Factor V Leiden mutation in patients with breast cancer with a central venous catheter: Risk of deep vein thrombosis

Giuseppe Curigliano, Mario Mandalà, Alberto Sbanotto, Marco Colleoni, Gianluigi Ferretti, Paolo Bucciarelli, Giulia Peruzzotti, Filippo De Braud, Tommaso De Pas, Gianluca Spitaleri, E. Pietri, Franco Orsi, Maria G. Banfi, Aron Goldhirsch

Research output: Contribution to journalArticlepeer-review


Background: The objective of this study was to analyze the influence of the prothrombotic factor V Leiden (FVL) and G20210A prothrombin mutations on the frequency of the first episode of catheter-related deep vein thrombosis (DVT) in a cohort of patients with locally advanced or metastatic breast cancer during continuous venous insult (infusion of 5-fluorouracil-based chemotherapy). Patients and Methods: Between January 1999 and February 2001, we retrospectively analyzed the incidence of first DVT in 300 consecutive patients with locally advanced or metastatic breast cancer treated at a single institution with a combination of chemotherapy administered continuously through a totally implanted access port. We identified 25 women (study group) with catheter-related DVT. For each of the 25 patients, we selected 2 women eligible for identical chemotherapy who had similar age, stage of disease, and prognostic features as a control group. The prothrombotic FVL and prothrombin mutation G20210A genotype analyses were performed in all patients. Analyses were performed on blinded samples, and all patients signed a specific informed consent form. A total of 25 cases (with thrombosis) and 50 frequency-matched controls were evaluated for FVL. Results: Five cases and 2 controls were found with the mutation in the FVL, for incidences of 20% (95% CI, 9%-39%) and 4% (95% CI, 1%-14%), respectively. Thus, the frequency of the mutation was significantly higher in the cases than in controls (P = 0.04), and a logistic regression analysis, adjusted by age, yielded an odds ratio of 6.1 (95% CI, 1.1%-34.3%; P = 0.04). Time from start of infusion chemotherapy to thrombosis was not significantly different between those with the mutation (median, 31 days) and without the mutation (median, 43 days; P = 0.6). Only 1 subject (in the case group) was found with the G20210A mutation in the prothrombin gene. Conclusion: Factor V Leiden carriers with locally advanced or metastatic breast cancer are at high risk of catheter-related DVT during chemotherapy. Clinicians should be aware of this increased risk, and alternative cytotoxic treatments not requiring continuous infusions should be considered for these patients.

Original languageEnglish
Pages (from-to)98-102
Number of pages5
JournalSupportive Cancer Therapy
Issue number2
Publication statusPublished - Jan 2006


  • Chemotherapy
  • Thrombophilic mutation
  • Vascular access devices
  • Venous thromboembolism

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pharmacology

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