bluuebunny/crossref_metadata_2025_split huggingface dataset:
Adherence reporting in phase III trials of approved oral anticancer agents: A systematic review.
Authors: Harvey R Donald , McKibbin Trevor , Behera Madhusmita , Ramalingam Suresh S 
Published: March 2020

e20596 Background: With the increasing number of orally administered anticancer agents, evaluation of treatment adherence is critical to assess efficacy and adverse events. When patients enrolled in registration clinical trials do not adhere to the investigational agent(s), conclusions made regarding efficacy and safety may be inaccurate and translate poorly to broader use. We performed a systematic review of adherence reporting in phase III trials of oral anticancer agents. Methods: We selected all oral anticancer agents approved by the FDA between 1996 and 2012. A PubMed search for generic name, with limits to "title" and "clinical trials", was performed. Publications from phase III trials were identified from the results. Medication adherence data were abstracted searching for the roots “compli” and “adher” and were categorized as follows: 1) mentioned or not, 2) methods described or not and 3) results reported or not. Results: Overall, publications or reports with 24 agents were identified. The search strategy yielded 5383 articles, of which 504 reporting on phase III trials were included for analysis. Of these, 106 (21%) mentioned either adherence or compliance to medications. Only 33 (7%) publications described methods of measuring adherence (e.g., diaries, interviews, pill counts), while 37 (7%) reported medication adherence results. Trials specifically identifying quantitative or qualitative rates of adherence in phase III trials involved abiraterone, anastrozole, capecitabine, dasatinib, exemestane, imatinib, lapatinib, letrozole, tamoxifen, thalidomide, topotecan, and toremifene (50% of agents). Within the 37 trials reporting adherence, 12 were qualitative (e.g., excellent, poor), 23 were quantitative, and 2 used pharmacokinetically-defined adherence measures. Conclusions: Medication adherence is infrequently reported in phase III trials of oral anti-cancer agents, leading to a knowledge gap in translation to clinical use. Our study underscores the need for standard metrics on measuring and reporting adherence to oral anticancer agents.
Results from a structured interprofessional palliative care rehabilitation program in oncology.
Authors: Chasen Martin Robert , Feldstain Andrea , Gravelle Debbie , MacDonald Neil , Pereira Jose 
Published: March 2020

e20598 Background: Post-treatment patients with active cancer face considerable burden from the effects of both disease and treatment. The Palliative Rehabilitation Program was designed to ease those challenges and to improve the patient’s functioning. The current study evaluated the changes in function scores of patients with advanced cancer upon completion of the structured program and examined the medical predictors of program completion. Methods: Referrals for 173 patients who were finished anticancer therapy were received. One hundred and thirty six patients were eligible and enrolled in the eight-week interprofessional palliative rehabilitation program. Of those, 84 completed the program. Measures of physical, nutritional, social and psychological functioning were evaluated at entry and completion of the program. Results: Significant improvements were experienced in physical performance (P =0.000), nutrition (P =0.000), symptom severity (P=0.005 to P= 0.000), symptom interference in functioning (P =0.001 to P=0.000), and fatigue (P=0.001 to P=0.000). Reasons for not completing the program were: disease progression, geographical inaccessibility, being too well, dying, and personal/unknown reasons. A normal CRP level (<10mg/L; P=0.013) was a predictor of program completion. Conclusions: Patients living with advanced heterogeneous cancers who underwent an interprofessional palliative rehabilitation program experienced significant improvement in their functioning in many domains. Program completion can be predicted by normal CRP level.
Recurring breast and arm cellulitis in patients with early breast cancer.
Authors: Cheema Faisal , Agloria Maliha , Mills Glenn Morris , Shi Runhua , Li Benjamin , Chu Quyen , Kim Roger Hoon , Ampil Fred , Burton Gary Von 
Published: March 2020

e20600 Background: Breast and arm cellulitis (BAC) is a recognized risk following treatment for early stage breast cancer with case reports suggesting an incidence <3%. However, there is limited information relative to risk factors, management, recurring BAC and outcome. We reviewed all incidences of BAC in patients (pts) with early stage breast cancer seen at our institution and correlate with co-morbid conditions, recurrent BAC events and treatment outcomes. Methods: A review of all pts with Stage I-III breast cancer seen between 2001-2011 identified pts with at least 1 episode of BAC. Data on age, race, stage, treatments, co-morbid conditions, lymphedema, incidence and recurrence of cellulitis, and antibiotic (Abx) therapy was extracted. We defined incident BAC to occur >30 days post chemotherapy/radiation completion. Chi-square test was used to assess variables associated with BAC recurrence. Results: 391,603 breast cancer pts (2.5%) were identified with BAC with median age 59 years. The median interval between completion of primary treatment and incident cellulitis was 330 days (30 – 3,650 days). 13 out of 39 pts (33%) had recurring BAC (range 1-7 events). Median duration of Abx therapy was 30 days (7 – 2,190). Lymphedema (p=0.04), chemotherapy (p=0.01), Stage > I (p=0.02) and initial poor response to Abx (p=0.003) were significantly associated with recurring BAC. Positive bacterial cultures were obtained in 4 of 62 BAC events. Initial Abx failure was lowest with vancomycin (Vanc). A protracted course (30 days) of oral Abx after initial Vanc was associated with a lower risk of early recurrence. Chronic Abx therapy, for pts with 3 episodes, appeared to reduce subsequent recurrent episodes. Conclusions: Results indicate that while BAC is relatively uncommon following breast cancer therapy, pts with BAC are at significant risk for recurring events. Lymphedema, higher stage and initial poor response to Abx proofed as parameters for recurrence. Despite treatment with Abx a significant number will have recurring events. For pts presenting with these variables we recommend a protracted course of initial Abx. Pts with recurring BAC should receive chronic Abx suppressive therapy. This approach was associated with good long term control in our pts.
Effect of chemotherapy on fatigue and presence of TNF- in breast cancer patients.
Authors: Fonseca Fernando Affonso , Cruz Felipe Melo , Lerner Tatiana Goberstein , Cubero Daniel Iracema , Alves Beatriz da Costa Aguiar , Souza Flavia , Kunyioshi Renata , Del Giglio Auro 
Published: March 2020

e20601 Background: Chemoterapy induced fatigue (CRF) is a common complain and few studies assessed so far the role of inflammatory biomarkers as predictors of CRF. OBJECTIVE: The primary objective of our study is to evaluate potential biomarkers of CRF in breast cancer (BC) patients receiving adjuvant Chemotherapy (CHT). Methods: Thirty-seven localized BC patients (clinical stages I-III) consecutively treated at the oncology service of Faculdade de Medicina da Fundação ABC were enrolled in this study. All patients received doxorubicin and cyclophosphamide based chemotherapy. Before the beginning of chemotherapy and before the second cycle, all patients answered the BFI (Brief Fatigue Inventory) questionnaire. The following inflammatory markers were collected: C-reactive protein (CRP), tumor necrosis Factor alpha (TNF-α) and interleukin 6 (IL-6). We correlated these inflammatory markers with BFI scores of each patient before and after cycle 1 and cycle 2 of chemotherapy. Results: The mean values of the inflammatory markers were: CRP 4.58 mg/dL (IC 95% 3.17-5.90), TNF-α 11 mg/dL ( IC 95% 8.84-13.79) and IL-6 3.74 (IC 95% 1.93-5.54). We observed a positive correlation between the BFI scores and TNF-α (p=0.0201). Conclusions: TNF-α may represent a potential CRF biomarker. Future studies may elucidate the potential usefulness of TNF-α for monitoring the anti-fatigue effects of new drugs for the treatment of CRF.
Traditional Chinese medicine (TCM) utilization among cancer survivors.
Authors: Chien Chun-Ru , Shih Ya-Chen T. , Liao Yu-Min , Su Shan-Yu 
Published: March 2020

e20604 Background: We investigated the utilization patterns of traditional Chinese medicine (TCM) among general cancer survivors before and after their cancer diagnosis when compared to normal population. Methods: Using population-based claim database, we identified 87249 cancer survivors diagnosed within 2000-2004 and 87,237 matched controls. We obtained information on TCM utilization 2 years before and after their diagnosis. We quantified the utilization of TCM in two ways: initiation (any use in a specific year) and intensity (visit counts per year). Descriptive analysis was applied to explore the trends in initiation and intensity for all cancer and controls as well as each major cancer sites separately. Results: TCM intensity (mean annual visits, with 95%CI) was increased substantially (23%) for general cancer survivors after diagnosis: from 1.58 (1.55-1.61) for 1~2 years before diagnosis to 1.94 (1.9-1.98) for 2nd years after diagnosis, in contrast to the minor increase (10%) for the control group. For most of the major cancer sites, the initiation rate of TCM among cancer survivors increased before diagnosis then gradually returned to around baseline afterward, whereas the intensity increased gradually after diagnosis. The initiation and intensity for the control groups was relatively stable during the corresponding periods. Conclusions: We found that the initiation of TCM was increased in the pre-diagnostic period and the intensity of TCM gradually increased after diagnosis when compared to normal population. Further research is needed to explore whether TCM, or more broadly CAM, can either serve as a clinical alter or bring additional benefits to these patients.
Fosaprepitant-induced phlebitis: A focus on patients receiving doxorubicin/cyclophosphamide therapy.
Authors: Leal Alexis D. , Kadakia Kunal C. , Looker Sherry , Hilger Crystal , Sorgatz Kristine , Anderson Kari , Jacobson Alison , Grendahl Darryl , Seisler Drew K. , Hobday Timothy J. , Loprinzi Charles L. 
Published: March 2020

e20605 Background: Intravenous (IV) fosaprepitant is a potent antiemetic, commonly used in patients receiving chemotherapy. The purpose of this study was to investigate the incidence of IV fosaprepitant-associated infusion site adverse events (ISAEs) among a cohort of breast cancer patients receiving doxorubicin and cyclophosphamide (AC) chemotherapy at Mayo Rochester. Methods: A retrospective review of electronic medical record (EMR) data was performed for all patients who were initiated on AC chemotherapy from January 2011 to April 2012. Data collected from the EMR included baseline demographics, antiemetic regimen, documentation of ISAEs and type of IV access (peripheral vs. central). Descriptive statistics (mean and standard deviation or percentages) were summarized overall and by type of IV access and initially administered antiemetic. Results: 148 patients were included, with a median age of 54 years (range 28-76). 98 patients initially received IV fosaprepitant; 44 oral aprepitant; 6 neither. 132 (89%) initially had peripheral IV access and 16 (11%) had central venous access. Overall, 33 patients (34%) experienced an IV fosaprepitant associated ISAE including: erythema (n=22), pain (n=26), swelling (n=12), infusion site hives (n=5), extravasation (n=4), deep venous thrombosis (n=3), superficial thrombosis (n=7), phlebitis/thrombophlebitis (n=5), venous discoloration (n=1), venous engorgement (n=1), venous hardening/induration (n=4) and local scarring (n=1). Only 1 patient (2%) experienced an oral aprepitant associated ISAE, which was infusion site pain. This patient had previously had a fosaprepitant associated ISAE at the same site. All experienced ISAEs occurred in patients with peripheral IV access. Conclusions: The incidence and severity of ISAEs associated with IV fosaprepitant administration among a group of patients receiving doxorubicin/cyclophosphamide chemotherapy is significant and is appreciably higher than what has been noted in other reports. The higher incidence observed is likely related to the predominance of peripheral venous access used in the studied cohort.
Platinum-containing regimens as front-line treatment of advanced non-small cell lung cancer in two groups of elderly (≥ 70 year old) patients of different age.
Authors: Giuliani Jacopo , Bonetti Andrea , Mercanti Anna , Furini Lara , Durante Emilia , Greco Filippo , Trolese Anna Rita , Piacentini Paolo , Moratello Giacomo , Tognetto Michele 
Published: March 2020

e20617 Background: Elderly patients with advanced Non-Small Cell Lung Cancer (NSCLC) are underrepresented in clinical trials. Therefore we sought to evaluate the impact of a platinum-based doublet, given as a front-line chemotherapy, in two groups of elderly patients of different age with advanced NSCLC. Methods: A retrospective analysis of all consecutives elderly patients ( ≥70 year old) with advanced NSCLC who received a platinum based doublet as front line therapy at our Medical Oncology Unit from February 2005 to September 2011 was performed. The general case study was divided in two groups of patients of different age: “young-old” patients (70-74 year-old) and “old-old” patients (75-81 year-old). Results: Sixty-two consecutive elderly patients with advanced NSCLC were included in this study. Forty patients (65%) were “young-old” patients (group 1, median age 72 years) and 22 (35%) were “old-old” patients (group 2, median age 77 years). Overall, a total of 249 cycles were administered to the 62 patients; 164 cycles were administered to patients in group 1 and 85 cycles were given to patients in group 2; median number of administered cycles per patient was 4 (range 1-6) in both groups. Relevant clincal variables such as sex, stage, ECOG PS, Charlson score and histology were evenly distributed between the two subgroups. Regarding the type of first line chemotherapy, the great majority (92%) was treated with a carboplatin-containing regimen while only five patients (8%) received a cisplatin-based doublet: notably, all these patients are in group 1. Toxicity was mild, with grade 3-4 neutropenia in 17% of group 1 patients and in 9% of group 2 patients. Median OS was 9.8 months in both groups. Conclusions: This retrospective evaluation shows the safety and efficacy of a platinum-based doublet given as first-line chemotherapy in elderly advanced NSCLC patients. For several reasons, including the ease of administration, carboplatin is the preferred platinum analogue. The combination with vinorelbine or gemcitabine is associated with a very good toxicity profile that does not seem to have a detrimental effect on efficacy.
Iyengar yoga compared to exercise in women with stage I-III breast cancer: Feasibility of therapeutic interventions during adjuvant cytotoxic or endocrine therapy.
Authors: Wiedemann Florian , Buessing Arndt , Halle Martin , Kiechle Marion , Kohls Nikola , Ostermann Thomas , Sattler Daniel , Ettl Johannes 
Published: March 2020

e20623 Background: Exercise and mind/body intervention studies have shown benefits when undertaken during cancer treatment. This ongoing trial aims to elucidate the different effects of yoga and conventional exercise on physical and psychological factors in breast cancer patients undergoing endocrine or cytotoxic therapy. This first interim analysis presents feasibility data comparing the two mentioned interventions. Methods: Patients are randomly assigned to receive Iyengar-yoga or conventional exercise on a 1:1 ratio during adjuvant therapy. The intervention consists of a weekly 60-minute yoga or physiotherapy exercise session together with individual home-based, self-contained 20-minute sessions twice a week. Data assessments via questionnaires are done at baseline, right after the 12-week intervention period and 2 months after the end of intervention. Patient accrual within two breast care units started in April 2011 with 66 patients being on study to date (2013, Jan 25). Results: So far, 57 patients (yoga: n=28; exercise: n=29) have completed the trial, while 9 patients dropped out (yoga: 5 patients; exercise: 4 patients). 46 patients received cytotoxic therapy (mean age: 48 y) and 11 patients received endocrine therapy (mean age: 60 y). 8 women participating either in yoga or exercise intervention were younger than 35 years (14%) and 6 women were older than 65 years (11%). Mean number of attended sessions is 9.0 (yoga: 9.3; exercise: 8.8; age >65: 10.3). Overall 19 patients (33%) attended 11-12 out of 12 sessions (yoga: 32%; exercise: 35%; age >65: 67%), 20 patients (35%) attended 8-10 sessions (yoga: 54%; exercise: 17%; age >65: 17%), while 18 women (32%) participated only in 5-7 sessions (yoga: 14%; exercise: 48%; age >65: 17%). 10 out of 51 participants accomplished 40 minutes of home-based training per week (yoga: 11%; exercise: 29%; age >65: 50%). Conclusions: Yoga and exercise interventions are feasible during cancer treatment, although amount and frequency of training should be accommodated to individual condition. Both interventions seem to be practicable for elderly (> 65 years) patients and for patients undergoing cytotoxic therapy.
A phase II pilot study of fosaprepitant (F) for the rescue of acute nausea and vomiting with moderately (MEC) or highly emetogenic chemotherapy (HEC) in adults.
Authors: Bubalo Joseph S. , Schnadig Ian D. , Meyers Gabrielle , Chen Andy I. , Hayes-Lattin Brandon M. , Ryan Christopher W. , Digregorio Jocelyn , Maziarz Richard T. 
Published: March 2020

e20627^ Background: Patients receiving MEC or HEC continue to have breakthrough nausea and emesis despite antiemetic prophylaxis. Few trials have evaluated the efficacy of rescue antiemetics after failed prophylaxis. F, a prodrug of the neurokinin-1 antagonist (NK1a), aprepitant is FDA-approved for the prevention of acute and delayed nausea and vomiting associated with MEC and HEC. F’s safety and efficacy in the prophylactic setting make F an attractive potential rescue therapy. Methods: F 150mg was infused as the initial rescue agent in eligible patients receiving MEC or HEC who had either emesis or nausea despite guideline-based prophylaxis with a 5HT-3 antagonist and dexamethasone. The primary endpoint was improved nausea on a visual analogue scale (VAS) at 2 hours. Secondary endpoints included: VAS at 12 and 24 hrs, rescue medication use, emesis, nutritional intake, adverse events, and proof of the study design as a viable methodology. Results: Eleven adult patients, 6 males and 5 females, were treated per protocol and evaluable for the 24 hour study period. Chemotherapy regimens included HiDAC, R-CHOP, epirubicin/ifosfamide, EPOCH, R-ICE, 7+3, VAC, and HyperCVAD. 3 patients were treated for emesis and 8 for nausea. 91% of patients had improved nausea at 2 hrs, 100% at 12 hrs and 63.6% at 24 hrs. F prevented further emesis in 2 of 3 patients and no patient with initial nausea had subsequent emesis. 9 of 11 (81.8%) patients required additional rescue medication during the study period, mainly due to nausea. Appetite was improved in 8/11 patients. Food and fluid intake improved in 5/11. Adverse effects included headache 18%, dizziness 18%, hiccups 9%, indigestion 9%, and 1 case ifosfamide encephalopathy. The study design required greater than anticipated consented patients due to the success rates of standard antiemetic therapy. Conclusions: F improves breakthrough nausea and related symptoms, and may prevent further emesis but was suboptimal as a single agent in that the majority of patients required a second rescue agent within 24 hrs. Complete response, defined as no emesis and no rescue therapy, may be a more clinically relevant primary endpoint in future trial designs. Clinical trial information: NCT00939302.
Health care worker attitudes about clinical trials at a comprehensive cancer center.
Authors: Campagnaro Erica Leigh , Margevicius Seunghee , Daly Barbara J. , Eads Jennifer Rachel , Kinzy Tyler G. , Liu Tasnuva Munir , Manne Sharon , Miller Dawn M. , Schluchter Mark D. , Meropol Neal J. 
Published: March 2020

e20633 Background: Cancer patient (pt) participation in clinical trials (CT) is low. Little is known about the beliefs and attitudes of health care workers (HCW) and how they impact intention to discuss CT with pts. The overall goal of this project was to develop a conceptual model to guide future interventions to enhance communication about CT between HCW and cancer pts. Methods: Two email surveys of non-physician HCW at an NCI-designated comprehensive cancer center were conducted. The first was sent to a random sample of 150 HCW. The second was sent to 80 who completed the first survey. Based on our prior work (Eads et al. ASCO 2011) and Ajzen’s Theory of Planned Behavior, domains of the first included CT knowledge (19 items, agree/disagree) and attitudes (27 items, 5-point Likert); the second included normative beliefs about institutional attitudes toward CT (6 items, 5-point Likert), self-efficacy about engaging in discussion about CT (14 items, 5-point Likert), and intention to discuss CT with pts (4 items, 7-point Likert). Results: 41 HCW completed both anonymous surveys; 27 could be matched by demographics. Median age of matched respondents was 44.3 yrs (range 24-63), 26 female, 22 caucasian, 9 nurses. Overall, CT knowledge was high (median 17/19 items correct). There were strong associations between attitudes and self-efficacy (Spearman r=-0.425, p=0.03), as well as perceived normative beliefs and self-efficacy (r=0.651, p=0.0002). These associations were strong amongst nurses (r=-0.818, p=0.007 and r=0.656, p=0.05, respectively), with a particularly strong correlation between self-efficacy and intention to discuss clinical trials with pts (r=0.891, p=0.001). Conclusions: In spite of a small sample size, these pilot data strongly support a behavioral framework to understand and address the impact of HCW attitudes and beliefs about CT on discussions of CT with pts. Insofar as HCW (especially nurses) have substantial pt contact, and serve as a resource for pts regarding treatment decisions, educational interventions to address HCW barriers to discussing CT with pts (i.e. attitudes, beliefs, and self-efficacy) could positively impact pt attitudes and improve decision making.