TY - JOUR
T1 - Thrombin generation predicts early recurrence in breast cancer patients.
AU - Investigators, HYPERCAN
AU - Marchetti, Marina
AU - Giaccherini, Cinzia
AU - Masci, Giovanna
AU - Verzeroli, Cristina
AU - Russo, Laura
AU - Celio, Luigi
AU - Sarmiento, Roberta
AU - Gamba, Sara
AU - Tartari, Carmen J
AU - Diani, Erika
AU - Vignoli, Alfonso
AU - Malighetti, Paolo
AU - Spinelli, Daniele
AU - Kuderer, Nicole M
AU - Nichetti, Federico
AU - Minelli, Mauro
AU - Tondini, Carlo
AU - Barni, Sandro
AU - Giuliani, Francesco
AU - Petrelli, Fausto
AU - D'Alessio, Andrea
AU - Gasparini, Giampietro
AU - Labianca, Roberto
AU - Santoro, Armando
AU - De Braud, Filippo
AU - Falanga, Anna
N1 - © 2020 International Society on Thrombosis and Haemostasis.
PY - 2020/9
Y1 - 2020/9
N2 - BACKGROUND: Cancer patients present with a hypercoagulable state often associated with poor disease prognosis.OBJECTIVES: This study aims to evaluate whether thrombin generation (TG), a global coagulation test, may be a useful tool to improve the identification of patients at high risk of early disease recurrence (ie, E-DR within 2 years) after breast cancer surgery.PATIENTS/METHODS: A cohort of 522 newly diagnosed patients with surgically resected high-risk breast cancer were enrolled in the ongoing prospective HYPERCAN study. TG potential was measured in plasma samples collected before starting systemic chemotherapy. Significant predictive hemostatic and clinic-pathological parameters were identified in the derivation cohort by Cox regression analysis. A risk prognostic score for E-DR was generated in the derivation and tested in the validation cohort.RESULTS: After a median observation period of 3.4 years, DR occurred in 51 patients, 28 of whom were E-DR. E-DR subjects presented with the highest TG values as compared to both late-DR (from 2 to 5 years) and no relapse subjects (P <.01). Multivariate analysis in the derivation cohort identified TG, mastectomy, triple negative and Luminal B HER2-neg molecular subtypes as significant independent predictors for E-DR, which were utilized to generate a risk assessment score. In the derivation and validation cohorts, E-DR rates were 2.3% and 0% in the low-risk, 10.1% and 6.3% in the intermediate-risk, and 18.2% and 16.7%, in the high-risk categories, respectively.CONCLUSIONS: Inclusion of TG in a risk-assessment model for E-DR significantly helps the identification of operated breast cancer patients at high risk of very early relapse.
AB - BACKGROUND: Cancer patients present with a hypercoagulable state often associated with poor disease prognosis.OBJECTIVES: This study aims to evaluate whether thrombin generation (TG), a global coagulation test, may be a useful tool to improve the identification of patients at high risk of early disease recurrence (ie, E-DR within 2 years) after breast cancer surgery.PATIENTS/METHODS: A cohort of 522 newly diagnosed patients with surgically resected high-risk breast cancer were enrolled in the ongoing prospective HYPERCAN study. TG potential was measured in plasma samples collected before starting systemic chemotherapy. Significant predictive hemostatic and clinic-pathological parameters were identified in the derivation cohort by Cox regression analysis. A risk prognostic score for E-DR was generated in the derivation and tested in the validation cohort.RESULTS: After a median observation period of 3.4 years, DR occurred in 51 patients, 28 of whom were E-DR. E-DR subjects presented with the highest TG values as compared to both late-DR (from 2 to 5 years) and no relapse subjects (P <.01). Multivariate analysis in the derivation cohort identified TG, mastectomy, triple negative and Luminal B HER2-neg molecular subtypes as significant independent predictors for E-DR, which were utilized to generate a risk assessment score. In the derivation and validation cohorts, E-DR rates were 2.3% and 0% in the low-risk, 10.1% and 6.3% in the intermediate-risk, and 18.2% and 16.7%, in the high-risk categories, respectively.CONCLUSIONS: Inclusion of TG in a risk-assessment model for E-DR significantly helps the identification of operated breast cancer patients at high risk of very early relapse.
U2 - 10.1111/jth.14891
DO - 10.1111/jth.14891
M3 - Article
VL - 18
SP - 2220
EP - 2231
JO - Journal of Thrombosis and Haemostasis
JF - Journal of Thrombosis and Haemostasis
SN - 1538-7933
IS - 9
ER -