tbuckley/cabot-search huggingface dataset:
Retrospective review of pegfilgrastim on-body injector delivery rates in a large health system.
Authors: Peter Stuessy, Federico Augusto Sanchez, Madeline Schober
Journal: Journal of Clinical Oncology (2017)

e18273 Background: Pegfilgrastim is used in patients at significant risk for febrile neutropenia following myelosuppresive chemotherapy. Labeling for pegfilgrastim requires administration the day after administration of chemotherapy. The pegfilgrastim on-body injector allows for delivery at home, without having to return to the clinic. Rates of appropriate delivery of pegfilgrastim via the on-body injector have not been studied in large scale outside of controlled environments. This retrospective review investigates the rate of appropriate delivery of pegfilgrastim via the on-body injector in a large heath system. Methods: Reports were created listing monthly clinic administration of the pegfilgrastim on-body injector at nineteen outpatient cancer care clinics from July 1 st , 2016 to December 31 st , 2016. Patient charts were reviewed for reported non-delivery of the medication. Results: Three hundred eighty-nine injections from 149 patient charts were reviewed. Of these injections, eight were not delivered (non-delivered rate = 2.1%). Four other administrations resulted in only partial dose delivery or unknown if dose was delivered (partial/unknown rate = 1%), leading to a failure rate of 3.1 with an appropriate delivery rate of 96.9%. Conclusions: In one health system’s experience, 96.9% of pegfilgrastim on-body injector administrations were delivered as planned. A process for real time evaluation of delivery rates should be created to address the 3-4% non-delivered dosing.
Abstract 17739: Gender Differences in Fibrotic Remodeling in Patients With Long-Standing Persistent Atrial Fibrillation and Mitral Valve Disease
Authors: Huishan Wang, Zhi Li
Journal: Circulation (2016)

Background: Gender-related differences have been reported in atrial fibrillation (AF); however, their effects on fibrotic remodeling of AF associated with mitral valve disease (MVD) have yet to be explored. Methods and Results: Pulmonary vein sleeves (PVS) from 166 MVD patients with dilated left atria were examined. Among these, 101 patients (female, n=55; male, n=46) had long-standing persistent-AF (LSP-AF), while 65 (female, n=35; male, n=30) had no documented AF (NAF). Clinical characteristics showed no gender differences in left atrial enlargement ratio (LAER) between AF and NAF. Histological analysis revealed that female LSP-AF, rather than male, had a higher degree of fibrosis compared with NAF (female: 29.83%±11.22%vs 20.82% ±14.27%; male: 22.73% ± 10.42% vs 21.90% ± 10.20%). Moreover, the degree of fibrosis showed better predictive values for the presence of LSP-AF in female group (AUC = 0.7, P<0.01) than in male group (AUC = 0.508, P =0.902). Further analysis indicated gender differences in fibro...
Characteristics and outcomes of oncology patients requiring admission to an Australian intensive care unit.
Authors: Aaron Tan, Sarah Freyberg, Meredith Oatley, Alexander David Guminski
Journal: Journal of Clinical Oncology (2017)

e21653 Background: Patients with advanced malignancies have historically been considered poor candidates for the intensive care unit (ICU), however survival and prognosis is continually improving and requirements for use of intensive care services is increasing. This study aimed to understand the characteristics and outcomes of oncology patients admitted to an Australian ICU and identify potential prognostic factors. Methods: A single-centre, retrospective, cohort study was conducted at Royal North Shore Hospital, a tertiary public hospital in Sydney, Australia with a 58-bed quaternary ICU. All patients aged &gt; 18 years, admitted under the medical oncology team requiring ICU admission between June 2014 and June 2016 were evaluated. Data collected included basic demographics, cancer type and status, performance status (ECOG) and co-morbidities (ACE-27 score). Clinical outcomes were determined including ICU and hospital mortality, requirements (ventilation, dialysis, vasopressors, infection) and APACHE II scores. Results: There were 96 patients admitted to the ICU during the study period. Mean age was 61 years, 58% were male and 76% had metastatic disease. Most patients were receiving palliative treatment (89%), with recent chemotherapy (43%), immunotherapy (10%) and other therapies (5%). Of the 10 patients with recent immunotherapy, three (all melanoma) required ICU admission due to immunotoxicity with all three alive at time of data collection (mean 222 days follow-up). 13% were admitted due to an oncological emergency. Most common primary tumour site was thoracic (20%), genitourinary (11%), breast (10%) and melanoma (10%). Mean APACHE II score was 17 (SD 5.33), mean SOFA score was 4 (SD 2.70), ICU mortality was 5% and hospital mortality was 22%. For the 75 patients (78%) discharged from hospital, 42 (56%) were still alive at time of data collection (mean 321 days follow-up). Conclusions: Our patient population had good short-term outcomes for survival despite most receiving palliative treatment, although prognostic scores were also favourable. This suggests cancer patients can achieve positive outcomes after ICU admission with appropriate selection of patients crucial.
Soft-tissue sarcomas in adults: Consultation analysis.
Authors: Rosa Haydee Vassallo
Journal: Journal of Clinical Oncology (2018)

e23572 Background: Soft-tissue sarcomas are a rare heterogeneous group of malignant tumors. They originate in the mesodermal leaf and affect the soft tissues (fatty tissue, muscle, tendons, blood vessels, nerves and deep tissues of the skin). It is a heterogeneous disease in its histology with more than 50 subtypes. Because of the infrequent occurrence of the disease, its management is case by case by a interdisciplinary team. Methods: The present study is descriptive. It includes all patients older than 17 years with a diagnosis of soft tissue sarcoma who attended consultation in the Bone Tumors, Skin and Soft Tissue Unit at the Institute of Oncology ¨Dr. Heriberto Pieter¨ from September 2016 to April 2017. Patients with Kaposi sarcomas, GIST, Rhabdomyosarcomas, Ewing Tumors and patients younger than 17 years were excluded. The data obtained was processed in Epi Info and the results presented in graphs and tables. Results: From the sample of patients, 94 corresponded to adult soft tissue sarcomas, 75 were follow-up consultations (79.79%) and 19 first-time consultations (20.21%). The most frequent age of presentation was 41-50 years (23.40%), 51-60 years (20.21%) and 31-40 years (19.15%). The most affected gender was female (59.57%). The most frequent anatomic location was the extremities (55.32%), trunk and pelvis (15.96%) and head and neck (13.83%). Clinical stage III was the most frequent (37.23%), IA and IB were respectively 20.21% and 13.83%. The most frequent sarcomas were fibrous tissue (36.11%), unknown histogenesis (20.21%), and adipose tissue (19.16%). From the total sample, 71 patients (37.77%) underwent wide resection, 14 patients (7.45%) amputation, and 3 patients (1.60%) metastasis resection. Furthermore, 55.3% of patients received chemotherapy. Of these, 56.89% was adjuvant, 10.34% was neoadjuvant and 32.75% of cases were metastatic and / or unresectable disease. Total survival was 87%, with 58.5% of patients alive and disease-free, and 34.0% alive with disease. Conclusions: Based on our analysis, we see that treatment priority should focus on clinical stage III. Survival rates could be improved by a multidisciplinary approach including neoadjuvant chemotherapy, surgery, and post-surgery radiotherapy, specially in low-grade sarcoma.
TCT-107 Patient-Centered Decision-Making of Revascularization Strategy for Left Main or Multi-Vessel Coronary Artery Disease in Real-World Practice
Authors: Choongki Kim, Sung-Jin Hong, Chul-Min Ahn, Jung-Sun Kim, Byeong-Keuk Kim, Young-Guk Ko, Donghoon Choi, Yangsoo Jang, Myeong-Ki Hong
Journal: Journal of the American College of Cardiology (2018)
Idarubicin and cytarabine with clofarabine or fludarabine in adults with newly diagnosed acute myeloid leukemia: Updated results of a randomized phase II study.
Authors: Ghayas C. Issa, Hagop M. Kantarjian, Nicholas James Short, Farhad Ravandi, Xuelin Huang, Guillermo Garcia-Manero, William Plunkett, Varsha Gandhi, Naveen Pemmaraju, Naval Guastad Daver, Gautam Borthakur, Nitin Jain, Marina Konopleva, Zeev Estrov, Tapan M. Kadia, Courtney Denton Dinardo, Mark Brandt, Susan Mary O'Brien, Jorge E. Cortes, Elias Jabbour
Journal: Journal of Clinical Oncology (2017)

7037 Background: The purine nucleoside analogues fludarabine and clofarabine are effective agents in the treatment of acute myeloid leukemia (AML). This study evaluated the efficacy and safety of combining idarubicin and cytarabine with either clofarabine (CIA) or fludarabine (FIA) in adults with newly diagnosed AML. Methods: Using a Bayesian adaptive design, patients (pts) deemed suitable for intensive chemotherapy were randomized to receive CIA (n = 106) or FIA (n = 76). All pts received idarubicin 10 mg/m 2 IV daily on Days 1-3 and cytarabine 1 g/m 2 IV daily on Days 1-5. Clofarabine and fludarabine were given at 15 mg/m 2 and 30 mg/m 2 , respectively, IV daily on Days 1-5. Pts with FLT3 mutations could receive sorafenib. Up to 6 cycles of consolidation were allowed for responding pts. Results: Baseline characteristics were similar comparing CIA to FIA with a median age of 53 years (range, 20-66) vs 49 years (range, 18-66) respectively and ELN risk intermediate-2/adverse of 57% and 58% respectively. With a median follow-up of 27 months (range, 1-58), the CIA and FIA arms had a similar CR/CRp rate (80% and 82%, respectively). MRD negativity rate by multiparameter flow cytometry at the time of CR/CRp was higher comparing CIA to FIA (80% vs. 65%, respectively, P = 0.07). The median EFS were 13 months and 12 months, respectively (P = 0.91), and the median OS were 24 months and not reached, respectively (P = 0.23). There were more adverse events (all grades) associated with CIA, particularly AST/ALT elevation (29% vs 4%), hyperbilirubinemia (26% vs 9%) and rash (31% vs 9%). Early mortality was similar in the 2 arms (60-day mortality: 4% for CIA vs 1% for FIA; P = 0.32). Comparing the 2 arms to a historical cohort of pts treated with IA showed similar response rates, EFS and OS excluding pts with FLT3 mutations from this analysis. However, in pts &lt; 50 years of age, FIA was associated with improved survival compared with IA (2-year EFS rate: 58% vs 30%, P = 0.05; 2-year OS rate: 72% vs 36%; P = 0.009). Conclusions: CIA and FIA have similar efficacy in younger pts with newly diagnosed AML. FIA is associated with a better toxicity profile and may improve survival compared to IA in pts &lt; 50 years of age. Clinical trial information: NCT01289457.
Dendritic-cell vaccine (DCVAC) with first-line chemotherapy in patients with stage IV NSCLC: Final analysis of phase II, open label, randomized, multicenter trial.
Authors: Libor Havel, Vitezslav Kolek, Milos Pesek, Markéta Cernovská, Jirina Bartunkova, Radek Spisek, Ladislav Pecen, Inna Krasnopolskaya, Milada Zemanova
Journal: Journal of Clinical Oncology (2019)

9039 Background: Immunotherapy aiming the induction of tumor cell specific immune responses controlling the tumor growth, has emerged as a promising treatment modality in lung cancer(LuCa). Autologous DCVAC can present tumor antigens to elicit a durable immune response. We hypothesized that adding DCVAC to the standard of care chemotherapy (ct) could prolong overall survival (OS) and progression-free survival (PFS). Methods: This study evaluated the efficacy and safety of DCVAC/LuCa (active cellular immunotherapy based on dendritic cells) concomitantly added to ct (carboplatin/paclitaxel) - Arm A (A) vs DCVAC/LuCa + immune modulators (IFN-α and hydroxychloroquine) - Arm B (B)+ct vs ct - Arm C (C) in NSCLC patients (pts). Randomization 1:1:1; pts in A and B received up to 15 doses of DCVAC, ct was given 4-6 cycles in A and C. Stage IV NSCLC was confirmed histologically or cytologically, ECOG 0-1 pts were eligible. Stratification was done by histology subtype and smoking history. Primary efficacy analysis compared A vs C only as enrollment to B was closed early based on Sponsor’s assessment of further clinical development potential, there were no safety concerns or signals. Results: 112 pts at 12 sites were randomized (A/45 B/29 C/38). Patients characteristics were comparable across the study groups with the exception of gender (m/f, %: 65/35 (A) and 74/26 (C) and smoking history (75 % of smokers in A, 97 % in C). Median follow up time was 25.8 months, range 0.1-41.8. Median OS was 15.5 months in A compared to 11.8 months in C, hazard ratio (HR) 0.55, p-value 0.0232, 95% CI [0.33, 0,93], data maturity 77%. Median PFS was 6.74 in A and 5.63 months in C, HR 0.59, p-value 0.0415, 95% CI [0.36, 0.99], data maturity 86%. Overall response rate was 45% in A vs 34% in C. Most TEAEs were related to ct (anemia [35%-A, 32%-C], neutropenia [48% in A, 21%-C], thrombocytopenia [25% in A, 27% in C]). There were no grade ≥ 3 TEAEs solely related to DCVAC. Most common leukapheresis (lp)-related AE was vomiting in 2 pts out of 67 pts undergone lp. Conclusions: Addition of DCVAC-based immunotherapy to the standard of care chemotherapy significantly improved OS in stage IV NSCLC. Clinical trial information: NCT02470468.
Cardiovascular screening of Paralympic athletes reported by chief medical officers of the PyeongChang 2018 Paralympic Winter Games
Authors: Brett G Toresdahl, Cheri Blauwet, Cindy J Chang, Daphne I Ling, Irfan M Asif
Journal: British Journal of Sports Medicine (2018)

The 2009 IOC Consensus Statement on Periodic Health Evaluation (PHE) of Elite Athletes recommends a 12-lead ECG, but the frequency of the PHE elements is not defined.1 In 2011, the International Paralympic Committee (IPC) approved the IPC Medical Code, which describes the need for routine PHE based on the latest medical knowledge.2 However, the components and frequency of screening are also not delineated. Recent research has evaluated the cardiovascular (CV) screening practices of Olympic athletes, but there are limited data regarding CV screening of Paralympic athletes.3 4 

This study aimed to investigate current practices for CV screening of Paralympic athletes. Chief medical officers (CMOs) for National Paralympic Committees of the PyeongChang 2018 Paralympic Winter Games were identified by the IPC and surveyed regarding the CV screening practices of their respective teams. The primary outcome was the utilisation of CV screening components as part of the PHE. The secondary outcomes were the frequency of performing the CV screening components.

A total of 35 of the 49 (71.4%) countries …
Magnetic Tracer System Identifies Sentinel Lymph Nodes
Authors: Rebecca Voelker
Journal: JAMA (2018)

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A targeted next generation sequencing assay to characterize relevant cancer variants in solid tumor samples.
Authors: Vinay Kumar Mittal, Scott Myrand, Paul D Williams, David Chi, Santhoshi Bandla, Geoffrey Bien, Rajesh Gottimukkala, Fiona Hyland, James Veitch, Armand Bankhead, Thomas Ha, Jeremy Heath, You Korlann, Yuan-Chieh Ku, Sophie Rozenzhak, Madison Taylor, Warren Tom, Vanessa Lacey, Kate Rhodes, Seth Sadis
Journal: Journal of Clinical Oncology (2016)

e23224 Background: Development of scalable and cost-effective NGS solutions to accurately assess relevant genomic alterations is necessary to support translational research and a future precision oncology paradigm. Herein, we characterize the Oncomine Focus Assay, an integrative NGS assay for the detection of relevant alterations in 52 cancer genes in a retrospectively collected cohort of 127 samples. Methods: Sections from 127 FFPE blocks of solid tumor samples were distributed to four laboratories where DNA/RNA (10 ng each) were isolated; libraries were prepared and independently sequenced on the Ion Torrent PGM sequencer. Sequencing data was processed using Torrent Suite software and variant detection/annotation was performed using the Oncomine Focus Assay workflow in Ion Reporter software. Results: Ninety-six samples (115 unique IDs) passed a sample level quality control (base uniformity > 80%) across all laboratories. Median read coverage for hotspot amplicons was > 2,000X and < 0.5% of sample amplicon reads were < 350X. The most frequently mutated genes in these tumor samples included PIK3CA (15%), KRAS (13%), and EGFR (6%). Observed alternate allele frequencies were highly concordant across laboratories and closely matched the estimated alternate allele frequency determined by Sanger sequencing in all cases. Analysis of copy number (CN) data revealed frequent CN gains observed in CCND1 (8%), MYC (7%), and FGFR1 (2.5%). A subset of 19 samples was further characterized using fluorescent in situ hybridization to validate the predicted copy number gains observed by NGS. Overall, the NGS method displayed 97% and 94% sensitivity to detect CN > 8 or > 6, respectively. From the RNA component of the cohort, a total of six driver fusions were identified in ROS1, MET and EGFR. Fusion positive samples were confirmed using qPCR. Conclusions: Our study demonstrated the feasibility of a targeted NGS-based assay for genomic profiling of tumor samples. Detection of highly recurrent and relevant mutations, and their validation through orthogonal testing demonstrated that the Oncomine Focus Assay was reproducible and accurate.
Circulating cell-free tumor DNA (cfDNA) testing in small cell lung cancer.
Authors: Daniel Morgensztern, Siddhartha Hk Devarakonda, Ashiq Masood, Saiama Naheed Waqar, Alicia C Carmack, Kimberly C. Banks, Richard Burnham Lanman, Ramaswamy Govindan
Journal: Journal of Clinical Oncology (2016)

e23077 Background: The diagnosis of small cell lung cancer (SCLC) is often made using fine needle aspiration or small biopsy specimens, which may be insufficient for next generation sequencing (NGS). Guardant360 (G360), a blood-based liquid biopsy that analyzes circulating tumor DNA, may allow the detection of targetable gene abnormalities without the need for repeated biopsies. Methods: Peripheral blood samples from patients with SCLC were collected in two 10 mL tubes and cell-free DNA was analyzed by digital sequencing for the detection of single nucleotide variants (SNVs), copy number amplifications (CNAs), indels, and fusions. The Tumor Alterations Relevant for Genomics Driven Therapy (TARGET) curated database (http://www.broadinstitute.org/cancer/cga/target) was queried for potentially actionable mutations. Results: 143 consecutive samples from 134 de-identified patients were collected between June 2014 and December 2015. 6 patients had more than one sample. During the accrual time, the number of genes evaluated increased from 54 (6 tests) to 68 (98 tests) and finally to 70 (43 tests). The median time from collection to report was 15 days (range 9-27 days). Alterations in at least one gene were found in 132 (92.3%) of samples and 124 (92.5%) of patients. Inactivating mutations in TP53 and RB1 were seen in 70% and 32% of patients with detectable alterations respectively. Potentially targetable alterations were observed in 66 patients (49%). Amplifications in CCNE1 (12.0%) and FGFR1 (8.6%), and PIK3CAmutation (6.7%) were the most common potentially targetable alterations. Conclusions: G360 is non-invasive and rapid sequencing method, which may be particularly useful in patients with advanced stage SCLC where archival tissue samples may be suboptimal for NGS or no longer reflective of an evolving genomic profile. Due to the limited treatment options in this patient population, G360 may provide valuable information to guide treatment decisions.
Comparison of clinical characteristics and survival of metastatic breast cancer patients in United States according to insurance status as compared to outcomes in Canada.
Authors: Adriana Reis Brandao Matutino, Allan Andresson Lima Pereira, Elizabeth Kornaga, Sasha M. Lupichuk, Sunil Verma
Journal: Journal of Clinical Oncology (2018)

e18617 Background: Insurance status affects cancer survival in the US. In the Canadian system, health care access is similar for the whole population. The purpose of this study was to compare clinical characteristics and survival of metastatic breast cancer (MBC) patients in a Canadian province and in the US according to insurance status. Methods: US SEER and the Breast Data Mart, Alberta, Canada data were queried to obtain 20 to 64yo pts diagnosed with MBC from 2007-2012. Pts ≥65yo were excluded due to unreliable insurance status classification in the US. OS curves were calculated using the Kaplan-Meier method and the 50th percentile was estimated. Differences in OS were assessed with the log-rank test. Multivariate analysis was performed using the Cox proportional hazards model. Results: 10,927 pts from SEER and 392 pts from Canada were included. Most common age group among US and Canada pts was 60-64y (23.9%; 24.8%). Most common breast subtype in the US and Canada was HR+HER2- (58%; 61%), followed by any HER2+ (28%; 31%) and TN (15%; 8%). Median follow-up was 32m. Median OS in Canada was shorter than in insured (27.4 vs 36m), similar to Medicaid (27.4 vs 24m) and all groups had longer OS than uninsured (18m, P < 0.001). An adjusted Cox regression yielded the same results, with a worse OS in Canada relative to insured [HR = 0.71 95%CI 0.63-0.8 P < 0.001], similar OS to Medicaid [HR = 1.02 95%CI 0.90-1.15 P = 0.78] and better OS than uninsured [HR = 1.23 95%CI 1.12-1.5 P = 0.0005]. In subgroup analysis based on breast subtype, shortest Canadian median OS was for TN (15.2m), followed by HR+HER2- (30.9m), HR+HER2+ (44.3m) and HR-HER2+ (51.4m, P = 0.37). In the US, shortest median OS was from TN (13m), followed by HR-HER2+ (33m), HR+HER2- (39m) and HR+HER2+ (45m, P < 0.0001). Conclusions: Among MBC patients in the selected population, the Canadian group resembled the US Medicaid group for survival outcomes. In the US population, Medicaid and uninsured patients experienced worse survival when compared to insured.
コンプレックス細分化心房電位図(CFE)のアブレーションに対する組織的受動活性化領域へのベプリジルの予備投与
Authors: Aoyagi Hideshi, Azegami Koji, Sugiyama Koji, Kanda Shigetaka, Ueshima Daisuke, Shimabuku Tsukasa, Kurabayashi Manabu, Miwa Naoyuki, Yoshimura Kojiro, Keida Takehiko, Okishige Kaoru
Journal: Circulation (2011)