Acquired and inherited risk factors for developing venous thromboembolism in cancer patients receiving adjuvant chemotherapy: a prospective trial.
BACKGROUND
Acquired and inherited risk factors for venous thromboembolism (VTE) and the incidence of symptomatic VTE were investigated in patients on adjuvant chemotherapy for breast or gastrointestinal cancer (GI).


METHODS
In a prospective observational study (January 2003 and February 2006), 199 GI (82 women/117 men; age range, 26-84 years) and 182 breast (180 women/2 men; age range, 29-85 years) cancer patients were enrolled and followed-up for symptomatic VTE during adjuvant chemotherapy. The effect of acquired (i.e. age, chemotherapy, tumour histotype, history of thrombosis, body mass index and smoking) and inherited risk factors [i.e. antithrombin, protein C (PC), protein S, homocysteine, activated PC resistance, factor V Leiden (FVL) and prothrombin (PT) mutations) was prospectively evaluated.


RESULTS
Overall, 30 VTE events (7.87%) were recorded: 28 (7.35%) during treatment and 2 (0.52%) during the subsequent follow-up. Among all the 381 cancer patients, FVL was detected in 14 cases (3.67%) and PT mutation in 10 cases (2.62%). Multivariate analysis showed a significant association between the development of VTE and both thrombocytosis [hazard ratio (HR) 1.65; 95% confidence interval (CI), 1.04-2.637, P <0.0341] and a prior episode of thrombosis (HR 7.6; 95% CI, 1.77-33.1, P <0.006). FVL and PT mutations were not associated with the risk for VTE.


CONCLUSIONS
The present data indicate thrombocytosis and history of thrombosis as risk factors for development of a thrombotic event during adjuvant chemotherapy in patients with malignant diseases.
Mandalà
M
M
Department of Oncology and Hematology, Ospedali Riuniti di Bergamo. Electronic address: mariomandala@tin.it.
Barni
S
S
Division of Medical Oncology, Treviglio Hospital, Bergamo, Italy.
Prins
M
M
Department of Clinical Epidemiology and Medical Technology Assessment, Academic Hospital Maastricht, University of Maastricht, Maastricht, The Netherlands.
Labianca
R
R
Department of Oncology and Hematology, Ospedali Riuniti di Bergamo.
Tondini
C
C
Department of Oncology and Hematology, Ospedali Riuniti di Bergamo.
Russo
L
L
Division of Immunohematology/Transfusion Medicine, Hemostasis and Thrombosis Center, Department of Oncology and Hematology, Ospedali Riuniti, Bergamo.
Milesi
A
A
Department of Oncology and Hematology, Ospedali Riuniti di Bergamo.
Cremonesi
M
M
Division of Medical Oncology, Treviglio Hospital, Bergamo, Italy.
Zaccanelli
M
M
Unit of Transfusion and Hematology, Department of Clinical Pathology, Treviglio Hospital, Treviglio, Italy.
Regonesi
C
C
Unit of Transfusion and Hematology, Department of Clinical Pathology, Treviglio Hospital, Treviglio, Italy.
Moro
C
C
Department of Oncology and Hematology, Ospedali Riuniti di Bergamo.
Falanga
A
A
Division of Immunohematology/Transfusion Medicine, Hemostasis and Thrombosis Center, Department of Oncology and Hematology, Ospedali Riuniti, Bergamo.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000032:analysis / Q000097:blood; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D020022:Genetic Predisposition to Disease; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy* / Q000453:epidemiology / Q000235:genetics; D012307:Risk Factors; D054556:Venous Thromboembolism / Q000453:epidemiology / Q000209:etiology* / Q000235:genetics / Q000517:prevention & control
D015415:Biomarkers