Dexamethasone-free antiemetic strategy for highly emetogenic chemotherapy: safety and efficacy-pilot study
| Autor: | Vinod Sharma, Akash Kumar, Annie Baa, Sudhir Kirar, Atul Sharma, Sameer Bakhshi, Ajay Gogia, Prabhat Singh Malik, Sameer Rastogi, Atul Batra, Deepam Pushpam, Babita Kataria, Hari Sagiraju, Aparna Sharma, Vishwajeet Singh |
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| Rok vydání: | 2023 |
| Předmět: | |
| Zdroj: | BMJ Supportive & Palliative Care. :spcare-2022 |
| ISSN: | 2045-4368 2045-435X |
| DOI: | 10.1136/spcare-2022-003864 |
| Popis: | ObjectivesDexamethasone sparing strategies have shown success. The feasibility of a dexamethasone-free antiemetic strategy remains undetermined. A prospective, single-arm, pilot study was planned to determine the efficacy of an olanzapine-based, dexamethasone-free, three-drug antiemetic regimen.MethodsChemotherapy naïve, adult patients (≥18 years) who received ondansetron, aprepitant and olanzapine during the first cycle of highly emetogenic chemotherapy were enrolled. The primary endpoint was the rate of complete response (CR: no vomiting and no use of rescue medications) during the overall period (0–120 hours).ResultsOut of the total of 101 patients enrolled, most were women (82%) and received anthracycline cyclophosphamide (73%) combination therapy. The rate of CR for the overall period was 65% (95% CI 55.2% to 74.5%). The rate of CR for the acute and delayed period was 79% (95% CI 70% to 86.7%) and 76% (95% CI 66.7% to 84.1%). The rate of nausea control rates for the acute, delayed and overall periods were 34%, 29% and 24%, respectively. The grade I, II and III sedation rates over the 5 days were 8%, 5% and 1%, respectively.ConclusionsThe dexamethasone-free antiemetic strategy showed modest efficacy with low incidence of clinically significant somnolence. There is a need to prospectively investigate the role of dexamethasone in the era of newer potent antiemetics in a randomised fashion.Trial registration numberCTRI/2021/07/034813. |
| Databáze: | OpenAIRE |
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