bluuebunny/crossref_metadata_2025 huggingface dataset:
Palliative care and palliative radiotherapy education in radiation oncology: A survey of US radiation oncology program directors.
Authors: Wei Randy , Colbert Lauren , Jones Joshua Adam , Kane Gabrielle , Racsa-Alamgir Margarita , Vapiwala Neha , Dharmarajan Kavita Vyas
Published: February 2017

178

Background: To assess the state of palliative care education curricula in radiation oncology residency programs in the United States. Methods: We surveyed 90 program directors of radiation oncology residency programs in the United States from September 2015 to November 2015. An electronic survey on palliative care education during residency was sent to all program directors. The survey consisted of questions on perceived relevance of palliative care in radiation oncology residency, formal didactics on domains of palliative care, effective teaching formats for palliative care education, and perceived barriers for integrating palliative care into the residency curriculum. Results: Sixty-three percent (57/90) residency program directors completed the survey. Most (93%) program directors agree or strongly agree that palliative care is an important competency for radiation oncologists. A vast majority (90%) of programs have dedicated palliative care services; however, only 57% of programs offer residents an opportunity to spend elective time on a palliative care service. Of these programs, only 30% reported residents rotating on a palliative care service in the past two years. Furthermore, 67% of residency programs have formal educational activities in principles and practice of palliative care. The palliative care curriculum included faculty-led lectures (73%), resident-led lectures (42%), and seminars (22%). Most programs have one or more hours of formal didactics on management of pain (66%), management of neuropathic pain (64%), and management of nausea and vomiting (64%). 35%, 46%, and 48% programs had one or more hours of management of non-physical symptoms including fatigue, anorexia, and anxiety, respectively. Conclusions: Residency program directors believe that palliative care is an important competency for their trainees. The survey revealed that many programs have structured curricula on PSC and palliative radiation education, but that there are still areas for improvement.
Advance care planning and specialty palliative care utilization for patients with hematologic malignancies who undergo allogeneic hematopoietic cell transplant.
Authors: Schoenbeck Kelly L. , McNey Lisa M. , Eckhert Erik , Galligan Derek , Mannis Gabriel N.
Published: February 2017

18

Background: Unlike most metastatic solid tumors, many advanced hematologic malignancies are treated with curative intent. Accordingly, aggressive interventions often continue until late in the disease course because it can be difficult to discern when cure is no longer possible. This is particularly true for recipients of allogeneic hematopoietic cell transplant (alloHCT). We hypothesized that alloHCT recipients and their providers would be less likely to utilize specialty Palliative Care (PC) services or to engage in early communication regarding advance care planning. Methods: This was a single-center, retrospective chart review of all alloHCT recipients at the University of California, San Francisco who died between 2012-2016. Patients were excluded if there was insufficient data available for analysis. Results: Of the 122 alloHCT deaths identified, 75 met inclusion criteria. The median age at alloHCT was 55, and most patients were Caucasian (69%), were transplanted for acute leukemia or MDS (77%), and received a well-matched allograft (81%). 57% died from disease relapse and 20% died from treatment-related causes. 61% of alloHCT recipients died in the hospital, with 37% dying in an ICU. 52% of patients received chemotherapy within 2 months of death, and 17% within 2 weeks. While 79% of patients were DNR/DNI at the time of death, the median time from change of code status to death was 4.5 days. 80% of patients had no prior code status documented in an outpatient note, and a specific goals-of-care conversation was documented in < 25% of outpatient charts. The PC service was consulted for the majority of patients (57%), although the median time from consultation to death was 13 days, with 23% of all consultations occurring within 3 days of death. Only 16% of patients accessed specialty PC services more than 30 days prior to their death. Conclusions: Despite high rates of both disease- and treatment-related mortality, as well as significant morbidity associated with alloHCT, recipients of alloHCT at our institution infrequently engaged in early conversations about end-of-life care and rarely utilized specialty PC services more than 1 month prior to dying.
Effect of supportive care consultation on reducing 30-day readmissions to oncology inpatient services at an academic hospital.
Authors: Knestrick Mark W. , Grey Carl , Kodali Dheeraj , Wen Sijin , Craig Michael D. , Moss Alvin Howard
Published: February 2017

181

Background: Decreasing 30-day hospital readmissions is an important quality care measure and signifies high-quality care. This study seeks to identify the benefits of Supportive Care consultations on 30-day readmissions to oncology inpatient services in an academic hospital. Methods: A retrospective review of all patients that had at least one 30-day readmission to the medical oncology or hematological malignancy service during a 2 year period (2011-2012). Data was collected on age, sex, cancer type, stage, number of readmissions, and presence of inpatient Supportive Care consultation. Results: During the study period 410 patients were identified with at least one 30-day readmission to an oncology service. Patients with a supportive care consult, 111 (27.7%), had an average of 2.5 readmissions and patients without a consultation, 299 (72.9%), had an average of 2.0 readmissions (p = 0.014). After Supportive Care consultation a reduction of 0.87 admissions (p < 0.001) was observed. Stage IV disease was observed in 203 (49.5%) of patients studied. Conclusions: Supportive Care is often consulted for patients with significant symptoms and suffering during advanced illness. The higher observed average readmissions in patients seen by Supportive Care may reflect the complex assistance needed by this patient population. This study demonstrates a benefit of Supportive Care consultation in reducing 30-day readmissions after consultation.
Symptom distress and patterns of palliative-care referral among oncology outpatients.
Authors: Christianer Kaylan , Blinderman Craig D
Published: February 2017

185

Background: The early implementation of palliative care services is recognized as an important aspect of oncologic care. However, rates of referral to palliative care services among oncology patients are still low, and the decision to refer is frequently at the discretion of the treating oncologist or by patient request. We sought to better identify the patterns of referral to outpatient palliative care, as well as patient symptom burden in an effort to target early and high-yield palliative care interventions. Methods: We conducted a cross-sectional survey among outpatients presenting to a Hematology/Oncology practice at a tertiary care hospital. Patients presenting to the clinic were asked to complete an Edmonton Symptom Assessment Scale (ESAS) survey at time of registration. Chart review was completed to identify basic demographic information, timing and extent of cancer diagnosis, basic medical and psychiatric comorbidities, and existing referral to palliative care services. Results: Between November 15, 2014 and December 24, 2014, a total of 146 complete surveys were collected from oncology outpatients. The most common malignancies were hematologic (40.4%), lung (24.6%), breast (8.2%), gastrointestinal (6.8%) and genitourinary (6.8%); 30.1% had metastatic disease at the time of the visit. A total of 13 patients (8.9%) were receiving outpatient palliative care services. As compared to patients not receiving palliative care services, those who were reported higher overall symptom distress scores (26.3 vs. 12.7, p = 0.013) and pain scores (3.5 vs. 1.6, p = 0.03). Patients receiving palliative care services also had fewer years since diagnosis (2.8 years vs. 4.5 years, p = 0.028), and a non-significant trend toward higher rates of metastatic disease (72.7% vs. 47.3%, p = 0.059). Conclusions: Overall, low rates of referrals to palliative care were found among oncology outpatients. In addition, this study suggests oncology patients are referred to palliative care at later stages of disease, when they are already experiencing significant symptom burden. Future research will determine which patients will benefit from earlier referrals to palliative care before symptoms become more advanced.
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.
Efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gastrointestinal and colorectal cancers.
Authors: Navari Rudolph M. , Jordan Karin , Rapoport Bernardo Leon , Schnadig Ian D. , Chasen Martin , Arora Sujata , Powers Daniel , Schwartzberg Lee Steven
Published: February 2017

222

Background: Rolapitant (VARUBI) is a selective, long-acting neurokinin-1 receptor antagonist (RA) for the prevention of CINV. Rolapitant effectively prevented CINV in phase 3 trials of patients (pts) receiving highly or moderately emetogenic chemotherapy (HEC, MEC). While MEC and HEC regimens are commonly used to treat pts with gastrointestinal and colorectal cancers (GI/CRC), very few studies have evaluated the effectiveness of a neurokinin-1 RA regimen in these pts. We assessed the incidence of CINV and efficacy of rolapitant in a subset of pts with GI/CRC. Methods: This is a post hoc analysis of 3 similarly-designed, randomized, placebo-controlled trials. Pts with cancer of the esophagus, stomach, colon/rectum, or anus received a single oral dose of 180 mg oral rolapitant or placebo prior to HEC or MEC. All pts received a 5-hydroxytryptamine type 3 (5-HT3) RA and dexamethasone (active control). The HEC studies included cisplatin, and the MEC study carboplatin, oxaliplatin, irinotecan, epirubicin, and doxorubicin. Endpoints included complete response (CR; no emesis and no use of rescue medication), no emesis, no nausea (maximum visual analogue scale [VAS] < 5 mm), no significant nausea (maximum VAS < 25mm) and complete protection (CP; no emesis, no use of rescue medication, and no significant nausea) in the overall (0-120 h), acute (≤ 24 h), and delayed (> 24-120 h) phases. Results: Out of 188 GI/CRC pts, 101 pts received rolapitant and 87 received active control. Pts treated with rolapitant had significantly higher rates of CR, no nausea, no emesis, and CP in the overall phase (P < 0.05). Rolapitant was well-tolerated and overall incidence of treatment-emergent adverse events comparable in both groups. Conclusions: Addition of rolapitant to 5-HT3RA and dexamethasone therapy significantly improved CR, no nausea, no emesis, and CP in pts with GI/CRC receiving emetogenic chemotherapy. Clinical trial information: NCT01500226, NCT01499849, NCT01500213. [Table: see text]
Rolapitant for the prevention of nausea in patients receiving moderately or highly emetogenic chemotherapy.
Authors: Navari Rudolph M. , Nagy Cindy K , Arora Sujata , Powers Daniel , Clark-Snow Rebecca Anne
Published: February 2017

224

Background: Nausea control remains an unmet need for patients receiving moderately or highly emetogenic chemotherapy (MEC, HEC). The objective of this analysis was to determine the effect of the neurokinin-1 (NK-1) receptor antagonist rolapitant (VARUBI) on the prevention of nausea in patients receiving either MEC or HEC. Methods: Post hoc analyses of nausea from three randomized, double-blind, active-controlled, phase 3 clinical trials were performed for carboplatin-based MEC (n = 401), non-carboplatin-based MEC (n = 228), total MEC (n = 629), anthracycline/cyclophosphamide (AC)-based chemotherapy (n = 703), and cisplatin-based HEC (n = 1070). Patients were randomized 1:1 to oral rolapitant 180 mg or placebo ~1–2 h before chemotherapy. All patients received active control: granisetron 2 mg oral or 10 mcg/kg IV and oral dexamethasone 20 mg. Granisetron was continued on days 2 and 3 for patients receiving MEC or AC-based therapy and dexamethasone 8 mg twice daily on days 2–4 for patients receiving HEC. Patients self-assessed nausea on days 1–6 using a 100-mm visual analog scale (VAS). Percentage of patients with no nausea (NN; maximum VAS < 5 mm) or no significant nausea (NSN; maximum VAS < 25 mm) was determined for overall, delayed, and acute phases of CINV in cycle 1. Results: Rates of NN in the carboplatin-based MEC and total MEC subgroups were significantly higher (P < 0.05) with rolapitant than active control in the delayed and overall phases. In the cisplatin-based HEC subgroup, rates of NN and NSN were significantly higher (P < 0.05) with rolapitant than active control in the delayed, acute, and overall phases. Conclusions: Rolapitant prevents nausea during all CINV phases in patients receiving cisplatin-based HEC, and during the delayed and overall phases in patients receiving carboplatin-based MEC. Clinical trial information: NCT01500226, NCT01499849, NCT01500213.
A two-group study to evaluate the impact of an educational handbook in the care of patients with head and neck cancer (HNC).
Authors: Bauman Jessica Ruth , El-Jawahri Areej , Quinn Karen , Arcikowski Lisa , Chan Gina , Viscosi Elene , Doherty Carol , Clark John Ross , Temel Jennifer S. , Wirth Lori J.
Published: February 2017

228

Background: Patients undergoing chemoradiotherapy for HNC have a significant symptom burden, psychological distress, and educational needs. We evaluated the impact of an educational handbook integrated into oncology care on patient outcomes. Methods: We conducted a two group, prospective, longitudinal study. Patients enrolled in group 1 received standard care as a control. Then, patients in group 2 received the intervention of a specialized handbook integrated into weekly visits with oncology clinicians during treatment. To assess preliminary efficacy, we evaluated satisfaction (Information Satisfaction Questionnaire-ISQ), mood (Hospital Anxiety and Depression Scale-HADS), illness perception (Brief Illness Perception Questionnaire-IPQ), and quality of life (QOL) (MD Anderson Symptom Inventory-Head and Neck-MDASI-HN) at baseline and week 3. We compared outcomes using two sample t-tests and measured effect size using Cohen’s D. Results: From 8/2014-5/2015 we enrolled and followed 30 patients in group 1. From 5/2015-12/2015, we enrolled and followed 30 patients in group 2. There were no significant differences in baseline characteristics. There were more missing data from group 2. There were high levels of satisfaction in both groups. 20/23 (87%) reported they would ‘definitely’ recommend the handbook to others. Changes in outcomes are shown in Table 1. Compared to group 1, group 2 reported a less threatening view of illness, lower better symptom burden, and less anxiety, but these were not statistically significant. Conclusions: The specialized handbook for patients with HNC was well received. The sample size was too small to detect differences in mood, QOL, illness perception, or satisfaction. Further development in a larger cohort is warranted. Clinical trial information: NCT02204631. [Table: see text]
Psychological distress in cancer patient during chemotherapy: A cross-sectional study.
Authors: Singh Harminder , Banipal Raja
Published: February 2017

231

Background: The State of Punjab is experiencing a rising burden of cancer. The objective of this study was to analyze and compare depression, anxiety and stress levels and their impacting factors in heterogenous surviving cancer patients. Methods: this is a cross sectional study, data collection was performed by Depression, anxiety, stress scale 21-DASS 21. Results: study population include 300 cancer patients and 300 matched controls. The mean age of the cases and controls were 50.58 years ± 13. 64 and 46.1 years ± 11.78 (M ± SD). A Statistical significant difference was observed in mean scoring of depression, anxiety and stress in cancer patients when compared to control groups. Anxiety mean score significantly affected by chemotherapy cycles and duration of disease. Conclusions: Holistic approach in cancer management is a need of time as the present study revealed, the range of depression, anxiety and stress was 90%, 56% and 28% respectively. [Table: see text]
Lessons learned from a clinical-research partnership in outpatient palliative care.
Authors: Cunningham Mary , Washington Karla T , Huenke Diane L
Published: February 2017

238

Background: Palliative care providers and investigators at the University of Missouri developed a clinical-research partnership to conduct a randomized clinical trial (R21CA191165; NCT02427490; PI: Washington) of a technologically-mediated intervention for family caregivers of cancer patients aimed at decreasing caregivers’ distress and improving their quality of life. As the first year of the project drew to a close, the clinician-research team sought to systematically examine the challenges they had encountered conducting research in the outpatient palliative care clinic, which serves a 91-county catchment area that is highly rural and underserved, and to document the strategies they had employed to address them. Methods: Researchers conducted a content analysis of all weekly meeting notes and communication (i.e., emails, memos) related to Year 1 of the project, identifying major categories of identified challenges and related solutions. Results were presented to other members of the team for verification and/or clarification of key points. Results: Researchers identified five categories of challenges and related strategies: adapting processes and materials for use earlier in the cancer trajectory, accommodating a broad range of literacy levels, reaching rural caregivers, responding to technological constraints, and integrating research into the clinic workflow. Selected strategies included consultation with a Patient Advisory Board to revise recruitment materials, broadening inclusion criteria to accommodate rural caregivers without broadband internet availability in their communities, and establishing processes to allow researchers to meet with potential participants between scheduled appointments during busy clinic days. Conclusions: There are many unique considerations clinicians and researchers should take into account when developing partnerships in outpatient palliative oncology settings, particularly within predominantly rural, publicly-funded health care systems. While challenging to develop, such partnerships are instrumental in establishing an evidence base for care for individuals who are otherwise often underrepresented in large research projects. Clinical trial information: NCT02427490.
Barriers to patients’ understanding of prognosis in advanced cancer.
Authors: Pompa Tiffany , Palopoli Jason , Maddox Mark , Woodard Adonas , Ward Kristine Marie , Jain Maneesh Rajiv , Crilley Pamela A. , Topolsky Dave , King John , Khan Sigmund Benham , Amat Maelys , Styler Michael
Published: February 2017

24

Background: An informed decision requires good communication between the patient and their oncologist in regards to diagnosis and prognosis, especially in patients with terminal cancer. This discussion entails education about their disease, treatment options, and potential outcomes. The purpose of this study was to assess advanced-stage cancer oncology patients’ comprehension of their disease, treatment options and goals of therapy. Methods: Subjects included patients with a diagnosis of metastatic cancer with an option for palliative or life extending chemotherapy in an out-patient office at Drexel University College of Medicine. Outpatient office charts were reviewed to identify eligible patients. All subjects consented to participate. Participation included completing a 34-item questionnaire about comprehension of their cancer, satisfaction, perception of their physician interaction regarding disease education and potential barriers to patient understanding. Results: 52 patients analyzed to date: 1 patient was not aware he had cancer. 3 patients (5.7%) thought there was no longer cancer in their bodies. 33 patients (62%) thought the goal of therapy was to cure their cancer. 27 patients (51%) thought the goal of therapy was to extend how long they will live. 11 patients (20.7%) thought the goal of therapy was to palliate symptoms. 5 patients (9.4%) did not know why they were on therapy for their cancer. 5 patients (9.4%) indicated they had talked about hospice with their doctor. 5 patients (9.4%) felt they shouldn’t ask any questions. 48 patients (90.5%) felt they were participating in their treatment decisions. 4 patients (7.5%) stated they didn’t understand the medical terms used by the doctors. Compared to what patients wish they knew, almost 30% felt they knew half or very little about their diagnosis and 33% felt they knew half, very little, or nothing about their prognosis. Conclusions: Due to discrepancies between patient understanding and the intended goals of care, our study highlights the need for further guidance in effectively communicating extent of disease and predicted outcome. It is also important to periodically ask patients to discuss their understanding of their diagnosis, prognosis, and treatment options.
Family Camp: A multi-disciplinary intervention for brain tumor patients and families.
Authors: Page Margaretta S , Lovely Mary , Levinson Marks Abigail , LaMarre Amanda K , Chang Susan M , Clarke Jennifer , Patt Judy , Barani Emelia
Published: February 2017

240

Background: The diagnosis of a brain tumor is a catastrophic life changing event that impacts the entire family. Patients and caregivers experience dramatic role changes, concern for their children, financial stress, and isolation. For many, the situation is overwhelming. A novel intervention to address these needs is “Family Camp”. Our vision for camp was to provide respite to the entire family, decrease caregiver stress, improve family connections and promote a sense of understanding and connection with the community at large. Methods: In a unique partnership with the widow of a former patient, the members of the UCSF Neuro-Oncology Division created and offered a weekend camp for brain tumor patients with children. Team members included MDs, RNs, social workers, psychologists, artists, body workers, “camp counselors” and community volunteers. In addition to respite, camp was structured through art, songs, projects and games to deliver opportunities for understanding and community building, including understanding the disease and its impact on the family. Therapeutic interventions included couples activities, counseling, parenting strategies, and providing a sense of connection to others dealing with brain tumors, the health care team, and camp volunteers. Anxiety, stress, depression, coping and values based living were measured pre and post camp using DASS21, CES-D, Brief Cope, Values Based Living instruments, and survey questions. Results: 11 families attended camp for 3 days in 2014. Improvement was noted in post camp testing of depression, anxiety and stress versus pre-camp. Survey questions showed the most common and important outcome to be connection, specifically that patients, caregivers, and children made connections with similar others. Families reported being able to relax and felt taken care of. They liked the opportunity for undistracted family time, getting to know their health providers outside of the office, and couples benefited from family counseling. Conclusions: Capitalizing on the unique skills of a multi-disciplinary team, one that includes the patient’s health care team, can lead to the delivery of a novel intervention that improves the illness experience of brain tumor patients and families.