Background Previous studies suggest isolated distal deep vein thrombosis (IDDVT) has a self‐limited clinical course. However, these studies excluded cancer patients, who remain a high‐risk population. In addition, studies to evaluate the long‐term clinical outcomes of IDDVT in cancer patients have been limited. Here, we report outcomes from our experience in treating cancer‐associated IDDVT versus proximal venous thromboembolism (VTE). Methods We prospectively evaluated a cohort of patients referred to our cancer‐associated thrombosis clinic from August 2014 through May 2018. We compared clinical characteristics, anticoagulation prescription, VTE recurrence, overall survival, major bleeding, and subsequent hospital admission between cancer patients with IDDVT and proximal VTE. A propensity score matching method was used to reduce bias from confounding variables. Results Of 1100 patients referred to the clinic, 124 IDDVT and 178 proximal VTE events were analyzed. After propensity score matching, 96 patients were included in each cohort. There was no difference in the rate of recurrent VTE between cancer patients with proximal VTE vs IDDVT, with or without matching (matched: hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.31‐1.92; P = .58). There was no difference in overall survival between cancer patients with proximal VTE vs. IDDVT with or without matching (matched: HR, 1.18; 95% CI, 0.77‐1.82; P = .45). Furthermore, subsequent hospital admissions and major bleeding events were similar between patients with proximal VTE events versus IDDVT. Conclusions Cancer patients with IDDVT have similar outcomes as their proximal counterparts, including rate of recurrence and overall survival. These findings suggest treatment of cancer‐associated IDDVT should mirror treatment of proximal events.
Introduction Thromboembolism (TE) is common in patients with non‐small cell lung cancer (NSCLC) and is associated with worse outcomes. Recent advances in the understanding of NSCLC have led to the identification of molecular subtypes such as anaplastic lymphocyte kinase (ALK) and epidermal growth factor receptor (EGFR) mutations. The association of these subtypes with risk of TE has not been fully explored. Methods We conducted a retrospective cohort study of consecutive NSCLC patients seen at the Cleveland Clinic from July 2002 through July 2017 for whom molecular classification and follow‐up were available. TE events included deep vein thrombosis (DVT), pulmonary embolism (PE), visceral vein thrombosis (VVT), and arterial events. TE‐free survival and overall survival rates for each of the molecular subtypes (wild‐type, ALK‐mutant, and EGFR‐mutant) were estimated by the Kaplan‐Meier method. Cox proportional hazard regression analysis was used to identify factors associated with the endpoints TE and overall survival. TE was analyzed as a conditional, time‐dependent covariate to assess its impact with respect to overall survival. Results The study population consisted of 461 patients. Approximately half were females (n = 263, 57%) and 58% (n = 270) were older than 65 years. TE occurred in 98 of 461 patients (21.3%) during a median follow‐up of 33.1 months. The highest cumulative rates of TE were observed in patients with ALK‐mutant NSCLC (N = 20/46, 43.5%) followed by patients with EGFR‐mutant cancers (N = 35/165, 21.2%) and wild‐type cancers (N = 43/250, 17.2%) P < .05. Cumulative incidence of TE at 6 months of follow‐up was 15.7% (95% confidence interval [CI]: 5.0%‐26.4%) for ALK‐mutant cancers, 8.8% (95% CI: 4.4%‐13.2%) for EGFR‐mutant cancers, and 9.2% (95% CI: 5.4%‐12.9%) for wild‐type cancers. Patients who experienced TE had worse overall survival (all patients: hazard ratio = 2.8 95% CI 2.1‐3.6, P < .001). Conclusions Patients with ALK‐mutant advanced lung adenocarcinoma have the highest rate of TE. TE is associated with worse survival across molecular subtypes. These findings should be taken into consideration in decision‐making regarding thromboprophylaxis.
Context:The coexistence of diabetes mellitus (DM) with hypothyroidism is a known clinical observation.Aims:To estimate prevalence and co-relate that of hypothyroidism in patients with DM in relation to the age and sex, the lipid profile, body mass index visiting diabetes clinic and inpatients in B. P. Koirala Institute of Health Sciences.Settings and Design:The hospital-based descriptive study.Materials and Methods:Two hundred and seventy-one known or newly detected cases of DM aged more than 15 years were selected randomly from September 2012 to September 2013 and subjected to evaluation for thyroid function – clinically and biochemically and other relevant investigations were done.Statistical Analysis Used:For descriptive statistics mean, standard deviation, percentage, proportion were calculated. For inferential statistics following test were carried out at the level of significant 0.05 where confidence interval is 95%. The statistical operations were done through Statistical Package for the Social Sciences version 10.Results:Of 271 subjects, the prevalence of hypothyroidism (clinical and subclinical) in diabetics was, 4.05% (11/271) with females preponderance, of which 7 (30.4%) were clinically hypothyroid and 4 (17.4%) were subclinical hypothyroid. One (4.3%) patient had subclinical hyperthyroidism. The mean age at diagnosis of type 2 DM was 51–60 years. 8.69% of diabetics with primary hypothyroids were having morbid obesity. High-density lipoprotein among different thyroid status were statistically significant (P = 0.042).Conclusions:Hypothyroidism is not uncommon in diabetes, and we found body mass index, mean triglyceride and cholesterol levels were more in those diabetic patients having coexisting hypothyroidism.
Introduction Randomized trials of venous thromboembolism (VTE) treatment in cancer have primarily focused on the initial 6-month period and the risk/benefit of additional anticoagulant therapy beyond this time point has not been fully evaluated. Current guidelines recommend continuing full dose anticoagulation after 6 months in patients who have ongoing active cancer and/or those undergoing anti-neoplastic treatment. This recommendation, however, is based on little evidence. Here, we describe clinical outcomes of patients who have completed at least 6 months of anticoagulation. Our aim was to compare VTE recurrence, bleeding rate, and overall survival in patients who continued vs. discontinued anticoagulation after the initial 6-month treatment period. Methods We evaluated a prospective cohort of patients referred to the Cleveland Clinic cancer-associated thrombosis clinic from 8/2014-12/2018. We evaluated clinical characteristics, VTE recurrence, bleeding (major or clinically relevant non-major bleeding (CRNMB) as defined by ISTH criteria), and overall survival in patients who continued vs. discontinued anticoagulation after 6 months. Low-risk for recurrent VTE was defined as not having active cancer and not receiving systemic therapy. Statistical methods included t-tests, chi-squared tests, Cox model, and log rank test where appropriate. Multivariable analysis was performed to analyze outcomes of interest. Results The study population was comprised 284 (73.2%) patients who were followed 6 months after the initial VTE event. Of these, 93 (32.7%) did not continue anticoagulation beyond 6 months, and 191 (67.3%) continued anticoagulation treatment (table 1). Anticoagulation was discontinued for the following reasons: low risk (n=33, 35.5%), bleeding (n=12, 12.9%), clinical decision (n=4, 4.3%) and other including financial reasons (n=43, 46.2%; table 2). In patients who continued anticoagulation, 86/191 (45%) had stage IV disease and the most frequent cancers were hematologic malignancies (58/191, 30.4%) and gastrointestinal cancers (37/191, 19.4%). Low molecular weight heparin was the most commonly prescribed anticoagulant (110/191; 57.6%) followed by direct oral anticoagulants (68/191, 35.6%). There was no difference in the rate of recurrent VTE in patients who remained on treatment beyond six months (23/191; 12%) vs. those who stopped treatment at six months (11/93; 11.8%; p= 0.81; figure 1). In patients who continued anticoagulation 6-12 months after the initial treatment period, 13/191 (6.8%) had a bleeding event (major bleeding n=4, CRNMB n=9). There was 1 major bleed and no CRNMB in the group that stopped anticoagulation. After multivariable analysis, recurrent VTE was associated with worse overall survival [hazard ratio (HR) 1.88; 95% Confidence Interval (CI) 1.06-3.35, p=0.03]. Discussion This prospective analysis found no difference in the rate of recurrent VTE and more bleeding in patients who continued anticoagulation, although recurrent VTE rates were high in both cohorts. Furthermore, a recurrent VTE event was associated with worse overall survival. Emerging data with DOACs may alter recurrence rates and the ability to continue treatment beyond 6 months. Although limited by a small study population, this study adds to available data regarding outcomes beyond six months of treatment. Future studies should focus on exploring the outcomes of extending anticoagulation and better identifying patients at risk for recurrent VTE. Disclosures McCrae: Rigel Pharmaceutical: Membership on an entity's Board of Directors or advisory committees; Pfizer Pharmaceutical: Membership on an entity's Board of Directors or advisory committees; Dova Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Sanofi Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees. Khorana:Janssen: Consultancy; Bayer: Consultancy; Pfizer: Consultancy; Sanofi: Consultancy.
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