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The efficacy and safety of the addition of olanzapine to ondansetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy

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Abstract

Objective

To evaluate the efficacy and safety of the addition of olanzapine to ondansetron and dexamethasone for chemotherapy-induced nausea vomiting (CINV) prevention in patients receiving highly emetogenic chemotherapy (HEC).

Methods

In this randomized, double-blind, placebo-controlled, crossover study, we randomly assigned chemotherapy-naïve patients receiving HEC to receive olanzapine or placebo in addition to ondansetron and dexamethasone. All subjects were crossed over to another treatment arm on second-cycle chemotherapy. The primary endpoint was complete response (CR) rate defined as no vomiting and no use of rescue drugs.

Results

At the first cycle, there were significantly more patients with CR in the olanzapine group than in the placebo group in overall phase (68.7% vs. 25.0%, p < 0.001), acute phase (0–24 h) (75.0% vs. 31.2%, p < 0.001) and delayed phase (24–120 h) (68.7% vs. 43.7%, p = 0.038). After crossover, there were significantly more patients with CR in the olanzapine group than in the placebo group in overall phase (67.2% vs. 25.0%, p < 0.001), acute phase (71.9% vs. 32.8%, p < 0.001) and delayed phase (67.2% vs. 37.5%, p < 0.001). In crossover analysis, the olanzapine group had significantly lower mean nausea (1.28 vs. 3.05, p < 0.001) and fatigue (3.5 vs. 4.58, p < 0.001) scores but higher mean appetite (2.5 vs. 1.55, p = 0.003) and sleepiness (3.26 vs. 2.2, p < 0.001) scores. There were no grade 3 and 4 anti-emetic-drug-related toxicities. Mean QT interval changes did not different between two groups (−4.30 vs. −1.86, p = 0.69).

Conclusion

The addition of olanzapine to ondansetron and dexamethasone significantly improved CINV prevention and was safe in patients receiving HEC.

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Acknowledgement

The project was funded by Chulalongkorn University supporting fund for thesis project and Chulalongkorn Medical Oncology Research Fund.

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Authors and Affiliations

  1. Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Rd., Pathumwan, Bangkok, 10330, Thailand

    Veerisa Vimolchalao, Siwat Sakdejayont, Virote Sriuranpong, Chanida Vinayanuwatikun, Napa Parinyanitikun & Suebpong Tanasanvimon

  2. Division of Medical Oncology, Department of Internal Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand

    Veerisa Vimolchalao, Siwat Sakdejayont, Ploytuangporn Wongchanapai, Pattama Angspatt & Nattaya Poovorawan

  3. Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand

    Siwat Sakdejayont

  4. Oncology Section, Production Division, Pharmacy Department, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand

    Shama Sukprakun

  5. Department of Nursing, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand

    Wilai Thawinwisan & Piyachut Chenaksara

Authors
  1. Veerisa Vimolchalao
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  2. Siwat Sakdejayont
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  11. Nattaya Poovorawan
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  12. Suebpong Tanasanvimon
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Corresponding author

Correspondence to Suebpong Tanasanvimon.

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Conflict of interest

Dr. Vimolchalao declares that she has no conflict of interest. Dr. Sakdejyont declares that he has no conflict of interest. Ms. Ploytuangporn declares that she has no conflict of interest. Ms. Sukprakun declares that she has no conflict of interest. Ms. Angspatt declares that she has no conflict of interest. Ms. Thawinwisan declares that she has no conflict of interest. Ms. Chenaksara declares that she has no conflict of interest. Dr. Sriuranpong declares that he has no conflict of interest. Dr. Vinayanuwatikun declares that she has no conflict of interest. Dr. Parinyanitikun declares that she has no conflict of interest. Dr. Poowarawan declares that she has no conflict of interest. Dr. Tanasanvimon declares that he has no conflict of interest.

Ethical approval

The study procedures were in accordance with and approved by the Institution Review Board of the Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand, and with the 1964 Helsinki declaration.

Informed consent

Informed consent was obtained from all individual participants included in this study.

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Vimolchalao, V., Sakdejayont, S., Wongchanapai, P. et al. The efficacy and safety of the addition of olanzapine to ondansetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy. Int J Clin Oncol 25, 396–402 (2020). https://doi.org/10.1007/s10147-019-01570-3

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  • DOI: https://doi.org/10.1007/s10147-019-01570-3

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