tbuckley/cabot-search huggingface dataset:
Coordination and timeliness of care by insurance status in a gastrointestinal (GI) multidisciplinary care (MDC) program.
Authors: Laurence E. McCahill, Jamie Kokko, Alan T. Davis, Wendy K. Taylor, Coralyn Martinez, Mary May
Journal: Journal of Clinical Oncology (2012)

272 Background: Patients with newly diagnosed GI cancers require diagnostic studies and evaluations by physicians that may delay initiation of cancer care. Uninsured populations are particularly vulnerable. A Nurse Navigator (NN) can help decrease barriers and improve timeliness of care. This study aims to compare timeliness of cancer care received by patients referred to a GI MDC Program by the patient’s insurance status at the time of referral. Methods: Patients referred to the GI MDC are assigned a NN who evaluates medical history, diagnostic studies, and coordinates further testing and physician evaluations. Timeliness measures assessing milestones in cancer care initiation are collected prospectively. Descriptive statistics are presented and average times for measures are compared by insurance status (insured vs. uninsured) using t-tests, chi-square tests, and the Fisher’s Exact test. Results: 366 patients were evaluated between January 2010 and June 2012. 70% (255/366) were for new cancer diagnoses. Median age of cancer patients was 64 years (range 29-94), 63.1% of patients were male, and 94.1% of patients had insurance. Major cancer diagnosis types were colon/rectal (19.2%), esophageal/gastric (25.1%), hepatobiliary (12.8%) and pancreatic/ampullary/duodenal (35.7%) and 1.6% other. The table describes timeliness and care coordination measures by insurance status. Conclusions: Uninsured cancer patients in our health system appear to receive care in a timely fashion which does not differ from patients with insurance. The impact of a dedicated GI NN in avoiding disparate care for uninsured warrants further study. [Table: see text]
Usability evaluation of HemOnc.org, a collaborative online hematology/oncology reference.
Authors: Peter C. Yang, Andrew Cowan, Jeremy Warner
Journal: Journal of Clinical Oncology (2013)

244 Background: With an ever-growing body of medical knowledge, open access to accurate information is critical to quality care. HemOnc.org is a free online collaborative wiki created by health care professionals to record, access, and share information about chemotherapy treatment regimens and drugs. As of June 2013, the site contains referenced information for 931 regimens and 316 drugs. The site receives &gt;7,000 visits/mo and has had &gt;425,000 total page views from around the world (29% from outside the United States). We conducted a survey to evaluate the usability of the site. Methods: The survey was open May 1 to May 31, 2013. Participants were invited by site announcements, social media, and emails to hematology/oncology fellowship programs. Usability was assessed by 100-point scales (higher = better). Other data were collected via multiple choice questions with optional free text entry. Results: There were 139 respondents; demographics are shown in the Table. They felt that the site was useful (median 90, interquartile range (IQR) 76-99.5), usable (median 85, IQR 69-98), and recommendable to colleagues (median 87, IQR 72-99). Although 100% of users reported using other references (e.g. textbooks), 70.5% reported accuracy issues with these references (Table). Conclusions: HemOnc.org provides a new way to access and share curated knowledge. No resource is 100% accurate, but the open and transparent nature of the site allows users to actively correct errors and inconsistencies. Feedback has been positive, suggesting that an unmet need for information is being satisfied. Our goal is to improve collaboration, foster greater knowledge sharing among the oncology community, and improve quality of care through open dissemination of accurate information to a widespread audience. [Table: see text]
Targeted temperature management after intraoperative cardiac arrest: a multicenter retrospective study
Authors: Anne-Laure Constant, Nicolas Mongardon, Quentin Morelot, Nicolas Pichon, David Grimaldi, Lauriane Bordenave, Alexis Soummer, Bertrand Sauneuf, Sybille Merceron, Sylvie Ricome, Benoit Misset, Cedric Bruel, David Schnell, Julie Boisramé-Helms, Etienne Dubuisson, Jennifer Brunet, Sigismond Lasocki, Pierrick Cronier, Belaid Bouhemad, Serge Carreira, Emmanuelle Begot, Benoit Vandenbunder, Gilles Dhonneur, Philippe Jullien, Matthieu Resche-Rigon, Jean-Pierre Bedos, Claire Montlahuc, Stephane Legriel
Journal: Intensive Care Medicine (2017)
Phase II trial of combined chemotherapy with S-1, oral leucovorin, and bevacizumab in heavily pretreated patients with metastatic colorectal cancer.
Authors: Kazuhisa Yamaguchi, Hiroya Taniguchi, Azusa Komori, Yukiya Narita, Shiori Uegaki, Sohei Nitta, Motoo Nomura, Shigenori Kadowaki, Daisuke Takahari, Takashi Ura, Masashi Andoh, Kei Muro
Journal: Journal of Clinical Oncology (2014)

627 Background: Regorafenib improves survival in refractory metastatic colorectal cancer (mCRC), but alternative chemotherapy is required to avoid severe toxicity. S-1+oral leucovorin (SL) has shown promising results in untreated mCRC without severe toxicity. TML trial demonstrated that continuation of bevacizumab (Bev) after progression prolongs overall survival. Thus, we hypothesized that combination chemotherapy of SL/Bev would be beneficial; we conducted a single-center phase II trial to assess the efficacy and safety of SL/Bev as a salvage therapy in mCRC. Methods: Major eligibility criteria were: mCRC with confirmed adenocarcinoma diagnosis; age &gt; 20 years; ECOG performance status, 0–2; and progression after administration or intolerance to approved drugs for mCRC (5-FU, oxaliplatin, irinotecan, Bev, and anti-EGFR antibody, if KRAS wild-type). S-1 (80–120 mg/body) and leucovorin (25 mg) were orally administered for 1 week followed by 1 week rest. Bev (5 mg/kg) was administered on day 1 of every 2-week cycle. Primary endpoint was disease control rate (DCR). Results: Twenty-three patients were enrolled: 8 (35%) females; median age, 70 years (range, 38–78); and 14 (61%) with KRAS wild-type. DCR was 65% [95% confidence interval (CI), 41.3–82.7%] and response rate was 6% (95% CI, 1.1–27.0%). One patient experiencing partial response to SL/Bev had BRAF mutant tumor with primary resistance to XELOX+Bev as first-line and irinotecan+cetuximab as second-line chemotherapy. Median progression-free and overall survival period were 4.1 and 9.5 months, respectively. Major adverse events were mucositis, (grade 3, 12%), diarrhea (grade 3, 12%), and decreased hemoglobin (grade 3, 12%). Conclusions: SL/Bev was well tolerated and delayed progression; therefore, it can be an alternative chemotherapy for refractory mCRC. We will report the data from final analysis at the meeting. Clinical trial information: 000009083.
Cosmesis from the viewpoint of patients who underwent breast-conserving therapy
Authors: H. Nakayama, K. Tokuuye, N. Kakuta, I. Morishima, Y. Tanaka, S. Mitsuhashi, A. Ishikawa
Journal: Journal of Clinical Oncology (2005)

8148 Background: Cosmesis from the viewpoint of patients after breast-conserving therapy is not always the same as that from the doctor’s appraisal. To examine patients’ satisfaction after the therapy, a patient survey was performed to determine what factors affected satisfaction of cosmesis. Methods: One hundred sixty relapse-free patients who underwent breast-conserving therapy between 1999 and 2004 at Tsukuba Medical Center in Tsukuba, Japan, were evaluated. The patient survey included questions about the quality of cosmesis in terms of breast size, deformity, nipple displacement, firmness, color of the irradiated skin and visibility of the scar in comparison with the untreated breast. The survey which employed a four point scale between good and poor was asked by three nurses. The mean patients’ age was 51.9±9.6 years old. Of the 160 patients, 101 received radiotherapy of 60 Gy or more with 2 Gy per fraction and the remaining 59 received less than 60 Gy. One hundred and one patients had a tumor stage of Tis/T1 and 59 had that of T2. Lumpectomy, quadrantectomy and re-excision were performed in 114, 46 and 21 patients, respectively. Axillary node dissections were performed in all patients. The mean scar length was 22.9±18.4 mm. Adjuvant chemotherapy CAF or CMF was administered in 67 patients. Results: The median follow up time was 6.0±2.3 months. One hundred one patients evaluated their cosmesis as good, and 59 as poor. A radiation dose of 60 Gy or more (hazard ratio 2.85, P<0.001) and re-excision (hazard ratio 1.95, P<0.05) were statistically significantly poor cosmetic factors. Age, administered chemotherapy, administered hormone therapy, length of scars, tumor size, breast size before breast conserving-surgery and position of tumor in breast were not statistically significantly different. Conclusions: A high radiation dose of 60 Gy or more was a poor cosmetic factor during the short observation period. The long-term effect of radiation dose on cosmesis needs to be observed further. No significant financial relationships to disclose.
Effect of human insulin on breast cancer risk in Taiwanese women with type 2 diabetes.
Authors: Chin-Hsiao Tseng
Journal: Journal of Clinical Oncology (2014)

43 Background: Whether human insulin may induce breast cancer is rarely studied. Methods: The reimbursement databases of all Taiwanese patients with diabetes from 1996 to 2009 were retrieved from the National Health Insurance. An entry date was set at January 1, 2004 and a total of 482,065 women with type 2 diabetes were followed up for breast-cancer incidence until the end of 2009. Incidences for ever-users, never-users, and subgroups of human insulin exposure (using tertile cutoffs of cumulative dose and cumulative duration of insulin) were calculated and the multivariable-adjusted hazard ratios were estimated by Cox regression. Results: There were 59,830 ever-users and 422,235 never-users, with respective numbers of incident breast cancer of 559 (0.93%) and 4,711 (1.12%), and respective incidence of 207.7 and 215.1 per 100,000 person-years. The overall adjusted hazard ratios (95% confidence intervals) did not show a significant association with insulin [1.098 (0.994-1.212)]. However, significant trends for the different categories of the dose-responsive parameters were observed. Patients in the third tertiles consistently showed a significantly higher risk of breast cancer compared to never-users: 1.339 (1.164-1.540) and 1.331 (1.158-1.531) for ≥ 39,000 units for cumulative dose of insulin, and ≥ 21.8 months for cumulative duration of insulin, respectively. Conclusions: This study discloses a significantly higher risk of breast cancer associated with the use of human insulin, demonstrating a significant dose-responsive relationship.
The Cancer Therapy Evaluation Program’s (CTEP) implementation of the Operational Efficiency Working Group (OEWG) recommendations.
Authors: K. DiPiazza, E. Souhan, S. Finnigan, A. Denicoff, S. Friedman, M. Montello, M. M. Mooney, P. Schettino, J. A. Zwiebel, J. H. Doroshow, J. S. Abrams
Journal: Journal of Clinical Oncology (2011)

6113 Background: In March 2010, the OEWG recommended strategies to decrease the activation time for NCI-sponsored clinical trials. A major element of the recommendations was the establishment of target timelines (210 days for phase I and II, 300 days for phase III) and absolute deadlines (540 days for phase I and II, 730 days for phase III) for studies to go from study submission to trial activation (i.e., open for patient enrollment). In response to the OEWG recommendations CTEP established new policies and procedures to streamline the protocol development process. Methods: CTEP hired Project Managers to track studies from submission through activation, developed a secure website to allow investigators real-time milestone monitoring, and instituted routine conference calls between CTEP reviewers and investigators at key timeline points to quickly resolve issues and decrease revisions. Also, CTEP’s enforcement of the absolute deadlines began on 1/1/11. Results: Since 4/1/10, 161 studies have been submitted and 196 conference calls have occurred. Of 122 studies with an absolute deadline of 1/1/11, 67% were activated before the deadline. The remaining studies were disapproved (1), withdrawn (30), given transition phase exceptions (6), or terminated for failure to meet the OEWG deadline (3). Preliminary data below shows an overall decrease in timelines. Conclusions: There is early evidence of timeline reduction since implementation of the OEWG recommendations. Updated results will be presented on timelines for all stages of protocol development and trial activation, including number of revisions required. Pre-OEWG Post-OEWG Phase III trials (Median days) Concept: receipt–approval 86 58 Concept approval–protocol receipt 138 * Protocol receipt–trial activation 497 * Large phase II trials Concept: Receipt–Approval New category post-OEWG, comparison N/A 64 Concept approval–Protocol receipt 76 Protocol receipt–Trial activation * Letters of intent for early phase I and II trials LOI: Receipt–Approval 1131 942 461 572 LOI approval–Protocol receipt 731 532 601 602 Protocol receipt–Trial activation 2851 2842 * * Not yet available.1 Cooperative group data. 2 Non-cooperative group data.
Matched pair analysis to examine the effects of a planned preoperative exercise program in early gastric cancer patients with metabolic syndrome to reduce operative risk: The Adjuvant Exercise for General Elective Surgery (AEGES) study group.
Authors: Haruhiko Cho, Takaki Yoshikawa, Mari Saito Oba, Naoki Hirabayashi, Junya Shirai, Toru Aoyama, Tsutomu Hayashi, Takanobu Yamada, Koji Oba, Akira Tsuburaya, Junichi Sakamoto
Journal: Journal of Clinical Oncology (2014)

166 Background: Since obesity is a risk factor during surgery, the effects of a preoperative exercise program to reduce the incidence of peri- and postoperative complications in patients with a high BMI (&gt; 25) and metabolic syndrome were investigated. An assessment of the effects of prospectively planned preoperative exercise was performed in a prospective matching study comparing an exercise testing group and a usual preoperative preparation group who underwent gastrectomy for gastric cancer in Japan. Methods: Stage I gastric cancer patients with metabolic syndrome diagnosed according to the criteria of the Japanese Ministry of Health, Labour and Welfare were enrolled in a surgery after preoperative exercise group. The control group was selected from a database using an individual matching approach for surgery, sex, weight, BMI, volume of visceral fat and institution. The primary end point was the frequency of postoperative complications (cardiovascular events, pneumonia, surgery-related abdominal complications, etc.). Results: A total of 72 patients (54 in the surgery alone group, 18 in the preoperative exercise group) were analyzed. The median operative time and amount of bleeding were 208 min and 130 ml in the surgery alone group and 248 min and 105 ml in the exercise group, respectively. Postoperative complications occurred in one case (5.5%) in the exercise group and 22 (40.7%) cases in the surgery alone group. Conclusions: Preoperative exercise is safe, and its benefits in reducing postoperative complications are promising and therefore warrant further investigation.
Non-invasive volatile organic compound analysis from exhaled breath for the diagnosis of gastroesophageal cancer.
Authors: Sheraz Markar, George Hanna
Journal: Journal of Clinical Oncology (2015)

TPS225 Background: The work carried out in our laboratory using Selective Ion Flow-Tube Mass Spectrometry (SIFT-MS) analysis of volatile organic compounds (VOCs) in exhaled breath has identified compounds that can differentiate gastro-esophageal cancer from non-cancer patients. A model has been developed based on 220 patients with upper gastrointestinal pathology (81 cancer, 88 positive control and 51 patients with endoscopically normal gastrointestinal tract). Methods: Clinical trial registry number: 14/LO/1136. Study 1: Refinement of VOC exhaled breath model. Exhaled breath from 120 patients undergoing diagnostic lower endoscopy for the investigation of gastrointestinal symptoms will be used to refine the existing model by studying the influence of lower gastrointestinal diseases and in particular colorectal cancer, upon VOC analysis. To date 94 patients have been recruited. Study 2: Blinded validation multi-centre study for the use of exhaled Breath SIFT-MS analysis to predict gastro-esophageal cancer. This study will be conducted across four centers and will utilize SIFT-MS exhaled breath analysis, for comparison of predicted cancer risk based upon the VOC exhaled breath model compared to endoscopic findings and histology biopsies in order to determine the overall diagnostic accuracy for this non-invasive test. Sample Size – Based upon a prevalence of cancer of 50% in the study population and maintaining a sensitivity and specificity of 80% for the diagnostic model derived from our previous research, the sample size estimated is 325 patients. Inclusion criteria:Patients with upper gastrointestinal symptoms attending for endoscopy or surgery. Exclusion criteria: Patients with a documented active infection or liver disease. Statistical methods: Comparison of predicted cancer risk and actual OGD findings or histology from endoscopic biopsies will then be made, and the overall diagnostic accuracy (sensitivity, specificity, positive and negative predictive value, ROC curve analysis) for this non-invasive diagnostic investigation will be determined. Deliverables: The diagnostic accuracy of the exhaled breath test for the prediction of oesophago-gastric cancer. Clinical trial information: 14/LO/1136.
Mortality among women diagnosed with stage II or III breast cancer based on SEER-Medicare data.
Authors: Rohini Khorana Hernandez, Alexander Liede, Shuling Li, Jiannong Liu, Yan Hu, Scott Stryker, Anne Hudson Blaes, Allan J Collins
Journal: Journal of Clinical Oncology (2014)

111 Background: Increasing emphasis on assessing the quality of treatment (tx) for cancer patients highlights the need for real-world data sets that can address critical policy questions about cancer care in the US. This study examined treatment and mortality in women with incident early-stage breast cancer (BC) 2007-2009 using the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data. Methods: We identified women age ≥66 years at the diagnosis of AJCC stage II/III BC between 2007-2009, who received surgery and were enrolled with Medicare Parts A and B. Women were followed from definitive surgery until the end of 2010, death, or change in enrollment status. Risk (cumulative incidence proportion [CIP]) of all-cause death was calculated with 95% confidence intervals (CI) using the Kaplan-Meier method stratified by tumor characteristics and tx type. Results: The cohort included 10,048 women with stage II (78%) or III (22%); 58% were ≥75 years and 78% had hormone-receptor (HR) positive tumors (77% ER positive, 64% PR positive). After the definitive surgery, 1,271 deaths reflected a CIP of 5.7% (95% CI 5.3-6.2) at 1 year, 10.9% (10.2-11.5) at 2 years, and 16.9% (15.9-17.9) at 3 years. Unadjusted mortality (Table) was higher among those without chemotherapy (chemo), women with neo-adjuvant tx, and those identified as “triple negative” phenotype (HR negative, no trastuzumab). Conclusions: Linking SEER and Medicare allowed us to assess mortality according to tumor characteristics and cancer treatments, respectively, which are both related to prognosis. The use of administrative data from Medicare should be further enhanced with inclusion of test results from standard gene expression panels to ensure a better match of therapy for the patient and adequate assessment of resource utilization. [Table: see text]
Analysis of the PROCEED registry by baseline prostate-specific antigen (PSA) quartiles: Preliminary analysis of real-world sipuleucel-T (sip-T) use.
Authors: Celestia S. Higano, Andrew J. Armstrong, Matthew R. Cooperberg, Raoul S. Concepcion, Ronald F. Tutrone, Carl A. Olsson, Christopher Michael Pieczonka, Neal D. Shore, Nancy N. Chang, Jennifer Susan LIll, A. Oliver Sartor
Journal: Journal of Clinical Oncology (2016)

193 Background: Sip-T is an FDA-approved, autologous cellular immunotherapy for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Post-hoc analysis of the phase 3 IMPACT study revealed that compared with the highest baseline PSA quartile, patients (pts) in the lowest quartile treated with sip-T had a larger overall survival (OS) benefit, suggesting sip-T is most beneficial if administered earlier in the treatment of mCRPC (Schellhammer et al., Urology. 2013.). This analysis evaluated pt characteristics by PSA quartiles in PROCEED (NCT01306890). Methods: Pts enrolled in PROCEED with baseline PSA and ≥ 1 sip-T infusion were included in this analysis. PSA values were divided into quartiles, and trends in baseline pt characteristics were evaluated as well as time to first anticancer intervention (tACI) with approved mCRPC therapies (docetaxel [D], cabazitaxel, abiraterone [abi], or enzalutamide [enz]) following sip-T treatment. Radium-223 was approved too late in the conduct of PROCEED to be included in the tACI analysis. Results: PSA quartiles from 1880 eligible PROCEED pts were lower than those of IMPACT (Table). Pts in the highest PROCEED quartile were older, more likely to have ECOG performance status ≥ 1, &gt; 10 bone metastases, visceral metastases, and higher ALP and LDH, and lower hemoglobin compared with the lowest PROCEED quartile. More African American men and greater prior systemic therapy use were observed in the highest PSA quartile. Following sip-T, the median tACI (11.0, 8.2, 7.6, and 6.6 mos) was inversely proportional to PSA quartile. Conclusions: Lower baseline PSA values in PROCEED relative to IMPACT suggest that in a real-world setting, clinicians are using sip-T earlier in the treatment of mCRPC. Pts in the lowest PSA quartile had the best prognostic features and longest tACI. Additional patient follow-up is ongoing to evaluate OS and survival by quartile from PROCEED. Clinical trial information: NCT01306890. [Table: see text]