bluuebunny/crossref_metadata_2025_split huggingface dataset:
Doxorubicin, cardiac risk factors and cardiac toxicity in elderly patients with diffuse b-cell non-Hodgkin's lymphoma
Authors: Hershman D. L. , Eisenberger A. , Wang J. , Jacobson J. , Grann V. , McBride R. , Tsai W. , Neugut A. 
Published: March 2020

9050 Background: Anthracyclines are known to cause acute and chronic cardiotoxicity. In a population-based sample of elderly patients with diffuse large B-cell lymphoma (DLBCL), we studied the cardiac effects of doxorubicin (DOX)-containing regimens and of pre-existing diabetes (DM), hypertension (HTN), and heart disease (HD). Methods: Patients aged =65 years diagnosed with DLBCL 1/1/1992–12/31/2000 in the SEER/Medicare database were grouped by treatment: no chemotherapy, doxorubicin-based chemotherapy, or other chemotherapy. We developed multivariable logistic regression models of the associations of DOX-based chemotherapy with demographic and clinical variables and pre-diagnosis DM, HTN, and HD. We then developed Cox proportional hazards regression models of the association between treatment and subsequent congestive heart failure (CHF) taking the predictors of treatment into account. Results: Of 6,413 patients with DLBCL, 2,536 (39%) received doxorubicin-based chemotherapy. DOX use was associated with later year of diagnosis, female gender, younger age, and being married. Black race (HR 0.50, 95% CI 0.33–0.75), comorbidities, preexisting CHF, HD, and DM (HR 0.73, 95% CI 0.62–0.86) were associated with decreased DOX use. The post-treatment HR for CHF following DOX treatment vs. no chemotherapy was 1.39 (95% CI 1.15–1.67); CHF risk increased with duration of DOX use. It was also associated with increasing age, comorbidities, black race, DM, HTN, and HD. There was a significant interaction between race and DOX (P=0.01); For black patients treated with DOX the HR for CHF was 3.4, as compared to a HR of 1.3 for white patients. Conclusions: Among patients with DLBCL, black race, CRFs and pre-existing HD are all associated with both a reduced likelihood of receiving anthracyclines, and an increased risk of CHF. We have previously found a powerful effect of DOX on survival in this patient population; thus, for most patients, the benefits of treatment would appear to outweigh the risks of cardiac toxicity. However, as the number of long-term survivors grows, the need for research on the side effects of treatment, on host factors that may increase the risk of adverse effects, and on ways to minimize such risks will also grow. No significant financial relationships to disclose.
A double-blind, randomized, placebo-controlled study of fentanyl buccal tablet (FBT) in opioid-tolerant patients with chronic cancer pain and breakthrough pain
Authors: Slatkin N. , Xie F. , Segal T. , Messina J. 
Published: March 2020

9057 Background: Episodes of cancer-related breakthrough pain (BTP) often peak in intensity in minutes. Pain relief with traditional, short-acting oral opioids is often not achieved for =30 min. Fentanyl buccal tablet (FBT) has a rapid onset of analgesia. This double- blind, randomized, placebo-controlled study evaluated the efficacy and safety of FBT in opioid-tolerant patients with cancer and BTP. Methods: After open-label titration to establish a successful dose of FBT, patients were randomized to prespecified, double-blinded sequences of 10 tablets (7 FBT, 3 placebo). Pain intensity (PI) was assessed from 5 to 120 min post dose. The primary efficacy measure was the sum of PI differences (PIDs) for the first 60 min (SPID60); secondary measures included PIDs, =33% and =50% improvements in PI, and global medication performance (GMP). Use of supplemental BTP medication and adverse events (AEs) were reported. Results: 129 patients were enrolled; 87/125 treated (70%) identified an effective FBT dose and entered the double-blind phase. SPID60 significantly favored FBT vs placebo (mean±SEM, 9.7±0.63 vs 4.9±0.50; p<0.0001). PID differed significantly vs placebo at 10 min (mean±SEM, 0.9±0.09 vs 0.5±0.09; p<0.0001) and at all time points through 2 hr (p<0.0001). Improvements in PI of =33% and =50% from baseline occurred in a larger proportion of episodes following FBT vs placebo from 10 min (16% vs 10% and 7% vs 4%, respectively; p<0.05) through 2 hr (74% vs 38% and 66% vs 28%; p<0.0001). Ratings of GMP were superior for FBT vs placebo at 60 and 120 min (p<0.0001). Supplemental opioids were required for approximately 3 times more BTP episodes following placebo compared with FBT. AEs were typical for opioids, e.g. nausea (13%), dizziness (11%), fatigue (8%), and constipation (6%). Application site-related AEs occurred in 12 patients (10%). A total of 11/125 (9%) patients had =1 serious AE; these were considered not/unlikely to be related to study drug. Conclusions: FBT was effective and well tolerated in the management of BTP in opioid-tolerant patients with cancer-related pain, with an early onset of analgesia and a sustained duration of effect. No significant financial relationships to disclose.
Secondary causes of cancer-related anorexia: Recognition in daily practice by a novel checklist, a pilot study
Authors: Omlin A. G. , Strasser F. 
Published: March 2020

9058 Background: Secondary - potentially reversible - causes of cancer-related anorexia, a common and devastating complication of advanced cancer, remain poorly recognised in daily practice. To explore the frequency of SecAn and evaluate the practice- guiding-potential (PGP) of a novel clinical assessment checklist (CL-SecAn). Methods: The 11 item CL-SecAn is based on literature review and multiprofessional clinical expert opinions. Patients rate the answers to the questions “I feel anorectic because of [i.e. stomatitis]” by an 1–4 categorical scale (no, little, moderate, a lot). Consecutive patients of an interdisciplinary palliative-oncological outpatient “nutrition & fatigue” clinic (NF-clinic) and of a multicenter cross-sectional advanced cancer pain study completed the CL-SecAn. Charts of the NF-clinic were retrospectively reviewed for onset or change of therapeutic interventions (Tx-SecAn) focused on identified causes of SecAn. Patients with (rating 3 or 4) or without (1 or 2) one of the 11 SecAn causes were compared to estimate PGP. In addition, matched (age, sex, tumor, cachexia) “regular” out-patients are compared to NF-clinic patients for Tx-SecAn. Results: SecAn was present (defined as =3/4) in 63 of 113 (56%) patients (53 NF-clinic, 60 study; f:m 45:68; age 64 [median, range 25, 88]; 30% gastrointestinal, 20% lung, 13% prostate, 10% urogenital, and 17% other cancer, 10% lymphoma). SecAn causes were: stomatitis 4%, dysgeusia 19%, dysphagia 8%, epigastric pain 9%, abdominal pain 14%, constipation19%, diarrhea 5%, defecation after a meal 2%, pain 12%, dyspnoea 3% and fatigue 13%. In 36 (32%) patients more than one cause was present. Tx-SecAn for dysgeusia was applied in 7 of 15 patients (46%) with and 3 of 38 (8%) without Sec-An Dysgeusia. For constipation, Tx-SecAn was modified in 70% with and 27% without Sec-An constipation. The other 9 Sec-An were analysed accordingly. The case-control study is currently ongoing. Conclusions: SecAn causes seem to be common in advanced cancer patients. The CL-SecAn carries a Practice-Guiding-Potential, at least for some of the 11 SecAn causes, its potential might be underrecognized in frequently treated syndromes, such as constipation. Future research will investigate further the impact of CL-SecAn. No significant financial relationships to disclose.
Attitudes on terminal sedation, physician assisted suicide and euthanasia in oncology personnel, oncological patients and relatives
Authors: Maier V. , Kunitz A. , Thuss-Patience P. C. 
Published: March 2020

9068 Background: This survey was performed to elucidate and compare the attitudes on end of life management of participants actively affected by/involved in oncology either as a doctor, nurse, patient or a relative. Methods: In this questionnaire based survey performed in Berlin, Germany, approved by the local ethics committee, 4 groups of participants (oncology doctors (D), oncology nurses (N), oncology patients (P) and relatives (R)) were asked about their attitudes on the management of terminally ill oncological patients. Participants were asked to mark their maximal ethically accepted management of a specific case from a series of 10 destinct management options (opt). These options were destilled into 4 groups ranging from sole pain control (SYM)(opt 1) at the bottom of the scale, through to terminal sedation (SED)(opt 2–4), physician assisted suicide (SUI)(opt 5–7) and finally active euthanasia (EUT)(opt 8–10) at the top of the scale. Each participant marked his attitude by putting himself in the role of the treating physician, in the role of the patient described in the case and in the role of a legislative body. Results: 435 questionnaires distributed, 185 returned (42.5%). Participants: D: 58 N: 61 P: 30 R: 36. All participants answering 1) in the role of a treating physician, 2) in the role of a terminally ill patient, 3) in the role of a legislative body. Table shows attitudes of a) all participants and of the 4 subgroups of participants b) doctors, c) nurses, d) relatives, e) patients. Conclusions: Only a minority of participants would themselves perform or assist in active life terminating measurements (SUI+EUT)(23%), more participants would wish for themselves active measurements (SUI+EUT)(30%) and significantly more participants are for legislation to allow active measurements (SUI+EUT)(47%). Medical personnel (doctors equally as nurses) are significantly more reluctant to assist/perform or wish for themselves active measurements (SUI+EUT) than relatives and patients. [Table: see text] No significant financial relationships to disclose.
Cytokine levels in patients (pts) with colorectal cancer and breast cancer and their relationship to fatigue and cognitive function
Authors: Vardy J. L. , Booth C. , Pond G. R. , Zhang H. , Galica J. , Dhillon H. , Clarke S. J. , Tannock I. F. 
Published: March 2020

9070 Background: Cytokines have been associated with fatigue and cognitive dysfunction. Here we evaluated plasma cytokine levels in pts with colorectal cancer (CRC) and breast cancer (BC) who were free of evident disease, and in healthy volunteers. Methods: Serum levels of 10 cytokines were measured using a LiquiChip assay on 251 subjects. CRC pts (n=136, ages 23–75) were evaluated at baseline (mean 8 weeks post-surgery [n=107] or before surgery [n=29]), with repeat measures at 6 months (56 post chemotherapy [CT], 14 without CT) and 12 months (32 post CT, 7 without CT). BC pts (n=51, ages 29–60) were within 5 years of diagnosis (33 after adjuvant CT). Healthy volunteers (n=64) had ages 20–62. Cancer pts completed questionnaires for fatigue & QOL (FACT-F), anxiety/depression (GHQ), and perceived cognitive function (FACT-COG); they had neuropsychological assessment. Results: Cytokines were elevated in all cancer groups compared to healthy controls (p-values <0.001; selected data in table ). Values were highest after surgery but remained significantly higher than healthy controls at 6–60 months after diagnosis, with a trend to being higher in cancer patients who had not received CT. There was a trend to elevated cytokines being associated with greater fatigue and cognitive impairment in both CRC and BC, but no association with QOL or anxiety & depression. Conclusions: Cytokine levels were elevated in all cancer groups compared to healthy volunteers and remained elevated up to 5 years post diagnosis; they may be associated with cognitive dysfunction and fatigue. [Table: see text] No significant financial relationships to disclose.
Methylnaltrexone treatment of opioid-induced constipation in cancer patients
Authors: Karver S. B. , Slatkin N. E. , Thomas J. , Israel R. J. 
Published: March 2020

9081 Background: Constipation is a common and distressing side effect of opioid treatment particularly in patients with cancer. Two phase 3 trials (Studies 301 and 302) reported that subcutaneous (SC) methylnaltrexone was well tolerated and effective in inducing laxation in patients with advanced illness with opioid-induced constipation (OIC) while maintaining central analgesia. Aims: To evaluate improvement in constipation in cancer patients treated with methylnaltrexone in the above studies. Methods: In Study 301, 124 cancer patients received a single dose of methylnaltrexone (SC 0.15mg/kg, 0.30mg/kg) or placebo. In Study 302, 78 cancer patients received either 0.15mg/kg SC QOD methylnaltrexone for 2 weeks (total of 7 doses) or placebo. Patients had a life expectancy of 1–6 months, no laxation within 48 hours, and were maintained on stable opioids and baseline laxatives. The primary efficacy endpoints were laxation within 4 hours after a single or first dose of study drug and laxation within 4 hours for at least 2 of the first 4 doses (Study 302). The secondary endpoints were laxation within 24 hours, pain scores, and opioid withdrawal symptoms. Results: A majority of the methylnaltrexone-treated cancer patients had a laxation within the first 4 hours of study drug administration ( Table ). There were no clinically significant changes in pain scores or opioid withdrawal symptoms. Conclusions: Our results demonstrate that in cancer patients with advanced illness and OIC, methylnaltrexone significantly improved constipation, without loss of pain control or opioid withdrawal. [Table: see text] No significant financial relationships to disclose.
Cetuximab-related hypersensitivity reactions associated with pre-existing cetuximab-specific IgE antibody
Authors: Chung C. H. , Chan E. , Berlin J. , Gilbert J. , Yarbrough W. , Satinover S. , Murphy B. , Slebos R. J. , Hatley T. , Platts- Mills T. 
Published: March 2020

9097 Background: Cetuximab is a chimeric (mouse/human) IgG1 monoclonal antibody against the epidermal growth factor receptor and is approved for use in patients (pts) with colorectal cancer and head and neck squamous cell carcinoma. Hypersensitivity reactions caused by cetuximab (C-HSR) have been reported; however, the mechanism underlying these reactions is unknown. We hypothesize that C-HSR are mediated by pre-existing cetuximab-specific IgE antibodies (C-IgE). Methods: A total of 140 serum samples were obtained under IRB approved protocols and retrospectively analyzed across 2 cohorts: 1) 71 pretreatment sera from cetuximab-treated pts collected from multiple centers (47 pts with no HSR and 24 pts with any grade HSR; samples were biased for HSR pts), and 2) 69 sera from healthy volunteers in the Nashville TN area. The samples were analyzed for total-, cetuximab-specific and mouse-specific IgE levels using a modified ImmunoCAP assay (Phadia US Inc.). Severe HSR was defined as grade 3/4 reactions during the first infusion by NCI CTC version 3.0 Allergic reaction/hypersensitivity criteria by a reviewer blinded to the immunoCAP assay results. Results: Of the 71 cetuximab-treated pts from cohort 1, 21 experienced severe HSR by retrospective evaluation. All C-IgE(+) pts (15/15) experienced severe HSR and were immediately discontinued from therapy. Of the remaining 6 severe HSR pts with C-IgE(-), 4 pts were re-challenged and completed their cetuximab infusion without any further reaction, suggestive of a non-IgE mediated mechanism, while 2 pts were not re-challenged. Also, the C- IgE(+) pts tended to have higher levels of total IgE compared to the C-IgE(-) pts. All 47 non-HSR pts were C-IgE(-). Mouse-specific IgE was not detected in any sera from the pts. Analysis of sera from healthy volunteers from the cohort 2 revealed that 15/69 (21.7%) were C-IgE(+), suggestive of pre-existing C-IgE; however, the association with C-HSR could not be made. Conclusion: Our data suggest that C-IgE antibodies are present prior to treatment and appears highly predictive of severe HSR during the first infusion; however, IgE-mediated reactions may not account for all cases of HSR. Prospective validation of the association between C-IgE and cetuximab-induced HSR is warranted. [Table: see text]
Cognitive function and fatigue in cancer patients after chemotherapy: A longitudinal cohort study in patients with colorectal cancer (CRC)
Authors: Vardy J. L. , Rourke S. , Pond G. R. , Galica J. , Park A. , Dhillon H. , Clarke S. J. , Tannock I. F. 
Published: March 2020

9099 Background: There is growing evidence that fatigue and cognitive dysfunction can affect cancer survivors. Here we evaluated these symptoms in patients with CRC in a longitudinal prospective study. Methods: Patients with localized CRC were evaluated for cognitive function and fatigue at baseline (mean 8 weeks post-surgery or before neoadjuvant therapy), 6 & 12 months. Group A (Stage III/high risk II) received chemotherapy (CT) and group B (Stage I/II) received no CT. Pts had neuropsychological (NP) assessment with traditional tests and CANTAB, a computerized NP battery. They completed concurrent questionnaires for fatigue & QOL (FACT-F), anxiety/depression (GHQ), and perception of cognitive function (FACT-COG). Blood tests evaluated cytokine levels, blood clotting factors, sex hormones and apolipoprotein genotyping as potential causal factors. Primary endpoints were cognitive function (traditional NP tests) and fatigue. Associations between test results, demographic and disease-related factors were sought. Results: Baseline data are available for 182 pts: 127 group A, and 55 group B, with follow-up at 6 and 12 months for 71 and 39 pts. Mean age was 57 years and 62% were male. At baseline (pre CT): 30% had cognitive impairment on traditional NP tests & 20% on CANTAB; 25% reported moderate fatigue and 10% extreme fatigue. At 6 months there was no significant difference on objective NP testing between the groups or in perceived cognitive impairment (median FACT- COG 82 vs 88, p=0.34). CT pts had more fatigue (median FACT-F 75 vs 91, p<0.001). At 12 months CT pts tend to have more cognitive impairment on traditional NP tests (26% vs 0%, p=.09), more perceived cognitive impairment (13.5% vs 0%, p=.57) & greater fatigue (16% vs 0%). Cytokine levels were elevated in all groups at all time points compared to healthy volunteers. There was a trend to higher cytokine levels with greater fatigue and worse cognitive impairment. Fatigue, QOL and anxiety and depression were highly correlated. Conclusions: Cognitive impairment is present in some pts prior to CT and there is a trend for CT pts to have worse cognitive impairment at 12 but not at 6 months. Fatigue is associated with CT. Cytokine levels remained elevated in all groups compared to healthy volunteers. No significant financial relationships to disclose.
Mitigating functional performance decrement in cancer patients undergoing treatment
Authors: Anton P. M. , Dennehy C. A. 
Published: March 2020

9105 Background: It is well-documented that treatment side-effects cause physical and psychosocial de-conditioning in cancer patient. Decrease in functional performance (FP), as measured by activities of daily living (ADL), is a major contributor to a decline in patient quality of life (QOL). Relatively little information is available on the effects of a specific exercise regimen targeting muscle groups/energy systems involved in FP. Methods: 30 male and female cancer patients receiving treatment were randomly assigned to either the experimental (EX) or control (C) groups. EX participated in two exercise sessions per week for 17 weeks. Sessions included a combination of aerobic, resistance, flexibility, and balance training. C did not participate in any structured exercise. Data were collected post-diagnosis (1), post- surgery (2), at 9 weeks post-diagnosis (3), and at 17 weeks post-diagnosis (4). Measurements included resting heart rate (RHR), fatigue, physical activity level (PA), QOL, and the FP tasks of: treadmill walking (TRED), stair climb/descent (STAIR), lifting/carrying (CARRY), sit to stand (STAND), and balance (REACH). Results: Factor analysis yielded four variables: FP1 = [(0.5 × TRED) - (0.5 × RHR)]; FP2 = [(STAIR) + (CARRY) + (STAND)]/3]; FP3 = [(0.333 × QOL) + (0.333 × PA) - (0.333 × FT)]; FP4 = REACH. Repeated-measures ANOVA with within-subjects contrasts detected significant differences between groups. No significant differences existed at 1 or from 1 to 2. Significant differences were found on all variables from 1 to 4, 1 to 3 and 3 to 4 (p < 0.001) (significant improvement for experimental group vs. significant decline for control group). Mean changes for the experimental vs. control groups from 1 to 4 are as follows: FP1 (+65.5 vs. -29.5); FP2 (-5.3 vs. +3.6); FP3 (+1.8 vs. -3.4); FP4 (+1.7 vs. -0.81). Conclusions: Specifically-designed exercise interventions promote positive adaptations that elicit significant improvement in ADL, QOL, and decrease fatigue. Prescriptive exercise is a viable therapy during treatment for mitigating side effects and avoiding de-conditioning. No significant financial relationships to disclose.
Effects of intravenous (IV) iron supplementation on responses to every-3-week (Q3W) darbepoetin alfa (DA) by baseline hemoglobin in patients (pts) with chemotherapy-induced anemia (CIA)
Authors: Pinter T. , Mossman T. , Suto T. , Vansteenkiste J. 
Published: March 2020

9106 Background: Pts with CIA receiving erythropoiesis-stimulating agents (ESAs) may benefit from IV iron supplementation. This randomized, multicenter, open-label, 16-week, phase IIIb study evaluated the safety and efficacy of darbepoetin alfa in pts with CIA who also received IV iron versus oral iron/no iron. This exploratory analysis presents the clinical outcomes by subgroups based on baseline (BL) hemoglobin (Hb). Methods: Eligible pts were of legal age, had a non-myeloid malignancy, and had CIA (BL Hb < 11g/dL). All pts received DA 500 mcg administered Q3W using the Aranesp (darbepoetin alfa) prefilled SureClick autoinjector. Patients were randomly allocated 1:1 to receive either DA plus 200 mg IV iron (200 mg Q3W with DA Q3W or two 100 mg doses within 3 weeks) or DA plus oral iron/no iron. Randomization was stratified by tumor type and BL Hb category (< 10 or = 10 g/dL). The primary endpoint was the percentage of pts achieving a hematopoietic response (Hb = 12 g/dL or an increase = 2 g/dL). Results: A total of 396 pts were randomized and received = 1 dose of DA (IV iron arm = 200; oral iron/no iron arm = 196). Mean (SD) age was 61.0 (11.5) years; 61% (n = 240) were women; 28% (n = 111) had lung or gynecological tumors; and 45% (n = 178) had BL Hb < 10 g/dL. Pt demographics were similar between arms. Clinical outcomes are shown in the table by BL Hb. Conclusions: DA 500 mcg Q3W with IV iron supplementation appeared to improve clinical outcomes in this study, especially in pts with BL Hb < 10 g/dL; more pts achieved a hematopoietic response, fewer received transfusions, and more achieved the target Hb (= 11 g/dL) compared with those receiving oral iron/no iron. Also, in both treatment arms, pts with BL Hb = 10 g/dL demonstrated better clinical outcomes than pts with BL Hb < 10 g/dL. Benefits associated with initiating ESA treatment on time, ie before pts Hb falls < 10 g/dL, have been suggested previously (Lyman and Glaspy, Cancer 2006). [Table: see text] No significant financial relationships to disclose.