Khorana score and histotype predicts incidence of early venous thromboembolism in Non-Hodgkin lymphomas: A Pooled-Data analysis of 12 clinical trials of fondazione italiana linfomi (FIL)

R.M. Santi, M. Ceccarelli, E. Bernocco, C. Monagheddu, A. Evangelista, F. Valeri, F. Monaco, U. Vitolo, S. Cortelazzo, M.G. Cabras, M. Spina, L. Baldini, C. Boccomini, A. Chiappella, A. Bari, S. Luminari, C. Visco, M. Calabrese, G. Limberti, A. Levis & 3 others L. Contino, G. Ciccone, M. Ladetto

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Current data suggests that the risk of venous thromboembolism (VTE) in patients with non-Hodgkin lymphoma (NHL) is comparable to that observed in patients with solid tumours, although more robust confirmatory analyses are required. With that in mind, we investigated the occurrence of VTE in a pooled analysis of 12 “Fondazione Italiana Linfomi” (FIL) prospective clinical studies. Specifically, we wished to assess the cumulative incidence of VTE in NHL patients, evaluate the predictive value of the Khorana Score (KS), and identify other potential risk factors for VTEs. Data for VTE occurrence were retrieved from study databases and pharmacovigilance reports. Our analysis includes 1717 patients from 12 prospective phase II and III trials, including newly diagnosed NHL. We observed 53 VTEs (any grade) in 46 patients, with 20 severe VTEs in 17 patients. The cumulative incidences for „all-grade“ or grade ≥3 VTEs were 2.9 % (95 % CI: 2.1-3.8) and 1.1 % (95 % CI: 0.6-1.6), respectively. KS categories were positively associated with the risk of VTE of any grade, and with severe events (i. e. grade ≥3; Gray’s test p-values = 0.048 and 0.012, respectively). Among NHL patients, those with diffuse large B-cell lymphoma (DLBCL) showed a greater risk of (any grade) VTE (HR: 3.42, 95 % CI: 1.32-8.84, p-value = 0.011). Our study indicates that 1) VTE is a relevant complication for NHL patients, 2) KS is predictive of VTE events and 3) DLBCL histotype is an independent risk factor for VTE incidence, for which preventative interventions could be considered. © Schattauer 2017.
Original languageEnglish
Pages (from-to)1615-1621
Number of pages7
JournalThrombosis and Haemostasis
Volume117
Issue number8
DOIs
Publication statusPublished - 2017

Fingerprint

Venous Thromboembolism
Non-Hodgkin's Lymphoma
Clinical Trials
Incidence
Lymphoma, Large B-Cell, Diffuse
Pharmacovigilance
Databases
Prospective Studies

Keywords

  • Khorana score
  • Non-Hodgkin lymphoma
  • Venous thromboembolism
  • hemoglobin
  • lenalidomide
  • low molecular weight heparin
  • adult
  • Article
  • autologous stem cell transplantation
  • cardiovascular disease assessment
  • cardiovascular risk
  • computer assisted tomography
  • diffuse large B cell lymphoma
  • drug surveillance program
  • female
  • human
  • Khorana Score
  • leukocyte count
  • major clinical study
  • male
  • middle aged
  • nonhodgkin lymphoma
  • phase 2 clinical trial (topic)
  • phase 3 clinical trial (topic)
  • priority journal
  • thrombocyte count
  • venous thromboembolism

Cite this

Khorana score and histotype predicts incidence of early venous thromboembolism in Non-Hodgkin lymphomas: A Pooled-Data analysis of 12 clinical trials of fondazione italiana linfomi (FIL). / Santi, R.M.; Ceccarelli, M.; Bernocco, E.; Monagheddu, C.; Evangelista, A.; Valeri, F.; Monaco, F.; Vitolo, U.; Cortelazzo, S.; Cabras, M.G.; Spina, M.; Baldini, L.; Boccomini, C.; Chiappella, A.; Bari, A.; Luminari, S.; Visco, C.; Calabrese, M.; Limberti, G.; Levis, A.; Contino, L.; Ciccone, G.; Ladetto, M.

In: Thrombosis and Haemostasis, Vol. 117, No. 8, 2017, p. 1615-1621.

Research output: Contribution to journalArticle

Santi, RM, Ceccarelli, M, Bernocco, E, Monagheddu, C, Evangelista, A, Valeri, F, Monaco, F, Vitolo, U, Cortelazzo, S, Cabras, MG, Spina, M, Baldini, L, Boccomini, C, Chiappella, A, Bari, A, Luminari, S, Visco, C, Calabrese, M, Limberti, G, Levis, A, Contino, L, Ciccone, G & Ladetto, M 2017, 'Khorana score and histotype predicts incidence of early venous thromboembolism in Non-Hodgkin lymphomas: A Pooled-Data analysis of 12 clinical trials of fondazione italiana linfomi (FIL)', Thrombosis and Haemostasis, vol. 117, no. 8, pp. 1615-1621. https://doi.org/10.1160/TH16-11-0895
Santi, R.M. ; Ceccarelli, M. ; Bernocco, E. ; Monagheddu, C. ; Evangelista, A. ; Valeri, F. ; Monaco, F. ; Vitolo, U. ; Cortelazzo, S. ; Cabras, M.G. ; Spina, M. ; Baldini, L. ; Boccomini, C. ; Chiappella, A. ; Bari, A. ; Luminari, S. ; Visco, C. ; Calabrese, M. ; Limberti, G. ; Levis, A. ; Contino, L. ; Ciccone, G. ; Ladetto, M. / Khorana score and histotype predicts incidence of early venous thromboembolism in Non-Hodgkin lymphomas: A Pooled-Data analysis of 12 clinical trials of fondazione italiana linfomi (FIL). In: Thrombosis and Haemostasis. 2017 ; Vol. 117, No. 8. pp. 1615-1621.
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T1 - Khorana score and histotype predicts incidence of early venous thromboembolism in Non-Hodgkin lymphomas: A Pooled-Data analysis of 12 clinical trials of fondazione italiana linfomi (FIL)

AU - Santi, R.M.

AU - Ceccarelli, M.

AU - Bernocco, E.

AU - Monagheddu, C.

AU - Evangelista, A.

AU - Valeri, F.

AU - Monaco, F.

AU - Vitolo, U.

AU - Cortelazzo, S.

AU - Cabras, M.G.

AU - Spina, M.

AU - Baldini, L.

AU - Boccomini, C.

AU - Chiappella, A.

AU - Bari, A.

AU - Luminari, S.

AU - Visco, C.

AU - Calabrese, M.

AU - Limberti, G.

AU - Levis, A.

AU - Contino, L.

AU - Ciccone, G.

AU - Ladetto, M.

N1 - Cited By :2 Export Date: 21 February 2018 CODEN: THHAD Correspondence Address: Santi, R.M.; AO SS Antonio e Biagio e C. Arrigo-SC Ematologia, Via Venezia 16, Italy; email: rsanti@ospedale.al.it

PY - 2017

Y1 - 2017

N2 - Current data suggests that the risk of venous thromboembolism (VTE) in patients with non-Hodgkin lymphoma (NHL) is comparable to that observed in patients with solid tumours, although more robust confirmatory analyses are required. With that in mind, we investigated the occurrence of VTE in a pooled analysis of 12 “Fondazione Italiana Linfomi” (FIL) prospective clinical studies. Specifically, we wished to assess the cumulative incidence of VTE in NHL patients, evaluate the predictive value of the Khorana Score (KS), and identify other potential risk factors for VTEs. Data for VTE occurrence were retrieved from study databases and pharmacovigilance reports. Our analysis includes 1717 patients from 12 prospective phase II and III trials, including newly diagnosed NHL. We observed 53 VTEs (any grade) in 46 patients, with 20 severe VTEs in 17 patients. The cumulative incidences for „all-grade“ or grade ≥3 VTEs were 2.9 % (95 % CI: 2.1-3.8) and 1.1 % (95 % CI: 0.6-1.6), respectively. KS categories were positively associated with the risk of VTE of any grade, and with severe events (i. e. grade ≥3; Gray’s test p-values = 0.048 and 0.012, respectively). Among NHL patients, those with diffuse large B-cell lymphoma (DLBCL) showed a greater risk of (any grade) VTE (HR: 3.42, 95 % CI: 1.32-8.84, p-value = 0.011). Our study indicates that 1) VTE is a relevant complication for NHL patients, 2) KS is predictive of VTE events and 3) DLBCL histotype is an independent risk factor for VTE incidence, for which preventative interventions could be considered. © Schattauer 2017.

AB - Current data suggests that the risk of venous thromboembolism (VTE) in patients with non-Hodgkin lymphoma (NHL) is comparable to that observed in patients with solid tumours, although more robust confirmatory analyses are required. With that in mind, we investigated the occurrence of VTE in a pooled analysis of 12 “Fondazione Italiana Linfomi” (FIL) prospective clinical studies. Specifically, we wished to assess the cumulative incidence of VTE in NHL patients, evaluate the predictive value of the Khorana Score (KS), and identify other potential risk factors for VTEs. Data for VTE occurrence were retrieved from study databases and pharmacovigilance reports. Our analysis includes 1717 patients from 12 prospective phase II and III trials, including newly diagnosed NHL. We observed 53 VTEs (any grade) in 46 patients, with 20 severe VTEs in 17 patients. The cumulative incidences for „all-grade“ or grade ≥3 VTEs were 2.9 % (95 % CI: 2.1-3.8) and 1.1 % (95 % CI: 0.6-1.6), respectively. KS categories were positively associated with the risk of VTE of any grade, and with severe events (i. e. grade ≥3; Gray’s test p-values = 0.048 and 0.012, respectively). Among NHL patients, those with diffuse large B-cell lymphoma (DLBCL) showed a greater risk of (any grade) VTE (HR: 3.42, 95 % CI: 1.32-8.84, p-value = 0.011). Our study indicates that 1) VTE is a relevant complication for NHL patients, 2) KS is predictive of VTE events and 3) DLBCL histotype is an independent risk factor for VTE incidence, for which preventative interventions could be considered. © Schattauer 2017.

KW - Khorana score

KW - Non-Hodgkin lymphoma

KW - Venous thromboembolism

KW - hemoglobin

KW - lenalidomide

KW - low molecular weight heparin

KW - adult

KW - Article

KW - autologous stem cell transplantation

KW - cardiovascular disease assessment

KW - cardiovascular risk

KW - computer assisted tomography

KW - diffuse large B cell lymphoma

KW - drug surveillance program

KW - female

KW - human

KW - Khorana Score

KW - leukocyte count

KW - major clinical study

KW - male

KW - middle aged

KW - nonhodgkin lymphoma

KW - phase 2 clinical trial (topic)

KW - phase 3 clinical trial (topic)

KW - priority journal

KW - thrombocyte count

KW - venous thromboembolism

U2 - 10.1160/TH16-11-0895

DO - 10.1160/TH16-11-0895

M3 - Article

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JO - Thrombosis and Haemostasis

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SN - 0340-6245

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