bluuebunny/crossref_metadata_2025_split huggingface dataset:
High flow oxygen for dyspnea in hospitalized patients with cancer: A 4x4 crossover randomized clinical trial.
Authors: Hui David , Hernandez Farley , Thomas Saji , Lu Zhanni , Elsayem Ahmed F. , Balachandran Dave , Bashoura Lara , Bruera Eduardo 
Published: May 2020

12077 Background: Dyspnea is common in hospitalized cancer patients and highly distressing. High flow oxygen (HFOx) is administered for oxygenation in this setting; however, its effect on dyspnea has not been well examined, particularly among non-hypoxemic patients. In this phase II trial, we assessed the effect of HFOx, high flow air (HFAir), low flow oxygen (LFOx) and low flow air (LFAir) on dyspnea. We hypothesized that HFO and HFA can alleviate dyspnea. Methods: This double-blind, 4x4 crossover clinical trial enrolled hospitalized patients with cancer who were dyspneic (NRS ≥3 at rest) and non-hypoxemic (SpO2>90% on room air). Patients were randomized to 10 minutes of HFOx, HFAir, LFOx and LFAir in different orders. The flow rate was titrated between 20-60 L/min in the high flow groups and 2 L/min in the low flow groups. The primary outcome was dyspnea 0-10 numeric rating scale (NRS) “now”, where 0=none and 10=worst. Secondary outcomes included modified Borg scale dyspnea intensity and unpleasantness, adverse effects, and overall preference. We compared among the interventions with a linear mixed model adjusting for time, treatment effect, period effect and carryover effect. Results: 17 patients completed 55 interventions in a random order. Mean age 51, 58% female, mean baseline dyspnea NRS 6.3 (SD 1.7). The absolute change of dyspnea NRS between 0 and 10 minutes was -1.8 (SD 1.7) for HFOx, -1.8 (2.0) for HFAir, -0.5 (0.8) for LFOx and -0.6 (1.2) for LFAir. In mixed model analysis, HFOx group provided greater dyspnea relief than LFOx (mean difference [95% CI] -0.80 [-1.45, -0.15], P=0.02) and LFAir (-1.24 [-1.90, -0.57], P<0.001). HFAir also provided a significantly greater dyspnea relief than LFOx (-0.95 [-1.61, -0.30], P=0.005) and LFAir (-1.39 [-2.05, -0.73], P<0.001). No difference was found between HFOx and HFAir nor between LFOx and LFAir. There was no significant carryover effect. Dyspnea Borg scale intensity and unpleasantness showed similar changes. Oxygen saturation increased in the HFOx group (97.2% to 99.7%) and LFOx group (95.5% to 98.2%) but not HFAir nor LFAir groups. HFOx was well tolerated. At the end of the study, 7 (54%), 4 (31%), 1 (8%) and 1 (8%) patients blindly preferred HFOx, HFAir, LFOx and LFAir, respectively. Conclusions: For the first time, we found that HFOx and HFAir provided a rapid and clinically significant reduction of dyspnea at rest in hospitalized cancer patients even when they were non-hypoxemic, supporting a role for high flow devices to provide palliation beyond oxygenation. Larger studies are needed to confirm these findings. Clinical trial information: NCT02932332 .
Symptom burden as a predictor of emergency room use and unplanned hospitalization in patients with head and neck cancer: A population-based study.
Authors: Noel Christopher , Sutradhar Rinku , Hallet Julie , Irish Jonathan Crawford , Coburn Natalie , Eskander Antoine 
Published: May 2020

12084 Background: Symptoms are common in oncology patients, though they remain undetected and untreated by clinicians in up to 50% of cases. Integrating patient reported outcomes (PRO) within routine clinical practice has been suggested as a way to improve detection. In order to inform an effective and efficient PRO symptom screening program, we sought to determine whether outpatient symptom scores could predict emergency room use and unplanned hospitalization (ER/Hosp) in a cancer patient population. Methods: This was a population-based study of patients diagnosed with head and neck cancer who had completed at least one outpatient Edmonton Symptom Assessment System (ESAS) assessment between January 2007 and March 2018 in Ontario. Logistic regression models were used to determine the relationship between reported outpatient ESAS scores and ER/Hosp use in the 14-day period following ESAS completion. A generalized estimating equations approach was incorporated to account for possible patient-level clustering. Results: There were 11,761 unique patients identified with a total of 73,282 ESAS assessments. There were 5,203 ER/Hosp outcome events. In adjusted analysis, the odds of ER/Hosp use increased log linearly with ESAS score (1.23 per 1 unit increase in index ESAS score, [95% confidence interval (CI) 1.22 – 1.25]). This corresponds to a 9.23 (95%CI 7.22-11.33) higher odds of ER/Hosp use for the maximum index ESAS score of 10. Seven of the nine ESAS symptom scores were significantly associated with ER/Hosp use with pain, appetite and shortness of breath demonstrating the strongest association. Conclusions: ESAS scores are independently associated with 14-day ER/Hosp in head and neck cancer patients. Appropriate and timely management of symptom burden may reduce rates of ER/Hosp. [Table: see text]
Improving cancer pain control: Potential impact of CYP2D6 pharmacogenomic (PGx) testing in oncology (Onc) patients.
Authors: Reizine Natalie , Danahey Keith , Schierer Emily , Truong Tien , Ratain Mark J. , O'Donnell Peter H. 
Published: May 2020

12089 Background: Several opioid analgesics have well-known germline PGx associations which may predict either inefficacy or exaggerated (toxic) responses, depending on the patient’s genotype. Despite this, germline PGx testing has not been routinely incorporated into oncology care. We hypothesized that CYP2D6 germline PGx profiling offers the potential to improve oncology patients’ pain control by identifying individuals at increased risk for inadequate analgesia with standard opioid dosing. Methods: We retrospectively analyzed the medication histories of over 81,000 adult oncology patients treated at the University of Chicago from 2012-2018 for exposure to opioids. CYP2D6 genotype (permitting assignment of metabolizer phenotype: normal metabolizer [NM], intermediate metabolizer [IM], or poor metabolizer [PM]) was determined post-hoc for 127 patients who were genotyped for other reasons unrelated to pain prescribing. The primary endpoint was the number of opioids required for pain control over the course of longitudinal care, comparing PM/IMs with NMs. The secondary endpoint was the number of hospitalizations for pain control. Results: Over 47,000 oncology patients were exposed to opioids, with an average of 2.67±1.6 different opioid medication exposures per patient. Thirteen percent of genotyped patients were IM/PM, who were at risk for inadequate analgesia. IM/PM patients demonstrated an increased number of different opioid exposures (4.5±2.1) compared to NM (2.7±2.1, P value = 0.002). IM/PM patients were also more likely to have a pain related hospitalization (OR 4.17, CI 1.3-13.2, P = 0.016). Conclusions: Based on population prevalence, we estimate that > 6000 oncology patients (1000 patients/year) who received opioids at our center were IM/PM and thus at risk for inadequate analgesia due to genetic predisposition. CYP2D6 germline PGx profiling offers the potential to improve oncology patients’ pain management.
A systematic review of evidence for cannabis and cannabinoids as adjuvant therapy in palliative and supportive oncology care.
Authors: Jugl Sebastian , Keshwani Shailina , Adkins Lauren , Heldermon Coy D. , Winterstein Almut , Goodin Amie 
Published: May 2020

12091 Background: Medical cannabis use is increasing significantly in the United States as states reduce restrictions. However, ambiguity concerning the evidence for medical cannabis efficacy and safety, especially in the field of oncology, is persistent. Clinicians therefore face challenges in examining benefits and risks of medical cannabis as adjuvant treatment for cancer patients. This study identifies and evaluates the most recent available evidence for the efficacy of cannabis and cannabinoids as adjuvant in supportive and/or palliative use in patients with cancer. Methods: Electronic databases searched included PubMed, Embase, Web of Science, and Cochrane Library to identify studies published following the latest available systematic review, between July 2016 through October 2019. Studies conducted outside the United States, studies not evaluating cannabis or cannabinoids in Oncology care, and preclinical studies were excluded. Findings were organized in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) framework. Lastly, qualitative synthesis was used to generate summary statements about the role of cannabis and cannabinoids as adjuvant in supportive and/or palliative cancer care. Results: We screened 2,267 articles and included 96 studies in our qualitative synthesis. Among those were 2 RCT’s (1 completed), 6 Systematic reviews with Meta-analysis, 4 Systematic reviews without Meta-analysis, 71 other types of reviews and 13 observational studies. The most frequently reported outcomes assessed were efficacy of cannabis and cannabinoids for: pain (40 of 96; 17 indicating improvement), nausea and vomiting (26 of 96; 20 indicating improvement), cachexia (22 of 96; 2 indicating improvement), and utilization patterns of cannabis and/or cannabinoids among cancer patients (8 of 96). Conclusions: Latest available prevalence estimates indicate that a significant proportion of patients in the United States with cancer use cannabis and/or cannabinoids (18.3-40.0%). There is substantial evidence for the effectiveness of cannabis and cannabinoids in treating cancer-related pain; specifically, oromucosal THC/CBD spray. There is conclusive evidence for the effectiveness of cannabis and cannabinoids in relieving chemotherapy-induced nausea and vomiting; specifically, oral THC. There is inconclusive evidence regarding the effectiveness of cannabis and cannabinoids in treating cancer-related cachexia.
Myelopreservation and reduced use of supportive care with trilaciclib in patients with small cell lung cancer.
Authors: Weiss Jared , Goldschmidt Jerome , Zoran Andric , Dragnev Konstantin H. , Pritchett Yili , Morris Shannon R. , Malik Rajesh K. , Daniel Davey B. 
Published: May 2020

12096 Background: Chemotherapy (CT) is a mainstay of cancer treatment; however, its side effects, notably myelosuppression, cause significant suffering. Trilaciclib (T) is an IV CDK4/6 inhibitor that protects hematopoietic stem and progenitor cells by preventing proliferation during CT administration. Results from three randomized, double-blind, placebo (P)-controlled phase II trials in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) have previously been reported. Data from these studies were pooled to understand the effects of T on specific myelosuppression endpoints with greater statistical precision. Methods: All pts received standard CT (etoposide/carboplatin [E/C], E/C/atezolizumab, or topotecan) plus T or P. Analyses were conducted on pooled intent-to-treat datasets from three ES-SCLC studies (NCT02499770; NCT03041311; NCT02514447). Results: 123 pts were treated with T and 119 with P. Median age in both groups was 64 years. Addition of T decreased measures of myelosuppression and the need for supportive care interventions (Table). From the pooled dataset, median OS and PFS (months [95% CI]) were comparable between pts treated with T vs P (OS: 10.6 [9.1, 11.7] vs 10.6 [7.9, 12.8]; PFS: 5.3 [4.6, 6.1] vs 5.0 [4.4, 5.5], respectively). Fewer pts on T had grade 3/4 hematologic events (54 [44.3%]) vs P (91 [77.1%]). Among pts who continued after cycle 1, 11 pts (9.2%) treated with T had ≥1 CT dose reduction vs 36 (30.8%) with P. Conclusions: T significantly and meaningfully reduced both CT-induced myelosuppression and its consequences, with no detrimental effect on PFS or OS, thus improving the patient experience with CT in ES-SCLC. T has potential to become a new standard of care for preventing myelosuppression in SCLC. [Table: see text]
Development and validation of a risk prediction model for poor performance status and severe symptoms among cancer patients.
Authors: Seow Hsien , Tanuseputro Peter , Barbera Lisa Catherine , Earle Craig , Guthrie Dawn , Isenberg Sarina , Juergens Rosalyn A. , Brouwers Melissa C. , Myers Jeffrey , Sutradhar Rinku 
Published: May 2020

12097 Background: Existing cancer predictive tools focus on survival, but few incorporate patient-reported outcomes to predict quality-of-life domains, such as symptoms and performance status. The objective was to develop and validate a predictive cancer model (called PROVIEW) for poor performance status and severe symptoms over time. Methods: We used a retrospective, population-based, cohort study of patients, with a cancer diagnosis, in Ontario, Canada between 2008-2015. We randomly selected 60% of patients for model derivation and 40% for validation. Using the derivation cohort, we developed multivariable logistic regression models with baseline characteristics, using a backward stepwise variable selection process. The primary outcome was odds of having poor performance status six months from index date, as measured by a score < = 30 out of 100 on the Palliative Performance Scale. The index date for each model was diagnosis (Year 0), which was then re-calculated at each of 4 annual survivor marks after diagnosis (up to Year 4). Secondary outcomes included having severe pain, dyspnea, well-being, or depression, as measured by a score of > = 7 out of 10 on the Edmonton Symptom Assessment System. Covariates included demographics, clinical information, current symptoms and performance status, and healthcare utilization. Model performance was assessed by AUC statistics and calibration plots. Results: Our population-based cohort identified 125,479 cancer patients for the performance status model in Year 0. The median diagnosis age was 64 years, 57% were female, and the most common cancers were breast (24%), lung (13%), and prostate (9%). 32% had Stage 3 or 4 disease. In Year 0 after backwards selection, the odds of having a poor performance status in 6 months was increased by more than 10% when the patient had: COPD, dementia, diabetes; radiation treatment; a hospital admission in the prior 3 months; high pain or depression; a current performance status < = 30; any issues with appetite; or received end-of-life homecare. Generally, these variables were also associated with a > 10% increased odds in other years and for the secondary outcomes. The average AUC across all 25 models is 0.7676 which indicates high model discrimination. Conclusions: The PROVIEW model accurately predicts risk of having a poor performance status or severe symptoms over time among cancer patients. It has the potential to be a useful online tool for patients to integrate earlier supportive and palliative care.
Evaluation of the incidence of acute nausea and vomiting after administration of an amino acid solution containing only arginine and lysine with lutetium Lu-177 dotatate.
Authors: Alonzo Nicholas , Seyer Magdalena , Kim Eun-Jeong , Keshavarzi Rawmina , Yee Kathryn , Kunz Pamela L. 
Published: May 2020

12113 Background: Lutetium Lu-177 dotatate is used to treat patients with gastroenteropancreatic neuroendocrine tumors, and an amino acid (AA) solution must be administered concurrently to mitigate nephrotoxicity. AA solutions may lead to increased rates of nausea and vomiting (NV) due to the inclusion of unnecessary non-essential and essential AA. Methods: This study is a single academic center retrospective chart review from October 6th, 2015 to December 17th, 2019 evaluating the incidence of acute NV in adult patients after administration of an AA solution containing only arginine 25 grams and lysine 25 grams in 1 liter of normal saline (Arginine-Lysine amino acid [AL AA]) with lutetium Lu-177 dotatate. The incidence of acute NV will be compared to the historical incidence in patients administered Parenteral amino acids 10%, Aminosyn II 10% or Clinisol 15% (commercial AA). Secondary endpoints include the incidence of rescue anti-emetic usage and the percentage of patients that require interruption of the AA infusion. Acute NV are defined as any occurrence of NV within twenty-four hours of the AA infusion. Results: 53 patients received a total of 164 treatments with the AL AA, while 18 patients received a total of 48 treatments with the commercial AA. The AL AA significantly decreased the incidence of acute NV, the mean AA infusion time, the interruption of the AA infusion, and the utilization of rescue anti-emetics compared to the commercial AA (Table) in patients on lutetium Lu-177 dotatate. Conclusions: The study findings support the use of an AL AA to be administered concurrently with lutetium Lu-177 dotatate to minimize commercial AA related acute NV. [Table: see text]
Associations of functional, psychosocial, and medical factors with cognitive impairment in older, chemotherapy-naïve patients with early breast cancer.
Authors: Nakamura Zev , Deal Allison Mary , Nyrop Kirsten A. , Damone Emily , Muss Hyman B. 
Published: May 2020

12114 Background: Cognitive decline related to cancer and its treatments is a common concern among patients receiving treatment for cancer. Routine cognitive screening in oncology practice has been limited by the absence of a reliable, cancer-specific cognitive test. The Blessed Orientation Memory Concentration Test (BOMC) [1], has been incorporated in cancer-specific geriatric assessments, but there is no established cutpoint for cancer-related cognitive impairment. Recent research suggests that BOMC scores ≥ 5 may represent cognitive impairment in older patients with cancer. The purpose of this study was to identify cognitive impairment and associated characteristics in chemotherapy-naïve patients with breast cancer. Methods: Women with stage I-III breast cancer were recruited between 2009 and 2018. The BOMC (range 0-28, higher is worse function) was administered prior to chemotherapy. Associations between cognitive dysfunction (BOMC ≥ 5) and functional, psychosocial, medical variable were assessed using log binomial regression analysis. Results: In a sample of 331 women with breast cancer, the mean age was 65.2 years and 68.6% were 65 and older. Twenty-seven percent demonstrated cognitive impairment prior to treatment. Patients with Time Up and Go Test (TUG) ≥ 14 had increased risk of cognitive impairment compared to those with TUG < 14 (44% vs. 23%, p = 0.0002). After controlling for demographic factors, the estimated increase in risk was 66% (RR: 1.66, 95% CI (1.20, 2.31), p = 0.002). For Medical Outcomes Survey (MOS) Physical Function, after controlling for demographic factors, each 1 point increase in physical function (range 0-20, higher is better function) was associated with a 5% decrease in risk of cognitive impairment (p = 0.0004). Conclusions: Using a newly proposed BOMC cutpoint of ≥ 5, our study identified cognitive impairment in over 25% of older, chemotherapy naïve women with breast cancer. This is similar to what has been reported using rigorous neuropsychological testing in comparable populations. Additionally, we found that this degree of cognitive dysfunction was associated with both patient-reported and clinician-assessed impairment in physical function, further supporting the clinical relevance of this new cutpoint. Reference: [1] Katzman et al. Am. J. Psychiatry. 140 (1983) 734–739.
An intervention RCT-study aimed at improving mental health and increasing understanding of fertility preservation with Oncofertility! Psycho-Education And Couple Enrichment (O!PEACE) therapy.
Authors: Suzuki Nao , Koizumi Tomoe , Sugishita Yodo , Matsumoto Hiroshi , Furui Tatsuro , Futamura Manabu , Takai Yasushi , Sugimoto Kohei , Nogi Hiroko , Yamauchi Hideko , Kataoka Akemi , Ohno Shinji , Tsugawa Koichiro , Kawai Kiyotaka , Fukuma Eisuke 
Published: May 2020

12119 Background: Although ASCO revised Guidelines (2013) recommends referring to psychological professionals if cancer patients show concerns or anxiety about fertility, there is no evidence regarding the efficacy of psychotherapy. The aim of this study is to examine whether the Psycho-Education And Couple Enrichment (O!PEACE) therapy can reduce psychiatric symptoms and improve stress coping and marital relationship in breast cancer patients. Methods: Trial design: multicenter randomized controlled trial, pre-post design. Subjects were women aged 20–39 years with breast cancer before cancer treatment and their husbands. Couples were randomly assigned to receive O!PEACE therapy (n = 37) or not (usual care: n = 37). Assessments of PTSD symptoms, depression and anxiety were made as the primary end points at baseline and at the end of therapy before cancer treatment. Stress coping strategies, resilience, marital relationships, and marital communication were examined as secondary end points. Results: Four participants in O!PEACE therapy and one participant in the usual care withdrew from the trial. Intention-to-treat analyses were conducted using analysis of covariance after multiple imputation by R and SPSS. Series of ANCOVAs were integrated according to Rubin’s rule. A significant decrease was observed in the primary outcome of PTSD symptoms, from baseline to post-intervention, in women who participated in O!PEACE therapy (p = .011, ηp2 = .089). According to post-hoc analyses, for patients with a higher baseline IES-R-J score, O!PEACE therapy resulted in a significantly higher reduction in follow-up assessment IES-R-J score when compared with usual care (U = 172.80, p = .027, r = .258): 59.3% of the women in O!PEACE therapy showed a 5-point or greater reduction, whereas in usual care, 30.0% showed a 5-point or greater reduction. For husbands, the O!PEACE therapy also showed a significant improvement of giving up and blaming others as the stress coping strategy and escape-avoidance coping strategy in their marital communication. For breast cancer patients, the O!PEACE therapy significantly improved support from husbands and the patients’ knowledge level of oncofertility compared with those receiving usual care. Conclusions: Only two counseling sessions of O!PEACE therapy can reduce patients’ distress, improve their husbands’ coping style, and may build a better cooperative relationship for couples in terms of fertility preservation and cancer treatment. Clinical trial information: UMIN000017754 .