bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patient level factors associated with chronic opioid use in cancer patients.
Authors: Cuthbert Colleen Ann , Xu Yuan , Boyne Devon J. , Kong Shiying , Hemmelgarn Brenda R. , Cheung Winson Y. 
Published: March 2020

11580 Background: Opioid prescribing in oncology is increasingly scrutinized given public health concerns about chronic opioid use, misuse, and harms. We aimed to evaluate patient reported pain scores, mental health indicators, prior opioid use, and number of opioid prescribers as potential risk factors for chronic opioid use in a large Canadian province. Methods: This was a population-based cohort study using administrative health data of patients in Alberta, Canada, diagnosed between Jan 2016 and Jan 2017, and completed a prospective comprehensive symptom survey within +/- 60 days of diagnosis. Patients were divided into two groups: chronic opioid use (COU) (defined as continuous prescriptions for opioids for at least 90 days post diagnosis) and non-chronic opioid use (NCOU). Logistic regression models were used to evaluate factors associated with COU. Results: We included 694 patients. Most had breast (20%), colorectal (13%), and lung (33%) cancers. There were no differences in mean age (65 years) or gender (50% female) between the groups. In total, 32% had moderate to high pain scores at diagnosis. Of the 14% with COU, 79% were opioid naïve at diagnosis. Those in the COU group were more often diagnosed with advanced stage of disease (66% vs 40%), had lung cancer (47%), and were opioid tolerant at diagnosis (defined as > 90 days of continuous opioids within 1 year prior to their diagnosis) (21% vs 3%). In comparison, 64% of COU versus 27% of NCOU had moderate to severe pain scores at diagnosis (p < 0.001). COU had significantly higher anxiety and depression scores at diagnosis versus NCOU (p = 0.004). Among patients with COU, morphine equivalent daily doses increased from 27.3 (pre-diagnosis) to 65.1 (post-diagnosis). Irrespective of treatment type or stage, those who had moderate to high pain scores, were opioid tolerant at diagnosis, or had multiple prescribers were at greater risk for COU (see Table). Conclusions: Specific patient groups were at increased risk of COU and should be the focus of adaptive prescribing approaches to ensure that opioid use is appropriate. [Table: see text]
Naldemedine for opioid-induced constipation in patients receiving palliative care: A real-world registry study (Phase-R OIC Study).
Authors: Shimizu Masaki , Kessoku Takaomi , Ishiki Hiroto , Matsuura Tetsuya , Hiratsuka Yusuke , Matsuda Yoshinobu , Hasegawa Takaaki , Imai Kengo , Maeda Isseki , Oyamada Shunsuke , Satomi Eriko 
Published: March 2020

11582 Background: Although naldemedine, a new peripherally-acting mu-opioid receptor antagonist, was approved for the management of opioid-induced constipation (OIC), its safety and effectiveness in real world clinical practice is unknown. Methods: We conducted a real world registry study in 14 hospital palliative care teams and inpatient palliative care units in Japan between April and December 2018. Consecutive cancer patients who received naldemedine for OIC were enrolled in a 7-day observational study. All treatment and assessment procedures were performed according to the accepted clinical practice. The primary outcome of the study was the proportion of patients who experienced spontaneous bowel movement within 24 hours after the initial administration of naldemedine. Adverse events, which indicated a possible or stronger causal relationship with naldemedine treatment, were reported according to the Common Terminology Criteria for Adverse Events (CTCAE) ver 4.0. Results: Overall, 204 patients were enrolled in the study. The mean age of the patients was 63±14 years, and 103 (50.5%) were male. The most common primary cancer site was lung (23.5%), followed by gastrointestinal (13.7%), and urological organs (9.3%). The proportion of patients undergoing active cancer treatment was 59.9%. Oxycodone was the most frequently used regular opioid (n = 115, 56.4%), and the median oral morphine-equivalent daily dose of opioids was 30 mg (interquartile range: 20-60 mg). Magnesium oxide (64.2%) and Senna (17.2%) were used as concomitant laxatives. All patients received 0.2 mg of naldemedine orally once daily. Most patients (90.2%) completed the 7-day observation. In 146 patients, spontaneous bowel movement was observed within 24 hour after the first administration of naldemedine (71.6%, 95% confidence interval 65.4-77.8%). Nearly two-thirds of the patients experienced increased frequency of spontaneous bowel movement in the week after naldemedine administration. The most prevalent adverse events were diarrhea (CTCAE grade 1-2, 35 cases; grade 3, 1 case) and abdominal pain (CTCAE grade 1-2, 10 cases; grade 3, 1 case). No serious adverse events including gastrointestinal perforation were reported. Conclusions: Naldemedine for opioid-induced constipation is safe and effective in the real world oncology and palliative care settings. Clinical trial information: UMIN000031381.
A community oncology palliative program: Early results for cost and quality measures within OCM program claims data.
Authors: Akhtar Adil Jamal , Margolis Jeffrey , Maxwell Karma , Muskovitz Andrew A. , Zekman Richard Philip , Sheth Karna , Ballouz Samer , Qamruzzaman Yusuf , Ibrahim Mohammed , Scott-Barney Tammy , Stortz Lexi , Fabbiano Maria 
Published: March 2020

11585 Background: Oncology Care Model (OCM) is an initiative of the Centers for Medicare and Medicaid Innovation which aims to provide higher quality and more coordinated oncology care while lowering the cost. Oncology Division of Michigan Health Professionals (MHP) participates in OCM. Palliative and End of Life care was identified as one of the quality improvement areas. A community oncology Palliative care (PC) program was launched in October 2017. Methods: The multidisciplinary PC team was led by Board certified palliative care and hospice physicians. Patients appropriate for PC referral were identified by participating medical oncologists. Patients were contacted by the PC team. If the patients agreed a Nurse Practitioner (NP) would assess and follow the patients at home. Care was coordinated by the NP’s in communication with the palliative care team and the primary medical oncologists. Last 30-day (limited by the OCM episode or patient death) OCM program claims data was analyzed by IntegraConnect. Results: From October 2017 to October 2018 a total of 273 patients were referred to the PC program. Fifty-eight patients were identified as having OCM episodes, of these 36 patients had claims data through June 30, 2018. Twenty patients accepted and were engaged with PC,16 patients declined or were unable to reach for PC and formed the comparison group. Even when drug and office costs were excluded, PC engaged patients spent 17% less versus the comparison group (93k vs 112k) in last 30-day claims data. PC engaged patients had a lower acute care facility costs which accounted for 50% (46k) of reimbursement, compared with 95% (105k) for the comparison group. Fourteen OCM patients referred to Palliative program died within episode. 80% (8/10) of engaged patients met quality measure for OCM-3, at least 3 days in hospice vs. 0% (0/4) of patients who declined palliative care, before episode-death. Conclusions: Palliative engaged OCM patients experienced more care at their homes at a lower cost. Palliative program improved practice performance in OCM-3 quality measure. MHP Palliative program is reaching patients in OCM episodes but the numbers are still small.
Risk factors for opioid abuse/dependence in hospitalized cancer patients in the United States.
Authors: Bakalov Veli , Tang Amy , Yellala Amulya , Babar Laila , Shah Rupin , Sadashiv Santhosh K. , Kaplan Robert B. , Lister John , Cuevas Elizabeth , Monga Dulabh K. 
Published: March 2020

11589 Background: Opioid medications are the mainstay for treating cancer pain. Goal of this study was to identify risk factors for opioid abuse/dependence in patients hospitalized with cancer, explore whether risk of opioid abuse/dependence varies by cancer type and to assess whether opioid abuse/dependence in cancer patients effects the outcomes of hospitalization. Methods: The Nationwide Inpatient Sample for the years of 2011-2015 was queried for the analysis. We used ICD-9-CM codes of solid tumors as a primary diagnosis for hospitalization, and opioid abuse/dependence as a secondary diagnosis of the hospitalization. We performed univariate and multivariate logistic regression analyses to examine the association between risk factors and opioid abuse/dependence. Data were analyzed using SAS v9.4 (SAS Institute, Cary, NC). Results: Total of 524,624 patients were included in our cohort. Rate of opioid abuse/dependence was highest in patients with liver cancer (1.77%). Opioid abuse/dependence was less associated with age (>65 years old: OR 0.29, 95% CI 0.21-0.39). Patients with Medicaid insurance associated with increased risk of opioid abuse/dependence comparing to other insurances (OR 5.29, 95% CI 4.78-5.86). Strongest association with opioid abuse/dependence were in patients with liver cancer (OR 6.07, 95% CI 5.11-7.20) followed by head and neck cancer (OR 3.20, 95% CI 2.67-3.84). Substance abuse (OR 9.9, 95% CI 9.04-10.84), mental disease (OR-2.87, 95% CI 2.64-3.13) and nutrition deficiency (OR-2.09, 95% CI 1.90-2.31) were highly associated with opioid abuse dependence. Inhospital mortality rate, total cost of hospitalization, and length of stay were significantly higher in patients with opioid abuse/dependence (Table). Conclusions: We identified risk factors for opioid abuse/dependence in hospitalized patients with cancer and demonstrated that risk of opioid abuse varies by cancer type, and opioid abuse/dependence affects the outcomes of hospitalization. Findings of our study can be used for development of the screening tools with higher sensitivity and specificity for predicting the risk of opioid abuse/dependence in cancer patients.[Table: see text]
Safety of intravenous (IV) NEPA and oral NEPA for prevention of CINV in patients (pts) with breast cancer (BC) receiving anthracycline/cyclophosphamide (AC) chemotherapy (CT).
Authors: Schwartzberg Lee S. , Voisin Daniel , Rizzi Giada , Patel Kamal , Aapro Matti S. 
Published: March 2020

11594 Background: NEPA, a combination antiemetic agent [NK1 receptor antagonist (RA) netupitant (oral) or fosnetupitant (IV) + 5-HT3RA palonosetron] offers 5-day CINV prevention with a single-dose. Unlike other IV NK1RAs, the fosnetupitant solution does not require a surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients. In a Phase 3 study in pts receiving cisplatin-based CT, there were no infusion site or anaphylactic reactions related to IV NEPA. In contrast, hypersensitivity reactions and anaphylaxis have been reported with IV aprepitant, fosaprepitant and rolapitant, with the highest rate (35%) for fosaprepitant in the AC setting. This study (NCT03403712) evaluates the safety of IV NEPA in BC pts receiving repeat cycles of AC CT. Methods: This was a Phase 3b, double-blind study in females with BC naïve to highly/moderately emetogenic CT. Pts were randomized 1:1 to receive a single 30-min infusion of IV NEPA or a single oral NEPA capsule on Day 1, prior to AC. Oral dexamethasone was also given to all patients before CT. The primary objective was a safety evaluation of IV NEPA based primarily on treatment-emergent adverse events (TEAEs). No formal between groups statistical comparison was planned. Results: 402 pts were treated with IV NEPA or oral NEPA and included in the safety population. The AE profiles were similar for the two groups; cycle 1 results are reported (Table). Comparable complete response (no emesis, no rescue) rates were seen during the cycle 1 overall phase (0-120h) (73.0% IV NEPA, 77.2% oral NEPA). Conclusions: There were no infusion-site AEs related to IV NEPA and no anaphylaxis reported for either formulation. Consistent with the pivotal study, IV NEPA is safe and effective in pts receiving AC. As a simplified single-dose formulation, IV NEPA may be better tolerated than other NK1 RAs. Clinical trial information: NCT03403712. [Table: see text]
Validation of a new prognostic body composition parameter in cancer patients.
Authors: Pedrazzoli Paolo , Caccialanza Riccardo , Stobäus Nicole , Turri Annalisa , Klersy Catherine , Caraccia Marilisa , Brugnatelli Silvia , Secondino Simona , Cicognini Daniela , Imarisio Ilaria , Filippi Andrea Riccardo , Monaco Teresa , Giannoni Atonello , Norman Kristina , Cereda Emanuele 
Published: March 2020

11597 Background: In cancer patients protein-calorie imbalances are responsible for decreased lean body mass and, in turn, for worse clinical outcome. We evaluated the prognostic value of a new body composition parameter (creatinine height index [CHI]) obtained from bioimpedance vectorial analysis-derived body cell mass and its association with nutritional and functional status. Methods: Data from Italian and German cancer patients based on information from previous prospective cohort studies were used. Multivariable models (adjusted for age, gender, hydration status, performance status, and disease stage) were built in both cohorts to assess the association between body composition outcome parameters (low fat-free mass [FFM], <15 [females] and <17 [males] kg/m2; low standardized phase angle [SPA], <-1.65; low CHI, <510 [females] and <660 [males] mg/24h/m) and 1-year all-cause mortality, low body mass index (BMI; <20 [<70 years] and <22 [>/=70 years] kg/m2), clinically significant weight loss (WL; >/=10% in 6 months) and low handgrip strength (HG; <20 [females] and <30 [males] kg). Results: Overall, 1084 cancer patients were included (Italians, N=454; Germans, N=630). Low CHI was independently associated with mortality in both Italian and German cohorts (Table). Low FFMI and low SPA did not predict survival in the German cohort. In patients with low CHI, worse nutritional and functional status were observed in both study populations. Performance of models addressing the study endpoints showed substantial consistency with both cohorts, particularly of those including low CHI. Conclusions: We validated a new prognostic body composition parameter, which is easier to interpret than standard nutritional parameters and may be useful for identifying cancer patients at nutritional risk, requiring early nutritional support. [Table: see text]
Effect of high flow oxygen on exertional dyspnea in cancer patients: A double-blind randomized clinical trial.
Authors: Hui David , Larsson Liliana , Thomas Sajan , Harrison Carol , Wu Jimin , Mahler Donald , Hess Kenneth R. , Lopez-Mattei Juan , Thompson Kara , Gomez Daniel Richard , Jeter Melenda , Lin Steven H. , Tsao Anne S. , Eapen George , Basen-Engquist Karen , Bruera Eduardo 
Published: March 2020

11600 Background: High flow oxygen therapy is effective for hypoxemic respiratory failure. However, its effect on dyspnea in non-hypoxemic patients is unknown. In this 2x2 factorial, double-blind randomized clinical trial, we assessed the effect of flow rate (high vs. low) and gas (oxygen vs. air) on exertional dyspnea in cancer patients. Methods: Non-hypoxemic patients with cancer completed two structured cycle ergometer exercise tests with Low Flow Air [LFAir] at 2 L/min. They were then randomized to receive High Flow Oxygen [HFOx] with up to 60 L/min, High Flow Air [HFAir], Low Flow Oxygen [LFOx] or LFAir during a constant work rate exercise test at 80% maximum. Dyspnea intensity was assessed with the modified 0-10 Borg scale. The primary outcome was difference in the slope of dyspnea intensity vs. time during the third test. Secondary outcomes included difference in exercise time, vital signs, and adverse events. We estimated that 10 patients per arm will provide 86% power to detect a 1-standard deviation main effect and 86% power to detect a 2-SD interaction effect with an alpha of 5%. A linear mixed effects model was used to assess the impact of flow rate and gas on study outcomes. Results: 45 patients were randomized and 44 completed the study (10, 11, 12, 11 patients on HFOx, HFAir, LFOx, LFAir, respectively). The mean age was 63 (range 47-77); 18 (41%) were female; 34 (44%) had lung cancer; and 20 (46%) had metastatic disease. In mixed effects model, the association between the change in dyspnea intensity over time with flow rate differed significantly between oxygen and air (P = 0.04). Specifically, HFOx (slope difference -0.20, P < 0.001) and LFOx (-0.14, P = 0.01) were significantly better than LFAir, but not HFAir (+0.09, P = 0.09). Exercise time also significantly increased with HFOx (difference +2.5 min, P = 0.009) compared to LFAir, but not HFAir (+0.63 min, P = 0.48) or LFOx (+0.39 min, P = 0.65). HFOx was well tolerated without significant adverse effects. Conclusions: The combination of high flow rate and oxygen improved dyspnea and exercise duration during constant work exercise test in non-hypoxemic cancer patients. Larger trials are needed to confirm the benefits of HFOx during exercises. Clinical trial information: NCT02357134.
Learning from best scalp cooling practices in a registry: Differences in results from n>7000 patients with solid tumors.
Authors: van den Hurk Corina , Dercksen Martin W , Nortier J. W. R. , Breed Wim 
Published: March 2020

11610 Background: Hair loss is a frequently occurring and stigmatizing side effect of chemotherapy. Worldwide scalp cooling is being introduced to prevent chemotherapy-induced alopecia (CIA). In the Netherlands scalp cooling is implemented in many hospitals since 2005. FDA clearance has been approved for scalp cooling among breast cancer patients in the USA in 2016. Recently approval has been expended for solid tumors. Methods: In a prospective, longitudinal registry data have been collected between 2006 and 2017. Patients could be included if they received chemotherapy that induced severe alopecia, regardless type of solid tumor, stage of disease, age, gender or receiving adjuvant or palliative treatment. Patients were eligible for evaluation of hair loss after they received at least 2 cycles of chemotherapy or if they ceased scalp cooling because of severe hair loss after the first cycle. Failure was defined as feeling the need to use a wig or head cover. Data will be presented using descriptive statistics and multivariate regression analysis to explore determinants of scalp cooling efficacy per largest groups of chemotherapy regimen, and evaluate variety between hospitals. Results: Preliminary results show data of 7378 patients from 68 hospital locations of whom 75% had breast cancer and 8% prostate cancer. Overall 57% of patients did not feel the need to wear a wig or head cover. Variation was observed between hospitals in scalp cooling procedures: e.g. wetting the hair (0-100% of patient) and cooling- and infusion times that varied per type of chemotherapy. Also results varied between hospitals per type and dose of chemotherapy (n > 10 patients), e.g. minimal 37% and maximal 86% success rates between hospitals for paclitaxel-carboplatin (n = 498), 17-54% success for irinotecan monotherapy (n = 275), 25-79% success for 5FU/epirubicin/cyclophosphamide-docetaxel (n = 843) and 79-94% for docetaxel monotherapy (n = 824). Also variation in satisfaction with information about scalp cooling and nursing expertise was observed. Results from the regression analyses will be presented at the conference. Conclusions: Scalp cooling efficacy varied enormously between hospitals. A registry is a useful tool to identify best practices and to provide guidance to further improve results. An international registry has been set up to also collect data on CIA among scalp cooled and non-scalp cooled patients in the USA, Australia and the UK.
Differences among Asian/Asian American, and Caucasian breast and gynecologic cancer patient-reported survivorship needs, symptoms, and illness mindsets (N=220).
Authors: Schapira Lidia , Hofmeister Elisa , Kurian Allison W. , Zion Sean , Shen Hanyang , Torres Tara , Berek Jonathan S. , Palesh Oxana 
Published: March 2020

11620 Background: Cancer experiences are mediated by host and disease factors and affected by social and cultural determinants of health. We sought to characterize perceived supportive care needs and domains of psychosocial functioning among a diverse group of women attending routine appointments for treatment or follow-up of breast and gynecologic cancers. Methods: From July 2018 until January 2019, all patients seen at the Stanford Women’s Cancers Program (serving women treated for breast and gynecologic cancers) were approached to participate. 220 cancer patients (78% breast and 22% gynecologic), mean age 54 (SD = 12) completed an online survey on their supportive care needs assessment (The Short-form Supportive Care Needs Survey Questionnaire) which contains physical, social, information, sexual and psychological scales, anxiety and depression (Patient Health Questionnaire-4) and mindsets about illness and the body mindset (Brief Illness Mindset Inventory). Only 14% of patients refused to take part in the survey. Results: T-test showed that Asian/Asian-American cancer patients (n = 57, 26%) reported fewer needs related to coping with physical symptoms, side effects of treatment and performing usual tasks and activities compared to Caucasian patients (n = 137, 62%), p = .038. Moreover, Asian/Asian-American cancer patients reported fewer depression symptoms (p = .049). Chi-square analyses showed that Asian/Asian-American patients reported less use of psychotherapy over their lifetimes (24.6% vs. 54.0%, p < .001), but significantly higher utilization of Chinese Medicine for cancer symptom management (24.6% vs. 5.8%; p < . 001) compared to the Caucasian patients. T-tests showed that Asian/Asian American patients reported significantly greater agreement with the mindsets that ‘cancer is a catastrophe’ (p = .006) and that their ‘body is an adversary’ (p = .047). Conclusions: In this population of breast and gynecologic patients and survivors we found differences in cancer mindsets, coping and use of mental health and complementary therapies between Asian and Asian-American and Caucasian women. Further analysis to understand the cultural differences are ongoing.