bluuebunny/crossref_metadata_2025_split huggingface dataset:
Panel-based methodology for assessing the impact of public policies on cancer patients and survivors.
Authors: Farner Amy , Smith Tenbroeck , Fleury Mark 
Published: May 2020

12059 Background: Cancer interventions are subject to a range of regulations, but data from large, nationally representative surveys are not always available in time to inform the policy process and do not always address issues specific to cancer patients and survivors. Understanding their experiences is critical to achieving policy solutions to issues such as access to effective pain relief, reducing unexpected medical bills, and reducing the impact of high prescription drug costs on treatment for lower income cancer patients. This research intended to better understand patient experiences and opinions in a statistically valid manner specifically targeted to the policy process. Methods: 3057 panelists were identified from ACS contacts, health systems, and social media advertising through ACS/ACS CAN pages and paid Facebook ads, to participate in a series of surveys across a year. The panel included diverse survivors across age, gender, race, ethnicity, economic status, and cancer type. Online surveys deployed semi-monthly on cancer survivorship topics impacted by current policy, including access to/affordability of care, pain treatment, and prescription drug costs. Responses were analyzed for the entire population and across subgroups of cancer survivors. Results: Each survey achieved a response rate between 35% and 50% of all panel members, resulting in a margin of error +/- 3% and 95% confidence level. Insights from cancer patient and survivor experiences helped support public policies through findings such as (but not limited to): 41% of those prescribed opioids had trouble getting their medicine, creating difficulty participating in work, family, or social events; extra trips to the doctor or pharmacy; negative impact on treatment, and trips to the Emergency Room due to uncontrolled pain; 24% received a surprise medical bill, increasing their anxiety, reducing likelihood to see a specialist, and reducing likelihood to seek emergency care during a serious health issue; and 31% of those with household income less than $30,000 report trouble affording prescription drugs and 17% have delayed or not filled a prescription due to cost. Findings supported the policy process by helping craft policy positions aligned with cancer patient preferences, raising public awareness, and communicating to policymakers the impact of policies on cancer. Conclusions: The panel methodology illustrates the impact of policy decisions on cancer patients and survivors. Findings provide an unprecedented level of input to the policy process for cancer patients and survivors.
Efficacy of ear acupuncture on sleep quality in breast cancer survivors: A randomized controlled trial.
Authors: Hoextermann Melanie Désirée , Buner Katja , Haller Heidemarie , Kohl Wiebke , Reinisch Mattea , Dobos Gustav , Cramer Holger , Voiss Petra 
Published: May 2020

12066 Background: Among females, breast cancer is the most commonly diagnosed cancer worldwide. Sleep problems impair 40 to 70 % of breast cancer survivors. The aim of this randomized controlled trial was to evaluate the effect of ear acupuncture on sleep quality in breast cancer survivors. Methods: Fifty-two female breast cancer survivors (mean age 55.73 ± 8.10) were randomized to either 10 treatments of ear acupuncture within five weeks (N = 26) or to a single session of psycho-education and given an advice booklet concerning insomnia (N = 26). Both interventions were delivered in a group setting. Primary outcome was sleep quality (measured by the Pittsburgh Sleep Quality Index) at week 5 corrected for treatment expectancies. Secondary outcomes were inflammation parameters (interleukin-6) at week 5, sleep quality at week 17, and stress, anxiety, depressive symptoms, quality of life and fatigue 5 weeks and 17 weeks after randomization. Results: Intention-to-treat analysis showed a significantly stronger increase of sleep quality in the ear acupuncture group compared to the psycho-education group ( p= .031; d = 0.64) at week 5. Furthermore, ear acupuncture improved stress ( p= .030; d = 0.64), anxiety ( p = .001; d = 0.97), and fatigue ( p = .012; d = 0.75) at week 5 compared to psycho-education. No significant group difference was found on any outcome at week 17. No serious adverse events occurred during the study period. Conclusions: Group ear acupuncture may be a helpful intervention in tackling sleep problems in breast cancer survivors in the short term and may reduce stress, anxiety and fatigue as well. Long-term effects remain questionable. Clinical trial information: NCT03874598 .
Long-term follow-up assessment of cardiac safety in SAFE-HEaRt, a clinical trial evaluating the use of HER2-targeted therapies in patients with HER2-positive breast cancer and compromised heart function.
Authors: Khoury Katia , Barac Ana , Lynce Filipa , Geng Xue , Dang Chau T. , Yu Anthony Francis , Smith Karen L. , Gallagher Christopher , Pohlmann Paula Raffin , Nunes Raquel , Herbolsheimer Pia Maarit , Warren Robert D. , Srichai M. Barbara , Hofmeyer Mark , Asch Federico M , Tan Ming Tony , Isaacs Claudine , Swain Sandra M. 
Published: May 2020

12069 Background: HER2-targeted therapies are associated with cardiotoxicity, mostly asymptomatic and reversible. The impact of withholding these therapies on breast cancer outcomes is unknown. SAFE-HEaRt trial was the first study to evaluate the safety of HER2-targeted agents in patients with reduced left ventricular ejection fraction (LVEF) receiving concomitant cardioprotective medications and close cardiac monitoring. We report the 3-year follow-up (f/u) results. Methods: Thirty patients with stage I-IV HER2-positive breast cancer receiving trastuzumab, pertuzumab or ado-trastuzumab emtansine (TDM-1), with asymptomatic LVEF 40-49%, were started on beta blockers (ß-blockers) and/or ACE inhibitors/ARBs, with the primary endpoint being completion of HER2-targeted therapy without cardiac events (CE) or protocol-defined asymptomatic worsening of LVEF. Results: Patients were accrued from 10/2013 to 12/2017 and median f/u as of 2/7/20 is 37 months. The study met its primary endpoint with 27 patients (90%) completing their HER2-targeted therapies without cardiac issues. 24 patients were reconsented for long-term f/u. There were 23 evaluable patients (1 lost for f/u). Off study, 2 patients continued treatment with trastuzumab, 3 with trastuzumab and pertuzumab, and 3 with TDM-1 for metastatic disease. 1 of the 2 patients who had developed a CE with symptomatic heart failure (HF) died of progressive oncological disease, and the second had LVEF recovery on cardiac medications after completion of adjuvant HER2-targeted therapy. Almost 5 years later, she had an asymptomatic decline in her LVEF to 35% after deciding to stop her ß-blocker and ARB. Of the remaining 21 patients, 15 had recovery of their LVEF to ≥50%, 9 of whom remain on cardiac medications. 5 patients had stable LVEF 40-49% and remain asymptomatic on cardiac medications. Only 1 patient had symptoms suggestive of HF, with last documented LVEF stable at 45-50%, but she has not sought medical care for the last 15 months since relocating to another country. There were no new CE and no cardiac deaths. Mean LVEF was 45% at baseline, 46% at end of treatment, and 51.5% at long term f/u. Conclusions: Long-term f/u of the SAFE-HEaRt study continues to provide safety data of HER2-targeted therapy use in patients with compromised heart function. The late development of cardiac dysfunction is uncommon and continued multi-disciplinary oncologic and cardiac care of patients is essential for improved patient outcomes. Clinical trial information: NCT04143594 .
Frequency and prediction of non-medical opioid use behaviors (NMOU) among advanced cancer patients referred to a supportive care center (SCC).
Authors: Yennu Sriram , Arthur Joseph Anthony , Reddy Suresh , Edwards Tonya , Lu Zhanni , Rozman de moraes Aline , Wilson Susamma M , Erdogan Elif , Joy Manju P , Ethridge Shirley Darlene , Kuriakose Leela , Malik Jimi S. , Najera John M , Rashid Saima , Qian Yu , Kubiak Michal J , Nguyen Kristy , Wu Jimin , Hui David , Bruera Eduardo 
Published: May 2020

12086 Background: One of the methodological barriers to conducting research on interventions for NOMU (Aberrant Opioid Use Behaviors) among cancer patients is the lack of data on the frequency of this problem. Although the frequency of risk factors has been established by our group and others, not all the patients with risk factors will be diagnosed with having NMOU behaviors, and some patients with no previous risk factors will engage in NMOU. AIM: To characterize the overall frequency of NMOU for a duration of 3 months, as well independent predictors for NMOU. Methods: In this retrospective study, 1558 consecutive patients referred to supportive care clinic (SCC) from 3/18/2016 to 6/6/2018 were reviewed for development of NMOU using established diagnostic criteria. Patients were eligible if they were ≥18 years, had a diagnosis of cancer, and were on opioids for pain for at least a week. All patients were assessed with the Edmonton Symptom Assessment Scale (ESAS), SOAPP-14, and CAGE-AID. Descriptive statistics, spearman correlation coefficient, multivariate analysis were performed. Results: 299 patients (19%) had ≥1 NMOU behavior. The median (IQR) NMOU behavior was 1 (1-2); range 1-10. Most NMOU occurred at 1st and 2nd follow up visits. The most frequent NMOU behavior was unscheduled clinic visit for inappropriate refills. 29/299 (10%) NMOU patients received specialized care for high-risk for aberrant opioid misuse by interdisciplinary team. Results of multivariate logistic regression model showed Marital status (Divorced vs. Married, OR=1.47, 95% CI: 0.98, 2.22, p=0.654 (marginally significant); Single vs. Married, OR=1.68, 95% CI: 1.15, 2.46, p=0.0079), SOAPP (Positive vs. Negative, OR=1.42, 95% CI: 1.05, 1.93, p=0.0238), morphine equivalent daily dose (MEDD) (OR=1.004, 95% CI: (1.003, 1.006), p<0.0001) and ESAS pain (OR=1.11, 95% CI: 1.06, 1.17, p<0.0001) were independently associated with the presence of NMOU during follow-up visits. Conclusions: 19% cancer patients followed at SCC had detectable NMOU behaviors. Being single, SOAPP+, pain severity and high MEDD were independent predictors for NMOU. This information will assist clinicians and investigators designing clinical and research programs in this important field.
Feasibility of olanzapine at reduced dose in highly emetogenic chemotherapy: A randomised controlled trial against aprepitant in triple therapy (FORESIGHT).
Authors: Chen Michelle , Baron Isabelle , Beaulieu Stephanie , Dufour Annick , Letarte Nathalie , Prady Catherine C. M. 
Published: May 2020

12087 Background: Olanzapine is used as an adjunct antiemetic in oncology as salvage therapy and in four-drug prophylaxis. Growing literature supports its effectiveness in initial three-drug prophylaxis in highly emetogenic chemotherapy (HEC). Methods: This prospective, multi-centre, open-label study evaluated the feasibility of a large-scale randomized controlled trial comparing the effectiveness and tolerability of 5 mg olanzapine once daily for four days (starting the night before chemotherapy) versus standard dose aprepitant (in tritherapy with standard ondansetron and dexamethasone) in treatment-naive patients receiving the first cycle of a HEC. Secondary outcomes included: complete response (no nausea, no emesis, no use of rescue medication), complete remission (no emesis, no rescue medication), intensity of patient-reported nausea and emesis on a visual analog scale, quality of life (scored with the Functional Living Index Emesis [FLIE]), and incidence of adverse events. Results: We randomized 30 patients in an intent-to-treat analysis. The large-scale trial was deemed not feasible without support from a research centre. Complete response rates were significantly higher in the olanzapine group in the delayed phase (24-120h post-chemotherapy) (86,7% v 21,4%, p < 0,001) and overall phase (0-120h post-chemotherapy) (60,0% v 21,4%, p = 0,04). Similar results were observed for complete remission. Intensity of patient-reported nausea was significantly lower in the olanzapine group in the delayed phase (p = 0,001). FLIE scores were significantly lower for the nausea domain (mean 62,3 v 60,9, p = 0,004) and overall score (124,3 v 108,8, p = 0,006). Depression on the ESAS-R was more common in the aprepitant group (0% v 38%, p = 0,01). Other adverse events were not significantly different. Conclusions: Support from a research centre must be ensured for study feasibility. Tritherapy olanzapine significantly improved complete response and remission in the delayed and overall phases post-chemotherapy among patients receiving HEC. It was also associated with higher quality of life and a reassuring safety profile. This feasibility trial, despite its small sample size, is one of the first prospective randomised trials to suggest similar efficacy of 5 mg olanzapine to aprepitant and to measure a difference in patient quality of life with this regimen. Clinical trial information: NCT04075955 .
A community oncology palliative care program: Pain-related inpatient utilization in oncology care model (OCM) patients.
Authors: Akhtar Adil Jamal , Margolis Jeffrey H. , Sheth Karna , Muskovitz Andrew A. , Maxwell Karma , Zekman Richard Philip , Howard George , Qamruzzaman Yusuf , Balaraman Savitha , Ballouz Samer , Ibrahim Mohammed , Folbe Mitchell , Ogaily Mohammed S. , Stortz Lexi , Fabbiano Maria , Pancholi Shehnaz , Tauquir Anoosha Maria 
Published: May 2020

12094 Background: Oncology Division of Michigan Health Professionals (MHP) participates in OCM. A comprehensive community oncology program for early and timely involvement of palliative care (PC) was launched in September 2017 to help achieve the OCM program goals of high-quality, cost-effective, coordinated care. PC provides a single point of care for all-cause pain management. PC program included pre-program training and continuous education for early and timely involvement of PC. This study aims to assess the educative effect of PC to reduce pain-related inpatient admissions (Pain IP) in all MHP OCM patients, irrespective of PC-referral. Methods: This initiative was led by palliative care physicians and included continuous education and reinforcement of the benefits, every 2-4 weeks, by sharing PC outcomes data with MHP physicians. Physician feedback was part of the program enhancements that were regularly reviewed during monthly MHP physician meetings. Retrospective claims review was performed with OCM episodes from Oct 2016 – Mar 2019. Monthly Pain IP utilization (based on diagnosis code) per 1000 OCM patients (UPK) was analyzed within pre- and post- PC Program start (Sep 2017). Cost per Pain IP included mean of 30-day follow-up skilled nursing facility (SNF) stay and 30-day outpatient facility expenses. Monthly historical Pain IP (pre-PC UPK) was compared to post-PC Pain IP UPK to calculate OCM savings from PC education at MHP. Results: Pain IP peaked at 7.12 UPK in September 2017 when PC program training and education started, then fell as low as 0.87 UPK in January 2019. Unit cost per Pain IP was $12,473. Post-PC (Sep 2017 – Mar 2019), there were 40 fewer Pain IP admissions compared to Pre-PC Pain IP for a total cost savings of $498,920. Conclusions: After PC Program, Pain IP decreased in MHP OCM population (PC-referred and PC not referred). This trend suggests PC training and continuous education for OCM providers is reducing IP utilization. This also translated to a significant cost saving for OCM/Medicare of $498,920. Study was limited by OCM claims available as of December 2019. Results may be refreshed as more data becomes available.
Antiemetic prophylaxis with NEPA: Final results of the German AKYPRO study.
Authors: Schilling Joerg Peter , Busch Steffi , Hielscher Carsten , Holländer Martin , Klenske Julia , Zahn Mark-Oliver , Karthaus Meinolf 
Published: May 2020

12095 Background: NEPA is a fixed combination antiemetic of the NK1-receptor-antagonist (RA) netupitant and the 5-HT3-RA palonosetron. Primary objective of this prospective non-interventional study in Germany was to assess quality of life of cancer patients (pts) undergoing moderately (MEC) or highly (HEC) emetogenic chemotherapy (CT) who received NEPA for prophylaxis of nausea and vomiting (CINV). Secondary objectives were patient reported outcomes as well as effectiveness and safety of NEPA. Here we report final data of the quality of life analysis. Methods: The study included 2.405 pts in 162 centers receiving 3 consecutive cycles of CT as one or two day MEC or HEC. Primary endpoint was impact of quality of life (QoL) due to vomiting or nausea, documented by Functional Living Index–Emesis (FLIE) questionnaires. Effectiveness was reported in patient diaries. Complete response (CR) was defined as no emesis and no rescue medication (RM). Non-significant nausea (NSN) was no or mild nausea. Adverse events (AEs) were reported on d1–21 of each cycle. Results: 2.173 patients were included in the final analysis (full analysis set; FAS). The majority of patients (n = 1976; 91%) received 1-day chemotherapy, 64% HEC, 36% MEC. Median age was 58 years and the majority (85%) was female. Cancer diagnoses: breast 66%, gastrointestinal 10%, ovarian 7% or lung 5%, other 12%. Chemotherapy: AC 57%, carboplatin 19%, cisplatin 8%, oxaliplatin 8% and other 8%. 84% of pts with HEC and 82% with MEC felt no impact on daily life due to vomiting in cycle 1 remaining constant in C2 and C3. 54% HEC patients and 59% MEC patients reported no impact on daily life due to nausea in cycle 1. CR rates ranged between 81-84% and were comparable between different HEC or MEC. NSN rates in MEC ranged from 75% (MEC) to 62% (HEC). Drug-related AEs were rare with constipation, fatigue, insomnia, and nausea as the most common (in > 1% pts). Conclusions: NEPA was highly effective in the prevention of CINV and maintenance of QoL in this real world study. Over 80% of pts reported that their daily live was not influenced by emesis while nausea was more difficult to control. Effectiveness was high and patients and physicians estimate was comparable.
The impact of the use of opioids among older breast cancer survivors and adverse events.
Authors: Winn Aaron N , Check Devon , Fergestrom Nicole , Neuner Joan Marie , Roberts Andrew 
Published: May 2020

12098 Background: Older adults and cancer survivors are underrepresented in the literature underpinning recent opioid prescribing guidelines. As prevention of unnecessary persistent opioid use and inadvertent opioid-related harms gains importance in clinical practice, it is necessary to fully capture the risks of opioid related adverse events among patients with cancer pain. The objective of this study was to determine the association between opioid use after cancer diagnosis and comprehensive opioid-related adverse events among older adult breast cancer survivors. Methods: We conducted a retrospective cohort study using Surveillance, Epidemiology, and End Results tumor registry data linked with Medicare administrative claims data from 2007-2016 of women with newly diagnosed non-metastatic breast cancer. The study observation period was the year following a patient’s end of active cancer treatment. The primary exposure was a daily measure of opioid exposure based on Part D prescription claims. The primary outcomes were daily indicators of all-cause hospitalization, substance use event and a composite of other opioid-related adverse events (infections, gastrointestinal events, falls/fractures, cardiovascular events) and each component of the composite adverse event. We estimated the association of current opioid use and the immediate risk of an outcome event the following day using modified Poisson generalized estimating equation models. We adjusted for patient demographics, cancer characteristics and cancer treatments received. Results: We found that opioid exposure more than doubled the immediate risk of all-cause hospitalization (aRR = 2.77; 95%CI = 2.57, 2.99; p < 0.001) and having a composite adverse event (aRR = 2.50; 95%CI = 2.18, 2.87; p < 0.001) and dramatically increases the immediate risk of a substance use event (aRR = 14.26; 95%CI = 7.11, 28.59; p < 0.001). We find consistent results when looking at individual components of the composite adverse event measure. Conclusions: Older adult breast cancer survivors with continued prescription opioid use in the year after completing active cancer treatment experienced an immediate increased risk of all-cause hospitalization, substance use events, and myriad opioid-related adverse effects.
Validity of patient-reported outcomes to describe the symptom experience of patients enrolled on phase I clinical trials.
Authors: Sedhom Ramy , Ferrell Betty R. , Ruel Nora , Koczywas Marianna , Chung Vincent , Smith Thomas J. 
Published: May 2020

12107 Background: Symptoms are common among patients enrolled in phase I trials. To integrate the patient perspective, the National Cancer Institute developed a patient-reported outcomes version of the CTCAE (PRO-CTCAE) to capture symptomatic adverse events (AEs) directly from patients; however, the tool has not been used often in early phase trials or in palliative care studies. Our overall objective was to assess the validity of PRO-CTCAE items to previously validated assessments of quality of life (FACT-G) and psychological distress (Distress Thermometer). We utilized data from a randomized trial testing a palliative care intervention for patients with cancer enrolled on phase I trials. Methods: Patients (n = 481) were accrued to the parent study prior to initiating a Phase I clinical trial with data collected at baseline, 4, and 12 weeks. We determined the correlation of PRO-CTCAE with Distress Level, FACT-G total and subscale domain scores. Aggregate scores using PRO-CTCAE were calculated to explore the effect of overall symptom frequency, severity, and interference by calculating the total of all scored items classified within each of those domains. We used these metrics to identify associations between this and other validated tools. Results: Patients were predominantly female (56.8%), over age 60, and 30.7% were minority populations. Correlations between PRO-CTCAE items and corresponding FACT-G (total and subscales) and Distress levels reached statistical significance for all items (p < 0.001). Importantly, many of symptoms captured would have been missed using HRQOL assessment tools. Some of these symptoms affected nearly 50% of patients and were frequently rated as severe or very severe. The correlation coefficient for Distress Level for all PRO-CTCAE items was small to moderate (Pearson r = 0.33 to 0.46). Pearson’s correlation coefficient for FACT-G total was moderate ( r = -0.45 to -0.69). Mood items of the PRO-CTCAE had stronger associations (Pearson r > 0.5). PRO-CTCAE symptom interference scores had the strongest correlation with Distress (Pearson r = 0.46) and FACT-G Total (Pearson r = -0.69). Conclusions: Patients entering Phase I trials are willing to report on symptoms they experience as a result of advancing disease and adverse effects from experimental treatment. Evidence demonstrates favorable validity of PRO-CTCAE in a heterogeneous US sample of patients undergoing cancer treatment on phase I trials. The granular assessment of symptomatic AEs may be on increasing importance as we enter a new therapeutic era in oncology. Clinical trial information: NCT01828775 .