bluuebunny/crossref_metadata_2025_split huggingface dataset:
A phase II single-arm study of nivolumab and ipilimumab (Nivo/Ipi) in previously treated Classic Kaposi sarcoma (CKS).
Authors: Zer Alona , Icht Oded , Joseph Lilach , Avram Dana , Jacobi Oded , Fenig Eyal , Shamai Sivan , Shapira Frommer Ronnie , Bernstine Hanna , Weitzen Rony , Bar-Sela Gil , Stemmer Salomon M. , Lotem Michal 
Published: March 2020

11064 Background: CKS is an angioproliferative mesenchymal neoplasm causatively associated with human herpes virus 8 infection. Though recombinant IFNa is approved for treatment of AIDS-related KS, data is limited regarding the role of immune modulation in CKS therapy. Based on favorable responses in viral-induced cancers, we hypothesized that CTLA-4 and PD-1 blockade can induce tumor regression in CKS. We present pre-planned interim analysis of a phase II study of Nivo/Ipi in previously treated progressive CKS (NCT03219671). Methods: CKS pts with progressive disease after ≥ 1 line of systemic therapy and measurable disease by PET/CT and/or physical exam received nivolumab 240mg d1,15,28 and ipilimumab 1mg/kg d1 q42 days until progression or toxicity. The primary endpoint was overall response rate (ORR), secondary endpoints include 6-months progression free survival rate (PFS) and safety. Correlative studies in tumor and serum samples are ongoing using an NGS panel for DNA and RNA and proteomic staining (Tempus Labs Inc). A pre-planned interim analysis was conducted after the first ten enrolled patients for efficacy and toxicity evaluation. Results: Ten patients were enrolled and evaluable between April2018 and February2019. Median age 72 (61-79), all male. At a median FU of 3.1 months (1.5-8.1) ORR was 50% (4 patients PR, 1 patient CR, 5 patients SD). Median PFS was not reached however no progression of disease was documented so far. The safety profile was as expected with all patients experiencing G1 toxicity and four patients with G2 toxicity (1 ALT/AST increase, 2 asymptomatic lipase increase). One SAE was reported (TIA considered not related to therapy) and treatment was discontinued in one patient (G2 LFT increase. maintaining CR 4 months after treatment discontinuation). Correlative results are pending. Conclusions: The interim analysis in this prospectively designed phase II study of nivolumab and low-dose ipilimumab demonstrate promising activity in progressive CKS, with 50% ORR and no events of progression thus far. We expect to report the updated efficacy and correlative data. Clinical trial information: NCT03219671.
Using machine learning to predict mortality in older patients with cancer: Decision tree and random forest analyses from the ELCAPA and ONCODAGE prospective cohorts.
Authors: Audureau Etienne , Soubeyran Pierre-Louis , Martinez-Tapia Claudia , Bellera Carine A. , Bastuji-Garin Sylvie , Boudou-Rouquette Pascaline , Rainfray Muriel , Chahwakilian Anne , Grellety Thomas , Hanon Olivier , Mathoulin-Pélissier Simone , Paillaud Elena , Canoui-Poitrine Florence 
Published: March 2020

11516 Background: Accurate prognosis is crucial to decision making in oncology, but remains challenging in older patients due to the heterogeneity of this population and the lack of ability of current models to capture complex interactions between oncological and geriatric predictors. We aimed to develop new predictive algorithms based on machine learning to refine individualized prognosis in older patients with cancer. Methods: Data were collected from 3409 patients ≥70 years referred to geriatric oncology clinics for completion of a geriatric assessment (GA), including 2012 and 1397 patients from the ELCAPA (training set) and ONCODAGE (validation set) French prospective cohorts, respectively. Candidate predictors included baseline oncological and geriatric parameters, G-8 score and routine biological data (CRP/albumin ratio). Prognostic models for 12-months mortality were built using Cox regression model, single decision tree (DT) and random survival forest (RSF). Models performance was compared based on externally validated Harrell’s C-indexes. Results: During the 1-year study period, 875 (43%) and 219 (16%) patients died in the training and validation sets, respectively (mean age: 81±6 / 78±5, women 47% / 70%, metastasis 50% / 34%). Cox model identified 9 independent predictors of mortality: tumor site/metastatic status, anticancer treatment, weight loss > 3kg, drugs > 5, renal failure, increased CRP/Albumin, ECOG-PS≥2, ADL≤5 and altered TGUG. DT identified more complex combinations between features, yielding 16 patient groups with highly differentiated survival, notably depending on the G-8 ( < 10 vs. ≥10 as the root node). RFS had the highest C-index (0.86 [RFS], 0.82 [Cox], 0.81 [DT]), identifying the G-8, CRP/albumin and tumor site/metastasis as the most important features. Conclusions: While Cox modeling confirmed known independent prognostic factors, DT revealed more complex interactions between them and random forest achieved superior prognostic performance by better capturing patient’s complexity. The latter model has been implemented into an interactive web interface for easy and direct use in clinical practice. Clinical trial information: NCT02884375.
Comparing outcomes data from dedicated oncology-subspecialist hospitalists to those from a traditional care model on an inpatient oncology service.
Authors: Fanucci Kristina , Yang Andrew Chung , Reinert Steven E. , Niroula Rabin 
Published: March 2020

11538 Background: Changes in the complexity and delivery of health care and efforts to contain rising costs gave rise to the hospitalist model of care delivery in the 1990s. More recently some hospitals have begun using the hospitalist model on inpatient oncology floors. Oncology patients are a unique population who require high rates of hospitalization for problems arising from their progressive disease burden and side effects of cancer-directed therapy and have high rates of 30 day readmissions (30DR), an important quality metric. The majority of studies in this area have shown similar outcomes comparing care given by internal medicine hospitalists working full time on an inpatient oncology service compared to multiple oncologists working in rotating shifts on the same inpatient oncology service (Traditional). A new care model using dedicated hematology/oncology subspecialist hospitalists (H-O) to care for patients admitted to the oncology service has been implemented at our academic medical center. Methods: We conducted a retrospective chart review to identify patients with a cancer diagnosis admitted to the oncology service over a six year period. 7/1/2012-6/30/2015 marked the Traditional care model and 7/1/2015-7/1/2018 the H-O model. We compared 30DR, discharge to hospice, length of stay (LOS), and inpatient mortality between these two groups. Results: We identified a total of 3778 patients admitted to the oncology service over this six year period—1932 patients admitted to the Traditional service and 1846 patients admitted to the H-O service. There was a significant difference in 30DR between the Traditional v. H-O service (36.7% v. 29.5%, χ2= 21.1, p < 0.00001) and discharge to hospice (7.6% v. 12.9%, χ2= 29.0, p < 0.0000001). There was no significant difference in LOS between the Traditional and H-O services (6.40 days v. 6.03 days, p = 0.122) or in-hospital mortality (2.6% v. 1.9%, χ2= 2.16, p = 0.14). Conclusions: The shift to dedicated hospitalist-oncologists caring for patients on the inpatient oncology service significantly decreased 30DR at our institution. There were also significantly more patients transferred to hospice care. We found no significant difference between the two groups in LOS or inpatient mortality. This care model may help reduce the cost of caring for oncology patients by decreasing 30DR.
Cancer-specific mortality and competing causes of death in older adults: A prospective, multicenter cohort study (ELCAPA-19).
Authors: Assouan Deborah , Paillaud Elena , Caillet Philippe , Kempf Emmanuelle , Vincent Helene , Brain Etienne , Rochette de Lempdes Godelieve , Touboul Cyril , Martinez-Tapia Claudia , Allain Mylene , Bastuji-Garin Sylvie , Hanon Olivier , Laurent Marie , Canoui-Poitrine Florence 
Published: March 2020

11547 Background: Among older adults with cancer, comorbidities compete with cancer as the cause of death. The objectives were to quantify the proportion and rate of cancer-specific death in older patients with cancer, and to analyze the associations between geriatric factors and cancer death. Methods: Between January 2007 and December 2014, older patients with cancer were prospectively included by the ELCAPA cohort study’s eight investigating centers. Competing risk methods were used to estimate 6-month and 3-year cancer mortality rates and to probe associations between geriatric factors and cancer death. Results: A total of 1678 patients were included (mean ± standard deviation age: 81.3 ± 5.8; women: 49%). The most common cancers were colorectal (19%), breast (17%) and urinary (15%) cancers and 49% had metastasis. After a median follow-up period of 34 months, a total of 948 deaths were observed. Of the 282 deaths in non-metastatic patients, 203 (72%; 95% confidence interval (CI): [66%-77%]) were attributable to cancer. This proportion was 92% (89–94; N = 448/498) for metastatic patients. The 6-month and 3-year cancer mortality rates was respectively 12% (9–15) and 34% (29-38) for non-metastatic tumors and 45% (41–49) and 83% (80–87) for metastatic stage tumors. At 6 months, the geriatric factors independently associated with cancer death were a dependency in activities of daily living (ADL) score ≤ 5 (adjusted subhazard ratio: 2.11 (95%CI: [1.68–2.64]), mobility impairment (Timed Get Up and Go (TGUG) test time > 20 s (1.40 [1.05–1.87]) or inability to perform the TGUG (2.41 [1.67–3.48])) and comorbidities (total Cumulative Index Rating Scale-Geriatric score ≥13) (1.59 [1.23–2.06]). At 3 years, the independently associated factors were ADL ≤ 5 (1.60, [1.34–1.91]), TGUG > 20 s (1.28, [1.04–1.59]) or inability to perform TGUG (2.02 [1.47–2.79]), and cognitive impairment (1.23 [1.01–1.50]). Conclusions: Most older adults with cancer die from this disease and not from other comorbidities. However, geriatric parameters (dependency, impaired mobility, comorbidities, and cognitive impairment) are independently associated with cancer death. These geriatric impairments should be taken into account when assessing the cancer patient’s prognosis in clinical practice. Clinical trial information: NCT02884375.
Tobacco retail availability and tobacco cessation in lung and head and neck (HN) cancer survivors.
Authors: Eng Lawson , Su Jie , Habbous Steven , Hueniken Katrina , Brown M. Catherine , Saunders Deborah , de Almeida John R. , Hope Andrew , Bezjak Andrea , Shepherd Frances A. , Leighl Natasha B. , Pierre Andrew , Selby Peter , Goldstein David Paul , Xu Wei , Giuliani Meredith Elana , Evans William K. , Liu Geoffrey , Chaiton Michael 
Published: March 2020

11559 Background: Continued smoking after a cancer diagnosis is associated with poorer outcomes. Tobacco retail availability is negatively associated with cessation in non-cancer patients (pts), but has not been explored in cancer survivors. We evaluated the impact of tobacco retail availability on cessation in lung and HN cancer pts. Methods: Lung and HN cancer pts (Princess Margaret Cancer Centre, Toronto) completed questionnaires evaluating changes in tobacco use with a median of 26 months apart. Validated tobacco retail location data were obtained from Ministry of Health and pt home addresses were geocoded using ArcGIS 10.6.1, which calculated walking time/distance to nearest vendor, and vendor density within 250 meters (m) and 500m from pts. Multivariable logistic regression and Cox proportional hazard models evaluated the impact of vendor availability on cessation and time to quitting after diagnosis respectively, adjusting for significant clinico-demographic and tobacco covariates. Results: 242/721 lung and 149/445 HN pts smoked at diagnosis; subsequent overall quit rates were 66% and 49% respectively. Mean distance and walking time to a vendor was 1 km (range 0-13) and 11 min (range 0-156). On average, there was one vendor (range 0-19) within 250m and four vendors (range 0-40) within 500m from pts; 37% and 61% of pts lived within 250m and 500m from at least one vendor respectively. Greater distance (aOR 1.18 per 1000m [95% CI 1.00-1.38] p = 0.05) and increased walking time (aOR 1.01 per minute [1.00-1.02] p = 0.05) were associated with quitting at one year. Living within 250m (aOR 0.52 [0.32-0.84] p = 0.008) or 500m (aOR 0.57 [0.35-0.92] p = 0.02) to at least one vendor reduced quitting at one year. Living near more vendors within 500m had an increasing dose effect on reducing cessation rates at one year (aOR 0.96 per vendor [0.93-1.00] p = 0.05). Living within 500m to a vendor reduced chance of quitting at any time (aHR 0.66 [0.48-0.91] p = 0.01). HN and lung subgroups revealed similar associations. Conclusions: Close access to tobacco retail outlets is associated with reduced cessation rates for lung and HN cancer survivors. Reducing density of tobacco vendors is a cessation strategy that can positively impact cancer pt outcomes.
Prospective trial in early-stage breast cancer (EBC) patients (pts) submitted to nutrition evidence-based educational intervention: Early results of adherence to dietary guidelines (ADG) and body weight change (BWC).
Authors: Carbognin Luisa , Trestini Ilaria , Sperduti Isabella , Bonaiuto Clelia , Zambonin Valentina , Fiorio Elena , Tregnago Daniela , Parolin Veronica , Pilotto Sara , Scambia Giovanni , Tortora Giampaolo , Milella Michele , Bria Emilio 
Published: March 2020

11575 Background: Weight gain and overweight have been related to an increased risk of recurrence and mortality in patients affected by EBC. However, the adherence to nutritional intervention is not entirely explored. The aims of this prospective study were to evaluate the ADG and the effectiveness of nutritional intervention in terms of BWC in pts with EBC undergoing treatment. Methods: Entry criteria: EBC pts candidate to neoadjuvant/adjuvant therapy. At study entry, pts received a nutrition evidence-based tailored educational intervention by a skilled dietitian. Anthropometric and dietary assessments were performed. ADG was estimated through the validated Med-Diet 14-item questionnaire. Health-Related Quality of Life was analyzed with the EORTC QLQ-C30. Descriptive statistics was adopted. Associations between variables and groups according to nutritional variables were analysed (Chi-square test). Results: From February 2016 to December 2018, 204 pts were enrolled (median age 49 years): 27.5%/72.5% neoadjuvant/adjuvant treatment. At baseline, 2.5% of pts were underweight, 41.7% were normal weight, 33.3% were overweight and 22.5% were obese. Moreover, 47.5% of pts gained ≥5% of their usual weight and 25.5% performed physical activity. Significant nutritional impact symptoms were reported: dyspepsia (51.5%), constipation (62.3%) and dysgeusia (34.8%). The majority of pts presented dietary patterns high in fat (median fat intake: 35.2% from total energy intake) and low in dietary fiber (median dietary fiber intake: 17.2 g/day). A significant correlation between baseline BMI and tension was observed ( p < 0.0001) as well as BMI and worry, irritability and depression ( p < 0.0001, p < 0.0001 and p = 0.008, respectively). Six months after the intervention, the median ADG was high (median Med-Diet score was 12). A high adherence to nutrition guidelines (defines as a Med-Diet score ≥10, 112 patients) significantly correlated with a weight loss ≥5% from the baseline weight ( p = 0.005). Furthermore, the weight loss ≥5% was correlated with a lower rate of depression ( p = 0.05). Conclusions: A tailored nutritional intervention for EBC pts undergoing adjuvant or neoadjuvant therapy has the potential to improve their ADG, in order to achieve a weight loss.
“If you don’t ask, you won’t know”: Do patient-reported outcome (PRO) instruments capture the symptom experience of patients treated with immune checkpoint inhibitors (ICIs)?
Authors: Gabster Brooke Peterson , Hall Evan Thomas , Singhal Surbhi , Dickerson James , Schapira Lidia 
Published: March 2020

11579 Background: PROs are increasingly used as a key tool in patient-focused treatment decisions. However, many cancer PROs were designed to capture the patient experience of those treated with chemotherapeutic agents. Less is known about the utility of PRO instruments in assessing symptoms from ICIs. Methods: We systematically searched the literature to identify peer-reviewed publications that reported PROs for patients receiving ICIs. We excluded case reports/series, narrative reviews, and publications without original data. We then selected the studies that compared ICIs to cytotoxic chemotherapy. Clinician-documented adverse events (AEs) occurring in at least 10% of patients in a study arm were extracted and examined for concordance with symptoms included in the PROs administered to study patients. Results: Of 1,450 identified studies, eight met criteria for inclusion. Seven assessed PROs with the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), six used the EuroQOL EQ-5D, and one used the Lung Cancer Symptom Scale (LCSS). Across the studies, fatigue, nausea, vomiting, appetite loss, diarrhea, constipation, pruritus, rash, and pyrexia were among the most common clinician-documented AEs. Of these AEs, six are directly correlated with questions on the PRO instruments, and three (pruritus, rash, and pyrexia) are not. AEs with corresponding PRO questions were more common in chemotherapy patients. Pruritus, rash, and pyrexia – AEs without corresponding PRO questions – were more common in patients treated with ICIs (see Table). Conclusions: Existing PRO instruments do not specifically query important symptoms associated with ICIs, underscoring the need to revise the instruments to more appropriately reflect the toxicity profiles of novel agents. [Table: see text]
Cognitive function in chronic lymphocytic leukemia (CLL): Examining effects of disease, treatment, and inflammation.
Authors: Williams AnnaLynn , van Wijngaarden Edwin , Seplaki Christopher , Heckler Charles E. , Weber Miriam , Barr Paul M. , Zent Clive , Janelsins Michelle Christine 
Published: March 2020

11584 Background: Cancer-related cognitive impairment (CRCI) is an important clinical problem that may occur through pro-inflammatory pathways, cancer-related pathology, or cancer treatment. However, their relative contribution to CRCI is unknown. We used CLL, an indolent cancer of the immune system, as a novel model to study differential roles of disease, treatment, and inflammation in CRCI. Methods: We assessed cognitive function and serum pro-inflammatory marker levels in 150 CLL patients (100 treatment naïve and 50 chemotherapy treated) including 84 patients with high risk of CLL progression (deletion 17p, deletion 11q, unmutated IGHV, Zap70+, or CD38+). Objective neuropsychological tests assessed global cognition, processing speed, attention, memory, and executive function (NIH Toolbox Cognition, Hopkins Verbal Learning Test Revised (HVLT), Trail Making Test (TMTA/B)). Linear regression models examined cognitive outcomes in relation to risk, treatment, and pro-inflammatory markers while adjusting for sociodemographic covariates. Results: High risk patients recalled almost 2 fewer words on a memory task (HVLT immediate recall β = -1.8, 95%CI -3.3, -0.3) and took 15 seconds longer on an executive function task (TMTB β = 15.4, 95%CI 3.1, 27.6) than low risk patients, independent of treatment status. Treated patients reported significantly greater cognitive difficulties than treatment naive patients (FACT-Cog β = -5.2, 95%CI -8.7, -1.6) but did not perform worse on objective cognitive measures. Higher CRP was significantly associated with more self-reported cognitive difficulties, but higher levels of interleukin-6 and interferon-γ were significantly associated with better performance on objective measures of global cognition, attention, and executive function. Conclusions: High risk patients experienced impairments in executive function and memory suggesting that disease biology contributes to CRCI independent of treatment. Increasing levels of pro-inflammatory cytokines were associated with better cognitive performance indicating that the role of inflammation with respect to CRCI in CLL may be complex, possibly due to tumor-related immune deficiencies.
Supportive care medications (SCMs) and pharmacogenomics (PGx) relevance in 6,985 cancer patients (pts) undergoing distress screening.
Authors: Patel Jai Narendra , Boselli Danielle , Jandrisevits Elizabeth , Hamadeh Issam , Salem Ahmed , Meadors Patrick Leland 
Published: March 2020

11592 Background: SCMs are prescribed based on symptom burden, but response is variable, possibly due to PGx. We investigated the association between symptom burden, SCM prescribing, and frequency of SCMs with PGx evidence. Methods: Cancer pts ≥ 18 years old and completing electronic distress screening within 90 days of intake between 1/1/2017-12/31/2017 were included. Anxiety was measured using Generalized Anxiety Disorder 2-item (0-6) and depression using Patient Health Questionnaire-2 (0-6). Fatigue, nausea, neuropathy, pain and sleep were measured on a 0-10 scale. SCM prescribing within 90 days of intake was documented. Logistic regression compared symptom scores and SCM prescribing. Receiver Operating Characteristics analysis estimated sensitivity/specificity. Optimal symptom thresholds were selected according to Youden’s J statistic. SCMs with PGx evidence level A or B (according to Clinical Pharmacogenetics Implementation Consortium) were summarized. Results: Of 6985 pts, 65% were female, 75% Caucasian, 20% African American and median age was 60. 49% reported ≥ 1 severe symptom, which correlated with SCM prescribing (p < 0.001). 3208 (46%) were prescribed SCM(s), mainly for pain (69%) or nausea (46%). Of these, 2759 (86%) received ≥ 1 SCM with PGx evidence and 2695 (84%) received a SCM metabolized by CYP2D6 - hydrocodone (47%), ondansetron (41%), and oxycodone (28%). Based on reported CYP2D6 allele frequencies conferring altered metabolism (~20%), 539 of the 2695 pts may have altered drug response. Threshold scores for each symptom are summarized in the table. Fatigue and nausea were not associated with SCM prescribing. Conclusions: Symptom burden is high in cancer pts and correlates with SCM prescribing. Many SCMs have PGx evidence, suggesting preemptive testing, particularly for CYP2D6, may have broad applicability in this population.[Table: see text]