bluuebunny/crossref_metadata_2025_split huggingface dataset:
Treatment of diseased quality of life in specific dimensions: Effectiveness of quality-of-life diagnosis and treatment in a community-based RCT in women with breast cancer.
Authors: Klinkhammer-Schalke Monika , Koller Michael , Steinger Brunhilde , Lindberg Patricia , Hofstädter Ferdinand , Lorenz Wilfried 
Published: March 2020

e16520 Background: Many studies described deficits in quality of life (QoL) in cancer patients. We developed a new pathway with QoL diagnosis and treatment which was implemented as complex intervention with theory building, modeling, exploratory trial and RCT, integrated in a population based (2.1 mio) Tumorcenter. Methods: We conducted a two-armed, randomized clinical trial with 200 breast cancer patients.QoL was measured prospectively in 10 specific dimensions in first year after surgery. Along new QoL pathway patients in intervention group (IG) received QoL diagnosis and treatment consisting of 5 therapeutic options (eg physiotherapy, psychotherapy, social counseling). Members of control group (CG) received standard postoperative care. Primary endpoint was rate of patients with diseased QoL (<50 points on at least one scale with 0=bad, 100=good QoL). χ2-tests were performed to compare rates of diseased QoL (Klinkhammer-Schalke et al, BrJCancer, 2012). Results: At begin of study there were no significant differences in both groups considering QoL. 6 months after surgery rate of patients with diseased QoL was significantly lower for emotion in IG (19.8%) vs CG (38.4%, p=.007), and for global QoL almost reached significance in IG (17.6%) vs CG (29.8%, p=.064). For other dimensions (except family life) there was a trend showing better QoL in IG, but results were not significant. Rates of patients with diseased QoL in 10 dimensions 6 months after surgery in intervention group [%] vs control [%]: Global QoL 17.6% vs 29.8%!, Physical functioning 4.7% vs 5.7%, Role functioning 26.4% vs 29.9%, Arm symptoms 13.8% vs 23.3%, Body image 13.8% vs 22.1%, Pain 19.5% vs 24.4%, Emotion 19.8 %vs 38.4%xx, Concentration, remembering 10.5% vs 17.4%, Fatigue 37.9 %vs 46.5%, Family life, social encounters 17.4% vs 16.3% (χ2-test: p<.10!, p<.01xx). Conclusions: Results confirm effectiveness of QoL pathway: 6 months after surgery IG showed better QoL in 2 important dimensions. Lower rates of diseased QoL in other dimensions support the result. Cancer patients will benefit from the QoL system implemented in clinical routine (long term implementation).
Evaluating the impact of a trial in breast cancer tumor markers: A value of research analysis.
Authors: Thariani Rahber , Blough David K , Barlow William , Henry Norah Lynn , Gralow Julie , Ramsey Scott David , Veenstra David L 
Published: March 2020

e16524 Background: Despite not being recommended by clinical guidelines, the tumor markers carcinoembryonic antigen (CEA), cancer antigen (CA)15-3, and CA 27.29 are used by some clinicians to screen for increased risk of breast cancer recurrence. Although additional research may be warranted to evaluate the benefits and risks of breast cancer tumor marker tests, clinical trials would likely need to involve thousands of women and would take many years to complete. We conducted an analysis to assess the societal value of a prospective randomized clinical trial (RCT) for breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors Methods: We used value of information techniques to assess the benefits of reducing uncertainty of using breast cancer tumor markers. We developed a decision-analytic model of biomarker testing in addition to standard surveillance at follow-up appointments every 3-6 months for five years. Expected value of sample information (EVSI) was assessed over a range of trial sizes and assumptions. Results: The overall value of research for an RCT involving 9,000 women was $166 million (EVSI). The value of improved information characterizing the survival impact of tumor markers was $81 million, quality-of-life $38 million, and test performance $95 million. Conclusions: Our analysis indicates that substantial societal value may be gained by conducting a clinical trial evaluating the use of breast cancer tumor markers. The most important aspects of the trial in our analysis were information gained on survival improvements as well as quality-of-life parameters associated with testing and test sensitivity and specificity. Our analysis indicates that smaller randomized trials, as well as adding quality of life instruments to existing trials, retrospective, and observational trials can also generate valuable and relevant information.
Impact of computerized provider order entry on medication errors in chemotherapy administration.
Authors: DeMoor Patricia A , Bazhenova Lyudmila 
Published: March 2020

e16535 Background: Computerized provider order entry (CPOE) reduces medication errors (ME) in ambulatory prescriber and hospital settings. We conducted a study to assess the effect of CPOE on ME in an outpatient NCI designated academic infusion center (IC). Methods: Both actual and prevented ME were reported by clinical staff as part of IC Standard Operating Procedure using the electronic Quality Variance Reporting (eQVR, Incident Reporting 2.0, University of California) system. Reported ME from 10/2007 to 03/2011 were reviewed by 2 investigators and classified into categories by consensus: wrong medication given (WM), medication missed (MM), wrong timing/rate (T/R), wrong dose (WD), unmet chemotherapy parameters (UP) and other (O). Classifications were further categorized by preventable or facilitated by CPOE. We compared ME 18 mo. pre and post implementation. The 6 month go live period was reviewed separately to examine ME related to a learning curve (LC). Results: 40,366 patients were seen pre-implementation, 47,460 post, and 14,343 during go live. The total ME per pt was similar pre and post (see table). There were dramatic rate differences in WM and MM, but no effect on T/R, WD, UP. In the pre period 66% of ME were felt preventable by CPOE. In turn 35% of ME were facilitated by CPOE. Preventability rates differed between categories. During go live 100% of CPOE facilitated ME were related to user and designer LC. Post implementation 58% of CPOE facilitated ME were still accounted by LC with the rest felt related to the complexity of CPOE. Conclusions: ME are rare in our outpatient oncology IC. CPOE did not change the total number of ME but significantly decreased the rate of WM. Complexities of CPOE resulted in increased MM. LC related errors still occur 24 mo. after implementation of CPOE and require constant monitoring and education. CPOE increased the rate of serious ME felt due to the change in workflow and adding an extra layer of complexity. Human errors cannot be fixed with CPOE and generally encompassed the ME in T/R, WD, and UP classifications. [Table: see text]
The incremental economic burden of clostridium-difficile associated diarrhea among hospitalized immunocompromised patients undergoing chemotherapy.
Authors: Quimbo Ralph A. , Palli Swetha , Strauss Marcie , Thomas Sheila 
Published: March 2020

e16542 Background: Hospital-acquired Clostridium-difficile associated diarrhea (CDAD) results in an estimated $1.3 billion in excess costs in the US. Patients undergoing chemotherapy are at elevated risk of CDAD due to diminished immune response and increased exposure to health care facilities. This study describes the incremental economic burden of CDAD in hospitalized immunocompromised (IC) patients. Methods: IC cases (undergoing chemotherapy or other qualifying conditions) hospitalized with a diagnosis of CDAD having ≥12 months of prior health plan eligibility and age ≥18 years between 1/1/2005 and 10/31/2010 were identified from the HealthCore Integrated Research Database (HIRDSM). Cases were matched to hospitalized IC controls without CDAD diagnosis based on: age±10 years, gender, selected preceding/in-hospital comorbidities and use of antibiotics. Incremental hospital length of stay (LOS) and costs were calculated between matched cases and controls via multivariate methods using a Gamma distribution. Covariates were determined from post-match univariate analysis of baseline characteristics. Results: 3,586 cases were matched to 10,758 controls. Chemotherapy occurred among 91.3% of cases and controls. While age (65±15), gender (53% female), and selected comorbidities were balanced between cases and controls, post-match disparities persisted (p<.001): geographic region (37% vs. 32% Midwest), type of health plan (24 vs. 18% HMO), overall comorbidity burden (6.0±3.6 vs. 6.5±3.7 Deyo-Charlson Comorbidity Index). Cases had a lower incidence of mortality during their index hospitalization (6.7% vs. 7.8%; p<0.0001). Adjusted hospital LOS was significantly greater for cases vs. controls (22.1 days (20.61 to 23.69) vs. 13.67 days (12.74 to 14.67); p<.0001). Incremental hospitalization costs indicated a significantly greater economic burden among cases vs.controls (Δ = $32K ($29K to $35K); p<0.0001). Conclusions: This study indicates that the acquisition of CDAD among immunocompromised patients, of which chemotherapy recipients represented the majority, presents significant incremental economic burden within the hospital setting.
Performance teamwork training in ambulatory oncology.
Authors: Gross Anne , Mann Susan , Kalfin Michael , Lane Sharon , Weingart Saul , Bunnell Craig A. 
Published: March 2020

e16559 Background: Increasingly complex diagnostic and multimodality treatment algorithms have yielded superior outcomes, but also magnified the risk for adverse events precipitated by failures of communication and coordination. We implemented team training principles in 14 outpatient oncology practices across 3 campuses (community and academic) to reduce the risk of errors and increase operational efficiency and quality. Methods: Over 950 physicians, nurses, pharmacists, and staff were trained in evidence-based concepts of teamwork. Intervention included 1) baseline data collection regarding key clinical processes, (e.g. non-communication of same-day chemotherapy order changes); 2) observations/interviews with care team members; 3) process meetings to identify vulnerabilities and develop agreements and tools to support them; 4) Train the Trainer methodology; 5) staff training; 6) post-training data collection. Results: Despite the infrequency of non-communicated same-day changes in chemotherapy orders at baseline (~2%), a trend toward improvement was seen (chi-square p=0.068). The incidence of missing chemotherapy orders for infusion visits not associated with an MD visit decreased significantly. Staff reported improved practice efficiencies and a more respectful, safer environment. Press Ganey patient-reported perceptions of teamwork improved significantly. Conclusions: Team training improved communication, task coordination, perceptions of efficiency, quality, safety and interactions among team members, as well as patient perception of teamwork in both community and academic environments of a comprehensive cancer center. [Table: see text]
Intervention to increase site activations for multicenter trials to improve accrual.
Authors: Massett Holly , Jaeckle Kurt A. , Hopkins Jenny R , Mann Bhupinder Singh , Denicoff Andrea , Dilts David M. 
Published: March 2020

e16569 Background: The National Cancer Institute’s (NCI) Cancer Trials Support Unit (CTSU) provides access to NCI-sponsored trials. To participate in a multi-center trial, sites must first complete the trial’s Protocol Specific Requirements (PSRs); interested sites are listed as “pending” in the CTSU database until all PSRs are completed. The aim of this investigation was to examine site activation delays for a study with multiple start-up steps and evaluate an intervention directed at helping sites more rapidly open it to patient accrual. Methods: NCCTG N0577, an anaplastic glioma trial named CODEL, was identified as a slow accruing trial with many sites listed as pending activation in the CTSU’s database (>85%; n=227 pending). Most N0577 pending sites had 1-2 incomplete PSRs (with 75% requiring only a neurocognitive certification), and we suspected that sites were not aware of these requirements. To accelerate site activation for N0577, we created an intervention using Awareness Theory. First, N0577 was amended to streamline the neurocognitive certification process. We then generated email lists of the 227 pending sites’ PIs (n=21; note: many were PIs of multiple sites) and their respective administrators (n=46), and created tailored email notices by PSR category explaining the necessary steps to complete N0577 activation at their site or to report their site as not planning to participate. Emails were sent to sites via the CTSU. Results: 31 sites (14%) registered activity for N0577 within 3 weeks of the intervention. Of these, 22 changed status to “approved,” 2 were disapproved, 1 withdrew, and 6 made changes but remained pending. This represents a marked increase (+520%) in site activity of the CTSU Regulatory Support Service (RSS) for N0577, compared with the monthly average (5 events/mo) during the preceding 6 months. Accrual is being monitored to observe for any increases and will be reported. Conclusions: Complicated and incomplete PSRs delay site activation of multi-center trials and may impact accrual. Streamlining PSR processes and early monitoring of CTSU site activation with notifications to sites of outstanding PSRs for trials can increase the timeliness of sites opening trials, with the potential to improve accrual.
A case report of long-term complete remission following cessation of romiplostim dosing in a previously severe ITP patient.
Authors: Baxley Allison Ashley , George James N , Terrell Deirdra , Moorman Meredith , Holter Jennifer L. 
Published: March 2020

e17001 Background: Primary Immune thrombocytopenia(ITP) is a chronic autoimmune disorder characterized by low platelet counts and bleeding complications. Platelet destruction together with insufficient platelet production occur through an antibody-mediated process and early treatment options revolve around targeting antibodies and immunologic pathways. Such therapies may not produce long-term responses and may be accompanied by considerable adverse effects which can lead to complications and/or drug discontinuation. Romiplostim is a thrombopoietic agent that stimulates platelet production and offers an alternative method for treatment of patients with ITP. In clinical trials, patients have achieved durable platelet count responses without clinically important side effects. Methods: We report the case of a 44 year-old female with refractory ITP who has achieved successful remission following treatment with romiplostim. Results: As previously described in Haematologica (2008;93:1445) this patient presented with purpura, menorrhagia, and a platelet count of 7,000. Throughout 2005 she had only transient responses to high dose dexamethasone, intravenous immunoglobulin, rituximab, and splenectomy. She was placed on romiplostim in August 2005 as part of a clinical trial and received a dose of 7 mcg/kg/week for approximately 50 weeks. She was able to tolerate dose reductions and by May 2007 her dose had been de-escalated to 3 mcg/kg/week, which she continued through 2009 as part of an open-label continuation study. In January 2010, after completion of the clinical trial, she began receiving romiplostim by prescription. She was able to gradually tolerate extended dosing intervals due to sustained platelet response. Her last dose was administered on October 27, 2010 and she has maintained a platelet count above 197,000 without further therapy. Conclusions: This case represents, to our knowledge, one of the longest maintained durable responses to romiplostim therapy. Romiplostim provides an alternative approach of treatment for ITP, and as evidenced by this case report, in some patients it may also lead to disease remission and eliminate the need for further treatment.
Phase II trial of daily pulse interleukin-2 (IL-2) therapy during marrow recovery in patients with acute myeloid leukemia (AML) NCT#01289678.
Authors: Kamdar Manali K. , Asch Adam Steven , Unger Jackie , Walker Paul R. 
Published: March 2020

e17008 Background: Therapeutic advances in treating AML have been limited in the past two decades. Allogeneic stem cell transplant (Allo-SCT) can cure patients with relapsed and high-risk AML with a graft versus leukemia immune effect. IL- 2 promotes the proliferation and activity of cytotoxic T cells, natural killer cells and lymphokine activated cells. IL-2 has been shown to abrogate the clonogenic leukemic blasts in murine leukemias and has achieved complete remissions in relapsed AML. Early absolute lymphocyte recovery after induction chemotherapy predicts a superior survival in AML suggesting a critical role of early immune recovery. (Behl et al Leukemia 2006) Stimulated LAK cells by IL-2 during this critical early lymphocyte recovery period may enhance a graft versus leukemia immune effect and potentially improve the outcome of first-line AML treatment. Methods: 12 adult patients with de novo or secondary AML were consented to receive IL-2 during induction and/or post-remission treatment marrow nadir recovery. The eligibility criteria included a rising WBC count >500mm3, supported platelet count >20,000 and hemodynamic stability. IL-2 18 million IU/m2 was administered over 15-30 minutes daily for 5 days within 7 days of a WBC rising above 500mm3. Primary end point overall survival (OS). Median age 52 yrs. (range 33-72). Results: 3 pts. received IL-2 during induction recovery; 3 during re-induction recovery, 3 during consolidation recovery. 1 pt. subsequently underwent an Allo-SCT in remission. Median OS 25 months. With a median followup of 36 months (range 12-60 months), 5 of 9 (55%) treated pts. and 4 of 8 (50%) pts. without an Allo-SCT, are alive and leukemia free. Of the 5 alive, 3 are over the age of 60 and 2 had complex cytogenetics. Expected toxicities with IL-2 included grade 3 fever/chills (77%) but there were no respiratory or hemodynamic complications requiring ventilator support. Conclusions: IL-2 therapy administered during marrow/lymphocyte recovery after standard induction/consolidation chemotherapy in first-line AML treatment achieved a 50% 3-year overall and leukemia free survival without an Allo-SCT.
Hypoplastic MDS with PNH clone treated successfully with eculizumab.
Authors: John Sonia , Parekh Hiral D. , Qubaiah Osama M. , Selby George Basil , Holter Jennifer L. 
Published: March 2020

e17010 Background: Myelodysplasia (MDS) is a myeloid clonal disorder characterized by dysplastic and ineffective hematopoiesis. Hypoplastic MDS is a rare variant found in <15 % of MDS patients.Severe aplastic anemia (SAA) is defined as <10% marrow cellularity associated with pancytopenia. Paroxysmal nocturnal hemoglobinuria (PNH) an acquired clonal hematopoietic disorder presenting as chronic intravascular hemolysis, venous thrombosis, deficient hematopoiesis and can be found in both SAA and MDS. PNH can be diagnosed by measuring the surface markers for phosphatidylinositolglycan (PIG),CD59, CD55 and CD14. In clinical practice, these three diagnoses have significant overlap with unclear thresholds for the level of clone for which therapy should be directed. Methods: We present a 69 year old patient who was found to have hypoplastic MDS/SAA by bone marrow biopsy and flow cytometry with no chromosomal abnormalities.Treatment with Anti-thymocyte globulin (ATG) and cyclosporine (CSA) was initiated. He achieved transfusion independence and was in complete remission for 6 months. He developed recurrent thrombocytopenia and was retreated with ATG & CSA with minimal improvement. He remained transfusion dependent.Repeat BM biopsy showed persistent hypoplastic MDS/SAA. PNH evaluation showed a small clone of PIG deficient cells quantified as 0 % red cell, 2% granulocytes and 0.9% monocytes which was negative at initial diagnosis. Eculizumab was instituted weekly for the last 18 months.Transfusion independence was obtained within 2 months with significant improvement in all cell lineages. BM biopsy performed 4 months after therapy showed hypercellular marrow. Patient continues to be treated with eculizumab and has maintained a complete remission for over 18 months. Results: The diagnosis hypoplastic MDS/aplastic anemia is usually highly sensitive to therapy with ATG and CSA. Although our patient initially responded to ATG, retreatment was not successful. Eculizumab has documented a significant and sustained response in this patient’s treatment. . Conclusions: We report a patient with less than 1% PNH clone that achieved complete transfusion independence with eculizumab and full resolution of hypoplastic MDS/SAA by marrow histology.
Allogeneic hematopoietic stem cell transplantation to improve survival in acute myeloid leukemia patients with FLT3 internal tandem duplication.
Authors: Lin Po-Han , Yang Hwai-I , Bai Li-Yuan , Yeh Su-Peng , Chiu Chang-Fang 
Published: March 2020

e17014 Background: Fms-like tyrosine kinase (FLT3) gene with internal tandem duplication (ITD) is a poor prognostic factor in patients with acute myeloid leukemia (AML). Allogeneic hematopoietic stem cell transplantation (HSCT) is considered as an effective treatment for AML patients with poor risk. However, the efficacy of allogenic HSCT in the treatment of AML patients with FLT3-ITD was not clear. Methods: A total of 122 patients, who were newly diagnosed as de novo AML and received intensive chemotherapy at China Medical University Hospital between 2003 January and 2010 December, were retrospectively analyzed. At diagnosis, all patients received French-American-British (FAB) classification, cytogenetic analyses and immunophenotyping. The HSCT was performed on the basis of the consensus of the hematologists in this institute, mainly according to the two factors: unfavorable karyotype and suitable donor availability. The FLT3-ITD was detected by polymerase chain reaction and confirmed by direct sequencing. The Cox proportional hazards regression analysis was used to estimate the hazards ratios of the overall survival and corresponding 95% confidence interval (CI) for various combinations of FLT3-ITD and HSCT status. Results: An FLT3-ITD was detected in 34 patients (27.9%). The allogeneic HSCT was performed in 39 patients; 29 patients with wild type (wt)-FLT3 and 10 patients with FLT3-ITD. The number of death/number of patients (medium overall survival) of wt-FLT3/HSCT(+), wt-FLT3/HSCT(-), FLT3-ITD/HSCT(+) and FLT3-ITD/HSCT(-) was 12/29 (53.4 months), 25/59 (40.7 months), 3/10 (medium not reached) and 17/24 (12.0 months), respectively (p=0.014). Comparing with wt-FLT3/HSCT(-) patients, the hazard ratio (95% CI) of overall survival for wt-FLT3/HSCT(+), FLT3-ITD/HSCT(+) and FLT3-ITD/HSCT(-) was 1.39 (0.61-3.18), 0.40 (0.11-1.49), and 3.57 (1.58-8.09), respectively, after adjustment of age, sex, WBC, LDH, karyotype and FAB classification. Conclusions: AML patients without FLT3-ITD had better survival than those with FLT3-ITD regardless of the allogeneic-HSCT. The allogeneic HSCT may improve overall survival in AML patients with FLT3-ITD.