Thromboembolic events and antithrombotic prophylaxis in advanced ovarian cancer patients treated with bevacizumab: secondary analysis of the phase IV MITO-16A/MaNGO-OV2A trial.

The use of routine antithrombotic prophylaxis is not recommended for advanced cancer patients receiving chemotherapy. The effect of bevacizumab-containing therapy on the risk of thromboembolic events remains controversial in ovarian cancer patients. We report on the incidence of thromboembolic events and the prevalence of antithrombotic therapy in patients enrolled in the single arm, phase IV, MITO-16A/MaNGO-OV2A trial. In this trial, potential prognostic factors for patients with previously untreated ovarian cancer receiving a combination of platinum-based chemotherapy and bevacizumab were explored and the final analysis has already been reported. In this secondary analysis, the occurrence of thromboembolic events and the use of antithrombotic therapy were described according to the clinical characteristics of the patients. The prognostic role of thromboembolic events for progression-free and overall survival were also evaluated. From October 2012 to November 2014, 398 eligible patients were enrolled. 76 patients (19.1%) were receiving some type of anticoagulant or anti-aggregant treatment at baseline. Overall, 24 thromboembolic events were reported (cumulative incidence of 6.0%). The occurrence of thromboembolic events was not associated with baseline patient characteristics and was not modified by the use of antithrombotic prophylaxis (HR 0.60, 95% CI 0.18 to 2.0). Occurrence of thromboembolic events was not associated with progression-free survival (HR 1.34, 95% CI 0.83 to 2.15) or overall survival (HR 0.78, 95% CI 0.37 to 1.61). In our study, a 6.0% rate of thromboembolic events was reported during treatment with bevacizumab plus chemotherapy. Thromboembolic events were not associated with the clinical characteristics of the patients or with the use of antithrombotic prophylaxis, nor did they significantly affect the long-term prognosis. NCT01706120.

Informations de copyright

© IGCS and ESGO 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: RDL reports personal fees from Astellas, outside the submitted work. FR reports grants from GSK, grants from MSD, grants from Roche, grants from Pharmamar, grants from AstraZeneca, outside the submitted work. NC reports personal fees from Roche, personal fees from Pharmamar, personal fees from AstraZeneca, personal fees from MSD/Merck, personal fees from Clovis Oncology, personal fees from Tesaro, personal fees from GSK, personal fees from Novartis, personal fees from Pfizer, personal fees from Takeda, personal fees from Biocad, personal fees from Immunogen, personal fees from Mersana, personal fees from Eisai, personal fees from Oncxerna, outside the submitted work. SF reports personal fees from Pharmastar, personal fees from GSK, personal fees from Pfizer, personal fees from Novartis, outside the submitted work. DG reports personal fees from Astellas, personal fees from Bayer, personal fees and non-financial support from BMS, personal fees and non-financial support from Ipsen, personal fees and non-financial support from Janssen, personal fees from Merck, personal fees and non-financial support from Pfizer, grants and personal fees from Sanofi, grants from Roche, from AstraZeneca, outside the submitted work. DL reports personal fees and non-financial support from AstraZeneca, grants, personal fees and non-financial support from Clovis, grants, personal fees and non-financial support from GSK, personal fees from Pharmamar, grants and non-financial support from Genmab, grants, personal fees and non-financial support from MSD, non-financial support from Immunogen, non-financial support from Incyte, non-financial support from Roche, from Amgen, outside the submitted work. VS reports personal fees from MSD, personal fees from GSK, personal fees from Tesaro, personal fees from AstraZeneca, personal fees from Roche, personal fees from Eisai, personal fees from Clovis, outside the submitted work. FP reports personal fees from Bayer, personal fees from Ipsen, personal fees from AstraZeneca, personal fees from Bristol Myers Squibb, personal fees from Sandoz, personal fees from Incyte, personal fees from Celgene, personal fees from Pierre Fabre, personal fees from Janssen-Cilag, outside the submitted work. SP reports grants and personal fees from AstraZeneca, grants and personal fees from MSD, grants and personal fees from Roche, personal fees from Pharmamar, personal fees from Clovis, grants and personal fees from Pfizer, outside the submitted work. MCP reports personal fees from Daichii-Sankyo, personal fees from GSK, personal fees from MSD, grants from Roche, grants and personal fees from AstraZeneca, non-financial support from Bayer, outside the submitted work. The other authors do not declare conflicts of interests.