bluuebunny/crossref_metadata_2025_split huggingface dataset:
Actigraphy findings and cancer-related fatigue (CRF) in advanced cancer patients treated with methylphenidate (MP) and nursing telephone intervention (NTI).
Authors: Bruera Eduardo , Yennurajalingam Sriram , Balachandran Dave , Padhye Nikhil S , Williams Janet L. , Frisbee-Hume Susan 
Published: March 2020

e20528 Background: There are limited studies about actigraphic sleep, wakefulness, activity and fatigue and treatment in advanced cancer patients. The objective of this study was to evaluate the changes in the nocturnal sleep/rest, and daytime wake/activity and subjective measures of fatigue before and after treatment with MP+/- NTI. Methods: A subset of patients from a previous reported placebo and control telephone intervention (CTI) controlled RCT of MP and/or NTI for CRF were reviewed. Subjective and objective assessments were analyzed at Day-8 and Day-15 as a result of treatment with MP and/or NTI or their control arms. Actigraphic sleep measures assessed were total sleep time (TST), sleep efficiency, and wake after sleep onset (WASO). Additionally, activity (mean day-time activity), and fatigue (FACIT-F, ESAS-Fatigue item) were included in the multivariate analysis. Results: A total of 60 (MP=30, Placebo=30; NTI=35; CTI=25) patients were evaluated. The median age was 56, 62% were female; most common cancer type was breast 13/60(22%). The baseline mean FACIT-F subscale, ESAS Fatigue item, TST, WASO, sleep efficiency and day-time activity were 22.4 (9.33), 6.5(1.74), 437(162.4), 139(121.4), 71(16.4), 202(438). Multivariate outcomes at Day-8 showed significant change from baseline (η2=0.38, p<0.001) and interaction effect between MP and NTI (η2=0.26, p=0.015). WASO had an interaction effect (β=-101.4, p=0.009), an MP effect (β=80.4, p=0.002) and reduction in time (β=-52.1, p=0.003). FACIT-F and ESAS-Fatigue item showed improvement in time (β=6.9, p=0.010; β=-2.4, p<0.001). Conclusions: WASO was significantly lower in patients receiving methylphenidate and nursing telephone intervention. Further larger studies are needed to validate these findings.
Effects of NEPA (novel combination of netupitant and palonosetron) on ECG of healthy volunteers: A randomized, controlled, thorough ECG trial.
Authors: Spinelli Tulla , Moresino Cecilia , Baumann Sybille , Timmer Wolfgang 
Published: March 2020

e20538 Background: Despite advances in supportive cancer care, chemotherapy-induced nausea and vomiting (CINV) is ranked by patients among the worst side effects of chemotherapy. NEPA is a new antiemetic under development composed of a unique fixed-dose combination of netupitant (NETU, 300 mg), a new, highly selective NK1 receptor antagonist (RA), and palonosetron (PALO, 0.5 mg), a pharmacologically and clinically distinct 5-HT3RA. NEPA targets the 2 most important emetic pathways with a single oral dose. Although PALO is not associated with cardiovascular issues, this study aimed to evaluate the tolerability and cardiovascular safety of different doses of NETU + PALO. Methods: This randomized, double-blind, parallel-group, placebo- and open-label positive-controlled study in 197 volunteers (106 men) included 4 treatment groups: placebo, 200 mg NETU + 0.5 mg PALO (NEPA 200/0.5), 600 mg NETU + 1.5 mg PALO (NEPA 600/1.5), and 400 mg moxifloxacin. Assessments, based on ICH E14 Guidelines, included a 24-h baseline ECG after which volunteers received a single dose of treatment, followed by ECG measurements for 2 days. The primary objective was to determine the individual heart rate-corrected QT interval (QTcI) (n=196). Safety and tolerability of NEPA groups were also assessed (n=197). Results: Mean placebo-corrected QTcI change from baseline was +5 and +4 ms for NEPA200/0.5 and NEPA600/1.5, respectively. Mean placebo-corrected change from baseline for heart rate (HR) was -3 bpm for the 2 NEPA groups. Placebo-corrected changes in pulse rate (PR) and QRS durations were similar in both NEPA groups (0 to 1 ms) and not clinically different from placebo. These data show no signs of an effect of NEPA groups on QTcI. In comparison, the moxifloxacin showed the expected increase in QTcI vs placebo (+8/9 ms). The frequency of all treatment-related AEs (TRAEs) for NEPA200/0.5 was lower than placebo but slightly higher in volunteers treated with NEPA600/1.5. The most commonly reported TRAEs in the NEPA groups were constipation, upper abdominal pain, and headache. Conclusions: NEPA treatments produced no significant effects on QTcI, HR, PR, QRS interval, or cardiac morphology relative to placebo.
The role of oncologic health care providers in end of life discussions for women with recurrent gynecologic or breast cancer.
Authors: Stuckey Ashley , Robison Katina , Dizon Don S. , Rogers Michelle , Ott Miles , Miller Susan , Politi Mary , Clark Melissa 
Published: March 2020

e20543 Background: Advance care planning (ACP) is an important topic for women with metastatic or recurrent cancer. Unfortunately, data suggest ACP is often not discussed at health care visits. Because patients with metastatic or recurrent cancer are incurable, the issue of end of life (EOL) is one faced by patients and providers. This study evaluates how often oncologic health care providers initiate EOL conversations with their patients. Methods: Eligible patients included women with metastatic or recurrent gynecologic or breast cancer of ≥3 month’s duration in an academic women’s oncology program. Interviews were conducted by research staff. Clinical characteristics and documentation of EOL decisions were obtained through chart reviews. Data were analyzed using SAS v.9.3. Multivariate logistic regression was used to model the association of EOL discussions with ACP. The study was approved by the hospital and university Institutional Review Boards. Results: 200 women were enrolled; 64% had stage III-IV cancer at diagnosis. The majority was white (91%) with a mean age of 60 (range 35-82). A total of 638 providers were identified (mean: 3.2 providers per patient; 57% female). Health care provider type and gender were not associated with EOL discussions. Only 49 women (25%) recalled an EOL conversation with at least one provider which appeared to correspond to the low proportion of people with documented ACP. Only 42 (22%) had an advanced directive (AD) and 29 (15%) a health care proxy (HCP) in the chart. Having an EOL conversation with at least one provider was not associated with a chart-documented AD (OR=1.6, 95% CI=0.7-3.6) or HCP (OR=1.8, 95% CI=0.7-4.5). The time since recurrence was shorter for those reporting EOL conversations (1.7 vs. 3.1 years, p=.0274). Conclusions: In this study, oncologic health care providers infrequently initiated EOL discussions with their patients with metastatic or recurrent cancer. More concerning, patient recollection of an EOL discussion with a provider was not associated with chart-documented ACP. Further studies evaluating the factors limiting EOL discussions as well as studies testing interventions to improve provider documentation of the ACP are warranted.
Primary metastatic breast cancer in elderly: An international comparison.
Authors: Van De Water Willemien , Bastiaannet Esther , Egan Kathleen , de Craen Anton J.M. , Van De Velde Cornelis J. H. , Liefers Gerrit-Jan , Extermann Martine 
Published: March 2020

e20545 Background: In primary metastatic breast cancer in elderly, both advanced age and advanced disease limit life expectancy. It remains a challenge to balancing the benefit from therapy and risk of adverse events impeding quality of life or survival. Our aim was to compare management and outcome of primary metastatic breast cancer in elderly treated in two health care settings. Methods: The first cohort comprised a hospital based series in the United States (US, n=73 women diagnosed between 2003 and 2012); the second comprised a population based series in The Netherlands (NL, n=125 women diagnosed between 2008 and 2012). All were ≥65 years at the time of diagnosis. Country was used as an instrumental variable, as a proxy for randomization to either care setting. Multivariable survival analyses were adjusted for age, comorbidity, T stage, nodal stage and hormone receptor status. Results: Characteristics of US and NL patients were similar, except for age (median 72; 79 years, p>0.001). US patients more often received breast surgery and chemotherapy in particular, less often endocrine therapy as monotherapy (Table), and received more lines of treatment (median 4; 2, p<0.001). Adverse events rarely were a reason for a next line of therapy (6% in each cohort). Three-year survival tended to be higher in US patients (HR for US patients was 0.71 (95% CI 0.48-1.05), p=0.089). Multivariable analyses revealed no survival differences (HR for US patients was 0.86 (95% CI 0.53-1.38), p=0.523). Results were similar after stratifying by age at diagnosis (<70; ≥70 years). Conclusions: Treatment of elderly with primary metastatic breast cancer varied considerably between the NL and the US cohort. However, no differences in overall survival were observed. These results warrant further studies to evaluate the extent of treatment in this population. [Table: see text]
A retrospective study of dose-dense adjuvant paclitaxel without G-CSF support in patients with breast cancer.
Authors: Singh Anurag Kumar , Malhotra Akshiv , Lemke Sheila M. 
Published: March 2020

e20547 Background: Dose dense AC (Adriamycin plus Cyclophosphamide) followed by paclitaxel (Pac) given every 2 weeks with Granulocyte-Colony Stimulating factor (G-CSF) support remains the standard of care for adjuvant chemotherapy in newly diagnosed breast cancer patients . Although, the need for growth factor support with AC is clear, its role with dose dense Pac is not so clear. The objective of this retrospective single institution study was to evaluate the need for primary prophylaxis with G-CSF with dose dense Pac. Methods: Data from 115 patients treated at Upstate Medical University from 2005-2012 was collected after IRB approval. All patients received four cycles of dose dense AC (A- 60mg/m2 with C- 600 mg/m2) with G-CSF support on day 2 followed by Pac (175 mg/m2) with no primary G-CSF support. The median age of patients was 48 years. There were 11 patients (10%) with Stage I, 68 (60%) with stage II and 36 (30%) with stage III disease. The prevalence of ER/HER2 status was as follows: ER+/Her2 + (13%), ER+/Her2-(60%), triple negative (26%) and ER-/Her2+ (1%). Results: Only 3 patients (2.6%) in this study population developed neutropenic fever. 109 patients received no G-CSF support and completed a total of 382 doses of Pac (average 3.5). Dose reduction was needed in 6 patients, related to neutropenic fever (n=3), neutropenia without fever (n=2) and severe arthralgia (n=1). A total of 88 patients completed all planned four cycles. Of the 27 patients who got less than the planned 4 cycles, most stopped because of neuropathy (n=17), arthralgia (n=4), hand foot syndrome (n=2), elevated LFTs (n=1), allergic reaction (n=1) and unknown reason (n=1). Most common Grade III/IV toxicity was neuropathy. Dose delays were seen in only 5 patients, 3 related to neutropenia and 2 because of elevated liver function tests. Conclusions: G-CSF has its own side effects, most common being bone pain. G-CSF also adds significantly to climbing costs of oncology care. Although retrospective in nature, this study shows that only a small minority of the patients develop neutropenic complications with dose-dense Pac. Avoiding primary prophylaxis with G-CSF will not only reduce costs but also reduce toxicity that can be additive to Pac toxicity.
Inappropriate prescribing in older patients with cancer.
Authors: Sui Jane Sze Yin , Kelly Ciara Marie , Barry Patrick , Jordan Emmet , Rehman Zia , Akhtar Mateen , Gallagher Loretto , Horan Anastasia , O'Keeffe Carmel , O'Connor Miriam , Calvert Paula , Power Derek Gerard , Horgan Anne M. 
Published: March 2020

e20550 Background: Inappropriate medication use is common among community dwelling and hospitalized older adults but understudied in the oncology population. We measured the incidence of inappropriate prescribing among older cancer patients attending an oncology day-ward for systemic therapy. Methods: The tools used to identify inappropriate prescribing were the Beers’ criteria (both Independent [ID] of and Considering diagnosis [CD] – 2012 version) and the STOPP tool (Screening Tool of Older People’s potentially inappropriate Prescriptions). The setting was an urban based hospital oncology day-ward. Consecutive subjects ≥ 70 years were screened and all had both tools applied to their prescription drugs, cross referenced with their current active medical diagnosis. Results: Medication lists were collected from 96 patients from November 1st 2012 to January 31st2013: 52% male, mean age 75 years (range 70-88). The most common cancers were colorectal (24%), breast (23%), lung (11%) and prostate (11%). 38 patients (40%) were on 0-4, 49 (51%) on 5-9 and 9 (9%) on >9 medications. The total number of inappropriate prescriptions (Beers ID and CD “medications to avoid”) was 34, prescribed in 29 (30%) patients. The most common drug prescribed inappropriately as per these criteria was the antiemetic, metoclopramide (n=10, 29%). An additional 70 prescriptions were dispensed for Beers “medications to use with caution” in 55 (57%) patients - predominantly vasodilators. The STOPP tool identified 13 inappropriate prescriptions in 12 patients (13%). The two most commonly prescribed inappropriate medications were long acting benzodiazepines (n=4) and long term use of sedating antihistamines (n=3). Conclusions: This study identified a high rate of inappropriate prescribing among this population using both tools, with a higher rate identified by the Beers Criteria. Routine application of a validated tool to identify inappropriate prescribing has merit in the oncology setting to minimize risk to patients. However, the development of an easy to apply tool that considers the underlying cancer diagnosis, prognosis, cancer treatment and necessary supportive therapy is warranted.
Breast cancer survivorship visits: Presenting concerns and resulting recommendations.
Authors: Stricker Carrie Tompkins , Jacobs Linda A. , Panzer SarahLena , Palmer Steven C 
Published: March 2020

e20553 Background: Survivorship care plans (SCPs) are mandated for cancer patients following initial cancer therapy. However, appropriate content, processes, and outcomes of survivorship visits are not yet defined. Neither the concerns that patients bring to these visits nor the degree to which they recall information given by providers is known. As part of a multicenter pilot study of breast cancer survivorship visits, we examined patient concerns at time of presentation for such visits, as well as patient and provider perceptions of resulting recommendations. Methods: We assessed post-treatment breast cancer survivors’ (BCSs’) survivorship concerns prior to a survivorship visit at 1 of 9 cancer centers associated with the LIVESTRONG Survivorship Center of Excellence Network. Following that visit we queried providers as to what referrals and recommendations were made during the visit. Three months later we asked patients to report what recommendations were made by providers. We then examined prevalence of patient concerns and agreement between patients and providers concerning survivorship visit recommendations for managing health. Results: 103 BCS at 9 centers participated. BCS most endorsed concerns were reducing risk of recurrence (81.4%), receipt of appropriate breast cancer follow up care (57.4%), weight loss (55.5%), risk for second cancers (54.9%), fatigue/sleep management (50.0%), and symptoms important to report to providers (50.0%). Although exercise was recommended to 63% of participants by providers, patients recalled this correctly only 79% of the time (Kappa = .16, ns). Moreover, there was a generally poor concordance between provider-reported and patient-recalled recommendations, with kappas ranging from 0.46 for recommendations about tobacco/alcohol to -0.11 for general health recommendations. Conclusions: Survivors report an array of concerns ranging from a risk of recurrence (81.4%) to concerns about peripheral neuropathy and lymphedema (51%). Survivors and providers, however, show little concordance concerning recommendations made visits. Provision of personalized survivorship care plans may improve agreement between survivors and providers concerning health recommendations.
Examining caregiver perceptions and distress related to patient pain.
Authors: Sherrod Amanda M. , Wells Nancy L. , Dietrich Mary S. , Murphy Barbara A. 
Published: March 2020

e20555 Background: We conducted a randomized trial comparing a brief baseline pain educational intervention with the addition of either a hot line for pain related issues or weekly calls from health providers to assess pain and medication use. Results of this trial have been previously reported (J Pain Symptom Manage. 2003 Apr;25(4):344-56). Caregiver beliefs may impact patient compliance with pain treatment so caregivers also received pain education. As a secondary endpoint we investigated caregiver beliefs related to: 1) known barriers to compliance with pain medication (feasibility of pain control, addiction concerns, fears of overdose and toxicity), 2) perceptions regarding patient pain level, 3) distress related to patient pain, and 4) efficacy in helping control patient pain. Methods: 28 informal caregivers completed the Family Pain Questionnaire (part 1: 8 items related to beliefs, part 2: 6 items related to pain perceptions). All items were scored using a 10cm visual analogue scale. Questionnaires were completed at baseline, immediately and 1 month post-education. Results: Caregiver characteristics: 64% married, 54% ≤ high school education. The caregiver pain belief subscale mean score was 4.9 (SD 1.7) at baseline, 5.6 (SD 1.4) post-education and 5.9 (SD 0.9) at 1 month indicating improved beliefs over time (p=.001). Caregivers consistently rated pain higher than patients (baseline: M=6.7 (SD=2.6) vs. M=4.1 (SD=2.3), p<0.001, 1-Month: M=5.1 (SD=3.2) vs. M=3.4 (SD=2.7), p=0.003). They also reported more distress related to pain than patients . Distress among caregivers due to patient pain was high at baseline (median=8.4, IQR: 5.6-9.5), and remained high at 1 month (median=7.7, IQR: 4.7-9.3). While not statistically significant, caregiver perception of ability to relieve pain improved from baseline (median=4.6, IQR: 0.8-8.3) to 1 month (median=2.4, IQR: 1.2-4.5, p=0.115). Conclusions: Despite improvements in caregiver beliefs regarding barriers to good pain control, decrease in levels of patient pain, and improved self-efficacy in assisting with pain control, caregiver distress related to patient pain remained high. Future research should be focused on further characterizing the factors that contribute to caregiver distress.
Incidence of febrile neutropenia and effectiveness of pegfilgrastim prophylaxis in patients with advanced-stage solid tumors receiving chemotherapy.
Authors: Crawford Jeffrey , Reiner Maureen , Morrow Phuong Khanh H. , Lyman Gary H. 
Published: March 2020

e20564 Background: Advanced disease stage has been identified as an independent risk factor for the development of febrile neutropenia (FN), which continues to be associated with substantial morbidity. We report here results from two clinical trials on the impact of pegfilgrastim (PEG) in patients with advanced stage solid tumors. Methods: Patients were pooled from two placebo-controlled trials: a) a phase III trial of 928 patients with breast cancer, randomized to placebo or PEG 6 mg on day 2 of each 21-day cycle (Vogel CL, et al. JCO 23:1178-84, 2005); and b) a phase II trial of 241 patients with colorectal cancer (CRC), randomized to placebo or PEG 6 mg on day 4 of each 14-day cycle (Hecht JR et al. Clin CRC 9:95-101, 2010). Patients were grouped by disease stage at baseline: advanced (stage III, IIIA, IIIB, IV) or limited (stage I, II, IIA, IIB). Grade 3/4FN was defined as a temperature of ≥ 38.2°C and an ANC of <1.0 x 109/L. The Cochran-Mantel-Haenszel test was used to evaluate the association between PEG and grade 3/4 FN, odds ratio (OR) for FN was estimated by logistic regression, and a trend in the number of FN events per patient was estimated using a Cochran-Armitage test. Results: Characteristics of the 982 patients with advanced stage cancer are shown in the table. PEG was associated with significantly fewer grade 3/4 FN events (p < 0.001), with OR for PEG vs placebo of 0.12 (95% CI: 0.07, 0.22). The percentage of patients with 0, 1, and ≥ 2 FN events was 97%, 3%, and 0% with PEG and 81%, 18%, and 0.4% with placebo, and PEG significantly reduced the number of FN events (p< 0.001). Conclusions: Patients with advanced stage cancer are at considerable risk for developing FN, and PEG prophylaxis reduced that risk. Assessment of FN risk is essential in the advanced/metastatic treatment setting. [Table: see text]
The burden of chemotherapy-induced nausea and vomiting in the Asia Pacific (AP) region: The Pan Australasian chemotherapy-induced emesis study.
Authors: Kim Hoon-Kyo , Chan Alexandre , Hsieh Ruey Kuen , Yu Shi Ying , Hernandez Ana Banos , Burke Thomas A. , Keefe Dorothy Mary Kate 
Published: March 2020

e20580 Background: There are limited data on CINV in AP, a region diverse in healthcare systems and standards of care. The primary objective was to estimate the country-specific percentage of patients with complete response (CR: no emesis and no use of rescue medication) in the overall phase (0-120 hours) during cycle 1 by regimen emetogenicity. Methods: This was a prospective, observational study of highly and moderately emetogenic chemotherapy (HEC/MEC)-naive adults from 6 AP countries. Patients completed a diary over a 120 hour period following chemotherapy. The study was designed to enroll a minimum of 45 patients by HEC/MEC and country to describe CR with a 95% CI +/-15%. Results: There were 648 evaluable patients enrolled at 31 sites from Aug. 2011 - Jul. 2012. The mean age was 55.8. 57.7% were female. The most common regimens were cisplatin-based (168/318; 52.8%) for HEC, and oxaliplatin-based (156/330; 47.3%) for MEC. Site of chemotherapy administration was outpatient/day case (51.4%; 333/648) and inpatient (48.6%; 315/648). Outpatient/day case chemotherapy administration was used for all patients in Australia and Singapore. Inpatient administration was common in China (85%, 130/153) and S. Korea (64.2%, 97/151). ASCO QOPI-recommended antiemetic prophylaxis was used in 38.7% (123/318) of HEC (5HT3-RA/steroid/NK1-RA) and 83.9% (277/330) of MEC (5HT3-RA/steroid). Prophylaxis differed between countries (p<0.001). CR is shown below. Conclusions: CINV outcomes, use of guideline-recommended prophylaxis, and site of chemotherapy administration significantly varied across AP countries. There is considerable room to improve CINV outcomes and use of recommended antiemetic prophylaxis in the region. [Table: see text]