bluuebunny/crossref_metadata_2025_split huggingface dataset:
In-hospital cancer care: Are we missing an opportunity for end of life care?
Authors: Rocque Gabrielle Betty , Barnett Anne Elizabeth , Illig Lisa , Bailey Howard Harry , Campbell Toby Christopher , Stewart James A. , Cleary James F. 
Published: March 2020

9039 Background: Little data exists on the estimated survival of patients with metastatic cancer after hospitalization. As part of a prospective quality improvement project, we characterized the population of patients admitted to an inpatient oncology service in an academic medical center with emphasis on the disposition at discharge and overall survival. Methods: We collected data over a 4 month period (9/1/10-12/23/10) representing 149 admissions of 119 unique patients. We measured patient characteristics, disease evaluation, procedures, consults, imaging studies performed, disposition, length of stay, and overall survival. These data were compared to a similar study conducted in our center in 2000. Results: Uncontrolled symptoms were the most common reason for admission (pain 28%, dyspnea 9%, nausea 9%). Imaging studies were more common than in 2000 (415 vs. 196 total procedures). Eighty-five percent of patients had progressive disease. Seventy percent of patients were discharged home without additional services such as home health or hospice. The overall median survival was poor in 2000 and in 2010, 100 days and 60 days from discharge, respectively. Despite an overall poor prognosis, palliative care consultation was obtained only 13 times (8% of admissions) and 18% of patients were enrolled in hospice at discharge. Conclusions: An unscheduled hospital admission portends a poor prognosis. Cancer patients in the hospital are nearing the end-of-life with a median life expectancy of approximately 3 months and could be considered hospice-eligible and appropriate for a palliative care consult. We believe that hospital admission represents a missed opportunity to provide palliative care services and end-of-life counseling to this patient population.
Pulmonary symptoms and their importance to patients with non-small cell lung cancer undergoing second- and third-line chemotherapy.
Authors: Magasi Susan , Kaiser Karen , Mallick Rajiv , Cella David 
Published: March 2020

9056 Background: As new cancer therapies are developed, it is important to evaluate their efficacy based not only on survival outcomes but also meaningful patient benefit in terms of symptoms and concerns that are important to patients. The purpose of this study of patients undergoing 2nd/3rd line chemotherapy for non-small cell lung cancer (NSCLC) was to characterize pulmonary symptoms and the importance patients place on these symptoms, as a part of assessing the content validity of the Pulmonary Symptom Index (PSI) of the Functional Assessment of Cancer Therapy – Lung (FACT-L). Methods: We conducted semi-structured thematic interviews with 20 stage III/IV NSCLC patients undergoing 2nd or 3rd line treatment. Interviews included open elicitation of NSCLC symptoms and their functional impact, and participant ratings of the relative importance of pulmonary symptoms. Results: Mean age was 62 years (range 30-79); 80% had non-squamous histology, and 30% had co-morbid COPD. While participants described a range of symptom experiences and severity, a core set of pulmonary symptoms emerged - shortness of breath (reported by 16/20, 13/20 rated as very important), cough (reported by 14/20, 10/20 rated as very important), and chest tightness (reported by 15/20, 9/20 rated as very important); these matched key symptoms in the PSI. Symptom importance ratings were influenced by the functional impact they had upon patient ability to perform valued roles and responsibilities. Patients described diverse coping strategies including breaking down activities into manageable tasks, priority setting, physical assistance, emotional support, and health promoting changes in diet and exercise. Ninety percent (18/20) of participants reported tiredness or fatigue; most said it was “very important.” A quarter (5/20) of the participants reported having no pulmonary symptoms. Conclusions: These results in NSCLC patients undergoing 2nd/3rd line treatment support the importance, relevance, and impact of core pulmonary symptoms included in the PSI and offer initial evidence that its content may constitute a key element of patient benefit in evaluating the efficacy of new cancer therapies.
Pharmacokinetics, pharmacodynamics, and tolerability of BCD-017, a novel pegylated filgrastim: Results of open-label controlled phase I study with dose escalation in healthy volunteers.
Authors: Nikitin Kirill D. , Fitilev Sergei B. , Chernovskaya Tatiana V. , Rudenko Elena G. , Vozzhaev Alexander V. , Titarova Yulia Y , Yakushev Vadim A. , Ivanov Roman A. 
Published: March 2020

9060 Background: Pegfilgrastim (conjugate of filgrastim and 20 kDa PEG) is approved for treatment of chemotherapy-associated neutropenia. BCD-017 is a covalent conjugate of filgrastim with 30 kDa PEG. Increased molecular weight of PEG molecule may provide additional benefits compared to pegfilgrastim. We have conducted this open-label phase I study to assess the PK, PD and tolerability of BCD-017. Methods: 24 healthy male volunteers signed the informed consent and were sequentially assigned to receive 1, 3 or 9 mg of BCD-017 or 5 mcg/kg/day of filgrastim for 7 days, 6 volunteers per group. Outcome measures included absolute neutrophil count (ANC) and СD34+ cell count, PK parameters and adverse events (AEs). Results: BCD-017 induced a fast and significant increase of ANC. Median maximum ANC (ANCmax) for BCD-017 1, 3, 9 mg and filgrastim was 18.68 (10.62-21.02), 25.92 (15.43-28.07), 32.22 (18.22-45.79), and 28.21 (21-31.95) ×103 cells/mm3, respectively; median time to ANCmax was 24 (12-24); 48 (24-72); 72 (48-72); and 132,5 (12-169) h, respectively; median increase in СD34+ cells number 96 h post dose was 4.7 (1.2-6.5), 6.5 (1.7-12.3), 40.9 (24.5-102), and 17.8 (3.3-35.2) times, respectively. Filgrastim serum concentration was analyzed using ELISA. Median Cmax for BCD-017 3 and 9 mg and filgrastim was 45 (31-65), 446 (191-649), and 40 (20-54) ng/mL, respectively; median Tmax was 48 (24-72), 36 (24-48), and 8 (6-8) h respectively; median T1/2 was 65 (51-70), 46 (41-57), and 6.7 (6.2-7.6) h, respectively. BCD-017 was well tolerated. No dose-limiting AEs were observed. AEs included headache, back pain, myalgia, arthralgia, thrombocytopenia, hyperuricemia, alkaline phosphatase/LDH increased. All AEs were of grade 1-2. Compared to filgrastim, the best tolerability was observed in 3 mg group. Conclusions: BCD-017 is shown to be a potent stimulator of granulopoiesis. BCD-017 3 mg did not differ from filgrastim in terms of ANC increase and its safety was shown in healthy volunteers. Further phase II study of BCD-017 for treatment and prophylaxis of neutropenia in patients receiving cytotoxic chemotherapy is necessary.
Interdisciplinary palliative care in metastatic non-small-cell lung cancer.
Authors: Koczywas Marianna , Cristea Mihaela C. , Reckamp Karen L. , Thomas Jay , Sun Virginia , Ferrell Betty R. 
Published: March 2020

9068 Background: Palliative cancer care is the integration into cancer care of therapies that address multiple issues that cause suffering for patients and their families and impact their life quality. Challenges and barriers continue to hinder the integration of palliative care into comprehensive, ambulatory oncology care. This paper aims to describe how symptoms, distress, and quality of life (QOL) data from the usual care phase of a NCI-supported Program Project (P01) informed the development of an interdisciplinary palliative care intervention for patients with metastatic non-small-cell lung cancer (NSCLC). Methods: Patients receiving usual care for metastatic NSCLC were recruited into this prospective longitudinal study. A total of 130 patients with stage IV NSCLC were accrued, and 114 patients had evaluable data. Upon informed consent, patients completed outcome measures that assessed physical function/cognitive status, social activities and support, symptom characteristics, psychological distress, and overall QOL. Patient-reported outcomes were completed at baseline, 6, 12, and 24 weeks post-accrual. Results: Subjects were primarily female (64%), ranged in age from 40-84 years, and 39% were ethnic minorities. The majority were former smokers (66%). KPS, IADL, and Cognitive scores deteriorated significantly over time (p=.001, .009, and .042, respectively). Patients reported higher severity scores with symptoms such as dyspnea, fatigue, insomnia, lack of appetite, peripheral neuropathy, pain, dry skin, nail changes, and problems with sexual interest in all four time periods. Global Symptom Distress Index and Total Symptom score both significantly worsened at 24 weeks (p=.003 and .017, respectively). Physical Well-Being worsened significantly (p=.036), while overall QOL, spiritual well-being, and psychological distress scores remained statistically stable over time. Conclusions: Patients with metastatic NSCLC continue to experience high symptom burden and diminished physical well-being over time while receiving treatments. An interdisciplinary palliative care intervention is currently being tested to improve symptom burden and overall QOL.
Psychological impact of exercise in women with breast cancer receiving adjuvant therapy: What is the optimal dose needed?
Authors: Carayol Marion , Bernard Paquito , Boiche Julie , Riou Francois , Mercier Betty , Cousson-Gelie Florence , Romain Ahmed Jerome , Ninot Gregory 
Published: March 2020

9074 Background: Several meta-analyses have examined the role of exercise interventions in improving psychological outcomes in cancer survivors but most did not focus on adjuvant therapy period and did not investigate the optimal dose of exercise needed. Methods: The present meta-analysis examines the impact of exercise interventions delivered at this particular period on fatigue, anxiety, depression and quality-of-life (QoL) as well as dose-response relationships between volume of prescribed exercise and these psychological outcomes. Randomized controlled trials that proposed an exercise intervention to breast cancer patients undergoing chemotherapy and/or radiotherapy were systematically identified and coded. Standardized mean differences (SMDs) of psychological outcomes were weighted by the inverse of their variances to obtain a pooled estimate using random effects model. Linear and quadratic regressions were carried out to explore dose-response relationships. Results: In total, 17 studies involving 1380 participants and 20 exercise interventions were included. Intervention subjects significantly reduced their fatigue and depression levels showing pooled effect sizes (EF) and their associated 95% confidence interval (95%CI) of -0.28 [95%CI: -0.54; -0.03] and -0.28 [95%CI: -0.46; -0.09] respectively. Levels of anxiety also appeared to be reduced but pooled estimate did not reach significance (p=0.06). Significantly increased QoL was observed: EF=0.34 [95%CI: 0.07; 0.62] favouring intervention. Consistent and significant inverse associations of weekly and total volume of prescribed exercise were observed with fatigue (F test: p=0.04, R²=0.19 and p=0.009, R²=0.26 respectively) and QoL (F test: p=0.01, R²=0.14 and p=0.02, R²=0.29 respectively), implying that SMDs magnitude decreased as exercise dose increased. Conclusions: Exercise intervention enhanced fatigue, depression and QoL in breast cancer patients undergoing adjuvant therapy. Prescription of relatively low doses of exercise (<12 MET.h per week) consisting in approximately 90-120 min of weekly moderate physical exercise seems more efficacious in improving fatigue and QoL than higher doses.
Effect of aprepitant on adherence to high-dose cisplatin-based chemotherapy.
Authors: Makarenko Serge , Cheung Winson Y. 
Published: March 2020

9078 Background: Treatment of locally advanced head and neck cancers (HNC) and gastroesophageal cancers (GEC) frequently consists of high-dose cisplatin, which is highly emetogenic. Our aims were to 1) explore the impact of aprepitant for improving adherence to cisplatin-based chemotherapy in HNC and GEC, 2) examine its effect on reducing chemotherapy-induced nausea and vomiting (CINV) and 3) determine if use of aprepitant changed after introduction of insurance coverage for this drug. Methods: Patients diagnosed with HNC or GEC in British Columbia, Canada from Jan 2008 and June 2011 and prescribed high-dose cisplatin were reviewed. Using regression models that adjusted for confounders, we evaluated the relationship between aprepitant use and treatment and outcome characteristics, such as number of chemotherapy cycles, prevalence of CINV, and recurrence and survival. Results: A total of 333 patients were identified: 162 HNC and 171 GEC patients of whom 80% were men, 44% were aged >/=60 years, 35% were smokers, and 42% were alcohol users. Aprepitant was prescribed in 49%, nausea and vomiting occurred in 64 and 24%, respectively, and completion of all planned cisplatin was 52%. Younger patients (55 vs 41%, p=0.01) and those with less tumor burden (64 vs 38%, p<0.01) were more likely to be given aprepitant. Individuals who received aprepitant were significantly less likely to experience CINV (p<0.01). Use of aprepitant differed between HNC and GEC patients (p<0.01); however, its use did not increase when insurance coverage of this agent was introduced (p=0.16). In multivariate analyses, aprepitant use was significantly associated with adherence to all planned cisplatin treatments (OR 2.33, 95% CI 1.27-4.25, p<0.01). In Cox regression, completion of all cisplatin cycles was significantly correlated with a lower risk of recurrence (HR 0.56, 95%CI 0.32-0.97 p=0.04) and a trend towards decreased death (HR 0.56, 95%CI 0.31-1.10, p=0.10). Conclusions: Aprepitant was associated with a reduction in CINV in both HNC and GEC patients and correlated with better adherence to high-dose cisplatin-based chemotherapy. Individuals who completed all planned cisplatin had improved outcomes, specifically a lower risk of recurrence from HNC and GEC.
Baseline subclinical sensory deficits and the development of pain and numbness in patients with multiple myeloma (MM) being treated with chemotherapy.
Authors: Vichaya Elisabeth G. , Wang Xin Shelley , Boyette-Davis Jessica A. , He Zijing , Thomas Sheeba K. , Shah Nina , Mendoza Tito R. , Williams Loretta A. , Cleeland Charles S. , Dougherty Patrick M. 
Published: March 2020

9082 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting toxicity experienced by patients with MM. Patients may develop painful and non-painful (e.g., numbness) symptoms that impair function and often persist after therapy is terminated. This study examined the predictive value of baseline subclinical sensory deficits on the development of treatment-related pain and numbness. Methods: Patients (N=56) who had two or fewer cycles of induction therapy and no obvious neuropathy were assessed for sensory deficits using quantitative sensory testing (QST). Patients reported the severity of pain and numbness (on a 0-10 scale) at least weekly via the MD Anderson Symptom Inventory during induction (up to 16 weeks); 15 of 56 patients provided data for up to 16 additional weeks of maintenance therapy. These values correlate to patient reported pain and numbness in the hands/feet. Based on data collected from healthy controls, patients were classified as being with or without a sensory deficit at baseline on each QST domain. We fit linear mixed models for pain and numbness with each sensory deficit and time, controlling for cumulative cycles, diabetes, age, and treatment agent. Data is shown as mean ± standard deviation. Results: Patients who showed baseline deficits in sharpness detection (20%) reported significantly lower levels of pain (1.2±1.9 vs 3.1±2.9, p=.004) and numbness (0.4±0.8 vs 2.4±2.6, p<.001) during induction therapy and less numbness (0.0 vs 3.5±2.8, p=.001) during maintenance therapy. Further, those who showed deficits in warmth detection (40%) reported higher levels of pain (5.2±2.8 vs 1.7±2.3, p<.001) and numbness (5.8±2.2 vs 1.6±1.8, p<.001) during maintenance therapy. Finally, those with lower skin temperature (47%) reported higher levels of pain (4.5±2.3 vs 1.7±2.9, p=.005) during maintenance therapy. Conclusions: Our results suggest that subclinical sensory deficits may be useful in determining a patient’s risk for developing CIPN prior to initiation of induction therapy. This information could be used to provide patients with more-personalized chemotherapy plans that take into account their neuropathy risk.
A randomized trial to determine if vitamin B6 can prevent hand and foot syndrome in cancer patients treated with capecitabine chemotherapy.
Authors: Braik Tareq , Yim Barbara , Evans Arthur T , Kassem Mohammed Azher , Phillips Tycel Jovelle , Mullane Michael Russell , Lad Thomas E. , Hussein Lily , Cleveland Barbara , McDunn Susan H. 
Published: March 2020

9085 Background: Capecitabine is an oral fluoropyrimidine that is used to treat various malignancies. Hand and Foot Syndrome (HFS) is a dose limiting toxicity of capecitabine and can limit the use of this agent in some patients. Some investigators have observed that pyridoxine (vitamin B6) can ameliorate HFS caused by capecitabine. We designed a prospective trial to determine if pyridoxine can prevent HFS in patients receiving capecitabine. Methods: In our double-blind, placebo controlled trial, we randomly assigned eligible patients treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first four cycles of capecitabine treatment. The primary end point was the incidence and grade of HFS that occurred in both arms. Results: Between 2008 and 2011, 77 patients were randomly assigned to receive either pyridoxine (n=38) or placebo (n=39). Both arms were matched in baseline characteristics. The median age was 53.5 years. The ethnic composition of the study population was African American 53%, Caucasian 22%, Hispanic 18%, and Asian 7%. The daily doses of capecitabine were: 2000 mg/m2 (69 pts), 1650 mg/m2 (5 pts), 1400 mg/m2 (2 pts) and 1000 mg/m2 (1 pt). Dosages of capecitabine were equally matched between the two arms of the study. HFS occurred after a median of 2 chemotherapy cycles in both groups. HFS developed in 10/38 (26%) patients in the pyridoxine group and in 8/39 (20%) patients in the placebo group (p=0.547). Therefore, the risk of HFS was 6 percentage points higher in pyridoxine group (95% CI for difference: -13 percentage points to +25 percentage points). Given our study results, we can be confident of excluding a true benefit from pyridoxine larger than 13 percentage points. No difference in HFS grades was observed. Conclusions: Prophylactic pyridoxine (vitamin B6), given concomitantly with capecitabine-containing chemotherapy, was not effective for the prevention of HFS. [Table: see text]
Risk of rash with nilotinib: A systematic review of the literature and meta-analysis.
Authors: Drucker Aaron Mark , Wu Shenhong , Berman Ellin , Lacouture Mario E. 
Published: March 2020

9088 Background: Nilotinib is indicated for the treatment of chronic myelogenous leukemia (CML). The reported incidence and risk of rash from this medication vary widely and have been inconsistently reported in published trials. Therefore we conducted a systematic review and meta-analysis of the literature to determine the incidence and risk of developing rash. Methods: Relevant studies were identified from the PubMed database (1998-2012), abstracts presented at ASCO and ASH Conferences (2004-2011) and Web of Science database (1998-2012). Eligible studies were limited to prospective Phase II-III clinical trials in which patients received nilotinib at doses of either 300 mg or 400 mg twice daily. Incidence, relative risk (RR), and 95% confidence intervals (CI) were calculated using random-effects or fixed-effects models based on heterogeneity of included studies. Results: Data from a total of 3,186 patients receiving nilotinib in 16 clinical trials were available for analysis. The overall incidence of all-grade and high-grade (grade ≥3) rash were 33.1% (95% CI: 27.7-39.1) and 2.6% (95% CI: 2.1-3.4), respectively. Incidence of all-grade rash for patients with CML, gastrointestinal stromal tumor (GIST) and systemic mastocytosis were 33.2% (95% CI: 27.2-39.9), 25.7% (95% CI: 14.0-42.5) and 25.0% (95% CI: 15.7-37.4), respectively. Nilotinib was associated with increased risk of all-grade rash (RR=2.891, 95% CI: 2.079-4.020; P<0.001) when compared to patients treated with imatinib. Risk of high-grade rash was increased compared to imatinib (RR=1.823, 95% CI: 0.670-4.957), but this was not statistically significant (P=0.24). Conclusions: Patients with hematologic malignancies and GIST who are treated with nilotinib are at significant risk for developing a rash. Further studies for characterization, prevention and treatment of this untoward toxicity are needed in order to maintain patients’ quality of life and minimize the need for dose modification, which may impact clinical outcome.
The chemotherapy-induced peripheral neuropathy (CIPN) outcome measure standardization (CI-PeriNomS) study: From consensus to validity and reliability in CIPN assessment.
Authors: Cavaletti Guido ,   CI-Perinoms Study Group
Published: March 2020

9089 Background: Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a debilitating and dose limiting complication of cancer treatment. However, the impact of CIPN has never been studied in a clinimetric manner, in its impact on quality of life. This study was performed to select appropriate outcome measures and to establish, for the first time with a clinimetric approach, their validity and reproducibility. Methods: After literature review and a consensus meeting, face/content validity were obtained for the following scales: the National Cancer Institute Common-Toxicity-Criteria (NCI-CTC), the Total Neuropathy Score (TNSc), the modified INCAT sensory sumscore (mISS), the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and CIPN20 quality of life measures. 281 patients with stable CIPN were examined through an EU/US collaboration involving 20 oncology/neurology centers. For each scale the inter- and intra-rater agreement was evaluated by means of weighted K-Cohen coefficients and 95% confidence intervals, when analyzing qualitative ordinal scales and by means of Spearman's rank correlation coefficient and t-test when analyzing quantitative ordinal scales. The adopted weights for the estimate of K-Cohen coefficients were the Fleiss-Cohen weights. For validity purposes, the Kruskal-Wallis equality-of-populations rank test was performed relating the mISS and TNSc to the NCI-CTC grades. Results: Proper, although slightly different, inter-/intra-observer scores (i.e. r > 0.7) were obtained for the TNSc, mISS, and NCI-CTC sensory/motor subscales. Test-retest values were also high for the EORTC QLQ-C30 and for the recently developed and never formally tested CIPN20. Acceptable validity scores were obtained through correlation between the the mISS and TNSc to the NCI-CTC scores (p values ranging from 0.04 to < 0.001). Conclusions: Proper validity and reliability scores were demonstrated for the set of selected outcome measures in CIPN. These results will allow to base new trials on a solid methodological background, although future studies are warranted to investigate the responsiveness issues.