bluuebunny/crossref_metadata_2025_split huggingface dataset:
Using cancer registry records linked with health insurance records to measure costs and services at end-of-life.
Authors: Kreizenbeck Karma L. , Fedorenko Catherine R. , Stickney Kristine , McDermott Cara L , Conklin Ted , Smith Bruce , Lyman Gary H. , Ramsey Scott David 
Published: February 2017

186 Background: Studies suggest that end-of-life (EOL) care for persons with cancer in the United States is variable and often misaligned with patient and family preferences. To better understand these issues, we developed reports on high-priority quality indicators and costs at EOL. Methods: Surveillance, Epidemiology, and End Results (SEER) records for solid tumor patients diagnosed with cancer in Western Washington state between 1/1/2007 and 12/31/2015 were linked with enrollment and claims from two regional commercial insurers. Using claims, we then developed algorithms to characterize EOL care for breast, colorectal, and non-small cell lung cancer (NSCLC), including costs of care at 90- and 30-days prior to death. Costs include all claims paid for ED, hospital, outpatient, and pharmacy care. We estimated patient out-of-pocket costs as the difference between allowed and paid claim amounts. Results: See Table. Across the largest 10 clinics in the region there was considerable variability in the average costs of cancer care in the last 90 days of life. The clinic-specific average ranged from $24,532 to $72,931 for breast cancer, $30,495 to $65,975 for colorectal cancer and $23,320 to $59,641 for NSCLC. Conclusions: At the end of life, care for patients with advanced breast, lung, and colorectal cancer is highly variable, costly to patients, and may be misaligned with the goals and preferences for patients and their family members. While the results may reflect both appropriate and unnecessary care, the large variation across clinics suggests opportunities for improvement. Further research is needed to identify factors associated with use of low-value, high-cost services at the end of life. [Table: see text]
Concordance between patient and family caregiver reports of quality of colorectal cancer care.
Authors: Havyer Rachel D. , van Ryn Michelle , Wilson Patrick , Griffin Joan M. 
Published: February 2017

187 Background: Patient-reported evaluations of interpersonal quality of care are essential elements of quality of cancer care assessment. At times, patients may be unable to report themselves on their care experience and systems may rely on proxy reports. The validity of this approach is dependent on the degree to which family caregiver assessments are concordant with patient assessments. Methods: A VA cohort of colorectal cancer (CRC) patients and their caregivers both completed a self-administered questionnaire on the quality of VA cancer care in 3 specific domains: surgery, chemotherapy overall and chemotherapy nursing care, all measured on a 5-point Likert scale. Because the kappa statistic penalizes skewed distributions which are commonly seen in patient satisfaction reports, agreement between patients and caregivers on perceptions of quality care were measured using Gwet’s AC2 statistic. Stratified analyses on caregiver burden, race, education, and age as well as patient’s stage of disease were used to assess variation in agreement. Results: 417 caregiver-patient dyads completed the survey (70% response rate), of whom 362 (86.8%) had surgery and 195 (46.8%) had chemotherapy. Overall agreement was high for the 3 quality of care domains: AC2 (95% CI): 0.870 (0.838, 0.903) for surgery, 0.835 (0.786, 0.884) for chemotherapy overall and 0.906 (0.868, 0.944) for chemotherapy nurses. Stratified analyses of agreement showed particular populations of higher or lower agreement; however the findings were inconsistent across the three domains and most were not statistically significant. Patients with lower stage (I-II) had higher agreement than higher stages (III-IV) (AC2: 0.967 and 0.879 respectively, P = 0.006) but only in the chemotherapy nurses domain. For the surgery domain, age was the only significant difference in agreement (0.816, 0.912, and 0.838 for < 50, 51-65, and > 65 respectively, P = 0.03). Conclusions: Family caregiver reports on the quality of CRC care were highly concordant with patient reports. Therefore, family caregivers may be able to provide reasonable proxy report on measures of quality of cancer care when patient reports are unavailable.
Practice patterns and outcomes of rivaroxaban usage in patients with cancer.
Authors: Escalante Carmelita P. , Zalpour Ali , Song Juhee , Richardson Marsha N. , Lam Tony , Halm Josiah , Yusuf SWamique , Gao Shuwei 
Published: February 2017

194 Background: Patients with cancer have an increased risk of venous thromboembolism (VTE) and frequently require anticoagulation. In addition, many patients with cancer also have comorbidities such as atrial fibrillation (AF) and are on stroke prevention. Rivaroxaban (RV) is an oral (factor Xa inhibitor) used in these scenarios; however, there is little experience utilizing this agent in patients with cancer. Our aim is to describe practice patterns and outcomes of RV usage in patients with cancer. Methods: We conducted a retrospective study of 62 patients with cancer receiving RV for at least 5 days for VTE or non-valvular AF from 1/1/2012 through 10/31/2015. Practice patterns included RV perioperative use and blood and platelet transfusions. Outcomes of interest were recurrent VTE and bleeding. Descriptive statistics were utilized to summarize demographic and clinical variables. Results: Of 62 patients with cancer, the mean age was 62 years (range 31-83), 50% were male, and 77% white. The most common cancer types were gastrointestinal 9 (15%), sarcoma 9 (15%), and breast and hematologic each with 8 (13%). Of those, 49 (79%) had VTE, 9 AF (15%), and 4 (7%) had both. 42 (68%) patients were switched to RV from a prior anticoagulant, the majority from low molecular weight heparin. 22 (36%) had RV withheld temporarily; 15 due to surgical procedure and 5 due to bleeding. 5 (33%) received bridging anticoagulation prior to surgery. RV was held a mean of 2 days prior to surgery and resumed 9 days post-op. 14 (21%) received blood and 2 (3%) received platelet transfusions while on RV. 2 (3%) patients had VTE recurrence while on RV. 18 (29%) discontinued RV due to bleeding, 5 (28%) due to hematuria and only 1 patient due to thrombocytopenia (6%). There were no major bleeds or deaths related to RV. Conclusions: RV was used in solid and hematologic cancers. The majority were transitioned from another anticoagulant. Although VTE recurrence was low, discontinuation of RV due to bleeding was higher. Further study of the use of RV in patients with cancer is needed for continued guidance of appropriate and safe usage.
A single-dose comparative bioavailability study of dronabinol oral solution versus dronabinol capsules in healthy volunteers.
Authors: Smith Christina Cognata , Parikh Neha , Kramer William G. , Khurana Varun , Vetticaden Santosh 
Published: February 2017

198 Background: The capsule formulation of dronabinol, a pharmaceutical tetrahydrocannabinol (THC), is approved for anorexia associated with weight loss in patients with AIDS and for cancer chemotherapy-associated nausea/vomiting in patients with inadequate response to conventional antiemetics. A new oral formulation (i.e., dronabinol solution) was evaluated in a bioequivalence study versus currently marketed dronabinol capsules. Methods: In an open-label, 2-treatment, 2-sequence, 4-period, single-dose crossover study, healthy volunteers were randomized to receive 1 of 2 treatment sequences (T-R-T-R or R-T-R-T; T = dronabinol 4.25 mg oral solution and R = dronabinol 5 mg capsules). Dosing occurred after an overnight fast, with a minimum 7-day washout period between treatment periods. A validated liquid chromatography-tandem mass spectrometry method was used to determine plasma concentrations of dronabinol and the primary metabolite 11-OH-Δ9-THC. Results: Fifty-one of 52 enrollees had pharmacokinetic data for analysis. Mean pharmacokinetics were (oral solution vs capsule): Cmax (2.0 vs 2.4 ng/mL), median Tmax (1.0 vs 1.5 h), AUC0-∞ (3.8 vs 4.1 h∙ng/mL), and t1/2 (5.6 vs 3.1 h). The 2 formulations were bioequivalent with respect to maximum plasma concentration (Cmax; reference-scaled criteria) and area under the plasma concentration-time curve (from time zero to last measurable concentration and from time zero to infinity [AUC0-∞]; average bioequivalence) of dronabinol. The data for the 11-OH-Δ9-THC metabolite provide further support for the bioequivalence of the 2 products. Post hoc analysis demonstrated that all volunteers (100%) had detectable plasma dronabinol concentrations at 15 min with the oral solution compared with < 25% of volunteers for the capsules. Intra-individual variability was lower with oral solution versus capsules (for AUC0-∞, 13.5% vs 36.8%, respectively). Conclusions: Dronabinol oral solution 4.25 mg was bioequivalent to dronabinol capsules 5 mg, and exhibited quicker onset of detectable levels and lower intra-individual variability in comparison with dronabinol capsules 5 mg. Clinical trial information: NCT01448772.
Radiation therapy for palliation of osseous metastasis from hepatocellular carcinoma.
Authors: Lau Steven , Singal Amit G. , Yopp Adam Charles , Meyer Jeffrey John , Hall Daniella , Folkert Michael Ryan 
Published: February 2017

204 Background: Osseous metastasis from hepatocellular carcinoma (HCC) is uncommon, and optimal palliative management for palliation is unclear. We present our clinical experience with palliative radiotherapy (RT) for osseous metastasis from HCC. Methods: Patients were identified using two prospectively maintained databases at our institution: all patients with HCC who developed metastases and all patients undergoing RT. Medical records were retrospectively reviewed following Institutional Review Board approval. We identified 146 patients with metastatic HCC, of which 28 patients with 38 osseous metastases were eligible for this analysis. All patients are seen in a multi-disciplinary clinic where consensus for management is developed. Most (89%) had metastasis at the time of initial tumor diagnosis, including 22 (79%) patients with osseous lesions at diagnosis. Tissue confirmation of metastasis was obtained in 22 (79%) patients. Outcomes of interest included patient-reported pain relief at time of follow-up, radiographic response at 6-12 months, and overall survival. Statistical analysis was performed with SPSS (IBM Corporation). Results: Median age at diagnosis was 61 years, and 86% (n = 24) were male. The most common site of metastasis was vertebral body (n = 26, 70%). Median time from bone metastasis diagnosis to RT was 1 month (range, 0-20). Only 1 patient received concomitant systemic therapy at the time of RT. Metastases were most commonly treated using 2D techniques (n = 26, 68%) to 30 Gy in 10 fractions (n = 18, 47%). Pain relief was complete, partial, and absent for 8 (21%), 24 (63%), and 6 (16%) metastases, respectively; no patient reported an increase in pain after treatment. Prescription BED3 > 50 Gy was associated with improved local control (P = .03). 7 (18%) radiographic local failures were observed at a median time of 5.4 months, and the 6-month local failure rate was 20.2%. Median survival was 3.4 months, with a 6-month survival rate of 39.1%. Conclusions: Mortality for patients with osseous metastasis from HCC is high, but palliative RT is associated with significant pain relief and/or disease control in many patients. This data on efficacy of palliative RT helps guide optimal management of these patients.
Comparison of two indwelling pleural catheter types for malignant pleural effusions.
Authors: Floudas Charalampos S. , Gupta Sushilkumar Satish , Chandra Abhinav Binod 
Published: February 2017

205 Background: Indwelling pleural catheter (IPC) placement is an alternative to chemical pleurodesis for malignant pleural effusion (MPE), a complication of advanced cancer. In 1997 an IPC was approved which uses vacuum bottles (VB) for drainage (PleurX, Becton, Dickinson and Company, Franklin Lakes, NJ), and later another IPC system, which employs a manually operated vacuum pump (VP) for drainage (Aspira, Bard Access Systems, Salt Lake City, UT). Most studies comparing IPC versus chemical pleurodesis used the VB IPC. In clinical practice VB and VP are used interchangeably. We conducted a single-center retrospective study to compare the efficacy and safety of these two IPC systems. Methods: With Institutional Review Board approval, we recorded baseline characteristics and outcomes in patients with MPE who received an IPC in our hospital from January 2013 to March 2015. Results: 27 patients were found (median age 59 years, range 30-92). ECOG performance status was 3-4 in 24 (89%); mean ±SD albumin, 2.49 ± 0.48g/dL; median respiratory rate 24 breaths / minute (range 18-40); median heart rate 106 beats / minute (range 59 – 138). A palliative care consultation was requested in 14 (52%) patients. Cancer was of lung (9 patients, 33%), breast (8, 30%), gastrointestinal (4, 15%), hematological (2, 7%), gynecological (2, 7%), prostate (1, 4%) and melanoma (1, 4%). Pleural fluid was exudate in 24 (89%); cytology malignant in 8 (31%). Six patients (22%) received chemotherapy with IPC in situ. VP group (VPG) consisted of 18 (67%) patients and the VB group (VBG) of 9 (33%), with similar characteristics. Spontaneous pleurodesis and IPC removal were achieved in 4 patients (22%) in VPG, 3 (33%) in VBG. Additional pleural procedures were required in 6 (33%) of VPG and 2 (22%) of VBG. Median length of stay was 9 days (range 2 – 38) in VPG, 13 days (range 4-32) in VBG. Catheter-related complications (pain, obstruction, infection, hemorrhage) rate was 39% (7 patients) in VPG and 33% (3 patients) in VBG; no death was caused. Intergroup differences were not statistically significant. Conclusions: In our sample, symptom palliation was achieved in all patients; efficacy and safety were similar for either type of IPC. More studies are needed for further comparisons.
Developing an eHealth intervention for cancer symptom management for rural residents.
Authors: Gilbertson-White Stephanie , Yeung Chi , Mercer Keri Nace , Bartoczszyk Dorota , Papke Todd 
Published: February 2017

207 Background: A disproportionate number of late-stage cancer diagnoses occur in rural residents. Paradoxically this population, with an increased need for palliative care, has minimal access to these services. As smartphone and high-speed internet connectivity reaches near universal penetrance across the country, eHealth technologies have the potential to address this palliative care access gap. Oncology Associated Symptoms and Individualized Strategies (OASIS) web-app was developed to provide tailored cancer symptom self-management support and address this gap. Methods: A two-phased, mixed-methods design was used to: (1) assess stakeholder needs and opinions on the role of eHealth technologies to manage cancer symptoms; and (2) beta test a symptom self-management web-app. Adult patients with advanced cancer and clinic staff from two rural cancer clinics were recruited. A descriptive qualitative approach was used to analyze the patient interviews and staff focus groups. Themes related to symptom management needs and the role of technology were identified. OASIS was developed to address the themes found in phase 1. OASIS consists of 57 self-management strategies for 15 cancer symptoms and a visual symptom/strategy tracker for patients to monitor their symptoms and improve their self-management skills. Results: n = 15 patients were interviewed and n = 11 staff participated in focus groups. Themes identified were “fatalistic acceptance”, “teaching self how to manage symptoms”, and “balancing information needs”. To address these themes OASIS was developed and beta-tested with n = 10 rural residents with advanced cancer. 100% of participants were able to access OASIS via their home internet connection, 80% understood how to use the web-app after one 15 min teaching session, and 50% requested access to the web-app for family to help them with their symptoms. Conclusions: Patients and staff in rural communities have significant cancer symptom management needs and are interested in using eHealth technologies to address these needs. OASIS was found to be accessible, user friendly, easily navigated, and visually appealing. Future research is needed to evaluate the feasibility and acceptability as well as the efficacy of OASIS.
Frequency and factors associated with placebo response in cancer-related fatigue treatment trials.
Authors: Yennu Sriram , Lim Kyu-Hyoung , Williams Janet L. , Lu Zhanni , Bruera Eduardo 
Published: February 2017

210 Background: There is limited literature on specific patient characteristics associated with response to placebo. The aim of this study was to identify frequency, and predictors of response to placebo. Methods: We conducted pooled analysis of the placebo arm in six randomized, double-blind, placebo-controlled clinical trials for cancer related fatigue. Baseline patient characteristics, symptoms (FACIT-F, and ESAS), Global Symptom Evaluation (GSE, rated as better, same and worse). Response was defined as an increase (D FACIT-F score) ≥ 3.5 points from baseline or change in ESAS of ≤ 1. Baseline patient characteristics and symptoms (as assessed by ESAS) were analyzed to determine their association with response to placebo using logistic regression analysis. ROC was calculated for GSE “better” of “4” or more (i.e., moderately better to very great deal better) and FACIT-F change. Results: Total of 306 patients with advanced cancer received placebo. The median age was 59, 54% were female, 76% were white, 51% were had college education or higher, the most common cancer type was genitourinary 24%. 55% had Zubrod performance ≤ 2. Median FACIF-F subscale score was 21. Placebo response was 176/306 (58%) with FACIT-F subscale ≥ 3.5 points and 185 (60%) with ESAS fatigue ≤ 1. Mean change in fatigue using FACIT- F subscale score was 7.18 (11.68) and ESAS was -2.21 (2.82). Change in FACIT-F and ESAS were significantly correlated (r = 0.56, P ≤ 0.001). 99/306 (32%) reported that their fatigue was “better” by GSE. Female gender (OR 2.72, P = 0.04), and anxiety (OR 1.39, P = 0.046) were significantly associated with placebo response. ROC with cut-off of GSE ≥ 4 and change in FACIT-F score was 11.5 and placebo response rate based on cut-off of 7.5 was 84/306 (27%). Conclusions: Our results confirm that placebo response is substantial in fatigue treatment trials in palliative patients. Placebo response rate varies based on the methods used to estimate response (from 27% to 60%). Female patients and higher anxiety at baseline were significantly associated with placebo response. More research is needed to accurately benchmark placebo response.
Pilot study of minocycline for the prevention of paclitaxel-associated neuropathy: ACCRU RU221408I.
Authors: Pachman Deirdre R. , Dockter Travis J. , Zekan Patricia J. , Fruth Briant , Ruddy Kathryn Jean , Ta Lauren E. , Dentchev Todor , Le-Lindqwister Nguyet , Sikov William M. , Loprinzi Charles L. 
Published: February 2017

220 Background: Paclitaxel is associated with both an acute pain syndrome (P-APS) and chronic chemotherapy-induced peripheral neuropathy (CIPN). Preliminary animal data suggest that minocycline may be effective for the prevention of chemotherapy-induced neurotoxicity. The purpose of this pilot study was to investigate the efficacy of minocycline for the prevention of CIPN and P-APS. Methods: Patients with breast cancer were enrolled prior to initiating neoadjuvant or adjuvant weekly paclitaxel for 12 weeks. They were randomized to receive minocycline 200mg on day 1 followed by 100mg twice daily or a placebo, with the same dosing schedule. Patients completed (1) an acute pain syndrome questionnaire daily during chemotherapy, and (2) the EORTC QLQ-CIPN20 questionnaire at baseline, prior to each dose of paclitaxel, and monthly for 6 months post treatment. The primary goal was to obtain pilot data regarding the possible effect of minocycline on the prevention of paclitaxel-induced CIPN and P-APS, to determine if conducting a larger phase III placebo-controlled trial was indicated. Scores obtained from patient questionnaires were converted to a 0-100 scale, where higher scores = better quality of life. Results: Forty-seven patients were randomized, 45 of which were evaluable, with a mean age of 55. There were no remarkable differences noted between the two groups for the overall sensory score of the EORTC-CIPN 20 or its individual sub-questions, which evaluated tingling, numbness, or shooting burning pain in hands and feet. However, there was a significant difference in the daily average AUC pain score attributed to P-APS, favoring minocycline (median 96.0 vs 84.3; p = 0.02). Correspondingly, patients receiving minocycline used less opioid pain medications for control of P-APS (0% vs 23%, P = 0.05). Not only were no increased toxicities reported with minocycline, but there was an apparent improvement in fatigue (median AUC 76.7 vs 59.0; P = 0.02). Conclusions: Based on the results of this pilot study, minocycline did not appear to be beneficial for the prevention of CIPN, but did look promising for reducing P-APS. Further study of this effect may be warranted. Clinical trial information: NCT02297412.
Adherence to anti-emetic guidelines with a newly approved chemotherapy agent, trifluridine/tipiracil (TAS-102): A single-institution study.
Authors: Childs Daniel , Jatoi Aminah 
Published: February 2017

221 Background: To our knowledge, no study has examined adherence to antiemetic guidelines with soon-to-be-approved or newly approved chemotherapy agents. In 2015, the Food and Drug Administration approved 18 cancer drugs, underscoring the timeliness of this topic. Here, we hypothesize that patients prescribed new drugs are at risk for poor guideline adherence, and we report on antiemetic prescribing practices and outcomes with TAS-102, a recently approved drug for metastatic colorectal cancer. Methods: This study focused on all patients prescribed TAS-102 in 2015 at the Mayo Clinic in Rochester, MN for compassionate use or routine care within 3 months of FDA approval. First-cycle antiemetic prophylaxis was examined for adherence to National Comprehensive Cancer Network Guidelines, version 1.2015, for chemotherapy of low emetogenic potential based on TAS-102 phase 3 data. Results: Among 44 patients, 28 (64%) had nausea and vomiting with prior chemotherapy. With the first cycle of TAS-102, 25 (57%) were prescribed antiemetics in a guideline-adherent manner; 15 (34%) in a non-guideline-adherent/more aggressive manner; and 4 (9%) in a non-guideline-adherent/less aggressive manner. In guideline-adherent patients, rates of nausea and vomiting were 52% and 24%, respectively, with one patient requiring an unscheduled clinic visit and another an emergency department visit and hospital admission - all for nausea and vomiting. In non-guideline-adherent/more aggressive patients (who received more prophylaxis than called for), these rates were 33% and 27%, respectively, with one patient requiring a clinic visit and emergency department visit and another an emergency department visit. In non-guideline-adherent/less aggressive patients, no nausea or vomiting was reported. Conclusions: Poor adherence to antiemetic guidelines occurred often. However, because adherence was not associated with better control of nausea and vomiting, clinical judgment should complement guidelines in patients about to receive new cancer drugs, particularly with drugs of low emetogenic potential and also in patients with a history of chemotherapy-induced nausea and vomiting.