Christian Daniel Fankhauser1, Ben Tran2, Manuel Pedregal3, José Manuel Ruiz-Morales4, Egon Gonzalez-Billalabeitia5, Anna Patrikidou6, Eitan Amir7, Christoph Seidel8, Carsten Bokemeyer8, Thomas Hermanns1, Alexey Rumyantsev9, Alexey Tryakin9, Margarida Brito10, Aude Fléchon11, Edmon M Kwan2, Tina Cheng4, Daniel Castellano12, Xavier Garcia Del Muro13, Anis A Hamid14, Margaret Ottaviano15, Giovanella Palmieri15, Robert Kitson6, Alison Reid6, Daniel Y C Heng4, Philippe L Bedard7, Christopher J Sweeney3, Jean M Connors16. 1. University Hospital Zurich, University of Zurich, Zurich, Switzerland. 2. Peter MacCallum Cancer Centre, Melbourne, Australia. 3. Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. 4. Tom Baker Cancer Centre, Calgary, Alberta, Canada. 5. Hospital Universitario Morales Meseguer-IMIB, UCAM, Murcia, Spain. 6. The Royal Marsden NHS Foundation Trust, London, UK. 7. Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Department of Medicine, University of Toronto, Toronto, Ontario, Canada. 8. Department of Oncology, Hematology, BMT with Division of Pneumology, University Medical Center, Hamburg-Eppendorf, Hamburg, Germany. 9. NN Blokhin Russian Cancer Research Centre, Moscow, Russia. 10. Instituto Português de Oncologia de Lisboa Francisco Gentil, Lisboa, Portugal. 11. Centre Léon Bérard, Lyon, France. 12. Institut Catala d'Oncologia, Idibell, University of Barcelona, Barcelona, Spain; Department of Oncology, Hospital Universitario 12 de octubre, Madrid, Spain. 13. Institut Catala d'Oncologia, Idibell, University of Barcelona, Barcelona, Spain. 14. Olivia Newton John Cancer, Wellness and Research Centre, Heidelberg, Victoria, Australia. 15. CRTR Rare Tumors Reference Center, Università Degli Studi di Napoli Federico II, Naples, Italy. 16. Hematology Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: jconnors@bwh.harvard.edu.
Abstract
BACKGROUND: It remains unclear which patients with metastatic germ cell tumours (mGCTs) need prophylactic anticoagulation to prevent venous thromboembolic events (VTEs). OBJECTIVE: To assess the risk and onset of VTEs stratified by risk factors. DESIGN, SETTING, AND PARTICIPANTS: This multi-institutional retrospective dataset included mGCT patients treated with first-line platinum-based chemotherapy. INTERVENTION: Patients with prophylactic anticoagulation were excluded. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: 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: 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: 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: 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.
BACKGROUND: It remains unclear which patients with metastatic germ cell tumours (mGCTs) need prophylactic anticoagulation to prevent venous thromboembolic events (VTEs). OBJECTIVE: To assess the risk and onset of VTEs stratified by risk factors. DESIGN, SETTING, AND PARTICIPANTS: This multi-institutional retrospective dataset included mGCT patients treated with first-line platinum-based chemotherapy. INTERVENTION: Patients with prophylactic anticoagulation were excluded. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: 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: 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: 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: 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.