RESUMO
BACKGROUND: Extended venous thromboembolism prophylaxis after abdominopelvic cancer surgery has not been widely adopted. We compared outcomes of patients pre- and postimplementation of extended venous thromboembolism prophylaxis with low molecular weight heparin. METHODS: Prospectively collected data from a quality initiative project aimed at prescribing extended venous thromboembolism prophylaxis after abdominopelvic cancer surgery was compared with previously published data from a prospective cohort without extended venous thromboembolism prophylaxis. The primary outcome was 6-month postoperative symptomatic venous thromboembolism incidence. SECONDARY OUTCOMES: differences in 1- and 3-month venous thromboembolism incidence and factors associated with venous thromboembolism using Cox-proportional hazard models. Cumulative incidence of venous thromboembolism was estimated using Kaplan-Meier methods and expressed as proportions with 95% confidence interval. RESULTS: There were 241 patients in the venous thromboembolism-prophylaxis cohort and 284 patients in the no venous thromboembolism prophylaxis cohort. Patients in the venous thromboembolism-prophylaxis cohort were more likely to be female (69% vs 60%, P = .018), have metastatic disease (49% vs 29%, P < .001), have longer operative times (236 min vs 197 min, P < .001), and to receive neoadjuvant chemotherapy (27% vs 23%, P = .006). Respectively, the 1- (0.5% [95% confidence interval, 0.1-2.5] vs 0.4% [95% confidence interval, 0.1-2.5]), 3- (2.6% [95% confidence interval, 1.2-5.6] vs 2.5% [95% confidence interval, 1.2-5.2]), and 6-month (7.5% [95% confidence interval, 4.8-11.5] vs 7.2% [95% confidence interval, 4.7-11.0]) venous thromboembolism incidence were similar. By multivariable analysis, history of venous thromboembolism (hazard ratio 3.52; 95% confidence interval, 1.03-12.05; P = .045) and longer duration of hospital stay (hazard ratio 1.07; 95% confidence interval, 1.01-1.12; P = .016) demonstrated increased risk of venous thromboembolism. CONCLUSION: This study failed to demonstrate a decreased 1-, 3-, and 6-month postoperative venous thromboembolism incidence after the implementation of extended venous thromboembolism prophylaxis.
Assuntos
Neoplasias , Tromboembolia Venosa , Anticoagulantes/uso terapêutico , Estudos de Coortes , Feminino , Humanos , Masculino , Neoplasias/complicações , Neoplasias/cirurgia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Estudos Prospectivos , Melhoria de Qualidade , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controleRESUMO
Importance: The recent development of targeted therapy and immunotherapy has made neoadjuvant therapy an attractive option for patients with hepatocellular carcinoma (HCC). However, surgeons are concerned that adverse effects of neoadjuvant therapy with these agents could lead to delayed or even cancelled surgeries. Objective: To summarize the current evidence regarding toxicity profiles for tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) among patients with HCC. Data Sources: Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from January 1990 and December 2021. Study Selection: Single-group, placebo-controlled, and dual-agent clinical trials comparing TKIs and ICIs in patients with HCC were eligible for inclusion. Data Extraction and Synthesis: Following the Preferred Reporting Items in Systematic Reviews and Meta-analysis guideline, 2 reviewers independently extracted data. A random-effects model was used. Main Outcomes and Measures: The primary outcome was the proportion of patients with clinically significant liver-related adverse events. Secondary outcomes included the proportion of patients who experienced clinically relevant (grade 3 or higher) adverse events and significant adverse events (ie, those that were life threatening, required hospitalization, or prolonged disability) as well as the risk ratio (RR) of these complications. Results: Overall, 30 studies with 12â¯921 patients were included. Patients had a mean (range) age of 62 (18-89) years; a mean (SD) 84% (3) were male; a mean (SD) 82% (16) had Barcelona Clinic Liver Cancer stage C HCC; and a mean (SD) 97% (6) had Childs A cirrhosis. Overall, 21% (95% CI, 16%-26%) of patients receiving TKIs had liver toxic effects compared with 28% (95% CI, 21%-35%) of patients receiving ICIs. Severe adverse events occurred in 46% (95% CI, 40%-51%) of patients receiving TKIs compared with 24% (95% CI, 13%-35%) of patients receiving ICIs. Compared with patients receiving sorafenib, other TKIs were associated with similar rates of liver toxic effects (RR, 1.06; 95% CI, 0.92-1.24) but higher rates of severe adverse events (RR, 1.24; 95% CI, 1.07-1.44). Comparing ICIs with sorafenib, there were similar rates of liver toxic effects (RR, 1.10; 95% CI, 0.86-1.40) and severe adverse events (RR, 1.19; 95% CI, 0.95-1.50). Conclusions and Relevance: In this systematic review and meta-analysis, serious adverse events were lower with ICIs than with TKIs, while liver toxic effects were similar. Combination therapy with novel ICIs is an appealing option in trials of neoadjuvant therapy for patients with HCC, requiring evaluation in preoperative trials.