1. A Risk-benefit Analysis of Prophylactic Anticoagulation for Patients with Metastatic Germ Cell Tumours Undergoing First-line Chemotherapy
- Author
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Alexey Rumyantsev, Xavier Garcia del Muro, Edmon M. Kwan, Christian D. Fankhauser, Egon Gonzalez-Billalabeitia, Anis A. Hamid, Giovanella Palmieri, Alexey Tryakin, Philippe L. Bedard, Anna Patrikidou, Eitan Amir, Robert Kitson, Jean M. Connors, Carsten Bokemeyer, Tina Cheng, Ben Tran, Daniel Y.C. Heng, Jose Manuel Ruiz-Morales, Daniel Castellano, Christopher Sweeney, Aude Flechon, Thomas Hermanns, Manuel Pedregal, Margaret Ottaviano, Alison Reid, Christoph Seidel, Margarida Brito, University of Zurich, and Connors, Jean M
- Subjects
2748 Urology ,Male ,medicine.medical_specialty ,Urology ,medicine.medical_treatment ,030232 urology & nephrology ,610 Medicine & health ,03 medical and health sciences ,0302 clinical medicine ,Testicular Neoplasms ,Internal medicine ,Humans ,Medicine ,Patient summary ,Testicular cancer ,Retrospective Studies ,Venous Thrombosis ,Chemotherapy ,business.industry ,Anticoagulants ,Venous Thromboembolism ,Number needed to harm ,Neoplasms, Germ Cell and Embryonal ,medicine.disease ,Pulmonary embolism ,10062 Urological Clinic ,030220 oncology & carcinogenesis ,Risk-benefit analysis ,Number needed to treat ,First line chemotherapy ,business - Abstract
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.
- Published
- 2021