A Risk-benefit Analysis of Prophylactic Anticoagulation for Patients with Metastatic Germ Cell Tumours Undergoing First-line Chemotherapy.

Anticoagulants / adverse effects Humans Male Neoplasms, Germ Cell and Embryonal / drug therapy Retrospective Studies Testicular Neoplasms / drug therapy Venous Thromboembolism / epidemiology Venous Thrombosis / epidemiology

Deep vein thrombosis Germ cell tumour Pulmonary embolism Testicular cancer Venous access device Venous thromboembolism

Journal

European urology focus

ISSN: 2405-4569

Titre abrégé: Eur Urol Focus

Pays: Netherlands

ID NLM: 101665661

Informations de publication

Date de publication:
Sep 2021

Historique:

received: 21 08 2020

revised: 14 09 2020

accepted: 22 09 2020

pubmed: 10 10 2020

medline: 14 4 2022

entrez: 9 10 2020

Statut: ppublish

Résumé

It remains unclear which patients with metastatic germ cell tumours (mGCTs) need prophylactic anticoagulation to prevent venous thromboembolic events (VTEs). To assess the risk and onset of VTEs stratified by risk factors. This multi-institutional retrospective dataset included mGCT patients treated with first-line platinum-based chemotherapy. Patients with prophylactic anticoagulation were excluded. A regression analysis was performed to select risk factors for VTEs. The simulated number needed to treat (NNT) and the number needed to harm (NNH) with prophylactic anticoagulation were calculated based on the cumulative incidences retrieved from this study and hazard rates of recently published trials describing the efficacy of prophylactic anticoagulation to prevent VTEs and the risk of bleeding events. From 1120 patients, 121 (11%) had a VTE, which occurred prior to chemotherapy in 49 (4%) and on or after chemotherapy in 72 (6%). Six patients (<1%) had a bleeding event without anticoagulation. After backward regression, the one risk factor for a VTE during or after chemotherapy was the use of a venous access device. The simulated cumulative VTE incidence from prophylactic anticoagulation for patients on or after chemotherapy would translate into an NNT of 45 (95% confidence interval [CI] 36-56) and an NNH of 186 (95% CI 87-506). Limitations are mainly related to the retrospective nature of the study. The mGCTs associated VTEs are most common before and during, but not after, chemotherapy. Avoiding venous access device and/or prophylactic anticoagulation with an acceptable risk-benefit profile may decrease VTE occurring on chemotherapy. We found that venous thromboembolic events (VTEs) occur rarely after chemotherapy. Based on experience of prophylactic anticoagulation in other cancers, we conclude that the risk of VTE in men undergoing chemotherapy for metastatic germ cell tumours can be decreased by thromboprophylaxis with a reasonable risk-benefit profile and by avoidance of venous access devices.

Sections du résumé

BACKGROUND BACKGROUND

It remains unclear which patients with metastatic germ cell tumours (mGCTs) need prophylactic anticoagulation to prevent venous thromboembolic events (VTEs).

OBJECTIVE OBJECTIVE

To assess the risk and onset of VTEs stratified by risk factors.

DESIGN, SETTING, AND PARTICIPANTS METHODS

This multi-institutional retrospective dataset included mGCT patients treated with first-line platinum-based chemotherapy.

INTERVENTION METHODS

Patients with prophylactic anticoagulation were excluded.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS METHODS

A regression analysis was performed to select risk factors for VTEs. The simulated number needed to treat (NNT) and the number needed to harm (NNH) with prophylactic anticoagulation were calculated based on the cumulative incidences retrieved from this study and hazard rates of recently published trials describing the efficacy of prophylactic anticoagulation to prevent VTEs and the risk of bleeding events.

RESULTS AND LIMITATIONS CONCLUSIONS

From 1120 patients, 121 (11%) had a VTE, which occurred prior to chemotherapy in 49 (4%) and on or after chemotherapy in 72 (6%). Six patients (<1%) had a bleeding event without anticoagulation. After backward regression, the one risk factor for a VTE during or after chemotherapy was the use of a venous access device. The simulated cumulative VTE incidence from prophylactic anticoagulation for patients on or after chemotherapy would translate into an NNT of 45 (95% confidence interval [CI] 36-56) and an NNH of 186 (95% CI 87-506). Limitations are mainly related to the retrospective nature of the study.

CONCLUSIONS CONCLUSIONS

The mGCTs associated VTEs are most common before and during, but not after, chemotherapy. Avoiding venous access device and/or prophylactic anticoagulation with an acceptable risk-benefit profile may decrease VTE occurring on chemotherapy.

PATIENT SUMMARY RESULTS

We found that venous thromboembolic events (VTEs) occur rarely after chemotherapy. Based on experience of prophylactic anticoagulation in other cancers, we conclude that the risk of VTE in men undergoing chemotherapy for metastatic germ cell tumours can be decreased by thromboprophylaxis with a reasonable risk-benefit profile and by avoidance of venous access devices.

Identifiants

DOI: 10.1016/j.euf.2020.09.017 PMID: 33032968

pubmed: 33032968

pii: S2405-4569(20)30280-7

doi: 10.1016/j.euf.2020.09.017

pii:

doi:

Substances chimiques

Anticoagulants 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

1130-1136