bluuebunny/crossref_metadata_2025_split huggingface dataset:
Economic impact of hyponatremia in hospitalized patients with cancer
Authors: Callahan M. A. , Do H. T. , Caplan D. W. , Yoon-Flannery K. , Seifeldin R. 
Published: March 2020

17053 Background: Hyponatremia, defined as a serum sodium concentration ([Na+]) =134 mEq/L, is a common electrolyte abnormality in hospitalized cancer patients that may be caused by the primary tumor or metastasis, diagnostic or therapeutic interventions, or a secondary complication. Hospital-acquired hyponatremia is associated with higher costs of care, but many patients present with hyponatremia at admission. Methods: This retrospective case-controlled study assessed the outcomes and cost of care among patients hospitalized for neoplasm who presented with hyponatremia at admission. Laboratory and cost-accounting data from 841 adult patients admitted to an 811-bed university hospital between January 2004 and May 2005 with a principal diagnosis of neoplasm and either mild-to- moderate or moderate-to-severe hyponatremia (serum [Na+] 130–134 mEq/L or <130 mEq/L, respectively) were compared with data from control subjects with matching ICD-9 codes and normal serum [Na+] (135–145 mEq/L) at admission during the same period. Endpoints included hospital length of stay (LOS), ICU admissions, in-hospital mortality, and total costs per admission. Results: Hyponatremia was evident in 18.9% of patients admitted for neoplasm. Patients with moderate-to-severe hyponatremia (n=192) and mild-to- moderate hyponatremia (n=649) demonstrated a significantly longer hospital LOS, higher ICU admission rate, higher in-hospital mortality, and higher median costs than control subjects (n=3610) (Table). These differences among groups remained significant after adjustments were made for age, race, sex, and comorbidity score. Conclusions: Cancer patients presenting with hyponatremia at admission have a longer hospital LOS and higher risk of death and cost of care than do cancer patients presenting without hyponatremia. [Table: see text] No significant financial relationships to disclose.
Symptom burden and survival outcome: 3 cycles versus 6 cycles of chemotherapy in advanced NSCLC
Authors: Wang X. S. , Lu C. , Shi Q. , Fariclough D. , Mobley G. , Palos L. , Mendoza T. , Cleeland C. 
Published: March 2020

17054 Background: Improving survival and quality of life is the primary treatment goal for patient with advanced NSCLC receiving palliative chemotherapy. The optimal treatment duration remains to be determined, and there are few studies that examine longitudinal symptom burden in this population. Methods: We prospectively collected self-reported symptom data from advanced stage NSCLC patients receiving chemotherapy. Symptom data was collected weekly utilizing the MD Anderson Symptom Inventory (15 symptoms) pre chemotherapy until therapy discontinuation or up to 26 weeks. Principal components analysis of symptoms measures with a Varimax rotation were used to identify symptom clusters. A piecewise linear mixed-effect regression model was used to estimate the changes over time in symptom severity, and Cox modeling was used for data analysis. Results: Data from 102 subjects were available for analysis. Chemotherapy was primarily discontinued because of tumor progression or a decline in the patient's functional status. Seventy patients received only 2 cycles of chemotherapy, while 46 and 29 patients received 4 and 6 cycles of chemotherapy, respectively. Four clusters of symptoms were identified prior to therapy, including: general symptoms (such as pain, fatigue, sleeping disturbance), GI distress (nausea, vomiting, lack of appetite & constipation), affective symptoms (sadness & distress) and specific disease related symptoms (coughing & shortness of breath). In patients who received = 3 cycles of chemotherapy, a rapid increased in symptom severity was observed, compared to those who received > 3 cycles (P<.05). Patients who received =3 cycles of chemotherapy demonstrated shorter survival compared to those who received > 3 of chemotherapy (HR=9.9, CI=4–22.7, P<.001). Conclusion: Patients with advanced NSCLC who received more than 3 cycles of chemotherapy demonstrated more stable symptom burden and longer survival compared to those who received = 3 cycles of chemotherapy. No significant financial relationships to disclose.
Regional models of care for systemic therapy: Standards for organization and delivery
Authors: Vandenberg T. , Smith A. , McLennan C. , Wilcock L. , Nayler J. , Coakley N. , DeGrasse C. , Green E. , Sawka C. , Trudeau M. E. 
Published: March 2020

17057 Background: Rapidly expanding indications for cancer systemic therapy combined with human resource and facility constraints require innovative approaches to deliver safe, patient-centred, and evidence-based care across Ontario, a province covering 1 million sq km, organized into 14 regions, each with about 1 million inhabitants. A systemic therapy project team recommended the best way to organize the delivery of ambulatory systemic therapy in Ontario. Methods: A core multidisciplinary panel reviewed the evidence and developed standards. The panel used evidence-based analysis of relevant publications, an environmental scan of other existing recommendations and expert opinion based on experience and consensus to formulate a standards document to guide treatment delivery. This was reviewed and amended by the full project team. The document was circulated to oncologists, family practitioners, internists, pharmacists, nurses and administrators who work in or have responsibility for systemic therapy in the regions for practitioner feedback. Results: A Regional Systemic Therapy Program (STP) Model was developed in which Integrated Cancer programs (ICPs) provide comprehensive cancer services, leadership of quality and overall organisation/coordination for the region. STPs include ICPs directly linked to satellite centres and also affiliated to centres with their own systemic therapy programs to provide appropriate systemic therapy services for all regions under a common set of standards. Five levels of care are recommended, with complexity and availability of services differentiating the levels. For each level, standards were established for; 1-Providers and their roles, 2-Education for providers, 3-Service type and complexity, 4-Service volumes, 5- Quality assurance and safety, 6-Facility requirements, 7-Administrative and organizational responsibilities. The intent is to provide the same standard of care in the most appropriate setting within the appropriate time frame. STPs will implement, monitor and evaluate quality indicators. Conclusions: A detailed review of the document including results of practitioner feedback as well as survey results from the 14 STPs to determine whether standards are being currently met will be presented. No significant financial relationships to disclose.
Hematologic outcomes and drug cost considerations of erythropoiesis stimulating agents (ESTs) in cancer patients (pts) with fixed dosing regimens: Results from practice patterns in a prospective observational study
Authors: Larholt K. , Chen E. , Peake C. , Bookhart B. , Piech C. Tak , McKenzie R. 
Published: March 2020

17063 Background: The erythropoietic agents available today have FDA-approval for weight-based as well as fixed dosing in cancer pts with chemotherapy-induced anemia [epoetin alfa (EPO) 40,000 Units QW, darbepoetin alfa (DARB) 500 mcg Q3W]. To understand hematologic outcomes and EST cost considerations based on actual patterns of use, not protocol-driven use, data were analyzed from the Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (D.O.S.E.) Registry, an ongoing registry of real-world practice. Methods: Data from 18 U.S. practice settings from 1/06–12/06 were assessed. Chemotherapy-treated adult cancer pts initiated at either EPO 40,000 Units or DARB 500 mcg were evaluated. Outcomes assessed included mean treatment duration, hematologic outcomes, mean administered dose, mean cumulative administered dose, and total EST cost (based on 9/2006 wholesale acquisition cost). Results: 168 pts (145 EPO, 23 DARB) were eligible. Patient groups were similar with regard to baseline age, gender distribution, tumor type, Karnofsky score and Hb. Treatment duration was similar for both agents, approximately 7 weeks. The proportion of pts transfused from Week 5 to end of study and number of units/ pt was not significantly different between groups (% transfused: EPO 10%, DARB 13%; Units/pt: EPO 0.2, DARB 0.3). Mean administered dose was 42,879 Units in the EPO group and 497 mcg in the DARB group. Mean cumulative administered dose for the treatment episode was 305,241 Units for EPO and 1,665 mcg for DARB, corresponding to an EST cost of $3,715 for EPO and $7,404 for DARB (p <.0001). Conclusions: Real-world practice pattern data from this observational study found similar treatment duration and transfusion patterns in the EPO-treated group versus the DARB-treated group in pts initiated with FDA-approved fixed dosing regimens. Cumulative EST cost was $3689 lower in the EPO group, a 50% reduction versus the DARB group. No significant financial relationships to disclose.
Comparison of the demographics of patients enrolled (E) versus those not enrolled (NE) on therapeutic clinical trials at a comprehensive cancer center
Authors: Goodin S. , Vamos D. C. , Kane M. P. , Nishioka J. , Lisi S. , Neceskas J. R. , Aisner J. , Rubin E. H. , Todd M. B. , Shih W. J. 
Published: March 2020

17065 Background: In the U.S., representation of minorities and the elderly in clinical trials has been low yet few reports have evaluated this potential barrier to enrollment by comparing the demographics of patients E vs NE within an institution. Therefore, we compared these groups to determine if there were significant differences in demographics at our center. Methods: For all E patients, demographic data is collected in a clinical trial database. For evaluated NE patients, data was captured through a ‘non-protocol’ form. A univariate analysis was performed on the demographic data, including gender, age, race, and insurance status, for each year to determine if there were differences in patients E vs NE on a therapeutic clinical trial. Results: From June 2003 through December 2005, there were 912 E patients and data available on 474 NE patients. The results were consistent for each year from 2003 to 2005, and therefore combinable, with no statistical difference in any parameter for E patients versus NE patients during any year with the exception of gender (p=0.05; Chi-square). The distribution of patients E by gender is 52% (474/912) female vs 48% (438/912) male and NE is 69% (325/474) female vs 31% (149/474) male. The mean age of E patients was 55 vs 56 years for NE patients, with 32% vs 33% representing those >65years, respectively. For the E patients, 84% were white, 7.2% black, 4.6% Asian, 4.2% unknown, and 0.4% Hawaiian/Pacific Islander (H/PI). For the NE patients, where race was not consistently available, 65% were white, 9.3% black, 3.2% Asian, 20.5% unknown, and 2.1% H/PI. In both groups, most patients had private insurance (E 60%, NE 54%), followed by Medicare (E 27.5%, NE 29%), Medicaid (E 4%, NE 9%), self pay (E 7.5%, NE 7.4%), and unknown (E 1.3%, NE 0.4%). Conclusions: When comparing E vs NE patients, gender was the only factor that differed significantly. Although this result suggests that males were more likely to be E in a clinical trial, this finding should be interpreted with caution, since this difference might relate to differences in trial availability. While lower enrollment rates for the elderly and minority patients have been identified nationally, enrolling this group of patients does not appear to be a barrier at our center. No significant financial relationships to disclose.
Knowledge of cancer clinical trials in screened populations
Authors: Walsh J. H. , Sahasrabudhe D. 
Published: March 2020

17076 Background/Methods: Previously, we reported results regarding knowledge of cancer clinical trials in men undergoing prostate cancer screening. We administered the same questionnaire to 103 women undergoing screening mammography at a single center. We report results from both studies here. Results: The mammography screening group was racially homogeneous as compared to the prostate cancer screening group. Fewer than 3% of women were nonwhite compared to over 20% of men. Fewer women reported college education, 49% vs. 79%. Half the women were employed compared to a third of the men. On 81% of test questions, participants in the breast cancer screening group chose the correct answer 80% or more of the time. This compared to 71% in the prostate cancer screening group. The mean percent correct answers in the breast group was 91% as compared to 82.4% in the prostate group. Women were significantly more knowledgeable about trial oversight, rationale behind clinical trials, and blinding. Randomization and use of placebo were poorly understood by both groups, with 45% of men and women incorrectly answering a question regarding placebo. Univariate t-tests and multi-way ANOVA analyses suggest that college educated women are significantly more knowledgeable about clinical trials. Race, income, employment status, and marital status did not have a significant effect on women's knowledge. When the breast and prostate data were combined in univariate analysis (see table ), gender, college education and race were found to significantly affect knowledge of clinical trials. These findings maintained significance in multi-way ANOVA analysis. Conclusion: In this hypothesis-generating study, white, female, college educated subjects were more knowledgeable about clinical trials. Importantly, similar knowledge gaps were observed in both studied groups. Targeted interventions to educate patients about the rationale behind clinical trials, randomization, and use of placebo may help increase accrual in clinical trials. [Table: see text] No significant financial relationships to disclose.
Validation of 12-item general health questionnaire into Kannada language
Authors: Javaregowda D. C. , Parthasarathy B. , Suresh A. , Lokanath D. , Govind Babu K. , Ullas B. , Anupama G. , Sani K. 
Published: March 2020

17077 Background: The cancer load in India is enormous and majority of the cases present in an advanced stage. There is no valid translation of 12-item General Health Questionnaire (GHQ-12) in Kannada, which is a simple but indispensable tool in the comprehensive cancer care (both for metastatic and in adjuvant settings). Therefore we thought of developing and validating the GHQ-12 Questionnaire into Kannada language. Methods: The study was conducted at kidwai memorial institute of Oncology, Bangalore, a tertiary cancer center with an annual attendance of 16,000 new cases. We have chosen educated patients who can speak and write both English and Kannada. We used ’forward-backward’ translation procedure into Kannada. We used scores from 0–3 for the Questionnaire. Total score for both languages was calculated. Internal consistency was assessed by Cronbach's alpha coefficient. Validity was performed using convergent validity. Finally, the factor structure of the questionnaire was extracted by performing principal component analysis using oblique factor solution. Results: A total of 118 patients with various malignancies were entered into the study. The mean age was 36.8 ± 12.1 years. The mean GHQ score was 21.6 ± 9.1 for the English and 22.6 ± 8.1 for Kannada. Reliability analysis showed satisfactory result (Cronbach's alpha coefficient = 0.79). The principal component analysis with oblique rotation solution showed that the GHQ-12 was a measure of psychological morbidity with four -factor structure that jointly accounted for 48 % of the variance. Conclusions: The Kannada version of the GHQ-12 is a reliable and valid instrument with a good structural characteristic. It can be used for measuring psychological well being at our institute for those patients who can read and write only Kannada. No significant financial relationships to disclose.
Aberrant immunophenotype in acute myeloid leukemia (AML): High frequency and association with dysplasia
Authors: Dogra S. , Mangipudy J. P. , Asatiani E. , Gamez R. , Cohen P. , Kessler C. , Mavromatis B. , Shad A. , Cheson B. D. , Ozdemirli M. 
Published: March 2020

17504 Background: Asynchronous expression of immunophenotypic markers on AML myeloblasts has been well described, but the association of aberrant phenotype with morphologic subclasses has not been reported previously. Methods: Multiparameter flow cytometry (MFC) data were analyzed for all patients (pts) diagnosed with AML at our institution from 2000–2006. MFC was done on fresh bone marrow aspirate and/or peripheral blood samples using the following panel of monoclonal antibodies in triple staining: CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11c, CD13, CD14, CD15, CD16, CD19, CD20, CD22, CD24, CD33, CD56, CD34, CD117, HLA-DR and TdT. Identification of myeloblasts was performed using Side Scatter (SS) characteristics and CD45 expression. Acute lymphoblastic leukemia (ALL) cases or cases with mixed lineage acute leukemia were excluded from the study. Results: We identified 76 pts with AML; median age 57, (range 10 weeks to 89 years), with 32 males and 44 females. The patients had the following French American British classification of AML: M0 (n=1), M1 (n=11), M2 (m=10), M3 (n=5), M4 (n=13), M5 (n=14), M6 (n=1), M7 (n=4) and not otherwise categorized non- M3 AML (n=17). Twenty two pts had AML with multilineage dysplasia (AML-MD) as classified by World Health Organization. Coexpression of TdT on myeloblasts was observed in 4 pts, one of these coexpressed CD5. T-cell lymphoid associated antigens (CD2, CD5 and/or CD7) were coexpressed on myeloblasts from12 pts. B cell lymphoid associated antigens (CD19 and/or CD20) were expressed on myeloblasts from11 pts. Both T and B cell lymphoid associated antigens were present on myeloblasts in 4 pts. Myeloblasts from 13 pts demonstrated the presence of the NK cell marker CD56. A total of 43 patients had AML with immunophenotypic lineage infidelity manifested by coexpression of one or more aberrant antigens on myeloblasts. The distribution of cases with lineage infidelity was higher in 22 pts with AML-MD (n=17, 77%) versus in 54 pts with no dysplasia (n=26, 48%), Chi square =5.4, p=0.02. Conclusions: Abnormal coexpression of lymphoid and NK cell markers was observed in significant number of AML pts and correlated with the presence of multilineage dysplasia. This finding may indicate an earlier stem cell origin of AML-MD. No significant financial relationships to disclose.
Therapy-related myelodysplastic syndrome (t-MDS) following treatment of acute myeloid leukemia (AML)
Authors: Arana-Yi C. , Block A. W. , Sait S. N. , Ford L. A. , Barcos M. , Baer M. R. 
Published: March 2020

17509 Background: t-MDS is well described following treatment of lymphomas, solid tumors and acute promyelocytic leukemia. In contrast, it has been reported only rarely following treatment of AML, possibly because of the smaller percentage of long-term survivors or the difficulty of distinguishing t-MDS from AML relapse. Methods: Roswell Park Cancer Institute (RPCI) patients with a diagnosis of MDS by French-American-British or World Health Organization criteria following a diagnosis of AML were retrospectively reviewed. Results: Five adult patients treated for de novo AML between 1996 and 2005 developed MDS, representing less than 1% of 548 RPCI AML patients during those years. MDS presented as cytopenias and marrow dysplasia, occurred 11 to 101 (median 27) months after diagnosis of de novo AML, and was associated with chromosome 7 abnormalities, including monosomy 7 or del(7q), in all five. All had been treated with cytarabine and topoisomerase II inhibitors and three had received alkylating agents as part of autologous transplant regimens. All had received granulocyte colony-stimulating factor or granulocyte-monocyte colony-stimulating factor in conjunction with chemotherapy and/or autologous transplantation. Fluorescence in situ hybridization with the CEP 7 probe or the dual-color LSI D7S486 (7q31)/CEP 7 probe set did not demonstrate chromosome 7 abnormalities in marrow prior to MDS diagnosis nor in peripheral blood stem cells of patients who had undergone autologous transplantation prior to diagnosis of MDS. MDS has progressed slowly in all patients; it evolved to AML in two following 18 and 24 months. Conclusions: These cases further document t-MDS following AML therapy. Presence of chromosome 7 abnormalities in cases without, as well as with, prior alkylating agent therapy suggests possible association with the anti-metabolite cytarabine. No significant financial relationships to disclose.
Chronic myeloid leukemia with variant translocations: A cytogenetic profile
Authors: Saini K. V. , Kumari P. , Saini M. L. , Latha P. , Jain A. , KV S. , Batra U. , Attili A. , Lakshmidevi V. , Lakshmaiah K. , Bapsy P. 
Published: March 2020

17517 Background: Chronic Myeloid Leukemia (CML) is characterized by the translocation between chromosomes 9 and 22. The resulting Philadelphia chromosome is the cytogenetic hallmark of this disease. Occasionally, other variant translocations may be present. Methods: We performed a retrospective analysis of case records between 1999 and 2006 of patients diagnosed with CML at the Kidwai Memorial Institute of Oncology, a tertiary care cancer centre in South India. The cytogenetic profile of CML patients was determined. Results: The total number of CML patients (proven by bone marrow aspiration) diagnosed at our centre during the study period was 1268. Of these, 79 cases (48 M, 31 F) had variant translocations ( Table 1 ). The mean age at diagnosis was 35.9 yrs (SD 11.4). The involved chromosomes were 22 (91.1%), 9 (69.9%), 1 (13.9%), 19 (11.4%), 12 (8.8%), 7 (7.6%), and 6 (7.6%). Other involved chromosomes were 11, 2, 3 13, 15, 17, 16, 20, 21, and 8 in decreasing order of frequency. Table 1 : Cytogenetic Profile of CML Conclusions: Other than chromosomes 22 and 9, the variant translocations commonly involved chromosomes no 1, 19, 12, 7, and 6. The identification of these variant translocations and their co-relation with the clinical behavior may identify new prognostic markers. [Table: see text] No significant financial relationships to disclose.