bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effective routine electronic symptom screening and use of evidence to improve cancer symptom management in Ontario, Canada.
Authors: Molloy Sean , Green Esther , Pereira Jose , Tabing Reena , Sawka Carol Anne 
Published: March 2020

e20507 Background: Improving symptom management is a critical component of high quality care. Cancer Care Ontario (CCO) is working to improve through a standardized approach to symptom screening and assessment that leverages electronic tools along the cancer journey. Methods: CCO has developed a web-based application that allows patients to report their symptoms using the Edmonton Symptom Assessment System (ESAS). ESAS is a validated screening tool that asks patients to rate the severity of nine common cancer symptoms. The use of ESAS promotes a common language among patients and providers and across care settings. To support clinicians in determining follow-up to scores, CCO has developed symptom management guides. The guides represent current evidence and best practices and are available in various formats to help the care team assess and manage a patient’s cancer-related symptoms. Results: Since the program’s introduction in 2007, over 1.6 million ESAS screens have been performed across the province. In November 2012, over 53% of all Regional Cancer Centre patients were screened representing over 23,000 patients and nearly 35,000 ESAS screens. Symptom assessments collected from 45,000 cancer patients revealed that 75% of patients reported fatigue as a concern, 57% reported anxiety and 53% reported pain. Patients have indicated that they value this approach. Results from a 2012 survey of 3,320 patients show that 93% thought that indicating their symptom severity is important as it helps their health care providers know how they are feeling. Evidence from chart audit reviews demonstrates that symptom screening is linked to higher rates of documented clinical interventions but further research is needed to analyze its impact on outcomes. Conclusions: Lessons learned include the importance of leadership at all levels, clinician engagement in change, point of care decision support tools and the importance of engaging patients in the management of their symptoms. Patients are overwhelmingly in support of this approach to cancer symptom screening and their involvement is critical to its expansion across all settings of care.
Epoetin biosimilars in the management of chemotherapy-induced anemia in elderly patients: A subanalysis of the ORHEO study.
Authors: Kurtz Jean-Emmanuel , Soubeyran Pierre-Louis , Michallet Mauricette , Luporsi-Gely Elisabeth 
Published: March 2020

e20513 Background: Chemotherapy-induced anemia (CIA) treatment requires transfusion, or epoietin administration. Elderly patients (pts) may experience severe complications from CIA, with fatigue and cardiovascular events. Methods: ORHEO (place of biOsimilaRs in the therapeutic management of anemia secondary to chemotherapy in HaEmatology and Oncology) was a post-marketing, observational, prospective, multicentric study. Adult CIA (Hb<110g/l) pts with solid tumors, lymphomas or myelomas and eligible for epoetin alpha biosimilar (EAB) treatment were included to receive EAB according to drugs approval recommendations. Recorded data included demographics, performance status, blood count and iron load profile. Safety (NCI-CTC V2.0) and efficacy were also assessed. The primary study endpoint was the rate of responders (defined as increase in Hb levels to 100 g/l or at least 10 g/l since inclusion visit, or reaching target Hb set at start of study, without any blood transfusions in the 3 weeks prior to measurement) at +3 months (M+3). Other endpoints included safety, patterns of treatment interruption and rate of responders at +6 months (M+6). Here we present data for the elderly (>= 70 years old) pts. Results: 1,009 pts (54.3% male, 45.7% female) >= 70 y.o. were included in this analysis. Median age was 77 y, range [70-93]. At baseline, 36.3, 57.8 and 3.4% of pts had respectively grade 1, 2 and 3 anemia. Iron supplementation was given in 9.9 (oral) and 16.0% (IV) of pts. At M+3, 84.0% of pts were responders (IC95% 81.4-86.3). Moreover, respectively 241 pts (23.8%) and 139 pts (13.7%) had stopped EAB permanently or temporarily, mainly because of efficacy (45.2 and 79.1% respectively); other reasons were side-effects (2.9 and 0.7% respectively), lack of efficacy (7.0 and 4.3%), and unspecified reason (44.8 and 15.8%). Similar results were observed at M+6 with 86.8% of responders. 17.0% of pts reported side effects (all grades); the most frequent were thromboembolic events (4.5%). No EAB-related death was reported. 94.6% of pts reported being satisfied with EAB therapy at M+3 and M+6 and willing to restart if needed. Conclusions: EAB therapy is efficacious on CIA management in elderly pts with low toxicity.
Robustness of circadian rest-activity rhythm for predicting efficacy of intravenous cetuximab (Cet) and hepatic artery infusion (HAI) of chronomodulated irinotecan, 5-fluorouracil and oxaliplatin (Chrono-Optiliv) for liver metastases from colorectal cancer (LM-CRC) (Optiliv translational study, NCT00852228).
Authors: Karaboué Abdoulaye , Innominato Pasquale F. , Bouchahda Mohamed , Mocquery Magali , Bossevot Rachel , Plessis Virginie , Bouchoucha Davina , Adam Rene , Levi Francis ,   ARTBC International Chronotherapy Group
Published: March 2020

e20519 Background: The rest-activity rhythm is a biomarker of the circadian timing system, whose disruption both accelerates cancer progression in experimental models (Filipski et al. JNCI 2002, 2005) and predicts for poor overall survival in cancer patients (pts) (Innominato et al. Cancer Res 2009; Int J Cancer 2012). Here we investigate the relevance of early signals of circadian disruption for the antitumor efficacy of intravenous Cet and chronomodulated triplet HAI in pts with unresectable and refractory LM-CRC. Methods: Rest-activity was monitored q1min using a wrist watch actigraph worn for three weeks, starting 1 week before HAI onset. A robust and validated parameter (I<O), the relative measure of activity In-bed vs Out-of-bed, was used to evaluate rest-activity patterns. Tumor response was evaluated using RECIST criteria. Results: 10M and 3F, aged 33-72 y (median, 60 y) had a good Performance Status (0, 10 pts; 1, 3 pts) and received one (7 pts), two or three (6 pts) prior chemotherapy lines. Pts displayed complete or partial response (1 CR, 6 PR), or stable disease (SD, 6 pts). Median I<0 was 95.4% (25-75% quartiles, 88.8-98.0) at baseline, 92.8% (89.4- 96.2) during the treatment week (p<0.001 vs “baseline”) and 95.0% (89.2- 97.6, NS) on the week after HAI. On this last week, I<O improved or recovered fully in 5 pts (38.5%), or partly in 3 pts (23.1%). Rest-activity rhythm disruption persisted in 5 pts (38.5%). An objective tumor response was achieved in 7/ 8 pts whose I<O improved or recovered (87.5%) while the poor I<O computed for 5 patients on the week after HAI predicted for SD only (p=0.003). This relation was independent of PS and prior chemotherapy lines (p=0.013). Conclusions: The robustness of the rest-activity rhythm during the first course of Chrono-Optiliv was an early signal that predicted subsequent antitumor activity. Further testing of this circadian biomarker is warranted as an early surrogate endpoint of antitumor efficacy of Chrono-Optiliv. Clinical trial information: NCT00852228.
Leucovorin (LV) pharmacokinetics in patients receiving high dose methotrexate (HDMTX), with or without glucarpidase treatment.
Authors: Schwartz Stefan , King Thomas , Ward Suzanne , Ogden Angela , Chauhan Nikhil , Howard Scott C. 
Published: March 2020

e20521 Background: Glucarpidase is a recombinant form of carboxypeptidase G2 and hydrolyzes MTX into inactive metabolites and provides alternate clearance in pts with delayed elimination and acute kidney injury. It is administered with IV hydration, urinary alkalinization, and LV. The primary objective was to investigate whether glucarpidase reduces exposure to LV and its active metabolite (5EMeTHF) to below the level achieved in pts who have not received glucarpidase, by assessing the PK of the active L-isomer of LV (6S-LV) following administration of HDMTX and LV. Methods: Open-label, multicenter PK study in pts treated with HDMTX (≥1 g/m2) and LV (either ≥15 mg or ≥10 mg/m2) with subsequent glucarpidase where indicated for renal impairment (Arm A) or without glucarpidase (Arm B). Plasma samples for LV and 5EMeTHF were taken pre-LV and at 5, 30, 60, 120, and 180 min after LV to calculate the area under the concentration curve of 6S-LV over 0-3 hours (AUC0-3) following the LV dose. Results: 17 pts (8 Arm A, 9 Arm B) were analyzed. The median pre-glucarpidase methotrexate (MTX) plasma concentration was higher for Arm A 7.5 µmol/L) than B (1.1 µmol/L). Similarly, median LV doses were 89.88 mg/m2 (Arm A) and 13.51 mg/m2(Arm B). Mean 6S-LV AUC0-3 values (µmol*h/L) for Arm A were 8.70±5.56, compared with 1.31±0.78 for Arm B, consistent with Arm A receiving a higher LV dose than Arm B. Mean 6S-5MeTHF AUC0-3 values (µmol*h/L) were similar in arms A and B (0.68 and 0.73). When normalized for LV doses, mean 6S-LV AUC0-3values (µmol*h/L) were similar between arms:10.02±4.83 in Arm A versus 9.79±5.18 for Arm B. Conclusions: Glucarpidase does not reduce exposure to 6S-LV and 5-MeTHF to below the level achieved in patients with normal renal function who did not receive glucarpidase. Adequate LV exposure is achieved if LV dosing is based on pre-glucarpidase plasma MTX concentration for at least 48 hours after glucarpidase administration. Clinical trial information: NCT00634504.
Rapid assessment of frailty prior to treatment of elderly colorectal cancer patients.
Authors: Dhesy-Thind Sukhbinder K. , Meyers Brandon Matthew , Al-Shamsi Humaid Obaid , Papaioannou Alexandra , Zbuk Kevin M. , Pond Gregory Russell 
Published: March 2020

e20522 Background: Frailty is traditionally assessed by a comprehensive geriatric assessment (CGA); there is no agreed upon standard for a CGA, and it is not feasible to implement in routine oncology practice. In contrast, the Edmonton Frailty Scale (EFS) is a simple questionnaire, requiring less than 5 minutes to complete, initially validated as a surrogate to the CGA in general medicine patients (Rolfson et al, 2006). We conducted a pilot study to establish if the EFS would add utility beyond clinician’s expertise. Methods: The EFS was administered to stage II-IV CRC patients ≥70 years, referred to a Medical Oncologist at a tertiary care centre. The EFS was completed by one of the investigators, with the treating oncology team blinded to results, and follow up of 14 months. Results: Forty-six patients were enrolled with the following characteristics: average age 76, 48% male, and 78% Zubrod performance status (PS) 0-1. The EFS was reproducible between visits (r = 0.81 [95%CI 0.64-0.9], p<0.01). No association existed for the EFS and receipt of chemotherapy for the study population as a whole, however none of the stage II patients had features requiring chemotherapy. Restricting the analysis to stage III/IV patients demonstrated a reduced likelihood of receiving chemotherapy with higher EFS scores (Odds ratio 0.56 per unit increment [95%CI 0.37-0.85] p<0.01). A similar effect was observed after multivariate analysis (adjusting for PS, age, stage and gender, Odds ratio 0.41 per unit increment [95%CI 0.18-0.96] p<0.05). The clinician’s qualitative impression was associated with the EFS (p<0.01). No association existed between the EFS and upfront dose reductions, choice of less toxic regimens, or hospitalization secondary to grade 3/4 toxicities. Conclusions: The EFS can identify patients that Oncologists may have thought were too frail for chemotherapy, independent of PS. The EFS has the potential to add a reproducible, and quantifiable measure of frailty to aid in decision making in oncology practice.
Second primary malignancies in acute myeloid leukemia.
Authors: Nepal Barsha , Ghimire Krishna Bilas , Shah Binay Kumar 
Published: March 2020

e20529 Background: Long-term survival rate in acute myeloid leukemia (AML) patients younger than 60 yrs is higher than 40% (Mayer RJ, et al N Engl J Med 2004). Development of second primary malignancy (SPM) in these patients is unknown. We analyzed the incidence of SPM in these AML patients using SEER database. Methods: We analyzed the Surveillance, Epidemiology, and End Results (SEER*Stat) database: Incidence - SEER 13 Regs Research Data, Nov 2011 Sub, Vintage 2009 Pops (1992-2009) using multiple primary standardized incidence ratio (MP-SIR) session. We evaluated SPM incidence rate among adult AML patients (age 20-59 yrs) during the period 1992 - 2009. We used SEER*Stat software for statistical analysis. Results: Total number of AML patients (age 20-59 yrs) reported during 1992-2009 period was 5,544. Median age at the time of diagnosis of SPM was 54.33 yrs ( 22.33-72.42 yrs). Median follow up was 8.13 yrs (2months – 17.8 yrs) and median latency period was 51 months ( 2-193months). The total number of all site SPM among AML patients reported during same time period was 100 with observed/expected (O/E) ratio of 1.03, (95% CI: 0.84-1.26), excess risk of 1.62 per 10,000 population. Ninety patients with AML developed SPM; 86 AML patients developed only 1 SPM and 7 patients developed 2 SPMs. The risk of oral cavity and pharyngeal cancer was significantly increased in AML patients with O/E: 3.99, p<0.05 (95% CI: 1.99-7.15), excess risk of 3.98 per 10,000 population. Similarly, cancer of urinary system was significantly increased in AML patients with O/E: 2.26, p<0.05 (95% CI: 1.23-3.79), excess risk of 3.77 per 10,000 population. Conclusions: This study showed significantly higher risk of second primary malignancies of oral cavity/pharyngeal cancer, and of urinary system in AML patients. [Table: see text]
Efficacy of a one-year exercise program to prevent bone loss in postmenopausal women prescribed aromatase inhibitor therapy: An RCT.
Authors: Kilbreath Sharon , Refshauge Kathryn M. , Beith Jane McNeil , Ward Leigh C. , Clifton-Bligh Philip , Simpson Judy M. , Moore Katrina H. , Lee Mi-Joung , Nery Lisa 
Published: March 2020

e20533 Background: The aim of this single blinded RCT was to determine the effect of exercise on bone mineral density (BMD) in postmenopausal women prescribed an aromatase inhibitor (AI) for the treatment of breast cancer. Methods: 66 sedentary, postmenopausal women, median age of 54.5 years, with early breast cancer and receiving an aromatase inhibitor participated. Women were stratified for taking tamoxifen prior to AI, and randomised to either the exercise (n = 27) or control (n = 39) group. All participants received daily vitamin D (1000 IU) and calcium carbonate (1200 mg) supplements and a booklet from Osteoporosis Australia outlining the benefits of exercise in preventing osteoporosis. The exercise group attended a gym three times per week for one year, supervised at regular intervals by a personal trainer, and were contacted weekly regarding progress and progression. Training sessions comprised warm-up, impact training, and resistance training. The control group was contacted monthly to monitor health status and to receive their supply of vitamins. The primary outcome was total hip BMD measured with a dual-energy X-ray absorptiometer. The secondary outcomes included trochanteric, femoral neck, lumbar spine and whole body BMD and t-scores. Results: Intention-to-treat analysis revealed that the change in BMD was not significantly different between groups. At baseline, the mean (SD) total hip BMD in the control group was 0.892 (0.115) g/cm2 and 0.878 (0.112) g/cm2 at 1 yr. In contrast, hip BMD in the Exercise group was 0.918 (0.119) g/cm2 at baseline and 0.910 (0.113) g/cm2at 1 yr. The mean (SD) change for both groups was <1%. The mean T-score of the hip for Controls at baseline was -0.42 (0.94) and -0.53 (0.91) at 1 year. The baseline T-score for the Exercise group was -0.20 (0.95) and -0.26 (0.93) at one year. The average compliance with attendance for the exercise group was 71% but ranged from 20 to 100%. Compliance with vitamins for both groups was high. Conclusions: A one year exercise program did not provide additional benefit to bone density in women on AIs compared to receipt of calcium and vitamin D and advice to exercise. Clinical trial information: (ACTRN12608000220369).
The incidence and impact of poor nutrition in gastrointestinal malignancies.
Authors: Guggenheim Douglas Eric , Ocean Allyson J. , Popa Elizabeta C. , Magli Amanda R , Karpenko Irene , Christos Paul J. , Rosales Veronica A. , Florendo Erika Ocampo , Ruggiero Joseph T. , Shah Manish A. 
Published: March 2020

e20549 Background: The impact and significance of malnutrition in gastrointestinal oncology is understudied. The Subjective Global Assessment (SGA) is a validated clinical tool to assess nutritional status. We examined baseline SGA to determine its significance across GI malignancies. Our hypothesis is that malnutrition is prevalent in gastrointestinal malignancies and may significantly affect treatment-related morbidity. Methods: The Weill Cornell Medical Center GI registry is a prospective database to collect clinical standardized data from all patients who present for evaluation in the outpatient academic practice office. We examined baseline SGA score (A=well nourished, B=moderate malnutrition, C=severe malnutrition) in all patients newly diagnosed with a GI malignancy, and correlated with baseline patient demographics, tumor type, and dose reductions in the first 2 months of chemotherapy treatment by the chi-square test and t-test. Results: From May-Dec 2012, 101 newly diagnosed GI cancer patients referred to oncology were enrolled. 23% of patients were SGA-B/C, and significantly associated with race and albumin. Among upper GI patients with poor nutrition, 75.0% required dose reductions within the first 2 months of treatment, resulting in a mean percent dose received of 78.3 ± 19.1. Conclusions: Moderate to poor nutrition is prevalent in ~23% of patients with GI malignancies, and significantly more prevalent in upper GI and pancreatobililary cancers. Moderate malnutrition is associated with low albumin, and for upper GI patients, reduced chemotherapy delivery, suggestive of increased toxicity. [Table: see text]
Plasma vascular endothelial growth factor level and cognitive changes in breast cancer patients.
Authors: Ng Terence , Cheung Yin Ting , Ham Guo Maung Shwe , Kee Yuan Chuan , Ho Han Kiat , Fan Gilbert , Yong Wei Sean , Madhukumar Preetha , Ooi Wei Seong , Chay Wen Yee , Ng Raymond C.H. , Ng Quan Sing , Ang Soo Fan , Lo Soo Kien , Yap Yoon Sim , Dent Rebecca Alexandra , Chan Alexandre 
Published: March 2020

e20566 Background: It is suggested that vascular endothelial growth factor (VEGF) induces neurogenesis in the brain and provides neuroprotectiveeffects. This study was designed to examine the relation between plasma VEGF level and cognitive functioning in breast cancer patients who have received chemotherapy. Methods: Early-stage breast cancer patients (stage I to III) who received anthracycline- and/or taxane-based chemotherapy were prospectively recruited at a single center. Perceived cognitive functioning (FACT-Cog) and computerized neuropsychological assessment (Headminder) were used to evaluate patients’ cognitive function at three time points: prior to chemotherapy (T1), at midpoint (T2), and end of chemotherapy (T3). Headminder evaluated four cognitive domains: Attention, Memory, Processing, and Response speed. Impairment in each domain were defined as a >2.5 reduction of the Z score from baseline, as calculated by the reliable change index for repeated cognitive measurements. Plasma VEGF levels were analyzed at each time point using the multiplex immunoassay. Spearman Correlation (rs) was utilized to correlate the change in plasma VEGF and neurocognitive functioning. Results: Thirty-six patients were recruited (median age: 51.5; Chinese: 80.6%; post-menopausal: 58.3%). Median plasma VEGF levels were T1: 19.2 pg/ml; T2: 26.5 pg/ml; T3: 21.9 pg/ml. Weak correlations were observed between the change in VEGF level and the change in FACT-Cog and Headminder scores for individual cognitive domain (Table). Conclusions: Results suggest a weak correlation between plasma VEGF level and cognitive functioning in the domains of attention, concentration, functional interferences, mental acuity and response speed. Larger sample size and longer follow up are required to further explore the findings. [Table: see text]
Recovery of complete antiemetic response with APF530 during treatment with moderately (MEC) and highly (HEC) emetogenic chemotherapy regimens in patients who failed palonosetron.
Authors: Arevalo-Araujo Roberto , O'Boyle Erin , Cooper William , Robertson Paul Alexander 
Published: March 2020

e20569 Background: Several 5-HT3 antagonists are available to prevent chemotherapy-induced nausea and vomiting (CINV); when control is inadequate with one agent, another may be used. Using data from a randomized phase III trial (Grous et al. ASCO 2009, #9627), we examined the efficacy of APF530, a sustained delivery formulation of the 5-HT3antagonist granisetron, in patients (pts) who failed to achieve a complete response (CR; no emesis or rescue medication) with palonosetron (PALO) in preventing acute (0-24 h) and delayed (24-120 h) CINV in pts receiving MEC or HEC. Methods: 1,428 pts receiving single doses of MEC or HEC were randomized to APF530 250 mg (5 mg granisetron) subcutaneously (SC), APF530 500 mg (10 mg granisetron) SC, or PALO 0.25 mg intravenously (IV) in cycle 1 (C1). Prior to C2, pts who received PALO in C1 and remained on study were re-randomized to APF530 250 mg or 500 mg SC. CR rates in C2 were assessed for pts receiving APF530 500 mg who did not achieve CR in C1 with PALO. Results: 446 pts received PALO in C1 (208 MEC; 238 HEC). Of these, 194 (43.5%) were overall (0-120 h) failures (100/208 [48.1%] MEC; 94/238 [39.5%] HEC). Of 194 C1 PALO failures, 72 were re-randomized prior to C2 to APF530 500 mg (38 MEC; 34 HEC). Of 38 MEC PALO failures who received APF530 in C2, overall CR was 39.5% (57.9% acute; 38.2% delayed). Of 34 HEC PALO failures who received APF530 in C2, overall CR was 41.2% (58.3% acute; 45.5% delayed). In the acute phase, > 50% of MEC and HEC pts who failed PALO in C1 achieved CR to APF530 500 mg in C2. CR rate for pts receiving MEC or HEC was slightly less in the delayed vs acute setting. Conclusions: APF530 500 mg demonstrated substantial activity (ie, CR) in pts receiving MEC or HEC who had failed PALO in C1. Failure to achieve an initial CR to PALO 0.25 mg IV does not predict failure of APF530 500 mg SC in subsequent MEC or HEC cycles. Further studies are needed to confirm these observations. Clinical trial information: NCT00343460. [Table: see text]