scholarly journals Durability of Efavirenz Compared With Boosted Protease Inhibitor-Based Regimens in Antiretroviral-Naïve Patients in the Caribbean and Central and South America

2018 ◽  
Vol 5 (3) ◽  
Author(s):  
Yanink Caro-Vega ◽  
Pablo F Belaunzarán-Zamudio ◽  
Brenda E Crabtree-Ramírez ◽  
Bryan E Shepherd ◽  
Beatriz Grinsztejn ◽  
...  
Keyword(s):  
South America ◽  
Cumulative Incidence ◽  
Incidence Rates ◽  
Secondary Outcome ◽  
Hiv Epidemiology ◽  
Kaplan Meier ◽  
The Caribbean ◽  
Third Line ◽  
National Programs

Abstract Background Efavirenz (EFV) and boosted protease inhibitors (bPIs) are still the preferred options for firstline antiretroviral regimens (firstline ART) in Latin America and have comparable short-term efficacy. We assessed the long-term durability and outcomes of patients receiving EFV or bPIs as firstline ART in the Caribbean, Central and South America network for HIV epidemiology (CCASAnet). Methods We included ART-naïve, HIV-positive adults on EFV or bPIs as firstline ART in CCASAnet between 2000 and 2016. We investigated the time from starting until ending firstline ART according to changes of third component for any reason, including toxicity and treatment failure, death, and/or loss to follow-up. Use of a third-line regimen was a secondary outcome. Kaplan-Meier estimators of composite end points were generated. Crude cumulative incidence of events and adjusted hazard ratios (aHRs) were estimated accounting for competing risk events. Results We included 14 519 patients: 12 898 (89%) started EFV and 1621 (11%) bPIs. The adjusted median years on firstline ART were 4.6 (95% confidence interval [CI], 4.4–4.7) on EFV and 3.8 (95% CI, 3.8–4.0) on bPI (P < .001). Cumulative incidence of firstline ART ending at 10 years of follow-up was 32% (95% CI, 31–33) on EFV and 44% (95% CI, 39–48) on bPI (aHR, 0.88; 95% CI, 0.78–0.97). The cumulative incidence rates of third-line initiation in the bPI-based group were 6% (95% CI, 2.4–9.6) and 2% (95% CI, 1.4–2.2) among the EFV-based group (P < .01). Conclusions Durability of firstline ART was longer with EFV than with bPIs. EFV-based regimens may continue to be the preferred firstline regimen for our region in the near future due to their high efficacy, relatively low toxicity (especially at lower doses), existence of generic formulations, and affordability for national programs.

scholarly journals Comparison of First- and Second-Generation Drug-Eluting Stents in Patients with Acute Myocardial Infarction and Prediabetes Based on the Hemoglobin A1c Level

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Yong Hoon Kim ◽  
Ae-Young Her ◽  
Myung Ho Jeong ◽  
Byeong-Keuk Kim ◽  
Sung-Jin Hong ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Cumulative Incidence ◽  
Second Generation ◽  
Coronary Intervention ◽  
Incidence Rates ◽  
Secondary Outcome ◽  
Drug Eluting Stents ◽  
Drug Eluting

Objective. To compare major clinical outcomes after successful percutaneous coronary intervention (PCI) with first-generation (1G) drug-eluting stents (DES) and second-generation (2G) DES in patients with acute myocardial infarction (AMI) and prediabetes. Background. Patients with prediabetes are associated with an increased incidence of coronary artery disease. The relative superiority of 1G- and 2G-DES in these patients is not well established. Methods. A total of 4997 patients with AMI and prediabetes were divided into two groups: the 1D-DES group (n = 726) and the 2G-DES group (n = 4271). The primary outcomes were the patient-oriented composite outcomes (POCOs) defined as all-cause death, recurrent myocardial infarction (Re-MI), and any disease revascularization at 2-year follow-up. The secondary outcome was probable or definite stent thrombosis (ST). Results. After propensity score-matching (PSM) analysis, two PSM groups (698 pairs, n = 1396, C-statistics = 0.725) were generated. The cumulative incidence rates of POCOs (hazard ratio (HR): 1.467; 95% confidence interval (CI): 1.068–2.015; p=0.018), any disease revascularization (HR: 2.259; 95% CI: 1.397–3.654; p=0.001), and ST (HR: 4.361; 95% CI: 1.243–15.30; p=0.021) in the 1G-DES group were significantly higher than those in the 2G-DES group. However, the cumulative incidence rates of all-cause death, cardiac death, and Re-MI were similar between the two groups. Conclusions. In patients with AMI and prediabetes, 2G-DES implantation was more efficacious than 1G-DES implantation over a 2-year follow-up period. However, further studies are needed to confirm these results.

Atrial fibrillation associated with increased risk of venous thromboembolism

2015 ◽  
Vol 113 (01) ◽  
pp. 185-192 ◽  
Author(s):  
Chun-Cheng Wang ◽  
Cheng-Li Lin ◽  
Guei-Jane Wang ◽  
Chiz-Tzung Chang ◽  
Fung-Chang Sung ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Venous Thromboembolism ◽  
Incidence Rates ◽  
Vein Thrombosis ◽  
Kaplan Meier ◽  
Increased Risk ◽  
Long Term Follow Up ◽  
Deep Vein

SummaryWhether atrial fibrillation (AF) is associated with an increased risk of venous thromboembolism (VTE) remains controversial. From Longitudinal Health Insurance Database 2000 (LHID2000), we identified 11,458 patients newly diagnosed with AF. The comparison group comprised 45,637 patients without AF. Both cohorts were followed up to measure the incidence of deep-vein thrombosis (DVT) and pulmonary embolism (PE). Univariable and multivariable competing-risks regression model and Kaplan-Meier analyses with the use of Aelon-Johansen estimator were used to measure the differences of cumulative incidences of DVT and PE, respectively. The overall incidence rates (per 1,000 person-years) of DVT and PE between the AF group and non-AF groups were 2.69 vs 1.12 (crude hazard ratio [HR] = 1.92; 95 % confidence interval [CI] = 1.54-2.39), 1.55 vs 0.46 (crude HR = 2.68; 95 % CI = 1.97-3.64), respectively. The baseline demographics indicated that the members of the AF group demonstrated a significantly older age and higher proportions of comorbidities than non-AF group. After adjusting for age, sex, and comorbidities, the risks of DVT and PE remained significantly elevated in the AF group compared with the non-AF group (adjusted HR = 1.74; 95 %CI = 1.36-2.24, adjusted HR = 2.18; 95 %CI = 1.51-3.15, respectively). The Kaplan-Meier curve with the use of Aelon-Johansen estimator indicated that the cumulative incidences of DVT and PE were both more significantly elevated in the AF group than in the non-AF group after a long-term follow-up period (p<0.01). In conclusion, the presence of AF is associated with increased risk of VTE after a long-term follow-up period.

scholarly journals CMET-41. OUTCOMES FOLLOWING STEREOTACTIC RADIOSURGERY (SRS) FOR LIMITED BRAIN METASTASES - AN AUSTRALIAN SINGLE INSTITUTIONAL EXPERIENCE

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi60-vi60
Author(s):  
Lilly Shen ◽  
Wee Loon Ong ◽  
Briana Farrugia ◽  
Anna Seeley ◽  
Carlos Augusto Gonzalvo ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Stereotactic Radiosurgery ◽  
Cumulative Incidence ◽  
Multivariate Analyses ◽  
Primary Lung Cancer ◽  
Factors Associated ◽  
Distant Failure ◽  
Kaplan Meier ◽  
Institutional Experience

Abstract INTRODUCTION Despite increasing use of stereotactic radiosurgery (SRS) for management of brain metastases (BM), published Australian data is scarce. We aim to report on the outcomes following SRS for limited BM in a single Australian institution. METHODS This is a retrospective cohort of patients with limited BM treated with SRS between August 2015 and March 2019. A dose of 24Gy/3# were prescribed to intact lesion, and 21Gy/3# to surgical cavity post-surgical resection. All patients were followed with 3-monthly surveillance MRI brain. Primary outcomes were: local failure (LF: increased in size of SRS-treated BM lesion/ recurrence in surgical cavity), distant failure (DF: intracranial progression outside of the SRS-treated lesion/ cavity), and overall survival (OS). LF, DF and OS were estimated using the Kaplan-Meier method. Multivariate Cox regressions were used to evaluate factors associated with outcomes of interest, with death as competing-risk events for LF and DF. RESULTS 76 courses of SRS were delivered in 65 patients (54 unresected BM lesions, and 22 surgical cavities). 43 (66%) patients were ECOG 0–1. 35 (54%) patients had solitary BM. 41 (63%) had symptomatic BM. Half of the patients had primary lung cancer. Median follow-up was 4.8 months (range:0.1–39 months). 10 LF were observed at a median of 3.5 month post-SRS, with 6- and 12-month LF cumulative incidence of 14% and 24% respectively. 30 DF were observed at a median of 3.3 months, with 6- and 12-month DF cumulative incidence of 38% and 63% respectively. The 12- and 24-month OS were 39% and 26% respectively. In multivariate analyses, better ECOG status, solitary BM lesion, resection of BM pre-SRS, and use of subsequent systemic therapy were independently associated with improved OS. CONCLUSION This is one of the few Australian series reporting on outcomes following SRS for limited BM, with comparable outcomes to published international series.

scholarly journals Prognostic significance of occlusion length in recanalized chronic total occlusion lesion: a retrospective cohort study with 5-year follow-up

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e038302
Author(s):  
Tao Tian ◽  
Changdong Guan ◽  
Lijian Gao ◽  
Lei Song ◽  
Jiansong Yuan ◽  
...  
Keyword(s):  
Cohort Study ◽  
Primary Endpoint ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Chronic Total Occlusion ◽  
Secondary Outcome ◽  
Total Occlusion ◽  
Risk Of Death ◽  
Kaplan Meier

ObjectivesThis study sought to investigate the relationship between occlusion length and long-term outcomes of patients with recanalised chronic total occlusion (CTO) lesion.DesignA retrospective cohort study.SettingFuwai Hospital, National Center for Cardiovascular Disease, Beijing, ChinaParticipantsConsecutive patients with successfully recanalised CTO were included from January 2010 to December 2013.Primary and secondary outcome measuresThe primary endpoint of the present study was a composite event of all-cause death and myocardial infarction (MI). The secondary endpoints included target lesion revascularisation (TLR) and target vessel revascularisation (TVR).ResultsA total of 1987 patients were included and 1801 (90.6%) subjects completed 5-year follow-up in this study. Based on occlusion length, the patients were divided equally into two groups: short (length <15 mm, n=957) and long (length ≥15 mm, n=1030) CTO group. Kaplan-Meier survival curve showed no significant difference in the risk of the composite primary endpoint between short and long CTO groups (p=0.242). Receiver operating characteristic curve analysis also established occlusion length ≥15 mm as a cut-off value for predicting TLR and TVR, with an area under the curve of 0.604 (95% CI: 0.569 to 0.638, p<0.001) and 0.605 (95% CI: 0.572 to 0.638; p<0.001). Kaplan-Meier analysis revealed that the risks for TLR (p=0.002) and TVR (p=0.002) were higher in a patient with long CTO lesion. Multivariate Cox analysis also identified long CTO lesion as an independent predictor of TLR (HR: 1.539, 95% CI: 1.033 to 2.293; p=0.034) and TVR (HR: 1.476, 95% CI: 1.012 to 2.151; p=0.043).ConclusionPatients with long CTO lesion did not show a higher risk of death and MI after recanalisation, but had higher risks of TLR and TVR. Lesion with occlusion length ≥15 mm should be under close surveillance for restenosis after recanalisation.

Long-Term Update of Stereotactic Radiosurgery for Benign Spinal Tumors

Neurosurgery ◽  
2018 ◽  
Vol 85 (5) ◽  
pp. 708-716 ◽  
Author(s):  
Alexander L Chin ◽  
Dylann Fujimoto ◽  
Kiran A Kumar ◽  
Laurie Tupper ◽  
Salma Mansour ◽  
...  
Keyword(s):  
Stereotactic Radiosurgery ◽  
Cumulative Incidence ◽  
Standard Of Care ◽  
Incidence Rates ◽  
Spinal Tumors ◽  
Secondary Malignancy ◽  
Intracranial Tumors ◽  
Symptom Response

Abstract BACKGROUND Stereotactic radiosurgery (SRS) for benign intracranial tumors is an established standard of care. The widespread implementation of SRS for benign spinal tumors has been limited by lack of long-term data. OBJECTIVE To update our institutional experience of safety and efficacy outcomes after SRS for benign spinal tumors. METHODS We performed a retrospective cohort study of 120 patients with 149 benign spinal tumors (39 meningiomas, 26 neurofibromas, and 84 schwannomas) treated with SRS between 1999 and 2016, with follow-up magnetic resonance imaging available for review. The primary endpoint was the cumulative incidence of local failure (LF), with death as a competing risk. Secondary endpoints included tumor shrinkage, symptom response, toxicity, and secondary malignancy. RESULTS Median follow-up was 49 mo (interquartile range: 25-103 mo, range: 3-216 mo), including 61 courses with >5 yr and 24 courses with >10 yr of follow-up. We observed 9 LF for a cumulative incidence of LF of 2%, 5%, and 12% at 3, 5, and 10 yr, respectively. Excluding 10 tumors that were previously irradiated or that arose within a previously irradiated field, the 3-, 5-, and 10-yr cumulative incidence rates of LF were 1%, 2%, and 8%, respectively. At last follow-up, 35% of all lesions had decreased in size. With a total of 776 patient-years of follow-up, no SRS-related secondary malignancies were observed. CONCLUSION Comparable to SRS for benign intracranial tumors, SRS provides longer term local control of benign spinal tumors and is a standard-of-care alternative to surgical resection.

Second Malignancies After Autologous Hematopoietic Cell Transplantation (AHCT) for Multiple Myeloma (MM): A Center for International Blood and Marrow Transplant Research (CIBMTR) Analysis

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 591-591
Author(s):  
Girindra Raval ◽  
Anuj Mahindra ◽  
Xiaobo Zhong ◽  
Ruta Brazauskas ◽  
Robert Peter Gale ◽  
...  
Keyword(s):  
Risk Factors ◽  
At Risk ◽  
Multivariate Analysis ◽  
General Population ◽  
Cumulative Incidence ◽  
Incidence Rates ◽  
High Dose ◽  
Risk Of Death ◽  
Age And Sex

Abstract Abstract 591 Background: Survival of patients with MM has improved over the past two decades, in part due to the use of AHCT. Increasingly, second primary malignancies (SPMs) are observed in MM survivors. Determining the baseline incidence and risk factors associated with SPMs after AHCT is important to assess risk and to evaluate the risk-benefit ratio of newer therapies. Methods: We analyzed the incidence of SPMs in 3784 MM patients receiving (“upfront”) AHCT for MM within 18 months of diagnosis between 1990 and 2010 and reported to the CIBMTR. Cumulative incidence rates of SPMs were estimated taking into account the competing risk of death. For each transplant recipient, the number of person-years at risk was calculated from the date of transplantation until date of last contact, death, or diagnosis of SPM, whichever occurred first. Incidence rates for all invasive cancers in the general population were obtained from the SEER database. Age-, sex-, and race- specific incidence rates for overall SPMs and particular anatomical sites were applied to the appropriate person-years at risk to compute the expected numbers of cancers. Observed–to –expected (O/E) ratios were calculated, and Poisson distribution 99% confidence intervals (CIs) were generated. Poisson regression model was used to analyze risk factors for overall SPMs and AML/MDS. Results: Pre-transplant therapy included novel agents in 56% including thalidomide (35%), lenalidomide (9%), bortezomib (16%) or their combinations (11%). Majority (80%) received high dose melphalan conditioning. Post-transplant maintenance therapy included thalidomide (16%), lenalidomide (8%), bortezomib (9%) and interferon (6%). Median follow-up of survivors was 52 months (range 3 to 192 months).With 12707 person years of follow up, 153 new malignancies were reported with a crude rate of 1.2 SPM per 100 person years of follow up. Observed/Expected [O/E] ratio for all SPMs was 0.99 (99% CI, 0.80–1.22). Cumulative incidence of SPM overall was 2.48% (95% CI, 1.96–3.05) at 3 years and 6.0% (95% CI, 4.96–7.10) at 7 years [Figure 1]. Individual SPMs observed significantly more frequently than expected are summarized in Table 1. The cumulative incidence of MDS/AML was 0.5% (95% CI, 0.28–0.78) at 3 years and 1.3 (95% CI, 0.85– 1.9%) at 7 years. Majority had MM progression prior to diagnosis of SPM (65 of 102 patients overall and 15 of 23 patients for MDS/AML). In multivariate analysis, significant risk factors for development of SPMs included: obesity [Hazard ratio = HR 1.89(95%CI, 1.21–2.93), p=0.0047 for BMI>30 vs. BMI<25], older age: [HR10.53 (95%CI, 1.46–75.82), p=0.0195] for 60–69 year olds and HR14.4 (95%CI, 1.89–109.75), p=0.01 for 70+ year olds compared to the 18–39 year old group. Specific conditioning regimens did not correlate with the risk of SPM. The low number of MDS/AML (33 events out of 3784 cases) limited the power of multivariate analysis. Increasing age was significantly associated with development of MDS (HR10.77, (95%CI,92.09–55.51), p=0.004 for 70+ year old vs. 40–49 year olds). Conclusion: In this large cohort of AHCT recipients for MM, the incidence of MDS/AML, melanoma and other skin cancers was significantly higher compared to age and sex matched general population. However the overall risk of SPM was similar to that expected for age and sex matched population. It was also similar to the placebo arms of recent reports by McCarthy Pl et al and Attal M et al (N Engl J Med. 10; 366(19):1770–91). Lenalidomide (8%) or thalidomide maintenance (16%) used in a small subset of patients with comparatively short follow up, was not associated with risk of SPM in the analysis of the overall cohort. Disclosures: Gale: Celgene: Employment. Brandenburg:Celgene: Employment, Equity Ownership. Lonial:Millennium, Celgene, Novartis, BMS, Onyx, Merck all Consultancy. Krishnan:Celgene and Millennium: Consultancy, Speakers Bureau. Dispenzieri:Celgene and Millennium: Research Funding. Hari:Celgene: Consultancy, Honoraria.

Analysis and follow-up of the patients diagnosed with metastatic gastric adenocarcinoma in the Parc Taulí Hospital, Sabadell, between 2010 and 2013.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 169-169
Author(s):  
Marta Ferrer ◽  
Carles Pericay ◽  
Ismael Macias ◽  
Emma Dotor ◽  
Aleydis Pisa ◽  
...  
Keyword(s):  
Gastric Adenocarcinoma ◽  
Clinical Information ◽  
Gastric Body ◽  
Second Line ◽  
First Line ◽  
Kaplan Meier ◽  
Secondary Endpoints ◽  
Third Line ◽  
Line Chemotherapy

169 Background: The primary endpoint of this study was to know the incidence and treatment of gastric carcinoma in our area. Other secondary endpoints were percentage of treated patients, overall survival (OS), survival in subgroups, and more frequent treatments. Methods: Since 2010 to 2013 all the patients diagnosed with metastatic gastric adenocarcinoma and treated at the hospital Parc Taulí from Sabadell were registered. The clinical information was compiled and analyzed. Survivals curves were determined with Kaplan-Meier functions Results: 168 patients were studied, with 79 metastatic (47%). 56% men and median age 67 years. Localizations were gastric body 52%, gastro-esophageal junction 20%, and antrum 25%. OS of the series was 5,05 months (95% CI, 2,99-7,10). 60% of the patients were treated with first line chemotherapy (CT). From them, 42% had a second line and 25% a third line. DFS were respectively 6,62 months (4,06-9,17), 4,29 months (2,28-6,30), and 2,88 months (1,12-4,64) for every line of treatment. OS of the patients that received chemotherapy was 9.7 months (6,40-13,00). CT more used in first line were triplets of fluropyrimidines, platinum and taxanes, in 45% (21 patients). Also just fluoropyrimidines and platinum without taxanes, in 38%. As a second line the predominant CT is also platinum and fluoropyrimidines (37%), and irinotecan (30%). In third line, 50% are combinations based on irinotecan. Conclusions: The OS of the patients who received CT is significantly prolonged respect the ones who didn’t. The data obtained matches the data already published in the literature, even the more frequent chemotherapy.

scholarly journals DOP72 Perianal Crohn’s Disease in the biologic era: A population-based cohort study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S105-S107
Author(s):  
P Jenkinson ◽  
N Plevris ◽  
M Lyons ◽  
S Siakavellas ◽  
I Arnott ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Cumulative Incidence ◽  
Population Based ◽  
Incidence Rates ◽  
Percentage Change ◽  
Prescription Data ◽  
Annual Percentage Change ◽  
Kaplan Meier ◽  
Significant Difference

Abstract Background Peri-anal Crohn’s disease (pCD) significantly affects quality of life in patients with CD. The natural history of pCD in the era of biologic therapy is poorly understood. Perianal surgery includes examination under anaesthesia (EUA), drainage of peri-anal sepsis, seton instertion and fistula manipulation. EUA forms part of the standard of care at diagnosis of pCD and therefore can be used as a proxy for incidence of pCD. Methods CD patients were identified from the Lothian IBD registry, a physician validated registry of all IBD cases within Lothian which has been shown to be 94.3% complete. Prospectively collected coding data was used to identify peri-anal surgery, which was validated by review of the electronic health record. Biologic prescription data was extracted from the Lothian biologics database; a physician validated, prospectively collected registry. Time trend analysis was performed for the period 2000 to 2017 by 1) calculating annual incidence rates of peri-anal interventions for all patients with CD and estimating annual percentage change and 2) by calculating cumulative incidence of pCD and biologic prescription in newly diagnosed CD and 3) stratifying by era of diagnosis (Cohort 1: 2000–2008 and Cohort 2: 2009–2017. Results 2937 patients with CD were identified in the study period, with 1108 operations for pCD performed on 381 patients. Rates of surgery fell from 5.1 to 2.0 operations per 100 CD patients per year between 2000 and 2017 (p&lt;0.001) giving an annual percentage change of -3.4% (-4.9% to -1.9% 95% CI) (fig 1). 1753 new diagnoses of CD were made of whom 247 developed pCD. 5 year risk of pCD was 12.8% (9.5–16.6%) with no significant difference identified between cohort 1 (11.5%) and cohort 2 (13.8%) (p=0.116) (fig 2). The 5 year incidence of biologic prescription for patients with pCD increased from 11.2% in cohort 1 to 58.1% in cohort 2 (p&lt;0.001) (fig 3). Figure 1: Number of peri-anal interventions per 100 CD patients per year (multiple procedures per patient included). Figure 2: Kaplan Meier curves showing cumulative incidence of pCD stratified by era of diagnosis. Figure 3: Kaplan Meier curves showing cumulative incidence of biologic prescription in patients with CD stratified by era of diagnosis and presence of pCD. Conclusion The incidence of pCD remains unchanged over time. Although we cannot ascribe causality, the overall decrease in surgery for pCD has been paralleled by a marked increase in the use of biologic medication.

scholarly journals Outcomes Associated with Therapeutic Anticoagulation in Patients with Brain Metastasis

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1242-1242
Author(s):  
Shafia Rahman ◽  
Fahrettin Covut ◽  
Yihong Zhou ◽  
Shab E Gul Rahim ◽  
Sudha Amarnath ◽  
...  
Keyword(s):  
Overall Survival ◽  
Brain Metastasis ◽  
Cumulative Incidence ◽  
Initial Diagnosis ◽  
Leptomeningeal Disease ◽  
Primary Cancer ◽  
Kaplan Meier ◽  
Therapeutic Anticoagulation ◽  
Clinically Significant

Abstract Background:Venous thromboembolism (VTE) is a highly prevalent complication of cancer and its treatment and is commonly treated with anticoagulation1. However, there are limited data regarding the use of therapeutic anticoagulation in patients with brain metastases, due to concerns for intracranial hemorrhage (ICH). Methods:We retrospectively identified cancer patients who were diagnosed with brain metastasis between 12/2005 and 7/2017, and subsequently underwent whole brain radiation at the Cleveland Clinic. Patients with primary brain tumors, leptomeningeal disease alone, and absence of follow-up brain imaging were excluded. Clinically significant ICH was defined as ICH resulting in focal neurologic deficit or required neurosurgery, as previously described2. Cumulative incidence of ICH from initial diagnosis of brain metastasis was calculated with death as competing risk. Difference between cumulative incidence estimates was tested using Gray's test. Overall survival (OS) calculated from initial diagnosis of brain metastasis, estimated by the Kaplan-Meier method, and compared by the log-rank test. Median follow-up time was calculated using reverse Kaplan-Meier method. Predictors identified as statistically significant on univariate logistic regression analysis (p<0.05) were selected for multivariate analysis. Results:We screened568 patients and identified 407 who meet inclusion criteria. Seventy-eight (19%) patients received therapeutic anticoagulation (AC) [enoxaparin: n = 46 (59%), warfarin: n = 27 (35%), apixaban/rivaroxaban: n = 3 (4%), unfractionated heparin: n = 2 (2%)] due to VTE after diagnosis of brain metastasis, whereas 329 (81%) patients did not receive any therapeutic dose of AC. There were more female patients in the AC cohort, but other baseline characteristics were similar in both cohorts (Table 1). In the AC cohort, 11 of 78 (14%) patients had ICH, of which 6 (55%) were clinically insignificant and 5 (45%) were clinically significant at initial diagnosis of brain metastasis. Five of 11 patients were already on AC before diagnosis of brain metastasis. In the no-AC cohort, 65 of 329 (20%) patients had ICH, of which 53 (82%) clinically insignificant and 12 (18%) clinically significant at initial diagnosis of brain metastasis. Median follow-up of patients was 28 months. The 3-year cumulative incidence of clinically insignificant ICH in AC and no-AC groups was 7.7 (95% CI: 1.8 - 13.6) and 21.3 (95% CI: 16.5 - 26.1), respectively (p = 0.017). The 3-year cumulative incidence of clinically significant ICH in AC and no-AC groups was 12.0 (95% CI: 4.6 - 19.4) and 4.9 (95% CI: 2.6 - 7.4), respectively (p = 0.044). The 3-year cumulative incidence of all ICH in AC and no-AC groups was 19.7 (95% CI: 10.7 - 28.7) and 25.8 (95% CI: 20.9 - 30.7), respectively (p = 0.27). The 3-year OS in AC and no-AC groups was 13.6 (95% CI: 6.9 - 26.4) and 17.6 (95% CI: 12.9 - 23.9), respectively (p = 0.64) (Figure 1). In univariable analysis, AC vs no-AC [OR: 2.39, 95% CI: 1.00 - 5.48, p = 0.044] and primary cancer (melanoma vs lung) [OR: 5.62, 95% CI: 1.78 - 16.49, p = 0.002] were predictors of clinically significant ICH after diagnosis of brain metastasis (Table 2). In multivariable analysis, only primary cancer (melanoma vs lung) [OR: 6.19, 95% CI: 1.92 - 18.88, p = 0.001]remained a statistically significant predictor of clinically significant ICH after diagnosis of brain metastasis. Conclusion: In this relatively large cohort of patients with brain metastasis, use of therapeutic anticoagulation did not influence the incidence of developing ICH but was associated with a greater risk of clinically significant ICH. This increase was, however, not linked to differences in overall survival. Nearly all patients in our AC cohort were treated with enoxaparin; ongoing studies will examine whether anticoagulation with DOACs is associated with similar outcomes. Disclosures Khorana: Bayer: Consultancy; Sanofi: Consultancy; Janssen: Consultancy; Pfizer: Consultancy.

Competing risk events determining probability of cause-specific failure in nasopharyngeal carcinoma

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10082-10082
Author(s):  
Y. Huang ◽  
B. Zee ◽  
M. Lam ◽  
P. Teo
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Distant Metastasis ◽  
Incidence Rates ◽  
Competing Risk ◽  
Competing Risk Analysis ◽  
Kaplan Meier ◽  
Competing Events ◽  
Regional Failure ◽  
Failure Types

10082 Background: The commonly employed Kaplan-Meier (KM) method is based on the assumption that different failure types (local-regional, distant, etc.) are independent. In reality, these failures occur at different stages in disease progression and are strongly correlated with each other. The assumption of independence of different failure types may violate certain assumptions in the modeling, and hence may affect the clinical interpretation and treatment selection. A better approach to estimate cause-specific failure probability is to calculate cumulative incidence rates by taking into account other events within a competing risk framework, in which the dependency of different failures are considered. Methods: The data was based on a large retrospective cohort study conducted at the Prince of Wales Hospital in Hong Kong, China, in 1996–97. 945 patients with nasopharyngeal carcinoma (NPC) had been treated with a standard protocol and been followed up regularly with a median follow-up period of 69 months (1–122 months). We calculated the cumulative incidence rates of local-regional failure and distant metastasis, and compared the result against KM method. In competing risk analysis, local regional failure, distant metastases and death were considered as competing events during the remaining lifetime of NPC patients from first presentation. Results: The probability of local-regional failure and distant metastasis was higher by KM method than by competing risk method. The result indicated that KM analysis overestimated event rate and the difference became larger in a longer follow-up period, when more competing events occurred. Conclusion: Kaplan-Meier analysis overestimates the probability of cause-specific failure. Competing risk analysis provides us a more accurate method in the determination of the pattern of failure. It provides better evidence to clinicians to enable them to predict the prognosis and select proper therapy. [Table: see text] No significant financial relationships to disclose.

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