Abbott Labs, Boston Scientific, and Janssen. Speaker bureau: Abbott Labs The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Aliakbar, Manouvakhova, Wong, Htut, Pulst-Korenberg, Janakiram, Rosenzweig, Goldsmith and Mason.)

Chemotherapy treatment-related side-effects are common and increase the risk of suboptimal outcomes. Exercise interventions during cancer treatment improve self-reported physical functioning, fatigue, anxiety, and depression, but it is unclear whether these interventions improve important clinical outcomes, such as chemotherapy relative dose intensity (RDI). The National Cancer Institute funded the Exercise and Nutrition to Improve Cancer Treatment-Related Outcomes (ENICTO) Consortium, to address this knowledge gap. This paper describes the mechanisms hypothesized to underpin intervention effects on clinically-relevant treatment outcomes, briefly outlines each project's distinct research aims, summarizes the scope and organizational structure of ENICTO, and provides an overview of the integrated common data elements used to pursue research questions collectively. In addition, the paper includes a description of consortium-wide activities and broader research community opportunities for collaborative research. Findings from the ENICTO Consortium have the potential to accelerate a paradigm shift in oncology care such that cancer patients could receive exercise and nutrition programming as the standard of care in tandem with chemotherapy to improve RDI for a curative outcome., (© The Author(s) 2024. Published by Oxford University Press.)

High-dose chemotherapy with autologous hematopoietic cell transplantation (AutoHCT) has long been an integral treatment modality for multiple myeloma and non-Hodgkin lymphoma. Over the past 25 years, numerous institutions have shifted this practice from requiring hospitalization to one that can be performed in an ambulatory setting, resulting in cost savings and improved quality of life for patients. The recent advent immune-effector cell (IEC) therapies and expansion of their indications is changing the treatment landscape for hematologic and non-hematologic malignancies. However, current financial models and reimbursement structures threaten the viability and sustainability of this treatment modality should it continue to require inpatient administration and management. This threat is leading institutions to develop outpatient IEC programs based off the outpatient AutoHCT templates. Integral to the success of both is a cohesive program with outpatient-specific standard operating protocols, highly-trained providers and staff with expertise specific in these treatment modalities, evidenced-based supportive care and prophylaxis plans, extensive caregiver vetting and education, and the infrastructure to support all individuals involved. In this policy and practice review we provide an overview of the guidelines and published academic experiences, give a perspective-based description of the roles and responsibilities of the individuals involved in this process at our institution, and highlight actionable recommendations that could allow for the dissemination and implementation of outpatient AutoHCT and IEC programs more broadly., Competing Interests: SG reports the following financial disclosures outside of this review article: Consultancy: Oncovalent, Wugen Inc., Sanofi-Genzyme, Janssen Pharmaceuticals; Speakers Bureau: Janssen Pharmaceuticals, Adaptive Biotechnologies; Research Funding: Bristol Myers Squibb. MR also reports the following: Grant support: Jannsen, Pfizer; Speaker Bureau: Jannsen, BMS. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Goldsmith, San-Rozano, Katindoy, Rattanapichetkul and Rosenzweig.)

Objective: We conducted a phase 1 study of a conditioning regimen with or without total marrow irradiation (TMI) before allogeneic hematopoietic stem cell transplantation for patients with high-risk or refractory multiple myeloma., Methods: Eighteen patients were enrolled on one of 2 strata. Patients with no prior radiation received TMI (900 cGy), fludarabine (FLU), and melphalan (MEL) conditioning, with bortezomib added in the second cohort (stratum I). Patients with prior radiation received FLU, MEL, and bortezomib, without TMI (stratum II)., Results: Eight patients were enrolled in the TMI arm (stratum I). One of 3 patients in cohort 1 experienced dose-limiting toxicity (DLT), which led to the expansion to 3 more patients with no DLT. Cohort 2 enrolled only 2 patients due to low accrual, with bortezomib, added at 0.5 mg/m 2 ; neither experienced DLT. Nine patients were enrolled in the non-TMI arm (stratum II). Three patients were enrolled in cohort 1 (bortezomib 0.5 mg/m 2 ) and none experienced DLT. Three were enrolled in cohort 2 (bortezomib 0.7 mg/m 2 ), and 1 experienced DLT; therefore, the cohort expanded to 3 more patients. One more patient experienced DLT. Median overall survival on strata I and II was 44.5 months (95% CI: 1.73-not reached) and 21.6 months (95% CI: 4.1-72.7), respectively. Median progression-free survival on strata I and II was 18.1 months (95% CI: 1.73-not reached) and 8.9 months (95% CI: 2.7-24.4), respectively., Conclusion: TMI 900 cGy, FLU, and MEL are considered feasible as conditioning for allogeneic stem cell transplantation and may warrant further investigation due to favorable response rates and survival., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

While there is a great clinical need to understand the biology of metastatic cancer in order to treat it more effectively, research is hampered by limited sample availability. Research autopsy programmes can crucially advance the field through synchronous, extensive, and high-volume sample collection. However, it remains an underused strategy in translational research. Via an extensive questionnaire, we collected information on the study design, enrolment strategy, study conduct, sample and data management, and challenges and opportunities of research autopsy programmes in oncology worldwide. Fourteen programmes participated in this study. Eight programmes operated 24 h/7 days, resulting in a lower median postmortem interval (time between death and start of the autopsy, 4 h) compared with those operating during working hours (9 h). Most programmes (n = 10) succeeded in collecting all samples within a median of 12 h after death. A large number of tumour sites were sampled during each autopsy (median 15.5 per patient). The median number of samples collected per patient was 58, including different processing methods for tumour samples but also non-tumour tissues and liquid biopsies. Unique biological insights derived from these samples included metastatic progression, treatment resistance, disease heterogeneity, tumour dormancy, interactions with the tumour micro-environment, and tumour representation in liquid biopsies. Tumour patient-derived xenograft (PDX) or organoid (PDO) models were additionally established, allowing for drug discovery and treatment sensitivity assays. Apart from the opportunities and achievements, we also present the challenges related with postmortem sample collections and strategies to overcome them, based on the shared experience of these 14 programmes. Through this work, we hope to increase the transparency of postmortem tissue donation, to encourage and aid the creation of new programmes, and to foster collaborations on these unique sample collections. © 2024 The Authors. The Journal of Pathology published by John Wiley & Sons Ltd on behalf of The Pathological Society of Great Britain and Ireland., (© 2024 The Authors. The Journal of Pathology published by John Wiley & Sons Ltd on behalf of The Pathological Society of Great Britain and Ireland.)

Importance: Socioeconomic deprivation is associated with increased risk of poor health and quality-of-life (QOL) outcomes in head and neck cancer (HNC) survivors. However, there are few data on how neighborhood deprivation affects patient-reported outcome measures (PROMs) in HNC survivors., Objective: To investigate whether neighborhood socioeconomic deprivation is associated with symptom burden, psychological distress, and QOL among HNC survivors., Design, Setting, and Participants: This cross-sectional study used prospectively collected data from patients seen in a university-affiliated multidisciplinary HNC survivorship clinic between September 2018 and September 2021 who received radiotherapy for squamous cell carcinoma of the oral cavity, oropharynx, and larynx or hypopharynx., Exposure: Neighborhood socioeconomic deprivation, measured using the Area Deprivation Index (ADI)., Main Outcomes and Measures: The PROMs pertaining to symptom burden and severity of psychological distress were measured using the Neck Disability Index, Insomnia Severity Index, the 10-item Eating Assessment Tool, the Generalized Anxiety Disorder 7-item scale, and the 8-item Patient Health Questionnaire. Physical and social-emotional QOL were obtained using the University of Washington QOL questionnaire. Multivariable linear regression analysis adjusting for individual-level sociodemographic, comorbidity, and treatment characteristics investigated the association between ADI and PROMs. A subgroup analysis was performed to compare the lowest (most affluent areas: ADI, 0%-20%) and highest (most deprived areas: ADI, 80%-100%) ADI quintiles., Results: A total of 277 patients were included in the final analysis (mean [SD] age, 64.18 [9.60] years; 215 [77.6%] male). Cancer sites were the oral cavity (52 [18.8%]), oropharyngeal area (171 [61.7%]), and larynx or hypopharynx (54 [19.5%]). Multivariable analysis showed that for every 1-point increase in ADI, social-emotional QOL changed by -0.14 points (95% CI, -0.24 to -0.05 points), anxiety increased by 0.03 points (95% CI, 0.01-0.06 points), and neck disability worsened by 0.05 points (95% CI, 0.01-0.10 points). Compared with patients in the most affluent areas, those in the most deprived areas had significantly lower physical (-15.89 points; 95% CI, -25.96 to -2.31 points; Cohen d = -0.83) and social-emotional (-13.57 points; 95% CI, -22.79 to -3.49 points; Cohen d = -0.69) QOL and higher depression (2.60 points; 95% CI, 0.21-4.40 points; Cohen d = 0.52), anxiety (3.12 points; 95% CI, 1.56-4.66 points; Cohen d = 0.61), insomnia (3.55 points; 95% CI, 0.33-6.41 points; Cohen d = 0.54), and neck disability (5.65 points; 95% CI, 1.66-9.55 points; Cohen d = 0.66) scores., Conclusions and Relevance: In this cross-sectional study, a higher ADI score was associated with higher risk of increased psychological distress, higher symptom burden, and decreased QOL after treatment among HNC survivors. These findings suggest that proactive, patient-centered interventions are needed to address these disparities.

Importance: There is a paucity of information on the association between clonal hematopoiesis of indeterminate potential (CHIP) and cardiovascular disease (CVD) in patients with cancer, including those with multiple myeloma (MM) undergoing hematopoietic cell transplant (HCT), a population at high risk of developing CVD after HCT., Objective: To examine the association between CHIP and CVD in patients with MM and to describe modifiers of CVD risk among those with CHIP., Design, Setting, and Participants: This was a retrospective cohort study of patients with MM who underwent HCT between 2010 and 2016 at City of Hope Comprehensive Cancer Center in Duarte, California, and had pre-HCT mobilized peripheral blood stem cell (PBSC) products cryopreserved and accessible for CHIP analyses. The study team performed targeted panel DNA sequencing to detect the presence of CHIP (variant allele frequency 2% or more)., Main Outcomes and Measures: The primary end point was the 5-year cumulative incidence and risk for developing de novo CVD (heart failure, coronary artery disease, or stroke) after HCT., Results: Of 1036 consecutive patients with MM (580 male [56%]; median age, 60.0 years) who underwent a first autologous HCT, 201 patients had at least 1 CHIP variant (19.4%) and 35 patients had 2 or more variants (3.4%). The 5-year incidence of CVD was significantly higher in patients with CHIP (21.1% vs 8.4%; P < .001) compared with those without CHIP; the 5-year incidence among those with 2 or more variants was 25.6%. In the multivariable model, CHIP was associated with increased risk of CVD (hazard ratio [HR], 2.72; 95% CI, 1.70-4.39), as well as of individual outcomes of interest, including heart failure (HR, 4.02; 95% CI, 2.32-6.98), coronary artery disease (HR, 2.22; 95% CI, 1.06-4.63), and stroke (HR, 3.02; 95% CI, 1.07-8.52). Patients who had both CHIP and preexisting hypertension or dyslipidemia were at nearly 7-fold and 4-fold increased risk of CVD, respectively (reference: no CHIP, no hypertension, or dyslipidemia)., Conclusion and Relevance: CHIP was significantly and independently associated with risk of CVD in patients with MM undergoing HCT and may serve as a novel biologically plausible biomarker for CVD in this cohort. Patients with MM and both CHIP and cardiovascular risk factors had an exceptionally high risk of CVD. Additional studies are warranted to determine if cardiovascular preventive measures can reduce CHIP-associated CVD risk.

Introduction: Economic hardship (EH) can negatively influence cancer outcomes. Little is known about the factors that are associated with higher levels of EH among patients with breast cancer (BC). This paper describes EH in women with early-stage BC prior to or at their first chemotherapy treatment (baseline) and explores whether there are differences by race, area deprivation, stress, symptom distress, and social support., Patients and Methods: A descriptive comparative/correlational design was employed using baseline data of a multisite, longitudinal, multimethod study comparing the symptom experience and management prior to prescribed chemotherapy for women with early-stage BC. Participants completed measures for EH, perceived stress, symptom distress, and social support. Race was measured by self-report. Area deprivation indices (ADI) measuring neighborhood economic factors were calculated from publicly available websites., Results: Participants (N = 248; age = 52.9 ± 12.3 years) were 62% White and 38% Black, 54% partnered, and 98% insured. Compared to White patients, Black patients reported higher (worse) EH (1.2 ± 3.0 vs. -0.7 ± 2.4), lived in areas of greater deprivation (80.1 ± 2.1 vs. 50.5 ± 23.5),and were more likely to report inadequate household income (Black: 30.5%; White: 11.1%). Adjusting for race and age, being Black (P< .001), living in an area of greater deprivation (P = .049), higher perceived stress (P = .008), lower perceived appraisal (P = .040), and less tangible support (P < .001) contributed to greater EH. Worse symptom distress trended toward greater EH (P = .07)., Conclusions: This study emphasizes the importance of incorporating baseline holistic assessment to identify patients most likely to experience EH during early-stage BC treatment., Competing Interests: Disclosure All authors have no conflicts of interest to disclose., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Cancer clinicians and systems aim to provide patient-centered care, but not all patients have the self-advocacy skills necessary to ensure their care reflects their needs and priorities. This study examines the feasibility, acceptability, and preliminary efficacy of a self-advocacy serious game (an educational video game) intervention in women with advanced breast or gynecologic cancer., Methods: Women with recently diagnosed (<3 months) metastatic breast or advanced gynecologic cancer were randomized 2:1 to receive a tablet-based serious game (Strong Together) (n = 52) or enhanced care as usual (n = 26). Feasibility was based on recruitment, retention, data completion, and intervention engagement. Acceptability was assessed via a postintervention questionnaire and exit interview. Preliminary efficacy was assessed on the basis of change scores from baseline to 3 and 6 months in self-advocacy (Female Self-Advocacy in Cancer Survivorship Scale) using intention-to-treat analysis., Results: Seventy-eight women (55.1% with breast cancer; 44.9% with gynecologic cancer) were enrolled. Feasibility was demonstrated by satisfactory recruitment (69% approach-to-consent rate; 93% enroll-to-randomize rate), retention (90% and 86% at 3 and 6 months, respectively; 85% data completion), and intervention engagement (84% completed ≥75% of the game). Participants endorsed the intervention's (75%) and trial's (87%) acceptability. Participants in the intervention group experienced significant improvements in self-advocacy at 3 and 6 months compared to participants in the control group., Conclusions: Strong Together is feasible and acceptable among women with advanced breast or gynecologic cancer. This intervention demonstrates promising evidence of clinical efficacy. A future confirmatory trial is warranted to test the efficacy of the intervention for patient and health system outcomes., (© 2023 American Cancer Society.)

Hematopoietic cell transplantation (HCT) and chimeric antigen receptor (CAR)-T cell patients are immunocompromised, remain at high risk following SARS-CoV-2 infection, and are less likely than immunocompetent individuals to respond to vaccination. As part of the safety lead-in portion of a phase 2 clinical trial in patients post HCT/CAR-T for hematological malignancies (HM), we tested the immunogenicity of the synthetic modified vaccinia Ankara-based COVID-19 vaccine COH04S1 co-expressing spike (S) and nucleocapsid (N) antigens. Thirteen patients were vaccinated 3-12 months post HCT/CAR-T with two to four doses of COH04S1. SARS-CoV-2 antigen-specific humoral and cellular immune responses, including neutralizing antibodies to ancestral virus and variants of concern (VOC), were measured up to six months post vaccination and compared to immune responses in historical cohorts of naïve healthy volunteers (HV) vaccinated with COH04S1 and naïve healthcare workers (HCW) vaccinated with the FDA-approved mRNA vaccine Comirnaty ® (Pfizer, New York, NY, USA). After one or two COH04S1 vaccine doses, HCT/CAR-T recipients showed a significant increase in S- and N-specific binding antibody titers and neutralizing antibodies with potent activity against SARS-CoV-2 ancestral virus and VOC, including the highly immune evasive Omicron XBB.1.5 variant. Furthermore, vaccination with COH04S1 resulted in a significant increase in S- and N-specific T cells, predominantly CD4 + T lymphocytes. Elevated S- and N-specific immune responses continued to persist at six months post vaccination. Furthermore, both humoral and cellular immune responses in COH04S1-vaccinated HCT/CAR-T patients were superior or comparable to those measured in COH04S1-vaccinated HV or Comirnaty ® -vaccinated HCW. These results demonstrate robust stimulation of SARS-CoV-2 S- and N-specific immune responses including cross-reactive neutralizing antibodies by COH04S1 in HM patients post HCT/CAR-T, supporting further testing of COH04S1 in immunocompromised populations.

Standard US practice for donation after circulatory death (DCD) abdominal organ procurement is superrapid recovery (SRR). A newer approach using thoracoabdominal normothermic regional perfusion (TA-NRP) shows promise for better recipient outcomes for all organs, but there are few reports of abdominal recipient outcomes from TA-NRP donors. We used the United Network for Organ Sharing data to identify all cardiac DCD donors from October 1, 2020, to May 20, 2022, and categorized them by recovery procedure (SRR vs TA-NRP). We then identified all liver, kidney, and pancreas recipients of these donors for whom 6-month outcome data were available and compared patient and graft survival, kidney delayed graft function (DGF), and biliary complications between TA-NRP DCD and SRR DCD organ recipients. Patient and graft survival did not differ significantly between groups for either kidney or liver recipients. Significantly fewer TA-NRP kidney recipients developed DGF (12.7% [15/118] vs 42.0% [84/200], P <.001), and TA-NRP and pumped kidneys had lower odds for DGF on multivariate analysis. No liver recipients in either group had biliary complications or were relisted for transplantation for ischemic cholangiopathy. Although long-term outcomes need to be investigated, our early results show similar outcomes for recipients of TA-NRP DCD abdominal organs versus recipients of SRR DCD abdominal organs. We believe that TA-NRP is an effective approach to expand the use of DCD organs., (Copyright © 2023 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved.)

Purpose: Disparities in cancer care persist between patients living in rural versus urban areas. The COVID-19 pandemic may have impacted concerns related to care and personal health differently in rural cancer patients. Using survey data collected from cancer patients in western Pennsylvania, we examined pandemic-related distress, concerns related to cancer care, impact on personal health, and the extent to which these differed by urban-rural residence., Methods: Patients filled out an initial survey in August-December 2020; a second survey was completed in March 2021. The following patient concerns related to the pandemic were evaluated: threat of COVID-19 to their health, pandemic-related distress, perceptions of cancer care, and vaccine hesitancy. Multivariable logistic regression models were used to examine relationships between these outcomes and urban-rural residence as well as patient-related factors, including anxiety symptoms and social support., Results: The study sample included 1,980 patients, 17% resided in rural areas. COVID-19 represented a major or catastrophic threat to personal health for 39.7% of rural and 49.0% of urban patients (p = 0.0017). Patients with high general anxiety were 10-times more likely to experience pandemic-related distress (p < 0.001). In the follow-up survey (n = 983), vaccine hesitancy was twice as prevalent among rural patients compared to urban (p = 0.012)., Conclusions: The extent to which perceptions of the threat of COVD-19 to personal health and vaccine hesitancy exacerbates rural-urban disparities in cancer care and prognosis warrants further study. Cancer patients may be vulnerable to heightened anxiety and distress triggered by the pandemic., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Patient-led advocacy organizations in the anaplastic lymphoma kinase (ALK)-positive lung cancer space are becoming increasingly influential. ALK Positive Inc. (hereafter "ALK Positive") is probably the most widely known among these organizations. Evolving from a private Facebook Support Group created in 2015 to provide a forum for ALK-positive lung cancer patients and caregivers to exchange information, empathy and support, ALK Positive transitioned in 2021 into a 501(c)(3) non-profit organization (NPO), with the mission to improve the life expectancy and quality of life for ALK-positive cancer patients worldwide. This review provides a historical perspective on the growth, activities and aspirations of ALK Positive to pursue patient advocacy and enable development of new therapies for individuals with ALK-positive cancers. This growth has been enabled by the collaborative efforts of ALK-positive cancer patients, their care-partners and oncologists, academic researchers, other NPO advocacy organizations, and members of the biotech and pharma communities who develop new therapies for ALK-positive cancers. ALK Positive has grown to provide a variety of patient services, to award competitive support for translational research and clinical trials intended to enable new therapies and improved quality and extent of life for ALK-positive cancer patients, and to collaborate with industry and academia to accelerate the development of improved therapies for ALK-positive cancer patients. ALK Positive continues grappling with a variety of challenges including further improving patient quality of life, enabling the development of new therapies, and extending its already substantial global reach and impact. This review summarizes many of the tangible impacts and aspirations engendered by ALK Positive for ALK-positive cancer patients in the past, present and future tenses-where we have been, where we stand and where we hope to go. The content is based on the historical recollections of the authors, and is accurate as of November 30, 2022, to the best of the authors' knowledge., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-22-713/coif). The series “ALK-Positive NSCLC” was commissioned by the editorial office without any funding or sponsorship. CB reports payments received from Genentech and Pfizer, and participates on advisory boards of University of Michigan, Judy Tam ALK Lung Cancer Initiative and ALK Positive Medical Committee. SHF reports payments or honoraria received from Nuvalent, Daiichi Sankyo, Inc. and ASCO Advantage, support from American Lung Association, Lung Force Advocacy Day Hero, and participates on board for ALK Positive, and University of Pennsylvania Telehealth Research Center of Excellence-Penn Trace Advisory Board. AMK is the founding member of and participates on board of ALK Positive Europe. DM participates as Accounting, Fundraising and Second Opinion Program roles for ALK Positive, and holds stock or stock options of Johnson & Johnson. NP participates on Board of Directors for ALK Positive. CV received monetary support for attending ASCO 2022 conference as a patient advocate, and participates on Research Acceleration Committee of ALK Positive. ESV is a member of the ALK Survey Working Group of the Lung Cancer Registry, created by GO2 for Lung Cancer, and is a member of the ALK Positive. Medical Committee. MATM received consulting fees from Summation Bio Inc., Black Diamond Therapeutics, and Civetta Therapeutics, and reports pending patent applications (Epigenetics and protein production, and Sequences and gene therapy), participated on the Scientific Advisory Board of Summation Bio Inc. and participates on the Medical Committee and the Board of Directors of ALK Positive. The authors have no other conflicts of interest to declare., (2023 Translational Lung Cancer Research. All rights reserved.)

Purpose: Primary palliative care (PPC) interventions are needed to address unmet symptom needs within standard oncology care. We designed an oncology nurse-led PPC intervention using shared care planning to facilitate patient engagement. This analysis examines the prevalence and severity of symptoms reported by patients and how symptoms were addressed on shared care plans (SCPs). Methods: Secondary analysis of a cluster randomized PPC intervention trial. Adult patients with metastatic solid tumors whose oncologist "would not be surprised if the patient died within a year" were included. Twenty-three oncology nurses received PPC training and conducted up to three monthly visits with patients. Symptom prevalence and severity were assessed before each visit using the Edmonton Symptom Assessment Scale (ESAS). Nurses collaboratively developed treatment strategies with patients, targeting the most bothersome symptoms for improvement. Results: Among 571 nurse-led PPC visits with 235 patients, the most prevalent and severe symptoms were tiredness (reported at 86% of visits; ESAS ≥4 in 55% of visits), low sense of wellbeing (78%; ESAS ≥4 in 38%), and poor appetite (69%; ESAS ≥4 in 42%). Moderately severe symptoms were addressed on SCPs ranging from 4% (drowsiness) to 35% (tiredness) of the time. Symptom management plans developed by PPC-trained oncology nurses primarily focused on nonpharmaceutical interventions (70%) compared with pharmaceutical interventions (30%). Conclusion: The symptoms that patients report most frequently and as most severe on SCPs were addressed less frequently than expected. Further research is needed to understand how PPC interventions can be designed to more effectively target and improve bothersome symptoms for patients with advanced cancer. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT02712229.

Background: Self-advocacy skills allow individuals with cancer to overcome challenges related to their health, care, and well-being. Understanding the self-advocacy behaviors and needs of individuals with cancer is critical to addressing the lack of evidence-based self-advocacy interventions. The aims of this study are to describe (1) self-advocacy behaviors and needs of women with advanced cancer and (2) associations between self-advocacy and sociodemographic, cancer, and patient-reported outcomes., Methods: We analyzed cross-sectional data from a clinical trial among women within 3 months of a metastatic breast or stage III or IV gynecologic cancer diagnosis. Descriptive and correlational statistics and tests of group difference were calculated for measures of self-advocacy (Female Self-Advocacy in Cancer Survivorship Scale), sociodemographic characteristics, quality of life (FACT-G), symptom burden (M.D. Anderson Symptom Inventory), and mood (Hospital Anxiety and Depression Scale)., Results: Participants (N = 78) reported self-advocacy behaviors including making decisions based on their priorities, asking questions to their healthcare providers, and comparing their experiences to others' experiences. Self-advocacy needs focused on finding health information and talking with healthcare providers. Self-advocacy behaviors and needs did not differ by participants' sociodemographic characteristics or mood. Higher self-advocacy behaviors were associated with higher quality of life (p ≤ .01) and lower symptom severity (p < .05) with a trend for cancer recurrence (p = .05)., Conclusions: Women with advanced cancer report engaging in self-advocacy behaviors and these are associated with higher quality of life and lower symptom burden. Future research should determine if self-advocacy behaviors and needs change over time and how patient characteristics impact self-advocacy behaviors and needs., (© 2022. International Society of Behavioral Medicine.)

Background: Palliative care specialists are experts in conducting advance care planning (ACP) but are a limited resource. Oncology nurses often have special relationships with their patients and thus may be poised to provide primary palliative care. We sought to determine the impact of a nurse-led primary palliative care intervention on ACP uptake among patients with advanced cancer., Methods: We performed a secondary analysis of a cluster randomized controlled trial examining the impact of nurse-based primary palliative care. In the parent trial, patients with advanced cancer received either monthly primary palliative care visits with trained nurses within their cancer center or standard care. Nurses in the intervention arm received special training in ACP. ACP uptake was assessed at enrollment and 3 months later evaluating (1) whether an end-of-life conversation (EOLC) occurred with one's oncologist, and (2) completion of an advance directive (AD). Multivariable logistic regression tested differences in ACP uptake by treatment arm adjusted for age, religious importance, education, time with current oncologist, and performance status., Results: Of 672 patients enrolled, 182/336 (54%) patients in the intervention arm and 196/336 (58%) in the standard care arm lacked an EOLC at baseline and completed the 3-month assessment. Of those, 82/182 (45.1%) patients in the intervention arm and 29/196 (14.8%) in the standard care arm reported having an EOLC at 3 months (adjusted odds ratio, 5.28; 95% CI, 3.10-8.97; P<.001). Similarly, 111/336 (33%) patients in the intervention arm and 105/336 (31%) in the standard care arm lacked an AD at baseline and completed the 3-month assessment. Of those, 48/111 (43.2%) patients in the intervention arm and 19/105 (18.1%) in the standard care arm completed an AD over the study period (adjusted odds ratio, 3.68; 95% CI, 1.89-7.16; P<.001)., Conclusions: Nurse-led primary palliative care increased ACP uptake among patients with advanced cancer. Training oncology nurses embedded within community cancer centers to provide primary palliative care may help improve ACP access.

In the current post-pandemic era, recipients of an allogeneic hematopoietic stem cell transplant (HCT) deserve special attention. In these vulnerable patients, vaccine effectiveness is reduced by post-transplant immune-suppressive therapy; consequently, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19) is often associated with elevated morbidity and mortality. Characterizing SARS-CoV-2 adaptive immunity transfer from immune donors to HCT recipients in the context of immunosuppression will help identify optimal timing and vaccination strategies that can provide adequate protection to HCT recipients against infection with evolving SARS-CoV-2 variants. We performed a prospective observational study (NCT04666025 at ClinicalTrials.gov) to longitudinally monitor the transfer of SARS-CoV-2-specific antiviral immunity from HCT donors, who were either vaccinated or had a history of COVID-19, to their recipients via T-cell replete graft. Levels, function, and quality of SARS-CoV-2-specific immune responses were longitudinally analyzed up to 6 months post-HCT in 14 matched unrelated donor/recipients and four haploidentical donor/recipient pairs. A markedly skewed donor-derived SARS-CoV-2 CD4 T-cell response was measurable in 15 (83%) recipients. It showed a polarized Th1 functional profile, with the prevalence of central memory phenotype subsets. SARS-CoV-2-specific IFN-γ was detectable throughout the observation period, including early post-transplant (day +30). Functionally experienced SARS-CoV-2 Th1-type T cells promptly expanded in two recipients at the time of post-HCT vaccination and in two others who were infected and survived post-transplant COVID-19 infection. Our data suggest that donor-derived SARS-CoV-2 T-cell responses are functional in immunosuppressed recipients and may play a critical role in post-HCT vaccine response and protection from the fatal disease., Clinical Trial Registration: clinicaltrials.gov, identifier NCT04666025., Competing Interests: CLR received consulting fees and research funding from Helocyte Inc. DJD received consulting fees, patent royalties, research funding, and fees for serving on the advisory board of Helocyte Inc. In addition, DJD has two patents, 8,580,276 and 9,675,689, that are licensed to Helocyte. DJD and FC are co-inventors of the Patent Cooperation Treaty PCT application that covers the development of a COVID-19 vaccine PCT/US2021/032821 licensed to GeoVax Labs Inc. DD receives consulting fees and research support from GeoVax Labs Inc. RN is a consultant for Omeros, Bluebird, Viracor Eurofins, Magenta Therapeutics, Kadmon, and Napajen Pharma; received research funding from Helocyte, Miyarisan Pharmaceutical; and receives travel, accommodations, expenses from Kyowa Hakko Kirin, Alexion Pharmaceuticals. SD is a consultant for Merck, Allovir, and Aseptiscope; an Advisory board for Merck and Aseptiscope; an investigator for Allovir, Merck, Ansun, Gilead, Janssen, Shire/Takeda; and on the speaker’s bureau of Merck, Takeda, and Astellas. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 La Rosa, Chiuppesi, Park, Zhou, Yang, Gendzekhadze, Ly, Li, Kaltcheva, Ortega Francisco, Gutierrez, Ali, Otoukesh, Amanam, Salhotra, Pullarkat, Aldoss, Rosenzweig, Aribi, Stein, Marcucci, Dadwal, Nakamura, Forman, Al Malki and Diamond.)

Purpose: Patients with advanced cancer experience many complicated situations that can make self-advocacy (defined as the ability speak up for yourself in the face of a challenge) difficult. Few self-advocacy interventions exist, and most are atheoretical with minimal patient engagement. The purpose of this study is to describe participant perspectives of a novel, self-advocacy serious game intervention called Strong Together., Methods: This was a qualitative cross-sectional descriptive study among women receiving cancer care at an academic cancer center within 3 months of an advanced gynecologic or breast cancer diagnosis. Participants randomized to receive the intervention completed one-on-one semi-structured interviews 3-months post Strong Together and had the option to share voice journals about their experiences. Inductive qualitative approaches were used to descriptively analyze transcripts and voice journals. Descriptive content analysis approaches were used to group similar codes together into themes summarizing participants' experiences engaging with the Strong Together intervention., Results: Participants (N = 40) reported that the Strong Together intervention was acceptable, noting that it was realistic and reflective of their personal experiences. Overarching themes included seeing myself in most scenarios and wanting more content; giving me the go ahead to expect more; offering ideas for how to stand up for myself; reinforcing what I am already doing; and reminding me of what I have. Participants suggested adding additional content including diverse characters., Conclusion: This study demonstrated that women with advanced cancer were receptive to a self-advocacy skills-building intervention. Future research should explore the mechanisms linking serious games to learning and health outcomes., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Vaccines for SARS-CoV-2 have been considerably effective in reducing rates of infection and severe COVID-19. However, many patients, especially those who are immunocompromised due to cancer or other factors, as well as individuals who are unable to receive vaccines or are in resource-poor countries, will continue to be at risk for COVID-19. We describe clinical, therapeutic, and immunologic correlatives in two patients with cancer and severe COVID-19 who were treated with leflunomide after failing to respond to standard-of-care comprising remdesivir and dexamethasone. Both patients had breast cancer and were on therapy for the malignancy., Methods: The protocol is designed with the primary objective to assess the safety and tolerability of leflunomide in treating severe COVID-19 in patients with cancer. Leflunomide dosing consisted of a loading dose of 100 mg daily for the first three days, followed by daily dosing, at the assigned dose level (Dose Level 1: 40 mg, Dose Level -1, 20 mg; Dose Level 2, 60 mg), for an additional 11 days. At defined intervals, serial monitoring of blood samples for toxicity, pharmacokinetics, and immunologic correlative studies were performed, as well as nasopharyngeal swabs for PCR analysis of SARS-CoV-2., Results: Preclinically, leflunomide impaired viral RNA replication, and clinically, it led to a rapid improvement in the two patients discussed herein. Both patients completely recovered, with minimal toxicities; all adverse events experienced were considered unrelated to leflunomide. Single-cell mass-cytometry analysis showed that leflunomide increased levels of CD8+ cytotoxic and terminal effector T cells and decreased naïve and memory B cells., Conclusions: With ongoing COVID-19 transmission and occurrence of breakthrough infections in vaccinated individuals, including patients with cancer, therapeutic agents that target both the virus and host inflammatory response would be helpful despite the availability of currently approved anti-viral agents. Furthermore, from an access to care perspective, especially in resource-limited areas, an inexpensive, readily available, effective drug with existing safety data in humans is relevant in the real-world setting., Competing Interests: Conflict of Interest The authors declare that they have no competing interests that are relevant to this study.

Background: Women with advanced cancer experience significant barriers to achieving high-quality care and maximizing their physical and emotional health. Our novel serious game, Strong Together, aims to teach women with advanced cancer self-advocacy skills needed to improve their symptom burden, quality of life, and patient-centered care., Methods: This is a single-center, multi-site randomized clinical trial of the Strong Together intervention among 336 women within three months of an advanced breast or gynecologic cancer diagnosis. Randomization occurs to the 3-month Strong Together serious game or enhanced care as usual group. The aims are to: (1) evaluate the effects of the intervention on patient self-advocacy (primary outcome); (2) evaluate the effects of the intervention on quality of life, symptom burden, and patient-centered care (secondary outcomes); and (3) evaluate the behavioral and game mechanisms that influence the efficacy of the intervention., Eligibility Criteria: female, age ≥ 18 years; diagnosis of advanced breast or gynecologic cancer within the past 3 months; Eastern Cooperative Oncology Group score of 0-2; English literacy; and ≥ 6-month life expectancy. Patient-reported outcome measures are collected at baseline, 3-months, and 6-months., Conclusion: This protocol is the first large-scale intervention aimed at promoting self-advocacy in women with advanced cancer. Understanding the ability of serious games to impact patient outcomes provides critical information for researchers, clinicians, and stakeholders aiming to improve patient-centered care., Trial Registration: NCT04813276., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Aggregation equations, such as the parabolic-elliptic Patlak-Keller-Segel model, are known to have an optimal threshold for global existence versus finite-time blow-up. In particular, if the diffusion is absent, then all smooth solutions with finite second moment can exist only locally in time. Nevertheless, one can ask whether global existence can be restored by adding a suitable noise to the equation, so that the dynamics are now stochastic. Inspired by the work of Buckmaster et al. (Int Math Res Not IMRN 23:9370-9385, 2020) showing that, with high probability, the inviscid SQG equation with random diffusion has global classical solutions, we investigate whether suitable random diffusion can restore global existence for a large class of active scalar equations in arbitrary dimension with possibly singular velocity fields. This class includes Hamiltonian flows, such as the SQG equation and its generalizations, and gradient flows, such as those arising in aggregation models. For this class, we show global existence of solutions in Gevrey-type Fourier-Lebesgue spaces with quantifiable high probability., (© The Author(s) 2022.)

Background: Transplanting kidneys from donors with a recent history of severe SARS-CoV-2 pneumonia is uncommon due to concerns about the risk of viral transmission and the quality of kidneys from these donors. To date, there are no conclusive data on viral transmission from extrapulmonary solid organ transplants. Given the prevalence of SARS-CoV-2 infections in potential donors, shortage of kidneys available for transplantation, and low risk of viral transmission, we developed a clinical protocol for accepting kidneys from donors with recent severe SARS-CoV-2 pneumonia who demonstrate preserved kidney function., Materials and Methods: We collected data on early outcomes of 5 kidney transplant recipients from 4 deceased donors hospitalized for severe SARS-CoV-2 infection., Results: Donor creatinine ranged from 0.51 to 0.60 mg/dL and kidney donor profile index (KDPI) from 14 to 52%. Three of the five kidneys were from donation after circulatory death. All recipients were fully vaccinated, and 4/5 received post-exposure prophylactic monoclonal antibody treatment. While 3 recipients had delayed graft function, all had excellent graft function at 3 or 4 weeks post-operatively. None of the recipients displayed signs or symptoms of SARS-CoV-2 infection post-transplant., Conclusion: Our findings suggest that kidney grafts from donors with a recent history of severe SARS-CoV-2 infection but with preserved kidney function can be safely used and have good early outcomes.

In the phase 3 ANDROMEDA trial, patients treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone (D-VCd) had significantly higher rates of organ and hematologic response compared with patients who received VCd alone. Here, we present patient-reported outcomes (PROs) from the ANDROMEDA trial. PROs were assessed through cycle 6 using three standardized questionnaires. Treatment effect through cycle 6 was measured by a repeated-measures, mixed-effects model. The magnitude of changes in PROs versus baseline was generally low, but between-group differences favored the D-VCd group. Results were generally consistent irrespective of hematologic, cardiac, or renal responses. More patients in the D-VCd group experienced meaningful improvements in PROs; median time to improvement was more rapid in the D-VCd group versus the VCd group. After cycle 6, patients in the D-VCd group received daratumumab monotherapy and their PRO assessments continued, with improvements in health-related quality of life (HRQoL) reported through cycle 19. PROs of subgroups with renal and cardiac involvement were consistent with those of the intent-to-treat population. These results demonstrate that the previously reported clinical benefits of D-VCd were achieved without decrement to patients' HRQoL and provide support of D-VCd in patients with AL amyloidosis., (© 2022 Wiley Periodicals LLC.)

Objectives: To examine (a) the impact of the COVID-19 pandemic on anxiety and post-traumatic stress disorder (PTSD) symptoms and (b) the impact of socioeconomic factors on COVID-19-related anxiety and PTSD symptoms., Sample & Setting: Women with early-stage invasive breast cancer who were receiving chemotherapy in western Pennsylvania and eastern Ohio., Methods & Variables: Baseline study variables included economic hardship, interpersonal relationships, and perceived stress. PTSD and anxiety symptoms were collected in June 2020 (T1) and February 2021 (T2). Group comparisons were made using paired-sample t tests, analysis of variance, and Pearson correlations., Results: There were 88 women at T1 and 64 women at T2. At T1, PTSD symptom scores were significantly associated with less interpersonal support, greater economic hardship, and greater perceived stress. Anxiety scores were associated with perceived stress. At T2, anxiety scores were still associated with perceived stress. However, PTSD symptom scores were no longer associated with interpersonal support, economic hardship, or perceived stress., Implications for Nursing: Anxiety and PTSD symptom measurement during a global pandemic is needed to identify vulnerable patients with breast cancer who need targeted support and emergency guidance in nursing practice.

Estrogen receptor alpha (ER/ESR1) is frequently mutated in endocrine resistant ER-positive (ER+) breast cancer and linked to ligand-independent growth and metastasis. Despite the distinct clinical features of ESR1 mutations, their role in intrinsic subtype switching remains largely unknown. Here we find that ESR1 mutant cells and clinical samples show a significant enrichment of basal subtype markers, and six basal cytokeratins (BCKs) are the most enriched genes. Induction of BCKs is independent of ER binding and instead associated with chromatin reprogramming centered around a progesterone receptor-orchestrated insulated neighborhood. BCK-high ER+ primary breast tumors exhibit a number of enriched immune pathways, shared with ESR1 mutant tumors. S100A8 and S100A9 are among the most induced immune mediators and involve in tumor-stroma paracrine crosstalk inferred by single-cell RNA-seq from metastatic tumors. Collectively, these observations demonstrate that ESR1 mutant tumors gain basal features associated with increased immune activation, encouraging additional studies of immune therapeutic vulnerabilities., (© 2022. The Author(s).)

Purpose: Patients with advanced cancer often have unrealistic expectations about prognosis and treatment. This study assessed the effect of an oncology nurse-led primary palliative care intervention on illness expectations among patients with advanced cancer., Methods: This study is a secondary analysis of a cluster-randomized trial of primary palliative care conducted at 17 oncology clinics. Adult patients with advanced solid tumors for whom the oncologist would not be surprised if died within 1 year were enrolled. Monthly visits were designed to foster realistic illness expectations by eliciting patient concerns and goals for their medical care and empowering patients and families to engage in discussions with oncologists about treatment options and preferences. Baseline and 3-month questionnaires included questions about life expectancy, treatment intent, and terminal illness acknowledgment. Odds of realistic illness expectations at 3 months were adjusted for baseline responses, patient demographic and clinical characteristics, and intervention dose., Results: Among 457 primarily White patients, there was little difference in realistic illness expectations at 3 months between intervention and standard care groups: 12.8% v 11.4% for life expectancy (adjusted odds ratio [aOR] = 1.15; 95% CI, 0.59 to 2.22; P = .684); 24.6% v 33.3% for treatment intent (aOR = 0.76; 95% CI, 0.44 to 1.27; P = .290); 53.6% v 44.7% for terminal illness acknowledgment (aOR = 1.28; 95% CI, 0.81 to 2.00; P = .288). Results did not differ when accounting for variation in clinic sites or intervention dose., Conclusion: Illness expectations are difficult to change among patients with advanced cancer. Additional work is needed to identify approaches within oncology practices that foster realistic illness expectations to improve patient decision making., Competing Interests: Teresa H. ThomasConsulting or Advisory Role: Healthline Media, Mashup Media Robert M. ArnoldOther Relationship: UpToDate, VitaTalk Douglas WhiteConsulting or Advisory Role: UpToDate Inc Thomas J. SmithEmployment: UpToDateHonoraria: Athenex, Association of Community Cancer Centers (ACCC)Patents, Royalties, Other Intellectual Property: Royalties from Oxford Textbook of Cancer Communication, coeditorOpen Payments Link: https://openpaymentsdata.cms.gov/physician/202382/general-payments Kenneth J. SmithResearch Funding: Nico Corporation (Inst) Yael SchenkerHonoraria: UpToDateNo other potential conflicts of interest were reported.

Background: In metastatic breast cancer (MBC), positive estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2) status allow for more long-term, sequential treatment options compared to ER-negative and HER2-negative diseases. It is unclear if end-of-life care (timely integration of palliative care, discontinuation of chemotherapy, and enrollment into hospice) in MBC is now tailored to the ER and HER2 status., Objectives: This article explores the association between ER and HER2 status and the quality of end-of-life care received among patients with MBC., Methods: A 20-year MBC clinical database captured demographics, tumor characteristics, and treatment histories of deceased patients with MBC (N = 1,258) at a tertiary hospital located in Pittsburgh, Pennsylvania. Descriptive and inferential statistics were used., Findings: Patients with ER-positive MBC had greater odds of receiving quality end-of-life care than those with ER-negative MBC. HER2 status was not associated with differences in the quality of end-of-life care.

Minimally invasive procurement of uterine grafts for transplantation can decrease living donor recovery time. We examined recipient outcomes for grafts procured by robotic-assisted donor hysterectomies with transvaginal extraction in the Dallas UtErus Transplant Study (DUETS). All 5 grafts were successfully transplanted. Recipients had a median 4.5-hour surgical time, 0.25 L estimated blood loss, and 4-day hospital stay. Four recipients had grade III surgical complications and three had acute cellular rejection. At 18 months, graft viability was 100%, with an 80% live birth rate. This report demonstrates the feasibility and reproducible success of using uterus grafts from living donors who underwent robotic-assisted donor hysterectomy., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Given limited evidence on opioid prescribing among patients receiving treatment for cancer during the ongoing opioid epidemic, our objective was to assess predictors of and trends in opioid receipt during cancer treatment, including how patterns differ by type of cancer., Methods: Using cancer registry data, we identified patients with a first lifetime primary diagnosis of breast, colorectal, or lung cancer from 2013 to 2017 who underwent treatment within a large cancer center network. Cancer registry data were linked to electronic health record information on opioid prescriptions. We examined predictors of and trends in receipt of any opioid prescription within 12 months of cancer diagnosis., Results: The percentage of patients receiving opioids varied by cancer type: breast cancer, 35% (1,996/5,649); colorectal, 37% (776/2,083); lung, 47% (1,259/2,654). In multivariable analysis, opioid use in the year before cancer diagnosis was the factor most strongly associated with receipt of opioids after cancer diagnosis, with 4.90 (95% CI, 4.10-5.86), 5.09 (95% CI, 3.88-6.69), and 3.31 (95% CI, 2.68-4.10) higher odds for breast, colorectal, and lung cancers, respectively. We did not observe a consistent decline in opioid prescribing over time, and trends differed by cancer type., Conclusions: Our findings suggest that prescription of opioids to patients with cancer varies by cancer type and other factors. In particular, patients are more likely to receive opioids after cancer diagnosis if they were previously exposed before diagnosis, suggesting that pain among patients with cancer may commonly include non-cancer-related pain. Heterogeneity and complexity among patients with cancer must be accounted for in developing policies and guidelines aimed at addressing pain management while minimizing the risk of opioid misuse.

Introduction: Rapid source control laparotomy (RSCL) for the management of non-traumatic intra-abdominal emergencies has increased over the past 25 years when it was advocated for trauma patients. Little data, however, support its widespread use. We hypothesize that the patients with RSCL will have poorer outcomes than those treated with primary fascial closure (PFC)., Methods: Patients operated for acute diverticulitis from 2014 to 2016 using The American College of Surgeons sponsored National Surgical Quality Improvement Program (NSQIP) data were reviewed. Two groups were identified: PFC, patients with their closed fascia but skin left open (PFC) and RSCL, patients with their left open fascia after the initial operation. The primary outcome of the study was 30-day mortality, with secondary analyses evaluating complications, discharge location and length of stay. Univariate analysis was initially performed followed by propensity score matching., Results: A total of 460 patients were surgically treated for Hinchey IV diverticulitis of whom 101 (21.9%) had RSCL. The length of stay of the RSCL patients was significantly longer (15 versus 12 days, p, 0.02) than patients in the PFC group. Similarly, the discharge destination for the PFC group was twice as likely to be discharged home as the RSCL group., Conclusion: RSCL for acute diverticulitis is a widely used but is associated with prolonged hospitalizations resulting in high rates of discharge to skilled nursing or rehabilitation facilities. Its routine use for diverticulitis should be limited., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Biobanking is one of the most valuable tools in precision medicine. The ability of scientists to sequence tumors, blood, and normal tissue obtained from biorepositories has defined efficacious tumor targeting and a much better understanding of cancer pathology pathways. However, these biorepositories require a great deal of effort to establish and maintain. Oncology nurses are key in helping to bank tissue during routine procedures as well as complex surgeries. Nurses can obtain informed consent from patients and coordinate the banking of samples in a timely manner to ensure sample quality. Oncology nurses play an important role in informing patients of their biobanking options and connecting patients with the appropriate team for their biobanking needs.

There is growing interest in tissue procurement for cancer research through autopsy. Establishing an autopsy/tissue donation programme for breast cancer research within an academic medical centre in the United States requires consideration, planning, multi-departmental collaboration and labour-intensive maintenance. It is the purpose of this paper to outline the necessary considerations in implementing and maintaining a tissue donation and autopsy programme within a breast cancer centre at a comprehensive cancer centre. Considerations of programme planning include: patient engagement, the recruitment of patients and families into the programme, the role and scope of work of the clinical coordinator, regulatory issues and the coordination with both pathology and the research team at time of death and autopsy/tissue donation. All aspects of the tissue donation/rapid autopsy programme development and implementation are discussed and illustrated through case study. An Autopsy/ Tissue Donation for breast cancer research can be successfully developed and implemented.