bluuebunny/crossref_metadata_2025_split huggingface dataset:
Improvement of pharmacokinetic, pharmacodynamic and thrombopoietic activities of human interleukin-11 mutein by PEGylation.
Authors: Ho Seong-Hyun , Yu Seung Shin , Kim Jong-Mook , Kim Sunyoung , Ma Suyong , Kim Dong-Sik , Lee Hwang-Jae 
Published: March 2020

e19574 Background: Chemical modification of recombinant human interleukin-11 (rhIL-11) by polyethylene glycol improved the pharmacokinetics (PK), but not remaining biological activity. Human interleukin-11 mutein (mIL-11) has been shown the improved safety and equivalent efficacy at one-third of the clinical dose of rhIL-11 in chemotherapy-induced thrombocytopenia (CIT) patients. Methods: To evaluate whether PEGylated mIL-11 (PEG-mIL-11) could reduce the toxicity and the frequency of administration without compromising biological activities, comparative preclinical studies on PEG-mIL-11 and mIL-11 in normal and myelosuppressed animals were performed. Results: In vitro biological assay showed that the ED50 value of purified mono-PEG-mIL11 was comparable to that of mIL-11. The PK parameters such as AUC of PEG-mIL-11 were at least 4-fold larger than those of mIL-11 at the same dosage. The thrombopoietic activity resulting from a single PEG-mIL-11 administration was almost similar to that achieved from multiple administrations of mIL-11 in normal rodents and monkeys. In myelosuppressed model, PEG-mIL-11 was s.c. administered twice at doses of 200, 420 or 900 μg/kg and the platelet number of each group was compared with that of control group injected with 200 μg/kg of mIL-11 once daily for 9 days. The high dose group of PEG-mIL-11 showed 2-fold increase in the nadir platelet count and the mean time to platelet recovery of PEG-mIL-11 groups was shortened up to a maximum of 7 days as compared with mIL-11 or untreated group. PEG-mIL-11 also significantly prevented the reduction of WBC and RBC counts which was considered a major hematological AE of chemotherapy and radiotherapy for cancer as compared with mIL-11 or naïve group. Conclusions: These results suggest that the PEG-mIL-11 show improved PK profile without compromising biological activities and prevent CIT more effectively with better safety profile than mIL-11.
Aprepitant in multiple-day cisplatin-based chemotherapy.
Authors: Ouellette Freve Johann-Francois , Soulieres Denis , Blais Normand , LeTarte Nathalie 
Published: March 2020

e19591 Background: Aprepitant is a NK-1 inhibitor approved in combination with serotonin antagonists and dexamethasone (Dex) for highly and moderately emetogenic chemotherapy. Antiemetic regimens for multiple-day chemotherapy are not standard and guidelines recommend serotonin antagonists and Dex for each day of chemotherapy and for following days. Studies with aprepitant in that setting are ongoing. In our center, aprepitant use with multiple-day chemotherapy was prescribed at the physician’s discretion. Methods: We did a retrospective study of the use of aprepitant with cisplatin-based multiple-day chemotherapy (CBMDC) regimens from November 2008 to November 2011. Pharmacy files were used to identify patients that received at least one dose of CBMDC. Data was extracted from pharmacy and medical records. Objectives included efficacy (complete response (CR), absence of nausea and vomiting, change in antiemetics) and safety of different regimens. Results: During the study period, 39 patients (34 men) received CBMDC, mostly BEP for testicular cancer. Three patients also received second-line treatment. Patients received BEP (93%), ICE (2%), or TIP (5%) chemotherapy. Eleven patients received 3-day aprepitant, 15 patients 5-day aprepitant and 16 patients did not receive aprepitant at all as primary prophylaxis. Patients were older in the 3-day group. CR was 1% in the 3 day-group, 64% in the 5-day group and 36% in the control group (p=0,08). There was a trend that nausea and vomiting were reported more frequently in the 3-day group. In 4 patients, aprepitant was added for days 4 and 5 in subsequent cycles with better control. Rescue medication was used in 100% of patients receiving the 3-day regimen, 36% in patients receiving the 5-day regimen and 64% of patients not receiving aprepitant. Three patients receiving 5-day aprepitant had to further decrease their Dex dose for adverse events (insomnia, emotional lability, pyrosis, acne). No severe adverse events were reported with the 5-day use of aprepitant. Conclusions: Even within a small population, five-day aprepitant is effective in inducing CR, reducing vomiting and is safe in patients receiving CBMDC. It has been chosen as a standard treatment in our patients.
Effects of cancer therapy on sexuality and quality of life (QoL) of patients with gynecologic malignancies (GM): Results from 55 pts.
Authors: Pilger Adak , Richter Rolf , Fotopoulou Christina , Beteta Carmen Rosa , Ismaeel Fakher , Sehouli Jalid 
Published: March 2020

e19597 Background: Sexuality is a crucial issue influenced by social norms, shame and moral taboos and is generally not discussed in the clinical day and research community. Aim of our study was to systematically evaluate the sexual function and quality of life of cancer pts after operative and systemic treatment in GM. Methods: We assessed in a prospective setting sexual function and quality of life aspects of patients with histological proven GM after completed treatment. Validated questionnaires about sexuality (Female Sexual Function Index 19 items), quality of life (SF-12) as well an additional semi-structured questionnaire consisting of 20 items were answered by all pts at the earliest 3 months after end of treatment during cancer care follow up visit. Results: Overall 55 pts with median age 61 (range, 22-74) were evaluated including 54% ovarian, 26% breast, 13% cervical cancer, 2% endometrial- and 6% vulvar cancer pts. Overall 32.7% (n=18) of the pts stated that they have sexual problems. Based on the FSFI (<26.5) more pts (58.2%) presented sexual problems. The main reasons for an impaired sexuality were a subjective lost of attractiveness (45%; n=9); vaginal dryness (25%; n=5) followed by fear of injury (20%; n=4). 36.4% (n=20) described a change of sexuality after cancer therapy, 8 pts stated positive, 12 pts negative changes. 40% of the pts stated that they have not searched for information about sexual aspects during or after cancer therapy while 25% of the pts have asked their physicians. Patients who lived in a partnership had higher SF12 scores than singles but not different global QoL-scores. Multivariate analysis revealed ovarian, endometrial, and vulvar cancer but not age, disease stage and presence of partner to negatively affect sexual function . SF12 evaluation showed significantly higher psychological functionality with increasing age. Impaired sexuality was always associated with lower scores in SF12. Conclusions: There is a high need of sexual function assessment after cancer treatment of GM patients using validated questionnaires. Only few pts have access to information about sexuality. Strategies are warranted to improve the discussion about this relevant topic.
Burnout in the Irish oncology community: Results of a single-institution study.
Authors: Smyth Lillian , Lavelle Aonghus , Salman Reem , Lucey James , McCaffrey John , Maher Michael A. , Gallagher David James 
Published: March 2020

e19601 Background: Several European studies suggest that healthcare professionals working in oncology display higher levels of professional burnout than their colleagues from non-oncology units. We aimed to identify the level of burnout of professionals working in cancer care at a single institution in Dublin, Ireland. Methods: 143 oncology staff members were emailed a 3 section questionaire. We employed the Maslach Burnout Inventory, a validated, burnout-specific instrument, incorporating a three-dimensional assessment of the syndrome through its subscales: emotional exhaustion (EE), depersonalization (DP) and personal achievment (PA). Sociodemographic, protective and predisposing variables were identified in tandem, while the final section afforded respondents an opportunity to speculate on workplace stressors and their potential remediation. The primary endpoint was overall high burnout. Secondary endpoints were mean scores for each individual category. Wilcoxon rank sum and Kruskal-Wallis tests were performed on SPSS version 18. Results: The overall response rate was 41.3% (59/143) (see table). Three respondents (5.1%) reported high levels of burnout in all 3 categories. In subcategory analysis, men had significantly higher mean DP scores [9, SD: 6.03] than women [5.3,SD: 4.46](p < .05) and residents had significantly higher DP scores [8.11,SD: 4.46] than attendings [4.14,SD: 3.2]( p < .05). Regression analysis, found that being male was a significant predictor for high levels of depersonalization but found no predictor for EE or PA. Conclusions: We identified low levels of burnout among Irish cancer care professional. Protective factors such as age <35yrs (66%), religion (68%), hobbies (86%),working <50 hours (66%) and being in a relationship (74%) were at high levels, which may have biased our results. A national expansion and comparison with international figures is planned and will be presented at ASCO. [Table: see text]
Clinical and sociodemographic data of cancer patients seeking out-patient based psycho-oncological psychotherapy.
Authors: Panse Jens Peter , Athanatou Evangelia , Kayser Clarissa , Simon Marike Anna , Singer Susanne , Brummendorf Tim H. , Petermann-Meyer Andrea 
Published: March 2020

e19610 Background: Although there is a defined need for out-patient psychosocial care for cancer patients, data about out-patient psycho-oncological health care services and patients’ usage of ambulatory infrastructure outside certified cancer centres are scarce. Methods: We retrospectively analyzed charts and treatment protocols from 1,369 patients treated between 1998 and 2009 in a psycho-oncology (PO) practice retrieving socio-demographic and cancer-specific data plus data regarding PO intervention. Results: Of 1,180 patients analysed so far, 808 were documented cancer patients and 372 were relatives or friends of cancer patients. Median age of cancer patients was 50 (range 21-81) years, the majority being female (91%). Although PO interventions are not generally covered by most health care insurances in Germany, 87.7% of patients had public health insurance and only 12.7% had private insurance. 62,5% of patients (n=505) were diagnosed with breast cancer, followed by colorectal cancer (n=46), ovarian cancer (n=42), leukemia/lymphoma (n=38) and lung cancer (n=34), although all types of malignancies were represented. 60.1% received curative and 20.3% palliative treatment, while 19.6% could not specify their treatment intention. 503/663 (n=186 not specified) patients had at least one child with 39.5% being less than 18 years of age. 75.9% (176/232) had received high school education, and 37.1% (151/407) were actively working, while 40.3% (164/407) were incapable of work or on retirement pay (22.6%, 92/407). Half of the patients (50.2%) were Aachen residents, while the other half resided within a 50 km radius. Median number of therapy sessions was 12 (range 1-97). Other treatment specific aspects are still being analysed and will be presented at the meeting. Conclusions: Despite the clear demand for all cancer patients, the majority of cancer patients actively seeking out-patient psycho-oncological support are women with breast cancer, while men and other cancer subtypes are clearly underrepresented. Better information, optimized resources, allocation strategies and comprehensive coverage of PO services are needed in order to address more cancer patients with psycho-social distress.
Effectiveness of complete decongestive therapy (CDT) in managing secondary lymphedema after modified radical mastectomy (MRM).
Authors: Jain Kunal , Dhinakaran Mullai , Benjamin Kamlakshi Esther 
Published: March 2020

e19622 Background: Lymphedema of ipsilateral arm is one of the common complications seen after MRM with varying incidence reported in literature ranging from 5% to 56%. Several therapeutic interventions exist to treat this potentially distressing and disabling condition, but no consensus regarding definitive treatment of lymphedema has been reached. Methods: We conducted a single centre, prospective pilot study in patients with secondary lymphedema developed after treatment of breast cancer. These subjects were selected according to predefined criteria with duly signed consent form, from Outpatient Department of Physiotherapy, Christian Medical College and Hospital, Ludhiana. Lymphedema assessment with limb volume measurement was done using modified truncated cone method. A daily intervention program of CDT was implemented consisting of education about skin care, manual lymph drainage techniques, compression garments and exercise for 45 minutes per day for 10 days. The patients were assessed at baseline and on 10th day. During this10 day supervised therapy in the hospital, patients were also trained to continue this therapy at home. Results: Fifteen patients have been enrolled prospectively in this study between March 2011 and December 2011. The mean age at presentation was 43.5 yrs (range 35-58 yrs). All patients underwent MRM and the mean duration of presentation from the time of MRM to development of lymphedema was 12.5 months (3-24 months). The mean pre-treatment volumes of normal and affected arms were 332.47mL (240-425mL) and 416.62mL (277.6-535.5 mL) respectively (p=0.004). Mean post treatment volume of affected limb at the end of 10th day was 329.93mL (249-400mL) showing an absolute reduction in mean volume of affected arm by 86.69 mL (p=0.02). Conclusions: Complete decongestive therapy was helpful in significant reduction of secondary lymphedema after MRM in this small patient group. These findings need to be verified in a larger sample size comparing other modalities used in managing lymphedema. CDT needs to be tested in early post-operative setting to assess its role in decreasing incidence of lymphedema after MRM.
The role of intensive care in the changing paradigm of modern cancer care.
Authors: Connell Louise Catherine , Othman Fauzi , McCaffrey John , Carney Desmond , Marsh Brian , Kelly Catherine Margaret 
Published: March 2020

e19632 Background: Many metastatic cancers are now treated like a chronic disease. Expanding treatment options, increasing age; varying co-morbid illness; and improving cancer-specific survival mean that decisions regarding the timeliness and appropriateness of transfer to the Intensive Care Unit (ICU) are complex. We sought to examine the clinical, demographic and outcome characteristics of oncology/haematology patients transferred to ICU at a large academic teaching hospital. Methods: Data was extracted from a prospectively maintained database for all patients with documented malignancy admitted to ICU between September 2009 & December 2011.Clinicopathological variables examined included; cancer type; tumour stage; time from diagnosis; age; co-morbidities; and treatment history. The Sequential Organ Failure Assessment (SOFA), an ICU-specific scoring system, was reviewed for each patient. We report 30 day and 6-month mortality. Results: A total of 52 patients have been analysed to date. The common cancer types were well represented; breast (11.5%), colorectal (11.5%), lung (11.5%) and acute leukaemia (19.2%). Mean age at time of ICU admission was 60 years (range 29-82). The maximum number of prior lines of chemotherapy (CT) was 5 (range 0-5). Approximately 50% of patients had metastatic disease at time of ICU admission. The most frequent reasons for admission were sepsis (n=16, 31%) and respiratory distress (n=15, 29 %). Use of mechanical ventilation, vasopressors and renal dialysis was 51.9%, 61.5% & 21.1% respectively. Four patients (7.7 %) received CT in the ICU setting. ICU-specific mortality was 28.8% (n=15).Thirty-day and 6-month mortality rates were 38.5% & 61.5% respectively. Conclusions: A significant proportion of patients admitted to ICU had advanced disease and had received multiple lines of CT previously. The ICU-specific mortality rate was lower than expected at 28.8% and may reflect stringent selection criteria. Patients transferred tended to have had long periods of disease remission/stabilisation or had a new diagnosis of malignancy with unknown CT sensitivity status. Analysis of patient selection at ward level is on-going and will identify other factors influencing ICU transfer decisions.
Pain assessment behavioral scale in agonic cancer patients: Experience in total care—An end-of-life care home service.
Authors: Alfaro Maricarmen , Baldeos Raquel , Rosales Beatriz , Berenguel Maria , Aguilar Alfredo 
Published: March 2020

e19636 Background: Assessing pain in nonverbal, especially agonic cancer patients is a great challenge. In the absence of self-report, measurement of pain could be difficult and patient`s behavior could be useful. The aim of this work was to evaluate the Pain Assessment Behavioral Scale (PABS) in cancer agonic patients. Methods: PABS scale was used to evaluate 118 cancer patients enter in agony. Pain levels was categorized according to PABS score in Mild Pain (score 1-3), Moderate Pain (score 4-5), Severe Pain (score>6). We correlated levels of pain with age, sex, cancer metastatic site or active tumor localization with the ANOVA, Chi square or Fisher tests when were appropriated. A P<0.05 was considered significant. Results: Fifty two patients (44.1%) were male and 66 female (55.9%). The median age was 74 (Standar Deviation [SD]:13.1; Range: 30-94). Most frequent primary tumors were colorectal (16%), lung (11%), Pancreas (9.3%), Breast (8.5%), lymphomas (6.8%), prostate (6.8%) and gastric (5.6%) cancer. Involvement of primary active tumor or active metastases was present in lung (22%), Central Nervous System (CNS) (13.6%), liver (22%), and bone (7.6%). The median of PABS score was 5 (SD=1.25; range: 2 – 8). Seven cases had mild pain (5.9%), 105 moderate pain (89%) and 6 severe pain (5.1%). There was no correlation of pain levels with age (P=0.420), sex (P=0.098), active tumor or metastatic involvement of lung (P=0.321), CNS (P=0.972), Liver (P=0.575) or bone (P=0.529). Conclusions: In our experience, PABS scale is a useful tool to evaluate pain in agony cancer patients. We found no correlation between active tumor or metastatic localization with the intensity of pain.
Febrile neutropenia in hematologic malignancies: Validation of a model to select patients manageable in the outpatient setting safely.
Authors: Bains Sarina , Goy Andre , Fuchs Barry , Gadaleta Gabriella , Singavi Arun , Hurtubise Brenda , Sebti Rani , Feldman Tatyana , Goldberg Stuart , Pecora Andrew , Mato Anthony R. 
Published: March 2020

e19641 Background: Febrile neutropenia (FN) is usually treated in an inpatient setting with empiric IV antibiotics. Accurate identification of low-risk hematologic malignancy (HM) pts (highest risk for life-threatening events) appropriate for outpatient management may reduce healthcare costs without impacting outcomes adversely. Prior studies using predictive models to identify low risk FN pts have not been validated in HM pts. Aim: To identify low risk HM pts as candidates for safe outpatient management. Methods: To determine parameters associated with an uncomplicated FN course in HM pts we tested the association between Talcott’s criteria (Talcott et al JCO Oct 2011) and additional candidate risk factors with the development of a medical event (ME) requiring urgent intervention. We conducted a retrospective cohort study of stable HM pts, admitted for FN management. Utilizing Cox regression, we examined the following factors: Talcott criteria, age, insurance status, prophylactic G-CSF/antibiotics, vitals signs and organ function. Results: We identified 97 consecutively admitted pts who met eligibility criteria of whom 27 pts developed a ME during the admission (validated by 2 investigators blinded to exposure status). In univariate analysis, Talcott’s criteria successfully identified pts at low risk for developing a ME (HR .4, p=.04 CI .17-.97). Additionally a preserved DPB (>65 mmHg) was also protective (HR .22 p<.01 CI .11-.51). Talcott’s criteria and DBP remained independent predictors of uncomplicated FN in a multivariate cox regression (AUROC curve=75%). Conclusions: This study provides support for the use of Talcott’s criteria in HM pts. The addition of DBP to Talcott’s model further improves its ability to identify low risk HM pts. Once prospectively validated, this approach may have important clinical and financial implications. [Table: see text]
Real-time informatics to collect data, toxicities, image response assessments, and patient-reported outcomes (PROs) in a phase II clinical trial.
Authors: Pietanza Maria Catherine , Basch Ethan M. , Lash Alex , Schwartz Lawrence H. , Ginsberg Michelle S. , Zhao Binsheng , Shouery Marwan , Shaw Mary , Rogak Lauren J. , Wilson Manda , Gabow Aaron , Latif Marcia , Wu Quinfei , Kass Samantha Lindsay , Miller Claire , Tyson Leslie B. , Sumner Dyana K. , Berkowitz Alison , Sima Camelia S. , Kris Mark G. 
Published: March 2020

e19647 Background: In clinical trials, delayed and disorganized data reporting due to traditional toxicity symptom monitoring methods, paper documentation and out-dated collection systems lead to inaccuracies of critical study information and inefficiencies in the process. Electronic systems offer an opportunity to collect this information in real-time from various sources. The feasibility of such an approach is unknown. Methods: We created a computer software system to collect PROs of symptomatic toxicities, automated RECIST-based tumor response, and lab data, and made this information available to investigators in real-time at the point of care during a phase II lung cancer trial. We assessed data completeness within 48hrs of each visit. Clinician satisfaction was measured. Results: We enrolled 44 patients from 1/23/09 to 09/20/11. There were a total of 725 visits, with mean and median being 13 (range, 1-64) and 10, respectively. At each visit, patients completed self-reports using a dedicated wireless laptop 99.6% of the time; only 3 reports were not completed due to lack of a laptop or technical issues with the institutional Intranet. All PROs were completely distributed in batch throughout the system within 24hrs of the visit, and similarly lab data were available for review with a mean of 26hrs from the time the laboratory received the specimen. Manual attribution to lab toxicities in the system took a median of 1 day. Automated RECIST tumor measurements were available to clinicians online with a median of 2 days from the time of imaging; only 8% obtained >7 days after scans were performed. Throughout the trial, there was improvement in data acquisition times (i.e., a “learning curve”). 89% (16/18) of clinicians and research study assistants felt there was greater accuracy in collection of PROs, radiographic responses and trial data. Conclusions: Existing data management systems can be harnessed to enable real-time collection and review of clinical information during trials. This approach facilitates reporting of information closer to the time of events and may improve accuracy and efficiency, as well as ability to make earlier clinical decisions.