bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluation of emergency department visits in patients treated with immune checkpoint inhibitors.
Authors: Guven Deniz Can , Sahin Taha Koray , Aksun Seren , Taban Hakan , Aktepe Oktay Halit , metin Aksu Nalan , Akkas Meltem , Erman Mustafa , Kilickap Saadettin , Dizdar Omer , Aksoy Sercan 
Published: May 2020

e24160 Background: Immune checkpoint inhibitors (ICIs) are the main drugs for immunotherapy. Their efficacy comes at the expense of adverse events including immune-related adverse events (IRAEs). The emergency department (ED) is an important encounter point in the cancer care. However, the data on the causes of ED visits is scarce. Therefore, we evaluated the ED visits of patients treated with ICIs and tried to determine the predisposing factors. Methods: We performed a retrospective review of adult cancer patients treated with ICIs for any cancer type between 09/2014 and 06/2019 in Hacettepe University Cancer Center. The data about ED visits after the first dose of ICIs to six months after the last dose of ICIs was collected from the hospital registries. Baseline characteristics, stages and types of patients’ tumors, types of ICI, causes for emergency visits and hospital admissions were recorded. Results: A total of 221 patients were included. The median age was 60.7 years (18-86) and 65.6% of patients were males. Median follow-up was 9 months (0.2-55). Nivolumab was the most common immunotherapy (67.9%). Melanoma was the most common diagnosis (27.6%) followed by kidney and lung cancer. 90% of patients had advanced disease and more than half of patients were treated with two or more lines of therapy. The 83 patients (37.6%) had at least one emergency department (ED) visit. Half of these visits resulted in hospital admissions. Thirty-eight patients had more than one ED visits with 14 patients having three or more ED visits. Immune-related adverse events comprised less than 10% of the ED visits with most of the ED visits were related to symptoms attributable to disease burden itself. The median time to ED visit after the first dose of ICI was 126 days. While baseline ECOG status, age, polypharmacy (defined as the regular use of five or more drugs), concomitant chemotherapy, eosinophilia and lactate dehydrogenase levels didn’t significantly increase the risk, patients with regular opioid use and baseline neutrophilia ( > 8000) had a statistically significant risk of ED visits (p values 0.001 and 0.19 respectively). These two factors remained significant in the multivariate analyses. Conclusions: In this study, almost 40% of ICI treated patients had ED visits. Recognition and addressing of this patient group’s problems in the ED is very important as evidenced by ability to discharging half of patients from the ED. Collaboration between the other specialists like emergency medicine specialists is vital for improving the care of patients treated with immunotherapy.
“Where did you read that?” External sources of information and patients perceptions of prognostic goals.
Authors: Patell Rushad , Einstein David Johnson , Miller Eric James , Halleck Jennifer , Dodge Laura , Buss Mary K. 
Published: May 2020

e24166 Background: Patients receiving palliative cancer treatment frequently misperceive likelihood of benefits/toxicity. Physicians fear that external sources of information regarding treatment enhance misperceptions and complicate decision-making. We investigated the sources of external information used, how much it affects patients' misperception and influences their treatment choices. Methods: We prospectively surveyed patients with advanced solid cancers and their oncologists regarding benefits/risks of palliative therapies including likelihood of tumor response and toxicity. Patients reported information-seeking behavior pre-treatment. We compared patients’ perceptions of benefits/risks to that of their oncologists. Results: Across four disease groups, 119 eligible patients enrolled. Their median age was 65 years (range 59–73), 55% were male, and 56% had undergone prior treatment. Treatments included chemotherapy (61%), targeted therapy (15%), and immunotherapy (24%). Over two thirds, 69% of participants stated that they wanted as much as possible information from their oncologist, and nearly all (95%) stated that they felt the amount of information provided by their clinician was “just right.” However, 60% wanted at least a moderate amount of information from external sources, and 58% reported obtaining information from sources other than their oncologist. The most common external sources of information used by participants were printed materials (35%), word of mouth (26%), the American Cancer Society (24%), and WebMD (21%). Nearly one in 3 (31%) of participants felt the information from external sources influenced their decisions more than a small amount. There was no correlation between self-education and misperception of tumor response (coefficient -0.04 p = 0.6) or of treatment toxicity (coefficient 0.05, p = 0.6) relative to their treating physicians’ estimates. Conclusions: While many patients sought information from external sources, most felt they were not substantially influenced by this information. Almost all felt their oncologists provided them with adequate information. Information-seeking behavior was not associated with greater misperception regarding the treatment goals/expectations. Thus, despite a common concern about misinformation in external information sources, oncologists should support patients who seek such sources and discuss their findings.
Accuracy of oncology patients’ expectations of cure.
Authors: Shin Paul , Romano Danielle R. , Bernal Camila , Knezevic Andrea , Desai Anjali V. , Nelson Judith Eve , Epstein Andrew S. 
Published: May 2020

e24167 Background: Efficacy of chemotherapy in gastrointestinal (GI) cancers is a well-studied endpoint. Patients require a realistic understanding of likely benefits to make informed treatment decisions. Prior studies show that patients with incurable cancer do not understand the palliative role of treatment. Patient understanding of chemotherapy intent (curative v. palliative) across all stages of GI cancers and modifying factors is unknown. Methods: Ambulatory clinic patients with GI cancers newly presenting for treatment answered validated questions on illness and treatment intent1 as part of an initiative integrating palliative care at diagnosis regardless of stage. Patients were asked to estimate probability of cure from chemotherapy with Likert responses (range ‘not at all likely’ to ‘very likely’). Two experienced oncologists (GI medical and surgical) independently assessed accuracy of patient response after reviewing patient data and grade one clinical evidence. (E.g. Patient with locally advanced stage II rectal cancer who felt chemotherapy was "somewhat likely" to be curative deemed to be 'accurate') Responses were coded as accurate or inaccurate and accuracy was compared between clinical factors with Chi-square test. Results: For 113 patients, median age was 59, 62% were male, 55% had stage IV disease. Patients were diagnosed with colon (27%), anorectal (25%), pancreatic (21%), biliary (13%), or other GI cancer (14%). There was 99% clinician agreement rating accuracy. 51 (45%) patients responded accurately. Accuracy was lower in stage IV vs. stage I-III disease (35% v 57%, p=0.02), lower in unresectable vs. resectable disease (32% v 64%, p=0.001) and higher in adjuvant vs. non-adjuvant setting of chemotherapy for stage I-III patients. (80% vs. 42%, p=0.007) Accuracy did not differ significantly by gender, age, cancer, prior surgeon visit or DNR status. Conclusions: Inaccurate perceptions about likelihood of cure with chemotherapy are prevalent across all stages of GI cancers, but particularly amongst patients with advanced GI cancer. Patients receiving adjuvant chemotherapy were more likely than metastatic patients to have accurate understanding. Next steps include mixed methods analysis of qualitative data from this cohort to evaluate factors driving inaccurate understanding of treatment. 1Weeks J et al. “Patients’ expectations about effects of chemotherapy for advanced cancer.” NEJM 367 (2012): 1616-1625.
Neural mechanisms of impaired executive function in untreated colorectal cancer patients.
Authors: Anderson David , Garlinghouse Matthew , Hauger Arica , Moody Alison , Berger Ann M. , Grem Jean L. 
Published: May 2020

e24170 Background: Cancer-related cognitive impairment (CRCI) affects 45% of colorectal cancer (CRC) patients prior to treatment. This study aimed to explore the neural mechanisms of CRCI in this severely understudied population by using a combination of neuropsychological and cognitive neurophysiology assessments. Methods: Newly diagnosed Stage I-IV CRC patients were recruited at a Midwestern tertiary medical center. Enrollment criteria included normal or corrected to normal vision and no prior cancer within 3 years. Healthy comparisons were recruited and demographically-matched to Stage III/IV patients scheduled to receive chemotherapy. Participants completed neuropsychological measures of processing speed, psychomotor speed, executive function, and verbal memory at study baseline. We recorded scalp electroencephalography while participants performed a computer-based cognitive task designed to measure control over spatial attention. Two event-related potentials were measured following presentation of a task-irrelevant spatial cue: (1) N2, a neural correlate of stimulus selection emerging approximately 160 milliseconds after stimulus presentation; and (2) N2pc, a neural correlate of spatial attention allocation emerging approximately 200 milliseconds after stimulus presentation. Results: CRC patients were enrolled within 4-8 weeks following surgery for Stage I (11%), II (31%), and III (35%) CRC; Stage IV patients (23%) started chemotherapy without surgery. Patients (n = 26) and controls (n = 14) were matched on age and gender; patients were trending toward lower education than controls (p = .06). Patients performed worse than controls on executive function assessments (Trials B: p = .049; Stroop: p = .025). N2 amplitudes were smaller in patients than controls (p = 0.032. N2pc amplitudes were larger in patients than controls (p = .092). N2 amplitudes were associated with Stroop interference scores (r = 0.50, p = .068). Conclusions: CRC patients demonstrated impaired executive function performance at baseline. Neurophysiological data suggest impairments may emerge from limited neural resources available for stimulus selection and poor control over spatial attention. Correlations between neurophysiological data and executive function performance suggest participants better able to overcome task-irrelevant interference had relatively more neural resources available for stimulus selection. Overall, these results suggest patients may be limited in their ability to focus their attention on caregiver and health care team instructions. Clinical trial information: NCT03683004 .
Lessons on humanity: The voice of cancer patients through a literary contest.
Authors: Niewiadomski Darío , Gil Deza Ernesto , Gercovich Daniela , Gil Deza Lourdes , Acuna Claudia Lorena , Smolje Leonel , Ares Sandra L. , Gercovich Natasha , Marin Ordoñez Alba , Muino Marcelo , Danussi Inés , Tognelli Flavio , Dragosky Marta , Morgenfeld Eduardo L. , Rivarola Edgardo G. J. , Gercovich Felipe G. 
Published: May 2020

e24189 Background: Most cancer narratives are provided by skilled American and British writers (Broyard, Hitchens, Jobs, Kalanithi, Pausch, Sacks, Sontag or Wishart). This paper highlights the voice of ordinary Latin American patients who wrote about their experience. Methods: Between February 2, 2019 and March 3, 2019, the first author encouraged cancer patients to narrate their experience with the disease for an online literary contest (“ www.oncologiaesperanzadora.com ”). After studying all submissions, we grouped attitudes, feelings, metaphors and descriptions used in different domains related to the course of the disease. A text-mining study was conducted to identify the context of keywords in each of the domains. Results: In total, 224 literary works were submitted to the contest. Characteristics of the population: sex F/M: 184/40; age at time of contest: 53 yo (18-82); time between diagnosis and submission to contest: 8 y (1-73); country of origin: Argentina (201), other countries (23); diagnosis: breast (130), hematological (15), colorectal (13), melanoma (6), lung (5), head and neck (5), kidney (3), other (47). The table shows keywords found in each of the domains. Conclusions: 1) Cancer patients are willing to share their story if they are given the opportunity. 2) Through the narratives of the disease, it is possible to study its impact on patients’ lives and the different coping strategies. 3) Reading the experience of patients with the disease in their own voice is a valuable instrument for medical education. [Table: see text]
Effect of informational charts on patient understanding of nontherapeutic research procedures in phase I trials.
Authors: Campbell Gavin Paul , Abernethy Eli Rowe , Cook John W. , Lohani Minisha , Lewis Colleen Margaret , Switchenko Jeffrey M. , Dixon Margie D , Harvey Donald , Pentz Rebecca D. 
Published: May 2020

e24193 Background: It is difficult for patients to distinguish non-therapeutic from therapeutic procedures in research. In phase I trials, day 1 pretreatment biological samples are used for research and care; posttreatment samples are for research purposes only. Preliminary data suggested patients did not understand this difference. Our study tested to see if a simple information chart would improve understanding of the nontherapeutic research procedure. Methods: A sequential two arm study was conducted. Controls (C) were asked whether samples taken at different times on day 1 of the trial were to be used for their care, for research only, or for both. The experimental (E) group provided patients with a study-specific information chart labeling the purpose of required samples and patients were then asked the same questions. Results: 100 patients (50 each C and E) were interviewed after consenting to a trial. Patients were mostly white (63%), male (53%), with an annual income > $60,000 (51%); 49% had a college degree. In both arms, understanding that pretreatment samples were for patient care and research was moderate (50% C; 62% E). Understanding that posttreatment samples were for research was significantly higher in the experimental arm (16% C; 44% E p = 0.002). Conclusions: Questions regarding the purpose of biological samples taken pre-administration of study drug were less susceptible to therapeutic misconception due to the “both” option being true. Since the provision of an informational chart significantly improved understanding of the purpose of the posttreatment sample, we suggest that providing such a chart may help alleviate this type of therapeutic misconception. [Table: see text]
A phase II study evaluating atezolizumab (A), cobimetinib (C), and vemurafenib (V) in patients (pts) with BRAF-mutant melanoma and central nervous system (CNS) metastases (mets).
Authors: Queirolo Paola , de la Cruz Merino Luis , Abajo Guijarro Ana Maria , Tawbi Hussein Abdul-Hassan , Dummer Reinhard 
Published: May 2020

TPS10081 Background: CNS mets, a common complication of melanoma, are associated with poor survival prognosis (median of 4-5 months). The rationale for combining PD-L1 pathway blockade using atezolizumab (A) with the small molecule BRAF pathway–targeted inhibitors cobimetinib (C) and vemurafenib (V) for the treatment of BRAFV600 mutation–positive melanoma is based on preclinical and translational evidence supporting the synergistic antitumoral effects of these approaches. Recently, the phase 3 IMspire150 study (NCT02908672) demonstrated improved progression-free survival outcomes with A + C + V vs C + V. Methods: This phase 2 study (NCT03625141) is currently evaluating A + C + V in pts with BRAFV600 mutation–positive advanced melanoma and CNS mets. The study originally included a parallel cohort evaluating A + C in pts with BRAFV600wild-type advanced melanoma and CNS mets. This cohort was closed at an enrollment of 15 pts after the primary analysis of the phase 3 IMspire170 study (NCT03273153), which showed no added benefit with A + C vs pembrolizumab in pts with BRAFV600 wild-type disease. Eligible pts are aged ≥18 years with histologically confirmed melanoma and magnetic resonance imaging–confirmed brain mets ≥5 mm in at least 1 dimension. In addition, pts should not have received prior systemic treatment for metastatic disease; they were required to have ECOG performance status ≤2 and adequate hematologic and end organ function. Prior stereotactic or surgical therapy of ≤10 brain mets is allowed. The primary endpoint is intracranial objective response rate (ORR) with A + C + V in BRAFV600mutation–positive melanoma as assessed by an independent review committee. Key secondary endpoints include investigator-assessed intracranial ORR, extracranial ORR, overall ORR, safety, and quality of life. Exploratory biomarker analyses are planned. The sample size for the cohort will be approximately 60 pts. No formal statistical hypothesis is being tested in this study. The primary study analysis and the analyses of all efficacy endpoints and safety summaries will be based on data collected ≤6 months after the last pt is enrolled. Clinical trial information: NCT03625141.
A phase Ib study of endogenous SLC45A2-specific cytotoxic T cells for the treatment of patients with metastatic uveal melanoma.
Authors: Phillips Suzanne , Lizee Gregory , Brown Courtney , Lara Jacqueline Marie , Bassett Roland L. , Beal Lisa G , Murthy Ravi , Talukder Amjad , Hawke David H , Lai Ivy , Hwu Patrick , Yee Cassian , Patel Sapna Pradyuman 
Published: May 2020

TPS10086 Background: Overall survival (OS) for patients (pts) with advanced uveal melanoma (UM) is poor with a median survival of approximately 12 months. Roughly half of all pts with UM will develop distant metastatic disease despite effective treatment of the primary site. Metastatic UM has a 90% prevalence of liver involvement. Currently, there are no specific FDA-approved treatments for metastatic UM and consensus guidelines recommend participation in a clinical trial. Modern treatments such as checkpoint inhibitors and targeted therapy have less impressive outcomes in UM. Our group has identified peptide epitopes of SLC45A2, a melanosomal transport protein, that is highly expressed in UM and present at very low levels in normal melanocytes. We demonstrated that cytotoxic T cells against SLC45A2 were able to kill HLA-matched UM cell lines. Through the use of enabling technologies, SLC45A2-specific cytotoxic T cells can be isolated and expanded ex-vivo from peripheral blood for use in endogenous T cell (ETC) therapy (a form of adoptive cellular therapy). These activated ETCs can then be infused to traffic to tumor sites. CTLA4 is a T-cell surface protein that binds to B7 with a higher affinity than the costimulatory receptor CD28, providing an inhibitory signal to T-cells. Anti-CTLA4 blockade can divert this inhibition and release the brake on antigen-specific T-cell activation of ETC. We hypothesize that antigen-specific ETCs infused via hepatic artery will be safe and tolerable for UM pts with liver metastasis. Methods: We are conducting a first-in-human clinical trial (NCT03068624 ) of ETC therapy targeting SLC45A2 in combination with anti-CTLA4 in pts with metastatic UM. Pts who express HLA-A*02:01 or A*24:02 undergo apheresis to collect T cells. Their cells then undergo ex vivo cloning and interleukin-21 primed expansion. Hepatic arterial infusion of ETCs will ensure direct localization to the target organ of interest. Conditioning with low-dose cyclophosphamide (300 mg/m2) occurs on Day -2. Hepatic arterial infusion of ETCs on Day 0 is followed by low dose subcutaneous interleukin-2 (IL-2) twice daily for 14 days. The initial dose escalation phase is a 3+3 design with a starting dose level of 3.3 x 109 cells/m2 of ETCs alone. Once the maximum tolerated dose of ETCs is established, the dose expansion phase will include ETCs in combination with anti-CTLA4 (Ipilimumab). The primary objective is to evaluate the safety of this first in human T cell regimen. Secondary objectives are to evaluate the in vivo persistence and anti-tumor efficacy. Clinical trial information: NCT03068624.
A phase II study of neoadjuvant pembrolizumab and lenvatinib for resectable stage III melanoma: The neopele study.
Authors: Gonzalez Maria , Menzies Alexander M. , Pennington Thomas , Saw Robyn PM , Spillane Andrew J. , Stretch Jonathan , Shannon Kerwin Frank , Ch'ng Sydney , Nieweg Omgo E. , Cruzado Rojas Maria , Osorio Monica , Rawson Robert V , Ferguson Peter M. , Rizos Helen , Lo Serigne , Scolyer Richard A. , Long Georgina V. 
Published: May 2020

TPS10088 Background: Recent clinical trials of neoadjuvant (neo-adj) ipilimumab combined with nivolumab (OpACIN & OpACIN-neo) in resectable stage III melanoma show that a pathological response ( < 50% viable tumour at the tumour bed as determined by histopathological analysis) is associated with a prolonged relapse-free survival compared to no pathological response. Furthermore, recurrences seldom occur in those who have a pathological response following neo-adj immunotherapy with only 1/71 pts (1.4%) having recurred. In contrast, 15/23 (65.2%) pts with no pathological response have relapsed to date. The NeoPeLe trial will test the hypothesis that the synergistic combination of PD-1 blockade (pembrolizumab) with anti-angiogenic/multiple RTK inhibitor (lenvatinib) will result in a high rate of pathological response in the resected surgical specimen with a low rate of toxicity. Tissue and blood biomarkers are drawn at several timepoints and correlated to clinical and pathological endpoints to explore mechanisms of response and resistance. We will compare pathological response rate, and other clinical outcomes in this study, with previously published neo-adj clinical trials to select the best schedules for larger-scale clinical testing. Across neo-adj studies, we will also analyse the tissue collected to explore determinants of the optimal therapy for individual pts, whilst minimising toxicity. Methods: Eligible pts with stage IIIB/C/D, resectable and measurable (RECIST 1.1) nodal metastatic melanoma will be enrolled to this phase II single-centre trial (n = 20). All pts undergo complete nodal resection (RES) at wk 6 following neo-adj therapy with pembrolizumab (200mg, IV, 3 wkly) and lenvatinib (20mg, oral, daily). Adjuvant therapy with pembrolizumab is given for 46 wks after RES. After 52 wks of the study treatment, pts will be followed for relapse and survival for 5 years. CT and FDG PET/CT are used to measure response and exclude progression in the neo-adj phase, and to monitor for recurrence during adj and post treatment phases. Blood and tumour samples are collected at baseline, day 8, RES and at relapse if feasible. Faecal samples are collected at baseline and before RES. The primary endpoint is the complete pathological response rate at RES following 6 wks of neo-adj therapy. Secondary endpoints include RECIST response, metabolic response, OS, RFS, safety/tolerability, surgical outcomes, quality of life, and biomarker analyses. Clinical trial information: NCTNCT04207086.