tbuckley/cabot-search huggingface dataset:
Association of diabetes mellitus with arsenic trioxide (ATO) evaluated in the treatment of acute promyelocytic leukemia (APL).
Authors: A. Kritharis, T. P. Bradley, D. R. Budman
Journal: Journal of Clinical Oncology (2011)

e19724 Background: ATO has been administered for leukemia since 1878. It was approved for use in refractory and relapsed APL in 2000 and shown to have survival benefit as initial consolidation therapy by C9710 in 2010. Studies suggest an association of long term exposure to low doses of environmental inorganic arsenic with the development of type 2 diabetes mellitus (DM II). This study seeks to evaluate whether ATO at doses used to treat patients with APL is associated with an increase in DM II. Methods: A retrospective chart review of 35 patients with newly diagnosed APL treated with ATO at one university teaching hospital was conducted. For each patient, demographics, lab data, and treatment course were reviewed. 11 patients were excluded. Of the remaining 24 patients, glucose levels from lab panels were evaluated. Elevated serum glucose was defined as a random glucose level of >120 mg/dl. Results: Within one year following ATO, 54.2% of patients receiving arsenic were noted to have elevated serum glucose levels on more than one occasion. There was an average increase in serum glucose of 42.4% from baseline. 76.9% of patients with elevated glucose levels were seen in the first three months following arsenic. Conclusions: The results suggest that ATO at levels used to treat APL may increase glucose levels and subsequent risk for DM II. This calls for a reexamination of the glycemic status of surviving leukemic patients who previously received ATO. Additionally, steps should be taken to monitor glycemic control in APL patients whose treatment regimens include ATO. Patient demographics. Age 50yo ± 10.76 (range 22-77) Sex 16F, 8M Comorbidities Colon ca (1), breast ca (1), thyroid ca (1), prostate ca (1), crohn's disease (1), AIDS (1), CKD (1), seizure disorder (1), HTN (6), dyslipidemia (4), psoriasis (1), gout (1), hypothyroidism (2), GERD (3), depression (1), anemia (1), bipolar disorder (1), TB (1) Treatment follow-up 1 mo ± 1.05 (range - 48 to 57) No. of patients with glucose >120 mg/dL post-arsenic 13/24 Total ATO received 0.15 mg/kg/d IV for 5 days per week for 5 weeks (1-3 cycles) Exclusion 11 patients (4 from prior hx of diabetes, 5 from expiration within four weeks of dx, 2 from insufficient follow-up)
Altered expression proteins involved in cytoskeletal formation and metabolic pathways in renal cell carcinoma linked to microRNA expression.
Authors: S. Jasinski, E. Wang, S. Dressler, R. Lichtenfels, C. Recktenwald, F. Marincola, B. Seliger
Journal: Journal of Clinical Oncology (2011)

e15125 Background: Although the majority of microRNAs (miRs) are thought to have an impact on the shaping of the protein expression profile only scarce information is currently available concerning comparative analyses of global proteomic and miR profilings data sets. Methods: In order to determine whether differentially expressed proteins defined by 2DE-based proteomics could be directly linked with the inverse regulation of putative targeting miRs we here explored this strategy using renal cell carcinoma (RCC) lesions and normal kidney ephitelium as a model system. Results: The study lead to the definition of a subset of relevant functional targets. A high percentage of these were also associated with chromosomal alterations characteristic for this tumor enttity. The set of inversely correlated proteins and putative miRs is comprised of targets involved in the remodeling of the cytoskeleton and in the altering of metabolic pathways. Conclusions: Thus our data suggest that the comparative analysis of miRNA and proteomics profiling might improve the identification of potential biomarkers for the diagnosis and prognosis of RCC.
Improving quality of care by obtaining patient-reported outcomes (PRO)-CTCAE chemotoxicities using tablet technology in daycare (DC) waiting rooms.
Authors: Tian Qi Wang, Catherine Brown, Ashlee Vennettilli, Lauren Wong, Aein Zarrin, Aditi Dobriyal, Linda Chen, Vivien Pat, Anthea Ho, Valerie Ho, Cindy Xin, Hannah Solomon, Margaret Irwin, Christina Gonos, Zahra Merali, Wei Xu, Doris Howell, Geoffrey Liu
Journal: Journal of Clinical Oncology (2014)

165 Background: In a busy chemo DC, any efficient means of tracking important chemotoxicities can improve quality of care. The study goal was to evaluate whether tablet technology available in a DC waiting room is able to capture prevalent and severe toxicities associated with chemotherapy using the patient reported outcome (PRO) - common toxicity criteria for adverse events (CTCAE). Methods: This cross-sectional PRO-CTCAE study of 160 adult solid/hematologic cancer outpatients of all stages, who were undergoing chemotherapy (CT), focused on common chemotoxicities captured using touchscreen tablets in the DC waiting room of Princess Margaret Cancer Centre (Toronto, CA). Individual health scores from the EQ-5D VAS tool and the prevalence of AEs experienced by cancer patients within the past seven days were captured. Symptoms that were listed as moderate to very severe were considered significant. Results: Across a wide range of tumours and patients on intravenous CT, the median age (range) was 56 (19-88) years; 38% were males.Patients reported a median (range) health score (100 = best health possible, 0 = worst) of 70 (4-100). The severity offiveprevalent, key side-effects of CT were tabulated (Table). 59% of patients felt their fatigue interfered significantly with their daily activities, and 30% felt decreased appetite interfered significantly. 32% experienced nausea occasionally to almost constantly. Conclusions: The common symptoms of CT were captured FEASIBLY, and found to be highly prevalent in this CT-treated population. Capturing additional symptom prevalence outside of the 7-day time frame may be important from a clinical standpoint. Administration of PRO-CTCAE instrument through tablet technology may be an excellent method to help collect such data systematically and reliably. Updated data on 300 patients will be presented at the meeting. [Table: see text]
An exploratory pilot study of palliative medicine versus anesthesia-pain consultation for cancer pain.
Authors: K. M. Swetz, W. D. Mauck, M. J. Pingree, B. C. Hoelzer, A. J. Haugland, T. J. Moynihan, R. H. Rho
Journal: Journal of Clinical Oncology (2010)

e19564 Background: Cancer-associated symptoms may be well managed by oncologists, though anesthesia-pain medicine (APM) and/or palliative medicine (PM) possess expertise in assessing and treating difficult symptoms. We compared PM vs. APM consultation in patients referred for “cancer pain management.” Methods: Patients referred to Anesthesia Cancer Pain Clinic over an 8-month period were evaluated by PM or APM randomly based on provider availability. PM and APM groups at baseline were comparable. Surveys including MD Anderson Symptom Inventory (MDASI) and Linear Analog Self Assessment were completed by all patients at baseline. Surveys were used by PM providers to assist with symptom and quality of life (QOL) assessment and treatment planning, but were not reviewed by APM providers. Follow up survey was completed by patients in person or by telephone 4-6 weeks after initial encounter as able. Data were analyzed on available-case basis with Wilcoxon Rank Sum test. Results: Sixty-two patients (37 PM, 25 APM, median age 61.2 y) completed initial survey with 48 (31 PM, 17 APM) completing follow up survey (6 unavailable, others expired—median survival 29 d). Mean pain score improved from 8 to 5.4 in PM group (P<0.001), 7.1 to 5.4 in the APM group (p<0.28). Disturbed sleep, anorexia, and mood showed statistically significant improvement in PM group, while others had a trend toward significance. Between PM and APM, a trend toward statistical significance was noted in nausea, disturbed sleep, and walking. PM demonstrated clinical significance (minimal important difference for MDASI = 1.2 point change) with 9/19 symptoms (PM) vs. 2/19 (APM). Twenty-four of 62 patients have since died with median survival 44 d. Conclusions: Cancer patients experience multiple symptoms including pain that adversely impact QOL. Though exploratory in design, these data suggest cancer pain and symptoms, QOL, and goals of care not requiring procedural intervention may be best suited for PM consultation over APM. Collective mortality in both groups was 39% at 157 d (range 6-157 d), suggesting poor prognosis in referred patients. Misconceptions of what PM entails may affect referral pattern; educational efforts are ongoing. No significant financial relationships to disclose.
Safety of concurrent bevacizumab therapy and anticoagulation in high-grade glioma patients.
Authors: J. Bartolomeo, A. D. Norden, J. Drappatz, A. S. Ciampa, L. M. Doherty, D. C. LaFrankie, E. C. Quant, R. Beroukhim, P. Y. Wen
Journal: Journal of Clinical Oncology (2010)

2043 Background: Venous thromboembolic events (VTE) are common in glioblastoma (GBM) patients, and bevacizumab increases the risk of VTE. There is little information on the risk of anticoagulation in GBM patients receiving bevacizumab. One study found that anticoagulation produced 1 symptomatic and 2 asymptomatic hemorrhages in 23 patients receiving bevacizumab (Nghiemphu PL et al. Neuro Oncol. 2008;10:355-360). Methods: We reviewed medical records from 282 bevacizumab-treated patients at our center and identified 64 who received concurrent anticoagulant therapy. The risk and severity of hemorrhagic complications were assessed. Fisher's exact test was used to compare the risk of serious hemorrhage between subjects who received and did not receive anticoagulants. Results: Forty-seven patients (73.4%) had GBM, 15 (23.4%) anaplastic glioma, and 2 (3.1%) other tumors. Thirteen patients (20.3%) received warfarin, 1 (1.6%) fondaparinux, and 50 (78.1%) enoxaparin. The indication was deep venous thrombosis in 37 patients (57.8%), pulmonary embolism in 22 (34.4%), and both in 5 (7.8%). Thirteen patients (20.3%) experienced hemorrhages, of which 7 (10.9%) were intracranial. Four hemorrhages (6.3%) were serious (grade ≥ 3): two (3.1%) were grade 4 intracranial hemorrhages, 1 (1.6%) grade 3 epistaxis, and 1 (1.6%) grade 3 gastrointestinal hemorrhage. Five others (7.8%) were grade 1 intracranial hemorrhages. Among the 218 patients who did not receive anticoagulants, there were 2 (0.9%) serious hemorrhages (both grade 4 intracranial hemorrhages). The serious hemorrhage rate was higher in patients who received anticoagulants (p = 0.025). Conclusions: Anticoagulant use during bevacizumab therapy may increase the risk of serious hemorrhage, although it is generally well tolerated. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech, Schering-Plough
The influence of venous thromboembolism on prognosis of esophageal cancer patients.
Authors: En Amada, Hiroya Takeuchi, Fumihiko Kato, Hirofumi Kawakubo, Kazumasa Fukuda, Rieko Nakamura, Tsunehiro Takahashi, Norihito Wada, Yuko Kitagawa
Journal: Journal of Clinical Oncology (2016)

29 Background: Venous thromboembolism (VTE) is sometimes found in esophageal cancer patients who underwent surgical treatment. VTE contains deep vein thrombosis, pulmonary embolism and catheter-related thrombosis. Our previous study revealed that pre-therapeutic plasma fibrinogen level, C-reactive protein level, adenocarcinoma histology and neck lymph node dissection are the risk factors for venous thromboembolism in patients[Surg Today, 2015]. However, the correlation between VTE and prognosis is not clear in esophageal cancer. We hypothesized that VTE may have an impact on prognosis of esophageal cancer patients. Methods: One hundred and seventy-two patients who underwent radical esophagectomy from March 2008 to December 2012 in our hospital were reviewed in this study. The existence of VTE was assessed from the neck to the pelvis with computed tomography at the initial visit and after neo-adjuvant chemotherapy (NAC) and 6 th postoperative day. The patient and tumor characteristics, neo-adjuvant chemotherapy were compared between patients with VTE (VTE group) and those without VTE (non-VTE group). The primary outcome is disease-free survival (DFS) and the secondary outcome is overall survival (OS). Results: Twenty-one VTE events among 172 patients (12%) were observed. Six of which occurred preoperatively and were considered to be associated with NAC, 14 were detected postoperatively and one occurred just after inserting a peripherally inserted central catheter preoperatively. The VTE group and the non-VTE group have homogenous characteristics in patients’ backgrounds and tumor features. We found no significant difference in median DFS and OS between two groups. However, in patients with pathologically N 0 or 1(7 th edition of UICC TNM classification, n = 157), the median DFS was significantly shorter in VTE group compared with non-VTE group (41 months versus 64 months, p = 0.04). The recurrence risk increased 50.9% in VTE group in comparison with non VTE group (p = 0.048). By using logistic regression analysis, we found that existence of VTE is an independent risk factor with Odd’s ratio 2.964 (p = 0.026). Conclusions: Our study suggests that VTE may be the risk factor for recurrence in esophageal cancer patients.
Health care utilization and economic burden of dermatologic adverse drug reactions (ADRs) in patients with NSCLC treated with an epidermal growth factor receptor inhibitor (EGFRI).
Authors: Vijayveer Bonthapally, Annie Guerin, Eric Q. Wu, Genevieve Gauthier, Martin Cloutier, Kyle D. Holen, Saurabh Ray
Journal: Journal of Clinical Oncology (2012)

e16571 Background: Non Small Cell Lung Cancer (NSCLC) patients treated with EGFRI therapies may develop dermatologic ADRs. ADRs negatively affect patients’ quality of life, require medical care, and may lead to a substantial economic burden. The objective of this study is to assess the economic burden of dermatologic ADRs in patients with NSCLC. Methods: Continuously enrolled adult patients with ≥ 1 NSCLC diagnosis initiated on an EGFRI therapy (i.e., erlotinib, gefitinib) were selected from a large US claims dataset. Patients were classified into two mutually exclusive cohorts depending on whether or not they had dermatologic ADR during the period following EGFRI initiation. Dermatologic ADRs were identified using ICD-9-CM codes. Patients were observed from the index date up to the end of the health plan enrollment, or data availability, or 90 days after the EGFRI discontinuation, whichever occurred first. Incidence rate ratios (IRRs) for healthcare resource utilization were estimated using Poisson regression models. Incremental costs (2010 USD) were estimated on a monthly basis using generalized linear or two-part models. Multivariate regressions controlled for age, gender, comorbidities, and baseline healthcare utilization and costs. Results: A total of 635 and 2,688 patients were included in the dermatologic ADR and ADR-free cohorts, respectively. After adjusting for confounding factors, compared to patients in the ADR-free cohort, patients in the ADR cohort had higher incidence of emergency room visits (IRR=1.28 ( CI 1.13-1.45); p=.0001),higher incidence of outpatient visits (IRR=1.28 (1.25-1.3); p&lt;.0001), and higher incidence of other medical services ( IRR=1.15 (1.11-1.19); p&lt;.0001). Moreover, patients in the ADR cohort incurred higher total healthcare costs by an estimated $3,210 (p=.003) per patient per month. Conclusions: ComparedtoADR-free patients, dermatologic ADR patients with NSCLC incurred a substantial economic burden related to higher healthcare resource utilization and costs. Efforts to improve the dermatologic side effect profile of EGFRI are needed to control this burden.
Chemotherapy ordering and delivery: Rigorously defining and analyzing a complex process employing software engineering techniques
Authors: W. C. Mertens, S. Christov, G. S. Avrunin, L. J. Cassells, B. Chen, D. E. Brown, R. Parisi, L. A. Clarke, L. J. Osterweil
Journal: Journal of Clinical Oncology (2008)

17514 Background: Software engineering tools offer a novel approach to the definition and analysis of complex and defect-prone healthcare processes such as chemotherapy ordering and delivery. Methods: Software engineering researchers and oncologists, nurses, and pharmacists collaboratively defined the processes necessary to order and deliver a first cycle of adjuvant chemotherapy. Discrete procedure steps were precisely defined employing Little-JIL, a language originally created to define software development processes. Process defects were then sought through finite-state verification (using the PROPEL tool to encode constraints on event sequences for specific properties, followed by analysis employing the FLAVERS finite-state verifier), algorithmically evaluating pathways through the process model to determine if any execution of the process violates a pre-specified system property. Results: The chemotherapy order and delivery process is large–more than 250 steps described in Little-JIL notation. Medical processes were often described by terms (“verify”, “confirm”, “check”, etc.) that were used loosely and with different meanings in different contexts, resulting in inconsistency. Consequently, a precise naming glossary was created to reduce ambiguity. Little-JIL uncovered process errors and weaknesses, particularly inconsistencies between articulated and actual processes, as well as medical process guidelines that were insufficiently detailed to handle exception and atypical scenarios. Finite-state verification helped to identify missing/misplaced steps, and helped healthcare professionals think of high-level safety and regulatory goals rather than failure anecdotes and simplistic descriptions. Errors arising from unconventional treatment plans, stale patient parameters, and deadlock scenarios were revealed. Conclusions: Rigorously defining and analyzing healthcare processes led to improved insights into healthcare processes, with errors, inconsistencies, and failure to anticipate and handle exceptions identified. Such robustly-described processes may then be evaluated by other testing approaches, such as fault-tree analysis and discrete event simulation. No significant financial relationships to disclose.
Durability of responses in patients with metastatic renal cell carcinoma treated with high-dose interleukin-2 (HD IL-2).
Authors: Joseph Clark, Michael A. Morse, Michael K.K. Wong, David F. McDermott, Howard Kaufman, Gregory A. Daniels, Jessica C Perritt, Hong Hua, Sandra Aung
Journal: Journal of Clinical Oncology (2016)

511 Background: HD IL-2 is FDA approved for advanced renal cell carcinoma (mRCC), however, the data supporting its use is 23 years old. In 2011, a HD IL-2 patient database was established called PROCLAIM SM , and comprises the largest active prospective collection of data from mRCC and metastatic melanoma (MM) patients receiving HD IL-2 treatment and provides longitudinal real-time insights into the clinical impact of sequencing drug treatments. These data report on the outcomes and interactions with prior targeted therapies in mRCC patients in the current era. Methods: Inclusion criteria require patients to receive at least one dose of HD IL-2. Patients who received HD IL-2 and had already undergone a post-treatment scan were not eligible. Survival analysis was performed by the method of Kaplan and Meier using datasets as of July 27, 2015. Results: The overall response rate (ORR) and median overall survival (mOS) are described in Table 1. The mOS was not reached (NR) for 364 patients. The 1, 2 and 3 year survival rates were 79%, 63%, and 51%, respectively. For patients with stable disease (SD), the mOS was not reached and the 1, 2 and 3 year survival rates were 96%, 80%, and 60% respectively. There was a significant difference in mOS between SD and progressive disease (PD) patients, NR vs 15.5 months, P&lt;.0001. The mOS was not reached for patients regardless of whether or not they received targeted therapy (TT) prior to HD IL-2. There were 4 reported treatment-related deaths in 364 patients (1.1%), none of these patients had prior TT. Conclusions: PROCLAIM data demonstrate that SD, previously grouped with the non-responders, is associated with extended survival rates. HD IL-2 is an active 2 nd line treatment option for patients who have failed TT. These data support that HD IL-2 has a favorable safety profile and remains an effective therapy for eligible patients with mRCC. Clinical trial information: NCT01415167. [Table: see text]
National Radiation Oncology Registry: The pilot prostate cancer registry.
Authors: Jason Alexander Efstathiou, Deborah Nassif, Ronald C. Chen, Karen Elizabeth Hoffman, Deborah A. Kuban, Colleen Anne Lawton, Jeff M. Michalski, Louis Potters, Christopher M. Rose, Howard Mark Sandler, Warren Suh, Terry Wall, Anthony L. Zietman, Justin E. Bekelman
Journal: Journal of Clinical Oncology (2012)

267 Background: The National Radiation Oncology Registry (NROR), sponsored by the Radiation Oncology Institute and the American Society for Radiation Oncology, is building a nationwide electronic infrastructure to collect standardized information on cancer care delivery among patients treated with radiotherapy in the United States. The NROR pilot registry will focus on patients with prostate cancer (PCa). Methods: Since October 2010 the NROR has undertaken four main efforts (1) stakeholder engagement, including hosting a forum with ongoing opportunities for feedback from patients, clinicians, payers, vendors, and federal agencies; (2) electronic infrastructure development to facilitate transfer of information from disparate clinical systems to a database model designed for efficient aggregate analysis; (3) data dictionary development with guidance from PCa and technical experts, and health services researchers; and (4) pilot site engagement, in which over 80 clinical centers indicated willingness to participate in the pilot registry by filling out an online survey. Results: The stakeholder forum revealed enthusiasm for the NROR and emphasized the need for patient-centered outcomes, minimal data burden, and maximal connectivity to existing registries and databases. In partnership with Healthcare IT, Inc, the NROR is building an electronic infrastructure to provide connectivity across radiation oncology and hospital information systems. The data dictionary provides standardized data elements in seven domains: facility characteristics, physician demographics, patient demographics and comorbidity status, radiotherapy technical data for external beam and brachytherapy, hormone therapy details, clinician- and patient-reported outcomes. Up to 30 clinical centers will be selected to serve as pilot sites through an objective, blinded, and transparent process. Pilot registry endpoints include percentage of eligible patients enrolled, percentage of data elements captured for each participant, determination of barriers to participation, and patterns of care delivery. Conclusions: The NROR pilot study will provide the framework for expansion to a nationwide electronic registry for radiation oncology.