bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of patient characteristics on compliance to adjuvant chemotherapy in hormone receptor negative breast cancer: A single institution experience.
Authors: Ahmed Alaa Abdelhalim , Ngamphaiboon Nuttapong , Kossoff Ellen , Meagher Alison , Attwood Kristopher , Edge Stephen B. , Ademuyiwa Foluso Olabisi 
Published: March 2020

e19568 Background: Adherence to adjuvant chemotherapy (ACT) has been implicated in poor outcomes in early breast cancer (BC). We investigated factors that may contribute to non-compliance (NC) in hormone receptor (HR) negative BC. Methods: 310 HR- patients (pts) who received adjuvant chemotherapy (ACT) at Roswell Park Cancer Institute (RPCI) between 2002 and 2008 were eligible for this retrospective analysis. Patients were categorized as Compliant or Non Compliant (NC). Compliance was subdivided into adequate Tx (AT) and inadequate Tx due to Toxicity (ITT). NC was discontinuation or delays in ACT for reasons other than toxicities. The 3 groups were compared based on baseline characteristics, treatment-related toxicities, and survival. Fisher’s exact, logistic regression, Cox regression, and log-rank tests were used to analyze the data. A significant p value was assigned at ≤ 0.05. Results: 192 pts were included, with a median age of 55 (range 27-86), and median follow up of 4.9 yrs. NC was observed in 19 (10%) pts, ITT in 47 (24%), and AT in 126 (66%). ITT and NC pts were more likely to have a higher Charlson co-morbidity index (CCI) (p=.019), ECOG performance status (p=.048), more hospital stays (p=<.001) and more heme/non-heme toxicities (p=<.001). Comparing NC/ITT/AT groups; 63/94/100 % completed ≥ half of planned Tx (p=<.001), 22/41/5 % had hematologic toxicity (p=<.001). The groups did not differ by trastuzumab use. There were no statistically significant differences in OS and DFS among the 3 groups. Conclusions: Predictors of non-compliance among HR- breast cancer patients receiving ACT include co-morbidities, and performance status. Clinicians should be aware that this group of pts are likely to have problems completing adjuvant chemotherapy and should be proactive about managing toxicities.
Pain severity and impairment of activity between pegfilgrastim (P) and fixed-dose filgrastim (F) in women with early-stage breast cancer receiving chemotherapy.
Authors: Leung Mova , Eustaquio Joy , Kano Jessica , Marr Tiffany , Higgins Brian Patrick , Myers Robert Edward , Kim Jenny , Jones Glenn 
Published: March 2020

e19570 Background: In comparative trials of P and F, bone and joint pain are evident and with similar incidences. Also, muscle pain is clinically noted. Pain severity may differ between P and F, especially when a short fixed-dose regimen of F is used. Methods: This is a prospective observational and ethics-approved study. It compares the incidence & severity of muscle and/or joint pain (MJP) in patients (pts) receiving P (6mg SC for 1 day) or fixed-dose F (300mcg SC for 7-8 days) initiated 24 hours after chemotherapy. Eligible were women with breast cancer receiving neo- or adjuvant chemotherapy, and P or F. Choice of P or F were at the oncologist’s discretion based on patient preference & insurance coverage. Pts were ineligible if they could not complete the pain diary, or had received P or F in the past 6 months. Efficacy of P and F was evaluated by comparing febrile neutropenia (FN) and neutropenia (N) requiring delay of the second cycle of chemotherapy. Patient & treatment characteristics were captured to assess for risk factors for developing MJP. A pain diary assessed MJP severity, its management and impact on everyday activities. It was completed starting the evening of chemotherapy for 14 consecutive days. Statistical analysis was performed with Stata 12, including multi-level longitudinal mixed models for MJP scores. Results: 140 pts were enrolled with mean age 52 yr and 58% receiving docetaxel-based chemotherapy. One-third received F and two-thirds received P. Both diary muscle and joint pain peaked in prevalence and severity on days 3 to 6. Over 50% of pts reported MJP at the peak. Pain that increased ≥3 points from baseline was reported by 48% of pts. Daily activities were affected in 48% of 1,960 reporting-days, with 26% reporting moderate or severe impairment. Despite similar incidences of pain, P was associated with lower mean muscle (p=0.0049) and joint (p=0.014) pain scores by regression analyses. FN and N were not different. Use of docetaxel was the sole baseline risk factor for developing MJP. Conclusions: Patients experience substantial MJP with impairment of daily activities but pts receiving pegfilgrastim experience less pain and less burden relating to pain.
Prevalence and impact of hypogonadism in cancer patients with severe muscle wasting in phase IIb enobosarm trial.
Authors: Steiner Mitchell S. , Dobs Adrian , Johnston Mary Ann , Hancock Michael L. , Morton Ronald A. , Dodson Shontelle 
Published: March 2020

e19582 Background: Hypogonadism has been associated with weight loss and poor outcomes in cancer patients. Up to 50% of males with advanced cancer are hypogonadal at presentation or during the course of treatment. Wasting in cancer patients has also been associated with a decline in physical function and performance status and has major public health significance. We conducted a Phase IIb randomized, double blind, placebo controlled, multi-center study to evaluate the effect of enobosarm on muscle wasting and physical function in cancer patients. Methods: Patients (n=159) were randomized to oral enobosarm (1 or 3 mg) or placebo daily for 16 wks. Patients were males >45 y and postmenopausal females, had ≥2% weight loss in the 6 mths prior to randomization, BMI <35 and either NSCLC, colorectal cancer, non-Hodgkins lymphoma, chronic lymphocytic leukemia or breast cancer. We report on the incidence and impact of hypogonadism (T<300 ng/dL) in this population. Results: Baseline testosterone levels were available for 93 of 103 men. 60% of male patients were hypogonadal at randomization. Distribution of hypogonadism was similar across cancers; however hypogonadal men were less likely to complete the study. Baseline T levels were positively correlated with weight loss (r=0.32, p=0.002,) with hypogonadal men demonstrating greater weight loss in the previous six months (median, -9.5%). Baseline physical function as measured by stair climb power was higher among eugonadal males compared to hypogonadal males (84.5 watts vs 70.6 watts; p=0.016). Enobosarm significantly improved physical function in this population regardless of baseline gonadal status (hypogonadal: 18.7%, p=0.0061; eugonadal: 13.2%, p=0.0032). The magnitude of improvement was greater in hypogonadal men. Conclusions: Hypogonadism is common in male cancer patients and is correlated with weight loss and diminished physical function. In this randomized, placebo controlled trial, enobosarm improved physical function in both hypogonadal and eugonadal men despite poorer baseline physical function in hypogonadal patients. These data provide evidence that enobosarm may play an important role in the management of cancer related muscle wasting.
Efficacy and safety of lipegfilgrastim compared with pegfilgrastim in patients with breast cancer who are receiving chemotherapy.
Authors: Bondarenko Igor , Gladkov Oleg , Elaesser Reiner , Buchner Anton , Bias Peter 
Published: March 2020

e19587 Background: Cancer chemotherapy frequently causes neutropenia, leading to an increased risk of infections and delays in subsequent chemotherapy treatments. Pegfilgrastim is a pegylated recombinant form of granulocyte colony stimulating factor (G-CSF) that extends the half-life and requires less frequent dosing than nonpegylated G-CSF. Lipegfilgrastim is a glycosylated and pegylated G-CSF. The objective of this study was to compare the efficacy and safety of lipegfilgrastim and pegfilgrastim in chemotherapy-naïve patients with breast cancer who are candidates to receive docetaxel/doxorubicin. Methods: In this double-blind, randomized, active-controlled, noninferiority trial, patients with high-risk stage II, III, or IV breast cancer and an absolute neutrophil count ≥1.5x109 cells/L were randomly assigned to lipegfilgrastim 6 mg (n=101) or pegfilgrastim 6 mg (n=101). Study medication was injected subcutaneously on day 2 of the chemotherapy cycle (4 cycles maximum). Primary efficacy endpoint was the duration of severe neutropenia (days with an absolute neutropenia count <0.5x109 cells/L) during cycle 1. Secondary endpoints included the incidence of febrile neutropenia. Efficacy analysis population included patients who were randomized but did not have major protocol violations. Results: Overall, 37%, 46%, and 17% of patients had stage II, III, and IV breast cancer, respectively. The mean duration of severe neutropenia in cycle 1 was 0.7 days in the lipegfilgrastim group and 0.8 days in the pegfilgrastim group (poisson regression least squares mean [95% CI] -0.218 [-0.498 to 0.062]). 56% and 49%, respectively, did not experience severe neutropenia in cycle 1. Three patients experienced febrile neutropenia; all were in the pegfilgrastim group during cycle 1. 28% of patients in the lipegfilgrastim group and 26% in the pegfilgrastim group had adverse events that the investigator considered to be related to study medication. Three and 7 patients, respectively had serious adverse events. Conclusions: The results of this study confirm that the efficacy of lipegfilgrastim is comparable with pegfilgrastim. No unexpected safety events were observed.
Risk factors for complicated grief (CG) and utilization of a hospice bereavement program.
Authors: Henry Elizabeth , Guo Rong , Ansari Aziz , Kristopaitis Theresa , Speyer Mark , Kiel Nancy , Bleeg Mary Lou , DeLongis Susan , Kareb Jacalyn , Shanahan Marie , Taylor Sally , Rundle Twana , Lo Shelly S. 
Published: March 2020

e19588 Background: The Medicare hospice benefit mandates that bereavement services be provided to a surviving caregiver for a period of one year following a patient’s (pt) death. Identifying caregivers at risk for CG is essential so that appropriate interventions can be provided. Methods: Our objective was to identify specific features predicting for CG in surviving caregivers of pts with a malignancy enrolled in an academic based hospice program and determine utilization of Medicare’s bereavement services. Hospice charts for 65 patients whose caregivers were consecutively discharged from bereavement follow-up between January 2009 and December 2011 were reviewed. Assessments for CG features were performed with use of chaplain and social worker visits, and phone calls from a trained bereavement volunteer to caregivers at 6-8 wks and 6 months after a pt’s death. A discharge assessment was completed at 13 months. Results: Fifty (77%) hospice pts had a cancer (ca) diagnosis and tended to have a shorter average length of hospice enrollment than non-ca pts (34 vs 60 days, p=0.11). There was no difference in risk of caregiver CG between ca vs non-ca diagnoses (p=0.12). Twenty-one (42%) of ca pt caregivers were identified at risk for CG. Ca pts ≤ 50 yrs at the time of hospice enrollment were more likely to have caregivers identified at risk for CG compared to those ≥ 50 yrs (3, 100% vs 18, 38%, p=0.07). At risk ca caregivers had a lower average pt age at time of hospice enrollment than lower risk caregivers (mean pt age 67 vs 76 yrs, p=0.03). Eight ca caregivers (38%) identified at risk for CG received intensive bereavement counseling; 13 (62%) subsequently received routine bereavement follow up; none were lost to follow up. Length of enrollment, caregiver employment status and caregiver relationship did not predict for risk of CG. No ca caregivers required intensive bereavement services beyond 12 months post pt death. Conclusions: Young patient age at time of hospice enrollment is associated with an increased risk of caregiver CG.Intensive bereavement counseling was required by 38% of ca caregivers, and none required >1 yr of service. Further study needs to be done to see if caregivers are receiving adequate bereavement support through the hospice benefit.
Association between prayer activity, inflammation, and survival in advanced cancer patients (ACPs): A preliminary study.
Authors: Paiva Carlos Eduardo , Paiva Bianca Sakamoto Ribeiro , Souza Crovador Camila , Yennurajalingam Sriram , Hui David 
Published: March 2020

e19602 Background: Prayers represent an important coping strategy among ACPs. The Religion Practice Questionnaire (RPQ) is a self-reported measure of religiosity validated in the Brazilian population, and includes a question assessing prayer activity. In this cross sectional prospective study, we determined the association among prayer activity, inflammation and survival in ACPs. Methods: Consecutive ACPs presenting for initial consultation at our Palliative Care Outpatient Clinic between March and December 2011 were enrolled. RPQ was administered by a research nurse, and consists of 15 items rated on a 5-point Likertscale (0=none, 5=very much). High prayer score (HPS) was defined as >3/5 for question 11 ("I make personal prayers – spontaneous communications with God"). Inflammatory markers included white blood cell (WBC), albumin and C-reactive protein (CRP). Correlation analysis was performed using Spearman test. Survival was calculated from study enrolment until death, and analyzed with log rank test and Cox regression model including age, sex, KPS, treatment type and HPS. Results: 112 patients were enrolled: average age 59 y (range 21-85), female 53% (N=59), Karnofsky performance status (KPS) ≤70 46% (N=51), most common cancers breast and upper GI (N=41, 37%), no longer on active cancer treatments 48% (N=54). All patients were Christians, and 77 (69%) had HPS. RPQ was not associated with WBC, albumin, CRP nor survival. HPS correlated with WBC (r=-0.24, p=0.02), and CRP (r=-0.26, p=0.01) but not albumin (r=0.18, p=0.08). Patients with HPS survived longer (median 198 d vs. 121 d, p=0.040), which remained significant in multivariate analysis (Table). Conclusions: The act of praying was associated with decreased inflammation and improved survival in ACPs. Further studies are necessary to confirm these findings. [Table: see text]
Targeted agent (TA) use at the end of life (EOL).
Authors: Karuturi Meghan Sri , Tanco Kimberson , Kwon Jung Hye , Zhang Tao , Rhondali Wadih , Kang Jung Hun , Chisholm Gary B. , Bruera Eduardo , Hui David 
Published: March 2020

e19603 Background: Chemotherapy in the last days of life has questionable benefit and has been proposed as an indicator of poor quality of EOL care. The use of TAs at the EOL has not been examined. We determined the proportion and predictors of TA use in the last 30 days of life. Methods: All adult patients in the Houston area who died of advanced cancer between 9/1/2009 and 2/28/2010 while under the care of our institution were included. We collected baseline demographics and data on chemotherapy and TAs. Multivariate logistic regression was used to identify predictors of targeted therapy use. Results: 912 patients were included: average age 63 (range 21-98), female 49%, Caucasian 63%. Within the last 30 and 14 days of life, 117 (13%) and 56 (6%) patients received TAs, respectively, while 148 (16%) and 65 (7%) received chemotherapy. The interval between last TA use and death was 49 (21-106) days. Regimens given in the last 30 days of life included a median of 2 (1-2) chemotherapeutic/targeted agents, and the most common TAs were erlotinib (N=22), bevacizumab (N=19), rituximab (N=9), gemtuzumab (N=9) and temsirolimus (N=8). 43/117 (37%) patients who received TAs within the last 30 days of life had concurrent chemotherapy. In multivariate analysis, younger age and hematologic malignancies were associated with increased TA use (Table). Conclusions: TAs were used as often as chemotherapy at the EOL, particularly among younger patients and those with hematologic malignancies. Use of TAs in the last 30 days of life may have implications for quality of EOL care. [Table: see text]
Etiologic agents in 54 consecutive febrile neutropenia (FN) isolates in a general hospital in Medellín, Colombia.
Authors: Betancur Carlos Alberto , Lema Mauricio , Arcila Giovanna 
Published: March 2020

e19604 Background: The etiology of FN is well established in the US and the EU. Less is known about it in Colombia. This cohort attempts to fill this void. Methods: We collected prospectively the information on all FN cases with an established etiology that were admitted to the Clínica SOMA (A 160 bed-facility in Medellín, Colombia) from September 2010 to October 2011. FN was defined as the coexistence of an absolute neutrophile count (ANC) <500 and a temperature >38.3 degrees Celsius following cytotoxic chemotherapy for cancer. Results: Fifty four cases of FN with known etiology were found. Twenty four in males and 30 in females. Age range from 16 to 73 years-old (median: 42). Acute lymphoblastic leukemia was the underlying diagnosis in 16 (30%), acute myelogenous leukemia in 13 (24% ), and non-Hodgkin’s lymphoma in 11 (20%). HyperCVAD (with o without rituximab), IdaFlag, bortezomib and HiDAC account for 17 (31%), 12 (22%), 7 (13%), and 5 (9%) cases, respectively. FN occurred 2 to 32 days after chemotherapy (average of 10 days). In 20 (37%) cases ANC on admission was 0, and the average ANC on admission was 120. In 51 cases germs were isolated in the blood (94%). Gram-negative bacilli were isolated in 38 cases (76%), S. aureus in 4 (7%), Candidemia was established in 4 patients (2 with C. krusei and 2 with C. parapsilosis). Pulmonary aspergillosis was established in one case. Of note, two cases of hospital-acquired Legionella pneumophila were found (Table). All patients recovered to non-neutropenic ANC with resolution of the infections. No deaths due to FN occurred in this group of patients. Conclusions: In this cohort from Colombia we found a large predominance of gram-negative bacilli and the isolation of L. Pneumophilla, an unusual pathogen in FN. This pattern differs from the usual germ mix reported in other series. [Table: see text]
Khorana risk score: Is the body mass index a predictable factor for thromboembolism in European countries? A retrospective analysis.
Authors: Barni Sandro , Labianca Roberto , Verso Melina , Gasparini Giampietro , Bonizzoni Erminio , Mandala Mario , Brighenti Matteo , Petrelli Fausto , Bianchini Carlo , Perrone Tania , Agnelli Giancarlo 
Published: March 2020

e19612 Background: Five variables (site of cancer, platelet count, haemoglobin level, leukocyte count, and body mass index-BMI) define the Khorana risk score (KS), predicting the high (≥ 3), the moderate (1-2) and the low (0) risk of thromboembolic events (TEs) in cancer outpatients. Nadroparin has been demonstrated to reduce the incidence of TEs by about 50% in cancer outpatients receiving chemotherapy (PROTECHT study) and patients receiving chemotherapy including gemcitabine, platinum analogues or their combination are at higher risk of TEs. Methods: 378 patients enrolled in the PROTECHT study didn’t receive thromboprophylaxis (placebo group) and were evaluable for the KS. The aim of this retrospective analysis was to assess the distribution of the five KS variables and if the replacing of BMI variable, in the KS, with a chemotherapy variable (administration of platinum compound or gemcitabine added 1point and their association 2points) in a PROTECHT score (PrS) could better predict high risk patients. A receiver operating characteristic (ROC) curve has been used to assess the accuracy of both scores. Results: Among patients the five KS variables were distributed as follow: 15% of stomach/pancreas cancer (2points), 33% with lung/gynecologic cancer (1point), 24% with platelet count of ≥350x10^9/L, 7.9% hemoglobin <10g/dL , 14.3% leukocyte count >11x10^9/L (1point each variable) and only 1.3% with BMI ≥ 35 (1point). 15 TEs occurred in the 378 pts, below the TEs distribution according to KS and PrS (see table). The area under the ROC curve was larger with PrS in comparison with KS (0.70 and 0.65 respectively). Conclusions: BMI ≥ 35 seems not to be a predictable factor for TEs in European cancer patients and the use of a chemotherapy variable could be more useful to identify patient at high risk of TE. A formal study is needed to evaluate which score could have a higher predictability to identify high risk patients for TEs. [Table: see text]
Predictive modeling of adverse events in chemotherapy.
Authors: Maguire Roma , van Berkel Cees , Cowie Julie , Blake Robert L. , Kearney Nora 
Published: March 2020

e19617 Background: Patients with cancer receiving chemotherapy are at risk of developing severe or life threatening adverse events (AEs). The aim of this study was to develop and test a risk model for six common toxicities based on a detailed analysis of daily self-reported symptoms. The retrospective study was performed on a data set of 33 breast cancer patients who self reported symptoms over multiple therapy cycles. The monitored symptoms were diarrhoea, hand-foot syndrome, mucositis, nausea, vomiting and fatigue. Methods: The data analysis focused on four toxicity aspects: the occurrence patterns, the severity distributions, the duration and the interrelationship between symptoms. The clustering of symptoms was a key aspect of the modeling. The data analysis was supported and augmented with knowledge from an expert group of clinicians and an advisory group of patients. The final model is a Bayesian network in which the probability of toxicity on a given day, depends on the probability of that toxicity on a previous day and on the probability of others with which it is linked. Personalized predictions are made by feeding patient self reported observations from a particular patient into the model. Results: The different toxicities show quite marked and varied time (day to day) behaviors and there are strong and significant interrelations between fatigue / nausea, vomiting / nausea and fatigue / vomiting. The model provides effective prediction of toxicity over the entire set of symptoms. The Area Under the Curve (AUC) values for personalized prediction over different forecasting periods ranged from one day ahead (AUC=0.89) to 7 days ahead (AUC=0.82). Non personalized prediction gives an AUC of 0.78 for all time periods. Conclusions: Personalized prediction based on real-time self-reported symptoms is effective on timescales up to one week. These predictions may be useful for patient care. If communicated appropriately to patients, they can be used to target information sharing on side effects, support self-care and plan activities of daily living in advance. For clinicians the information can be useful to identify patients who are at greater risk of developing certain AEs, facilitating more efficacious, timely and cost-effective interventions.