Global Prospective Cohort Study of Factors Associated with Venous Thromboembolism in Patients with Lung Cancer Receiving Cancer Therapy

BACKGROUND: Patients with lung cancer are known to be at increased risk for venous thromboembolism (VTE). However, there have been few studies of risk factors for VTE in lung cancer patients undergoing systemic chemotherapy.

METHODS: CANTARISK was a prospective, non-interventional, global cohort study including patients with lung cancer initiating a new chemotherapy regimen. Clinical data were collected at baseline and at 2, 4 and 6 months follow-up. The impact of patient-, disease- and treatment-related factors on the occurrence of VTE in the first 6 months was evaluated in univariable and multivariable Cox regression analyses.

RESULTS: A total of 1,980 patients with lung cancer were enrolled from 2011-12 of which 84% were diagnosed with non-small cell lung cancer (NSCLC). Median age was 63 years (range, 25-91) and 63% were male while 82% were active or former smokers. Race was white (70%), Asian (22%), or black (4%) with similar numbers from North America, Europe, and other regions including Asia. Metastatic disease was reported in 70% and ECOG PS was ≥2 in 13%. During the first six months, 121 patients developed a VTE (6.1%), of which 47.1% had pulmonary embolism (PE), 45.5% deep venous thrombosis (DVT), 3.3% catheter-associated thrombosis, and 4.1% visceral thrombosis. Among significant factors in univariable analysis, independent predictors for VTE in multivariable Cox regression analysis included female gender, US geographic region, leg immobilization, and presence of a central venous catheter (Table) with a trend toward greater risk for higher grade histology. Although predictive of early all-cause mortality in this study population (Kuderer et al ASCO 2016), the previously validated risk score for VTE in ambulatory cancer patients (Khorana et al: Blood 2008) was not significantly associated with VTE in either univariable or multivariable analysis.

CONCLUSIONS: Several demographic, geographic, and clinical factors are significantly associated with an increased risk of VTE in patients with lung cancer receiving systemic chemotherapy. Future analysis will attempt to assess how novel targeted treatment options might impact the Khorana score's predictive ability across all lung cancer patients.

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