bluuebunny/crossref_metadata_2025_split huggingface dataset:
Feasibility and acceptability of patient-reported outcomes data collection for clinical care following breast reconstruction.
Authors: Pusic Andrea , Klassen Anne , Scott Amie , Cano Stefan , Shouery Marwan , Basch Ethan M. 
Published: March 2020

9042 Background: To date, systematic measurement of patient-reported outcomes (PROs) has played an important role in cancer research, but not in routine clinical care. Our objective was to evaluate the feasibility of developing and piloting an electronic PRO data collection in clinical care among breast reconstruction patients using the BREAST-Q, a previously developed condition-specific PRO measure for breast surgery patients that measures quality of life (e.g. psychosocial, physical and sexual well-being) as well as patient satisfaction (e.g. satisfaction with breasts, with information, with surgeon). Methods: The BREAST-Q was loaded to the MSKCC WebCore, a generic electronic patient-reporting platform adhering to strict privacy and security standards. Patients attending visits at the MSKCC Breast Reconstruction Clinic were asked to complete the BREAST-Q electronically prior to scheduled visits. For patients with email addresses, a reminder with web-link to the questionnaire was emailed automatically prior to the visit. Results: Over a 9 month start-up period, BREAST-Q surveys were completed by 1442 patients. Patients completed the questionnaire at set time points before and after surgery. A total of 2340 BREAST-Q surveys were completed overall. Mean completion time was 5:53 minutes. Acceptability was high with both patients and clinical staff contributing positive comments along with suggestions for improvement via email. Conclusions: This pilot experience suggests that ePRO data can be efficiently collected among outpatient breast surgery patients with high acceptability. In the next phase of this project, we will introduce real-time individual patient reports to the clinical team and evaluate the impact of this information on clinical care and quality improvement.
A positron emission tomography (PET) study to assess the degree of neurokinin-1 (NK1) receptor occupancy in the human brain after single doses of netupitant to healthy male subjects.
Authors: Rossi Giorgia , Olivari Tilola Silvia , Rudengren Cecilia 
Published: March 2020

9054 Background: Netupitant (NETU) is a highly selective neurokinin 1 (NK1) receptor antagonist for the prevention of nausea and vomiting associated with emetogenic chemotherapy. In this study, PET imaging with the NK1 receptor-binding–selective tracer 11C-GR205171 was used to determine the levels and the duration of central NK1 receptor occupancy (RO) achieved by therapeutic doses of NETU. Methods: This was a single dose, randomized, open-label, PET study investigating the degree of NK1 RO in human brain after single oral doses of NETU (100, 300 or 450 mg) in 6 healthy male subjects. PET scans and blood samples for NETU determination were obtained up to 96 hrs post dose. The Patlak model was used to define the net uptake rate of 11C-GR205171 in the brain regions of interest while the percent of NK1 RO was calculated as the relative difference between the uptake rate at baseline and post-treatment administration. Results: NETU plasma concentrations over the 100 mg to 450 mg dose range were comparable with those obtained in previous single dose studies. A NK1 RO of 90% or higher was achieved with all tested single oral doses in the majority of the outlined brain regions 6 hrs after dosing (corresponding to netupitant Cmax). All doses had a long duration of blockade of NK1 receptors with the 300 mg dose showing moderate (62%) to high (94%) NK1 RO for all investigated brain regions at 96 hrs post dose. The relationship between NETU concentration and NK1 RO, assessed using a sigmoid Emax model, indicated that in the striatum, the reference brain area with the highest NK1 receptor expression, a concentration of 225 μg/L of NETU corresponded to an NK1 RO of 90%. This data suggests that a single oral dose between 100 and 300 mg NETU would be needed to reach 90% NK1 RO levels in human brain. Conclusions: PET results demonstrate that NETU is a potent agent targeting NK1 receptors with a high degree of occupancy for a long duration. NETU, given as single doses of 100 to 450 mg was well tolerated.
Prevention of palmoplantar erythrodysesthesia (PPE) with an antiperspirant in breast cancer patients treated with pegylated liposomal doxorubicin (PLD), a placebo-controlled, double blinded, phase lll trial (SAKK 92/08).
Authors: Ruhstaller Thomas , Ribi Karin , Sun Hong , Schmitz Shu-Fang , Borner Markus , Winkler Annette , Mueller Andreas , von Rohr Lukas , Winterhalder Ralph C. , Rochlitz Christoph , Von Moos Roger , Anchisi Sandro , Caspar Clemens B. , Zaman Khalil , Bodmer Alexandre , Beyeler Michael , Berardi Simona , Thurlimann Beat J. K. , Templeton Arnoud 
Published: March 2020

9059 Background: PPE, also known as hand-foot syndrome, is a distinctive adverse drug reaction of PLD treatment. PLD has been detected in elevated concentrations in eccrine sweat glands in palms and soles. We postulated that prophylactic administration of an antiperspirant (F511 cream) prior and during treatment with PLD could decrease the incidence of PPE. Methods: Patients (pts) with metastatic breast cancer treated with PLD monotherapy ≥10mg/m2 per week applied an antiperspirant to the left or right hand and foot and a corresponding placebo to the opposite site with double-blinding for the content of the cream applied to either side (intra-patient randomization). The creams were applied once daily during the first week, then three times per week. The primary endpoint was the rate of PPE grade (G) ≥ 2 in the antiperspirant or placebo treated side. Pts were evaluable if they developed PPE G ≥ 2 or had received cumulatively at least 160mg/m2 PLD. Patient-reported extent of symptom burden was a secondary endpoint. Using McNemar’s matched pairs design 53 pts were needed to detect a difference of 20% between the sides with a significance level of 5% and power of 90%. Results: 52 of 90 pts from 11 Swiss centers included were evaluable. Median age was 64.5 years; median duration of PLD treatment was 12 weeks. 30 pts developed PPE G ≥ 2. In 3 pts PPE G ≥ 2 occurred on the placebo side but not on the antiperspirant side (p=0.097; table). PPE G ≥ 2 was borderline significantly more frequent in placebo foot than antiperspirant foot (p=0.048). Patient-reported extent of symptom burden showed a trend in favor of the antiperspirant side for skin problems (peeling, blistering, bleeding) in the group of pts with PPE G ≥ 2 (p=0.051). Conclusions: In this double-blind trial with intra-patient randomization we observed a trend towards less PPE G ≥ 2 with application of the antiperspirant cream F511 in pts treated with PLD as determined by the treating physician and reported by the pts. [Table: see text]
Clinical needs of patients referred early to supportive and palliative care.
Authors: Kwon Jung Hye , Hui David , Ha Caroline Ann , Chisholm Gary B. , Yennurajalingam Sriram , Kang Jung Hun , Bruera Eduardo 
Published: March 2020

9065 Background: Palliative care is evolving from delivering care to patients at the end-of-life to those earlier in the disease trajectory. We evaluated the differences in clinical characteristics, symptoms burdens, and service utilization between traditional palliative care patients (late referrals, LR) and the new patients group who are in earlier in their course of disease (early referrals, ER). Methods: We reviewed consecutive cancer patients referred to the Supportive Care Clinic with follow up visit within 30 days between August 2008 and October 2010. Patients were divided into two groups: ER (defined as patients with expected survival ≥ 2 years or receiving treatment for curative intent) and LR (all others). We compared clinical characteristics, symptoms and service utilization between both groups using chi-square test and Wilcoxon rank sum test. Results: 58% (695/1208) patients had a 2nd visit within 30 days. Among them, 100 patients were classified as ER (14.4%) and 100/595 LR were randomly selected as the comparison group. ER patients were younger (median age 54 years vs 60 years, p=0.009), more likely to have head and neck cancer (67% vs 6%, p<0.001) and to have a shorter interval between cancer diagnosis and palliative care consultation (3.8 m vs 16.2 m, <0.001). ER patients were also more likely to be CAGE positive (15% vs 4%, p=.014), referred from radiation oncology (49% vs 3%, p<0.001), referred for treatment related side effects (70% vs 9%, p<0.001), and receiving active anti-cancer treatment at the time of consultation (74% vs 48%, p=0.0002). Baseline symptoms (Edmonton Symptom Assessment Scale) were similar between ER and LR except for insomnia (1.8 vs 2, p=0.004). LR patients experienced greater improvement in the symptom distress score (-5.5 vs -3, p=0.007). Overall median number of medical visits was 24 for ER vs 10.5 for LR (p<0.001); however, median visit per month was 4.3 for LR and 2.1 for ER (p<0.001). Conclusions: ER was associated with different patient characteristics; patients have similar distress but different needs and outcomes as compared to traditional LR patients.
Efficacy and safety of rolapitant, a novel NK-1 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting in subjects receiving highly emetogenic chemotherapy.
Authors: Fein Luis Enrique , Poma Allen , Hedley Mary Lynne 
Published: March 2020

9077 Background: Management of chemotherapy-induced nausea and vomiting (CINV) improves quality of life and increases the likelihood that patients will continue to receive appropriate treatment. The objective of this dose finding study was to evaluate rolapitant for the prevention of CINV in subjects receiving highly emetogenic chemotherapy (HEC). Methods: A phase II, double blind study in which 454 subjects receiving HEC (≥70mg/m2 cisplatin-based chemotherapy) were randomized in equal fashion prior to chemotherapy to receive ondansetron + dexamethasone + either placebo or 10, 25, 100 or 200mg of rolapitant. Subjects recorded episodes of emesis, severity of nausea, and use of rescue medication(s) daily within a subject diary from Days 1 through 6 of Cycle 1. Results: The rolapitant 200mg group had significantly greater complete response rates (no emesis and no use of rescue medication) in the overall (0 to 120 hours), acute (0 to ≤24 hours) and delayed (>24 to 120 hours) phases compared to the placebo group (62.5% vs. 46.7%, p=0.032; 87.6% vs. 66.7%, p=0.001 and 63.6% vs. 48.9%, p=0.045, respectively). Moreover, the 200mg group had significantly greater rates of no emesis and no significant nausea in the overall, acute, and delayed phases and achieved statistically significant better QoL scores (FLIE questionnaire) compared to the placebo group. Rates for no emesis and no significant nausea for the 200mg dose group in Cycles 2 to 6 continued to demonstrate superior treatment effect vs. placebo. Treatment-related adverse events were mild and included constipation, headache, fatigue and dizziness. Overall, serious adverse events (SAEs) occurred with similar incidences across all treatment groups (9% - 14%). Most common SAEs were febrile neutropenia, neutropenia, vomiting, dehydration, nausea and pneumonia and were considered related to chemotherapy or underlying cancer and not to rolapitant. Conclusions: Administration of rolapitant 200mg with ondansetron and dexamethasone is safe and effective at preventing CINV in subjects receiving HEC.
Longitudinal relationship between inflammatory markers and patient-reported symptom severity during induction therapy for multiple myeloma.
Authors: Sailors Mary H , Wang Xin Shelley , Liu Ping , Johnson Valen E. , Reuben James M. , Cohen Evan N. , Williams Loretta A. , Mendoza Tito R. , Cleeland Charles S. 
Published: March 2020

9083 Background: Multiple myeloma (MM) patients undergoing induction therapy experience both disease- and therapy-related symptoms. We investigated the association between the trajectory of symptom severity and changes in levels of inflammatory markers. Methods: MM patients (N=62) rated symptoms via the M. D. Anderson Symptom Inventory (MDASI) twice a week during induction therapy. Patients contributed serum samples before the start of every chemotherapy cycle. A panel of pro- and anti-inflammatory cytokines and markers was evaluated by Luminex. Ordinal regression analyses were used to describe the relationship between cytokines and symptom outcomes across time. These analyses were adjusted for patient and clinical factors (age, sex, diabetes diagnosis, anemia, BMI, comorbidity, staging, ECOG PS, prior treatment status, tumor response, opioid use, and chemo regimen). Results: Bortezomib-based induction therapy was received by 89% of the sample. Fatigue was persistently the most severe symptom during induction therapy, followed by disturbed sleep, muscle weakness, pain, drowsiness, and bone aches. Numbness, which is representative of chemotherapy-induced peripheral neuropathy, significantly worsened from baseline (p=0.01). We observed significant longitudinal associations between sIL-1R1 and distress and sadness (both p=0.02); between sIL-6R and disturbed sleep (p=0.001), poor appetite (p=0.04), and sore mouth (p=0.006). IL-6 was significantly associated with pain, fatigue, nausea, and sore mouth (all p<.05). A negative association between sTNF-RII and pain, sleep, distress, remembering, poor appetite, and nausea (all p<0.05) was also observed. MCP-1 was positively associated with numbness (p=0.04); while MIP-1α was negatively associated with sleep, numbness, constipation, poor attention (all p<0.01), and bone aches (p=0.0006). IL-10 was negatively associated with mood interference (p=0.04). Conclusions: Frequent assessment can document the longitudinal course of multiple symptoms during induction and provides opportunity to evaluate systemic inflammation as a potential source of symptom burden during induction therapy for MM.
Risk of skin rash with the proteasome inhibitor bortezomib: Updated systematic review and meta-analysis.
Authors: Case Emily Christine , Wu Shenhong , Gerecitano John F. , Lacouture Mario E. 
Published: March 2020

9092 Background: Rash is a common, adverse event to the novel proteasome inhibitor bortezomib (Velcade). Indicated for the treatment of multiple myeloma and mantle cell lymphoma, bortezomib is the first proteasome inhibitor approved by regulatory agencies. Because the incidence of bortezomib-induced skin rash varies widely in published manuscripts, we performed a systematic literature review and meta-analysis to determine the incidence and overall risk. Methods: We searched PubMed and Web of Science databases and abstracts presented at the American Society of Clinical Oncology and The American Society of Hematology annual meetings (1998 to July 2011) to identify relevant clinical studies. Eligible studies included prospective clinical phase II and phase III trials, with data on the incidence of rash in patients taking 1.3mg/m2, 1.5mg/m2, or 1.6 mg/m2 of bortezomib intravenously either weekly or twice weekly. The incidence of rash and relative risk (RR) were calculated using random-effects or fixed-effects model, depending on the heterogeneity of included studies. Results: A total of 2,616 patients with various hematologic and solid malignancies from 35 clinical trials were included for analysis. Among patients receiving twice weekly bortezomib, the summary incidence of all-grade and high-grade rash were 18.8 % (95% CI: 14.9% to 23.5%) and 3.6 % (95% CI: 2.3% to 5.7%), respectively. We found no significant increase in all grade rash incidence with higher doses of bortezomib: 19.3 % (95% CI: 15% to 24.5%) and 20.8% (95% CI: 11.6% to 34.4%) for doses of 1.3 mg/m2 and 1.5 mg/m2, respectively. In addition, bortezomib was associated with an increased risk in both all grade (RR: 19.70, 95% CI: 8.73 to 44.44, p<0.001) and high-grade rash (RR: 5.35, 95% CI: 2.16 to 13.29, p<0.001), compared to controls. Weekly bortezomib is associated with lower risk of rash compared to twice weekly dosing (incidence 3.9% versus 18.8%, p=0.001). Conclusions: Bortezomib is associated with a significant risk of developing rash with a higher risk among patients receiving twice weekly dosage. Management of rash to bortezomib is critical to prevent a negative effect on quality of life and dose modifications, both of which affect clinical outcome.
Early outpatient palliative care in patients with metastatic NSCLC: A qualitative study.
Authors: Yoong Jaclyn , Park Elyse R. , Greer Joseph A. , Jackson Vicki A. , Gallagher Emily R. , Pirl William F. , Back Anthony , Temel Jennifer S. 
Published: March 2020

9101 Background: Early outpatient palliative care (PC) is an emerging practice and its key components have not been defined. We conducted a qualitative analysis of data from a randomized controlled trial which demonstrated improved quality of life, mood and survival in outpatients who received early PC integrated with standard oncologic care versus standard oncologic care alone. Our objectives were to 1) identify the content and key components of early PC clinic visits, 2) explore timing of key components, and 3) compare the content of PC and oncology visit notes at the critical time points of clinical deterioration and radiographic disease progression. Methods: We chose a random selection of 20 patients with newly diagnosed metastatic NSCLC who received early PC who survived within 4 time frames: less than 3 months (n=5), 3 to 6 months (n=5), 6 to 12 months (n=5) and 12 to 24 months (n=5). We performed content analysis on PC and oncology electronic health record notes of these patients using NVivo 9 software. Results: Addressing symptoms and coping ability were the most prevalent components of the PC clinic visits. The content of initial visits focused on building relationships and rapport with patients and their families and illness understanding. Discussions about prognostic awareness occurred during earlier visits while goals of care and hospice discussions occurred in later visits. The frequency of addressing these components was similar regardless of patients’ length of life. Comparing PC and oncology visits around critical time points, both included discussions about current illness status and goals of care; however PC visits emphasized symptoms, coping, and implications of anti-cancer treatments, while oncology visits focused on medical discussions about treatment plans. Conclusions: Early PC clinic visits emphasize managing symptoms, strengthening coping, and cultivating illness understanding and prognostic awareness in a structured, responsive and time-sensitive model. Around critical clinical time points PC and oncology visits have distinct features that suggest a key role for PC involvement while enabling oncologists to focus on anti-cancer management.
Treatment and mortality rates of older cancer patients with a body mass index <20: Results from the IN-GHO registry.
Authors: Honecker Friedemann , Wedding Ulrich , Rettig Klaus , Huschens Susanne , Bokemeyer Carsten ,   on behalf of the IN-GHO Advisory Board
Published: March 2020

9114 Background: Older cancer patients (pts) compose a heterogeneous population. Data from clinical trials are limited, and little is known about treatment decisions and outcomes. The internet based IN-GHO registry prospectively collects data of cancer pts ≥ 70 years from >100 centers in Germany and Austria. Methods: Data from 1.563 cancer pts were analysed, comparing results between pts with a body mass index (BMI) <20 versus (vs) BMI ≥20 by Chi-square or Mann-Whitney U test. Analyses included results from a comprehensive geriatric assessment, physicians’ rating (fit vs compromised vs frail) and pts’ self rating of fitness for treatment (Likert scale 1= very fit to 6 = very unfit), type (combination vs. monotherapy vs no) and dosage of treatment (full vs adapted), as well as mortality within 5-7 months. Results: Mean BMI of the total cohort was 25.6. 119 (7.6%) pts had a BMI <20. Low BMI showed a positive association with female sex, small height, higher age (classified), adapted dosage of treatment, lower number of comedication, lower ADL, IADL, and Karnofsky index scores, reduced mobility, and a lower mean MMSE score. More pts with BMI <20 were judged compromised or frail, both by physicians’ or pts’ assessment (p<0.001 and p=0.038, respectively). The risk of early mortality was 1.5 fold increased in pts with low BMI compared to pts with BMI ≥20 (35.3% vs 22.3%, p=0.002). Interestingly, none of the following showed an association with lower BMI: comorbidity, type (hematologic vs solid neoplasia), stage (metastatic vs non-metastatic), time since first diagnosis, decision to apply chemotherapy, and curative vs palliative intention of treatment. Conclusions: The internet based registry is useful to gain data on prognostic factors, treatment, and outcome in older cancer pts. Significant differences regarding dosage of treatment and incidence of early mortality were found between pts with BMI <20 and pts with BMI ≥20. Elderly cancer pts with BMI <20 should be considered a high risk population.
Safety and efficacy of eltrombopag (epag) versus placebo (pbo) for the treatment (tx) of chemotherapy-induced thrombocytopenia (CIT) in patients with solid tumors receiving gemcitabine (gem)-based chemotherapy (ctx): A phase I study.
Authors: Winer Eric S. , Safran Howard , Karaszewska Boguslawa , Richards Donald A. , Hartner Lee , Forget Frederic , Ramlau Rodryg , Kumar Kirushna , Mayer Bhabita , Johnson Brendan Mark , Messam Conrad A. , Mostafa Kamel Yasser Mostafa 
Published: March 2020

9117 Background: There are limited tx options for CIT. Epag, an oral, small molecule, thrombopoietin-receptor agonist that increases platelet (plt) production, is being explored for tx of CIT. Methods: This was the Ph I portion of a Ph I/II, blinded, pbo-controlled multicenter study in adults with solid tumors and baseline plts ≤300,000µL, who received up to 6 cycles of gem (1000-1250 mg/m2 IV) as monotherapy on Days 1, 8, and 15 Q28 days or Days 1 and 8 Q21 days in combination with cisplatin (50-80 mg/m2 IV Day 1 or divided 1 and 8) or carboplatin (AUC 4-7 IV Day 1). Patients received ctx alone for Cycle 1 and ctx plus epag or matching pbo (randomized 3:1) daily on Days -5 to -1 and 2 to 6 for subsequent cycles. Epag or pbo was interrupted for plts ≥400,000/µL. Results: 33 patients were randomized; 26 received epag or pbo (Table). Data review with an external, independent physician found no safety concerns, and there were sufficient plt increases with a dose of 100 mg epag vs pbo. No dose-limiting toxicities were reported for epag but 1 for pbo. Most AEs were grade 1 or 2. The most common AE in combined epag- and combined pbo-treated groups was neutropenia. Conclusions: Epag was well-tolerated and improved plt counts. Based on these encouraging Ph I results, Ph II using 100 mg epag in thrombocytopenic patients is planned. [Table: see text]