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Dexamethasone-free antiemetic strategy for highly emetogenic chemotherapy: safety and efficacy-pilot study
  1. Vinod Sharma1,
  2. Akash Kumar1,
  3. Annie Baa2,
  4. Sudhir Kirar2,
  5. Atul Sharma2,
  6. Sameer Bakhshi2,
  7. Ajay Gogia2,
  8. Prabhat Singh Malik2,
  9. Sameer Rastogi2,
  10. Atul Batra2,
  11. Deepam Pushpam2,
  12. Babita Kataria1,
  13. Hari Sagiraju3,
  14. Aparna Sharma2 and
  15. Vishwajeet Singh4
  1. 1 Department of Medical Oncology, National Cancer Institute, Jhajjar, Haryana, India
  2. 2 Department of Medical Oncology, Dr B.R.A IRCH, AIIMS, New Delhi, India
  3. 3 Department of Preventive Oncology, National Cancer Institute, Jhajjar, Haryana, India
  4. 4 Department of Geriatric Medicine, AIIMS, New Delhi, India
  1. Correspondence to Dr Vinod Sharma, Department of Medical Oncology, National Cancer Institute, Jhajjar, Haryana, India; vinod_mbbs4u{at}yahoo.co.in

Abstract

Objectives Dexamethasone 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.

Methods Chemotherapy 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).

Results Out 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.

Conclusions The 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 number CTRI/2021/07/034813.

  • Supportive care
  • Nausea and vomiting
  • Symptoms and symptom management
  • Quality of life
  • Breast
  • Head and neck

https://doi.org/10.1136/spcare-2022-003864

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    Footnotes

    • Contributors VSh, AK and AS designed the study. VSh, AnB and SK recruited and data collection. VSh and HS conducted the data analysis. AK, AS, SB, AG, PSM, SR, DP, BK, AS and ABa provided the study patients. VSi helped with the initial sample size calculation and statistical plan. All authors reviewed the manuscript and approved the final version.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.