BackgroundNon-vitamin K oral antagonists are being increasingly used. However, broad clinical experience with them is lacking.ObjectivesTo review guidelines and evidence for the use of non-vitamin K oral antagonists in the periprocedural environment.ResultsDespite the clear advantages of vitamin K oral antagonists, their use can entail risks owing to the scarcity of reversal agents. Consensus has been reached about postoperative resumption, which is recommended at 24 hours and 48–72 hours, respectively, after low-risk and high-risk bleeding surgery. Bridging with heparin is recommended in patients with a high risk of thrombosis. Urgent interventions should ideally take place 24 hours after the last dose intake. Major discrepancies exist between the American and the European recommendations for neuraxial procedures. The American proposals recommend suspending the drug for five half-lives, whereas the European approaches suggest suspension of just two half-lives. Suggestions for perioperative discontinuation vary widely. Some authors recommend a longer time of resumption for patients with renal impairment. All agree that there should be an increase in the number of days of interruption in high-risk bleeding procedures versus low-risk bleeding procedures.ConclusionsA diverse number of approaches have been suggested for perioperative management of novel oral antagonists. American recommendations tend to be more rigorous than those of Europe. A need for more studies that measure health outcomes after the use of these drugs would be indispensable.
Median PFS of patients who started pembrolizumab as firstline therapy was 10 months (95% CI 7.1-12.92); in those treated as secondline and thirdline, median PFS was 4.2 months (95% CI 3.12-5.27). AEs included asthenia grades 1-2 in 15.79%, arthralgia grades 1-2 in 13.16%, dermatitis in 7.89%, diarrhoea in 7.89%, hypothyroidism in 5.26%, pneumonitis in 5.26%, vomiting in 5.26%, anorexia in 5.26%, constipation in 5.26% and myalgia in 2.63%. Conclusion and relevance Median PFS in our study was similar to the results of Keynote-024 (pembrolizumab as firstline treatment) 10 versus 10.3 months and Keynote-010 (pembrolizumab in previously treated patients) 4.2 versus 3.9 months. Pembrolizumab was safe and well tolerated; the safety profile was similar to that described in clinical trials.
Neutropenia (all grades CTC) occurred after 24 administrations (8.6%) and was grade !2 in 8 courses (2.9%), and grades 3 and 4 in 5 and 3 courses, respectively. Thrombocytopenia grade !2 occurred in 10 courses (3.6%), and was grade 3 in 3 cycles, No patient developed grade 4 thrombocytopenia. No statically significant relationship was found between age and primary diagnoses. Conclusion and relevance Although the incidence was low, severe and life threatening myelotoxicity was a serious side effect in non-cancer patients receiving cyclophosphamide and should be closely monitored. REFERENCES AND/OR ACKNOWLEDGEMENTS 1. Katsifis GE, Tzioufas AG, Vlachoyiannopoulos PG, et al. Risk of myelotoxicity with intravenous cyclophosphamide in patients with systemic lupus erythematosus. Rheumatology (Oxford) 2002;41:780-786. No conflict of interest.
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