Vascular thromboembolic events in patients (pts) with advanced urothelial cancer (UC) treated with carboplatin/gemcitabine alone or in combination with bevacizumab

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5074-5074
Author(s):  
A. B. Apolo ◽  
A. M. Regazzi ◽  
M. I. Milowsky ◽  
D. F. Bajorin

5074 Background: Vascular thromboembolic events (VTE) occur in 13% of UC pts treated with cisplatin-based therapy ( J Urol 160:2021, 1998). Carboplatin-based therapy is used in UC pts intolerant of cisplatin but the frequency of VTE is unknown. Bevacizumab added to chemotherapy increases VTE in non-small cell lung cancer (NSCLC; 5% vs 3%) (Oncologist 12:713, 2007), breast cancer (7.4% vs 5.5%) and colorectal cancer (19% vs 16%) (JAMA. 2008;300:2288). This study evaluated VTE in UC pts treated with carboplatin/gemcitabine alone or with bevacizumab. Methods: Pts with advanced UC treated on a Memorial Sloan-Kettering Cancer Center protocol from June 2006 to September 2008 were analyzed prospectively. Therapy included > 3 cycles of bevacizumab (15 mg/kg on day 1) plus carboplatin (AUC 5 or 4.5 on day 1) and gemcitabine (1000 mg/m2 on days 1,8) every 21 days. Evaluation for VTE on a contemporary UC control group of pts receiving carboplatin plus gemcitabine alone during the exact same time period was conducted retrospectively. VTE were defined as pulmonary embolism (PE), deep venous thrombosis (DVT), myocardial infarctions (MI) and cerebral vascular accidents (CVA). Pts with simultaneous PE and DVT were considered to have one VTE. Results: 89 pts were evaluated. Of the 25 pts treated with bevacizumab plus chemotherapy, 4 pts (16.0%; 95% CI 5–36%) had a VTE of which there were 2 PE alone, 1 DVT alone, and 1 DVT and PE. No MI was observed in bevacizumab-treated pts. Of the 64 contemporary control pts treated with gemcitabine plus carboplatin alone, there were 11 pts (17%; 95% CI 9–29%) who had a VTE of which there were 4 PE alone, 4 DVT alone, 2 DVT and PE, and 1 MI. No CVA were seen in either group. Conclusions: Pts with advanced UC receiving carboplatin plus gemcitabine have a very high rate of VTE (17%). The VTE incidence is similar to colon cancer (16%) and greater than NSCLC (3%) and breast cancer (5.5%). The VTE rate is similar for both cisplatin and carboplatin, suggesting that it is intrinsic to the UC disease state. In this study, the addition of bevacizumab to carboplatin/gemcitabine was not associated with an increase in VTE over that seen for carboplatin/gemcitabine alone. No significant financial relationships to disclose.

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e041626
Author(s):  
Jamie M Jacobs ◽  
Chelsea S Rapoport ◽  
Arielle Horenstein ◽  
Madison Clay ◽  
Emily A Walsh ◽  
...  

IntroductionPatient adherence to adjuvant endocrine therapy (AET) after a diagnosis of hormone-sensitive breast cancer is poor. Previous interventions have failed to produce changes in adherence, address patient preferences or include theoretically informed and evidence-based components. Therefore, we iteratively developed a patient-centred, evidence-based, small-group, videoconference intervention to improve adherence and symptom management as well as reduce distress for patients taking AET after breast cancer (Symptom-Targeted Randomised Intervention for Distress and Adherence to Adjuvant Endocrine Therapy, STRIDE).Methods and analysisThe current study is a non-blinded, randomised, controlled, feasibility trial of STRIDE compared with a medication monitoring control group. The primary objective is to examine the feasibility and acceptability of STRIDE, while secondary objectives are to assess changes in objective and subjective adherence, symptom distress and satisfaction with AET. Patients will be recruited from the Massachusetts General Hospital Cancer Center in Boston, Massachusetts. The total number of patients accrued will be 75, with ≥60 patients completing the study. All patients will store their AET in an electronic pill bottle for objective adherence monitoring. Patients randomly assigned to the STRIDE intervention will receive 6 weekly 1-hour sessions, in small groups of two, delivered via videoconferencing by a trained mental health professional. Patients assigned to the control group will store their medication in the electronic pill bottle and receive follow-up oncology care as usual. All participants will complete self-report psychosocial measures at baseline, 12 weeks and 24 weeks postbaseline.Ethics and disseminationThe study is funded by the National Cancer Institute of the National Institutes of Health and is approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board (Protocol #18–603, V.1.2, first approval date 1 February 2019). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. Results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patient organisations and media outlets.Trial registration numberNCT03837496; Pre-results.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9589-9589 ◽  
Author(s):  
Danilo Souza Reboucas ◽  
Luiz Claudio Santos Thuler ◽  
Maria Eduarda Ferro Costa ◽  
Alvaro Henrique Ingles Garces ◽  
Luciana Carla Martins de Aquino ◽  
...  

9589 Background: Breast cancer is frequently associated with thromboembolic events (TEE). TEE may result in significant morbidity, a substantial economic burden and they represent a leading cause of death. Methods: We conducted a case-control study to analyze patients’ baseline and treatment characteristics in predicting TEE occurrence as well as the prognosis of breast cancer patients with thromboembolic events. We identified all breast cancer patients with a TEE at INCA (Brazilian National Cancer Institute), between January 2007 and December 2011. The control group consisted of breast cancer patients that had a doppler ultrasound with normal findings during the same period. Variables found to be significant (P <0.10) by univariate analysis were subsequently entered into a multivariate logistic regression model. We used Kaplan-Meier and Cox regression for survival analysis. Results: Overall, 225 patients that developed TEE were compared to 225 matched controls. The majority of events were deep vein thrombosis of the lower extremity (78.7%) and unilateral (94.2%). Most TEE occurred within the first 3 years after the diagnosis of cancer (66.2%), with the highest incidence observed in the initial 6 months. Factors associated with the development of TEE were: age above 50 years (OR 1.85, 95% CI: 1.16 to 2.95), ECOG performance status (PS) equal to or above 3 (OR 2.01, CI 95%: 1.24 to 3.26) and the presence of a central venous catheter (CVC) (OR 2.56, 95% CI: 1.42 to 4.62). The occurrence of TEE led to systemic treatment changes (44.9%) and, most importantly, it was associated with decreased survival (HR = 1.34, 95% CI: 1.01 to 1.77, p = 0.041). Conclusions: This large retrospective analysis of TEE in breast cancer patients confirms that most events occur early in the treatment course. The incidence of TEE was associated with patients’ age, PS, and the presence of CVC. Prospective studies are needed to evaluate outpatient thromboprophylaxis for selected groups of patients.


2018 ◽  
Vol 4 (Supplement 2) ◽  
pp. 124s-124s
Author(s):  
I. Sallam ◽  
G. Amira ◽  
A. Youssri

Background: 40% of Egyptians has access to public health system, 60% served by NGOs and private centers. The problem is the late presentation and inadequate access to services due to lack of a structured screening program and awareness. Aim: To present a model of breast cancer (BC) care in low resource setting (LRS) and to assess risk factors for BC in Egypt the high BC incidence country based on registry estimates stating that about 22000 new BC cases will be diagnosed by 2020. Strategy: In Giza region there used to be no mammographic (MMG) reference service. Women with breast symptoms were referred to the NCI, where they were offered the services (diagnosis, treatment). With very long waiting times. Women aged 20 years or older visiting one of the 5 participating centers were evaluated in a cross-sectional study, which included: (1) Data entry form questionnaire of risk factors for breast cancer - including family history of cancer - and presence of breast symptoms, and (2) Breast examination by a trained professional (nurse or medical doctor). All patients with breast complaints or an abnormal physical exam were referred to NCI, MISR Cancer Center, Kasr El Aini, Agouza and Bahia Hospital for further evaluation. Women 40-69 years of age were invited to participate in the screening both actively (digital invitations, Facebook groups, brochures distributed in governmental buildings and WhatsApp groups) and passively (women that attended for any reason to other hospitals in the region are called and delivered brochures and vouchers to join the project). The screening program is based on annual MMG in women between the ages of 40 and 69 years, which are always preceded by physical examination performed by a breast surgeon or a trained nurse. Program: Close control of the frequency of visits using a simple computer program with patient listing and reminder. The close contact and continuous feedback that helped adherence to the screening program. The proposal of the project includes the performance of all clinical, imaging and pathology exams, as well as clinical visits and surgical treatment, in the same center in the shortest time and the highest standards of care. The health care approach is multidisciplinary, including nurses, breast surgeons and a nutritionist. Outcomes: High rate of compliance is the main strength of project, achieved by patient education about the importance of the screening, intense contact with the primary trained staff, with provision of lists of patients who should come next visits. Free transportation for women with very low income is arranged. Every 3-4 months, we established jointly a charity workshops and projects of handmade cloths and bags for BCPs and encouraged social clubs and societies to adopt parties and to host educational BC advocacy campaigns. What was learned: A simple project is successful and its cost-effectiveness is balanced in Egypt as a developing country where the mortality associated with this disease is very high.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12548-e12548
Author(s):  
Odalys Estefania Lara Garcia ◽  
Ruby Maini ◽  
Priyanka Parajuli ◽  
Manjari Rani Regmi ◽  
Cameron Koester ◽  
...  

e12548 Background: Chemotherapy-induced cardiotoxicity has been associated with certain breast cancer therapy regimens, such as anthracyclines. With the development of newer therapies, just as the anti HER2 agents,another association with cardiotoxicity has been recognized in these drug groups. We report the cardiac safety of anti-HER2 agents and anthracyclines. Methods: A retrospective chart review was conducted of patients diagnosed with breast cancer between January 1st 2014 and December 31st 2017, treated with chemotherapy were identified from a large cancer center database. Heart failure, ACS, and other comorbidities were identified using billing codes. Primary outcome was cardiac event,defined by New York Heart Association class II, III or IV heart failure, ACS and heart failure hospitalization. Fisher's exact test was used to test associations between medication categories and cardiac events. Results: A total of 478 patients were included in our study.Our results indicated a significant association of anti HER2 agents with new heart failure with 12.24% (6/49) of patients, compared to 4.04% (12/297) in the control group (p = 0.0288). For the compound of all cardiac events, patients on the anti HER2 arm did not have a significant association, representing 12.50%(6/48) (p = 0.117).Regarding anthracyclines, results demonstrated a significant association of cardiac events, with an incidence of 17.46%(11/63) compared to 4.59%(14/305) in the control group (p = 0.001). We also found that specifically for new onset heart failure, the anthracycline group had a proportion of 13.64%(9/66), in comparison to the control group which had an incidence of 3.21%(9/280) (p = 0.0023). Conclusions: These findings are comparable to rates reported in studies evaluating cardiac safety of anthracyclines and anti-HER2 agents,calling attention to the importance of novel techniques and treatments for the management of chemotherapy-induced cardiotoxicity.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Martinelli Filho ◽  
S F Siqueira ◽  
G A T Athayde ◽  
K M Dias ◽  
A O Pinheiro ◽  
...  

Abstract Background Atrial fibrillation (AF) is a well-established thromboembolic event risk factor. Episodes of subclinical AF (SCAF) recorded in implantable electronic cardiac devices (IECD) have been related to clinical AF and increased risk of stroke. However, there is no scientific evidence regarding the role of anticoagulation in this population. Objective: Our objective is to assess the association of SCAF with clinical AF and rate of systemic thromboembolic events, in a short-term follow-up. Methods This is a sub-study of SILENT, a prospective, randomized, unicentric study which included patients with sinus rhythm, IECD, with CHA2DS2-VASc ≥2, without previous history of AF. Patients were randomized to the Intervention Group and to the Control Group in the 1: 1 ratio. Patients of the Intervention Group with SCAF episodes (>6 min) received anticoagulation, as well as those with clinical AF in both groups. The primary end point was systemic thromboembolic phenomena and the secondary endpoints were SCAF rate, total and cardiovascular mortality, cardiovascular hospitalization and bleeding. Results A total of 758 patients were evaluated, with a mean age of 72.81 years (± 9.73), of which 461 (60.8%) were female. The mean follow-up was 19.59±4.24 months. Baseline characteristics were similar in both groups. Only 3 patients presented the primary outcome (two of them from Intervention Group). There were 16 deaths (2,1%) and 44 cardiovascular hospitalizations (5,8%), with no difference between groups. Atrial high rate episodes (AHRE) and clinical AF were more prevalent in Control Group, leading to an equal rate of anticoagulation between groups. Clinical AF was statistically associated to previous atrial high rate episodes of any duration (p=0.001) and correlated with SCAF (p<0.01 and R: 0,60) previously recorded in the device. Conclusion This sub study showed that, in a short term follow-up, SCAF has a good correlation with clinical AF occurrence with low rate of thromboembolic events. The Silent study will evaluate in an extended population the role of anticoagulation, in the long term. Acknowledgement/Funding None


2021 ◽  
Vol 103-B (3) ◽  
pp. 449-455
Author(s):  
Bjarke Viberg ◽  
Per Hviid Gundtoft ◽  
Jesper Ougaard Schønnemann ◽  
Lasse Pedersen ◽  
Lis Røhl Andersen ◽  
...  

Aims To assess the safety of tranexamic acid (TXA) in a large cohort of patients aged over 65 years who have sustained a hip fracture, with a focus on transfusion rates, mortality, and thromboembolic events. Methods This is a consecutive cohort study with prospectively collected registry data. Patients with a hip fracture in the Region of Southern Denmark were included over a two-year time period (2015 to 2017) with the first year constituting a control group. In the second year, perioperative TXA was introduced as an intervention. Outcome was transfusion frequency, 30-day and 90-day mortality, and thromboembolic events. The latter was defined as any diagnosis or death due to arterial or venous thrombosis. The results are presented as relative risk (RR) and hazard ratio (HR) with 95% confidence intervals (CIs). Results A total of 3,097 patients were included: 1,558 in the control group and 1,539 in the TXA group.31% (n = 477) of patients had transfusions in the control group compared to 27% (n = 405) in the TXA group yielding an adjusted RR of 0.83 (95% CI 0.75 to 0.91). TXA was not associated with increased 30-day mortality with an adjusted HR of 1.10 (95% CI 0.88 to 1.39) compared to the control group as well as no association with increased risk of 90-day mortality with a per protocol adjusted HR of 1.24 (95% CI 0.93 to 1.66). TXA was associated with a lower risk of thromboembolic events after 30 days (RR 0.63 (95% CI 0.42 to 0.93)) and 90 days (RR 0.72 (95% CI 0.52 to 0.99)). A subanalysis on haemoglobin demonstrated a median 17.7 g/L (interquartile range (IQR) 11.3 to 27.3) decrease in the control group compared to 17.7 g/L (IQR 9.7 to 25.8) in the per protocol TXA group (p = 0.060 on group level difference). Conclusion TXA use in patients with a hip fracture, was not associated with an increased risk of mortality but was associated with lower transfusion rate and reduced thromboembolic events. Thus, we conclude that it is safe to use TXA in this patient group. Cite this article: Bone Joint J 2021;103-B(3):449–455.


2018 ◽  
Vol 4 (Supplement 3) ◽  
pp. 38s-38s
Author(s):  
Ibrahim M. Sallam ◽  
Gamal Amira ◽  
Ahmed Yousri

Purpose Forty percent of Egyptians have access to the public health system, and 60% are served by nongovernmental organizations and private centers. A problem exists, however, with the late presentation and inadequate access to services because of a lack of a structured screening program and awareness. The aim of this work was to present a model of breast cancer (BC) care in a low-resource setting and to assess risk factors for BC in Egypt, which has a high incidence of BC on the basis of registry estimates that indicate that approximately 22,000 new BC cases will be diagnosed by 2020. Methods In the Giza region, there was no mammographic reference service. Women with breast symptoms were referred to the National Cancer Institute, where they were offered services—diagnosis and treatment—with long wait times. Women age 20 years or older visiting one of the five participating centers were evaluated in a cross-sectional study, which included a data entry form questionnaire of risk factors for BC, including a family history of cancer, and the presence of breast symptoms, and breast examination by a trained professional—nurse or medical doctor. All patients with breast complaints or an abnormal physical exam were referred to the National Cancer Institute, MISR Cancer Center, Kasr El Aini, Agouza, and Bahia Hospital for additional evaluation. Women age 40 to 69 years were invited to participate in the screening both actively (digital invitations, Facebook groups, brochures distributed in governmental buildings, and WhatsApp groups) and passively (women who visited other hospitals in the region for any reason were called and delivered brochures and vouchers to join the project). The screening program was based on annual mammographies in women age 40 to 69 years, which are always preceded by physical examination by a breast surgeon or trained nurse. Close control of the frequency of visits was kept using a simple computer program with patient listing and reminder. Close contact and continuous feedback that helped adherence to the screening program. The proposal of the project includes the performance of all clinical, imaging, and pathology exams, as well as clinical visits and surgical treatment, in the same center, in the shortest time, and with the highest standards of care. The health care approach is multidisciplinary and includes nurses, breast surgeons, and a nutritionist. Results A high rate of compliance is the main strength of project. We achieved this with patient education on the importance of screening, intense contact with the primary trained staff with the provision of patient lists of those who should be screened next, and free transportation for women with low income. Every 3 to 4 months, we established jointly a charity workshop and projects of handmade cloths and bags for patients with BC and encouraged social clubs and societies to host parties and educational BC advocacy campaigns. Conclusion A simple project was successful and its cost effectiveness is balanced in Egypt as a developing country where mortality associated with BC is high. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/site/ifc . No COIs from the authors.


2012 ◽  
Vol 73 (6) ◽  
pp. 584-602 ◽  
Author(s):  
Karen Antell

This paper reports the results of a citation analysis of the scholarly literature of LGBT Studies. EBSCO’s LGBT Life database was used to gather a sample of 4,321 citations from core scholarly journals in the field of LGBT Studies, covering the time period 1974 to 2010. The analysis reveals that, although LGBT Studies as an area of scholarship emerged from the gay rights activist movement of the 1960s and 1970s, the field’s literature appears to be firmly rooted in the mainstream academic literature rather than in popular publications or community and activist periodicals. However, the field has a very high rate of cross-disciplinary citation and cites particularly heavily from medical journals and books. In addition to illuminating the citation characteristics of LGBT Studies, this paper presents lists of highly cited books and journals that should prove useful for subject librarians supporting LGBT Studies programs.


1992 ◽  
Vol 68 (02) ◽  
pp. 102-105 ◽  
Author(s):  
P J Dörr ◽  
E J P Brommer ◽  
G Dooijewaard ◽  
H M Vemer

SummaryPrevious studies have shown that the fibrinolytic activity of peritoneum is depressed in local inflammation. We measured fibrinolytic parameters in peritoneal fluid and in plasma of 10 women with pelvic inflammatory disease (PID). Nine women, in whom laparoscopy for sterilisation was performed, served as a control group.In the peritoneal fluid of women with PID, PAI-Ag, t-PA-Ag and u-PA-Ag were many times higher than in the control group. In contrast to the antigens which may be present in inert complexes, the potentially active compounds, measured as t-PA activity and plasmin-activable scu-PA, were not significantly different in the two groups, and in none of the samples was the active enzyme tcu-PA detectable. Nevertheless, the mean peritoneal fluid TDP and FbDP concentrations were about twenty times higher in the PID group than in the control group. In plasma of PID patients, none of the parameters except u-PA-Ag differed from those in the control group. The difference between control and patient plasma u-PA-Ag was statistically significant, but too small to attach any relevance to the observation.Our data suggest that, in contrast to the classical concept of decreased fibrinolytic activity as a cause of adhesion formation, intraperitoneal fibrinolysis is enhanced in peritoneal inflammation through stimulation of the local production of t-PA and u-PA. Despite concomitant production of PAI, fibrinolysis occurs at a high rate, resulting in high levels of fibrin degradation products. Since this activated fibrinolysis does not meet the demand, therapeutic enhancement should be considered to prevent adhesions.


Author(s):  
Galina V. Kurenkova ◽  
Natalia A. Sudeikina ◽  
Elizaveta P. Lemeshevskaya

Introduction. Professional groups of railway workers engaged in the repair of wagons are directly responsible for the safety of railway traffic. The analysis of literature testifies to insufficient attention of researchers to the hygienic problems associated with labor activity of workers of wagon-repair production.The aim of the study is to assess the occupational risk to the health of wagon repair workers, due to the impact on them of factors of the working environment and the labor process.Materials and methods. The study used comprehensive hygienic studies using the methodology of occupational risk to worker’s health.Results. The leading factors of the working environment (class of working conditions 3.2–3.4), which are exposed to workers depending on the specifics of the work performed. Identified professional groups with medium (significant) high (unbearable) and very high (intolerable) category of a priori occupational risk: in wagon meintenance workshop — 17 groups (94% of jobs), in a wagon assembly workshop — 11 groups (80% jobs), in wagon wheel workshop — 3 group (100% jobs). At the same time, according to the request for medical care, employees were diagnosed with isolated cases of occupational diseases.The levels of morbidity with temporary disability of employees of the main workshops are statistically significant (p<0.05) higher than those of the control group in 1.4–1.9 times. The influence of the complex of chemical factors of low and medium intensity on the levels of morbidity of respiratory diseases in the group of workers of the wagon wheel workshop, which were 1.7–2.0 times higher than in the control group, is confirmed by the average degree of causation of the production condition of this pathology (RR=1.7; EF=42.0%).The combined effect of vibration and severity of the labor process forms a high level of temporary disability of employees of the main workshops in connection with diseases of the musculoskeletal system, which was 2.7–4.4 times higher than in the control group, and also determines the prevalence of this pathology in the structure of diseases detected on medical examinations (23.2%). Diseases of the musculoskeletal system are caused by the production of employees of the wagon meintenance workshop (RR=3,9; EF=74,9%), as the most unfavorable in terms of hygiene on these factors.The stressful influence of the complex of harmful production factors on the health of wagon repair workers is manifested by the high risk of diseases of the cardiovascular system, gastrointestinal tract, neurological disorders, violation of adaptation of the cardiovascular system in 97% of the examined, as well as the predominance of diseases of the digestive system and circulatory system detected on periodic medical examinations.Conclusions. Harmful working conditions (class 3.1–3.4) cause the suspected occupational risk from small (moderate) to very high (intolerable) to 100% of the jobs of wagon repair workers. The results of the study of morbidity and risk of pathology indicate a significant risk of damage to the health of workers.


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