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Evaluation of clinical outcomes and efficacy of palonosetron and granisetron in combination with dexamethasone in Egyptian patients receiving highly emetogenic chemotherapy

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Abstract

Background

Chemotherapy-induced nausea and vomiting (CINV) is considered one of the most serious adverse events affecting chemotherapy-receiving cancer patients. It dramatically affects their food intake, nutritional status and more importantly their quality of life. We can observe CINV in highly emetogenic chemotherapy (HEC) such as adriamycin–cyclophosphamide combination (AC) in breast cancer patients and cisplatin-based regimens in other cancer types. This study aimed to evaluate the antiemetic efficacy of palonosetron (PALO) over granisetron (GRA) in combination with dexamethasone for multiple highly emetogenic chemotherapy drugs (HEC), especially in chemotherapy regimens in Egyptian breast cancer patients and cisplatin-based regimens in other diseases.

Patients and methods

An open-label randomized trial was carried out, including 115 patients receiving at least four cycles of highly emetogenic chemotherapy regimens. All patients received dexamethasone in combination with the 5-HT3 receptor antagonist. We recorded patients' clinical and biochemical characteristics and withdraw blood samples to monitor serum substance P and serotonin in correlation with chemotherapy-induced nausea and vomiting (CINV). We use the MASCC antiemetic tool in the acute phase (0–24 hr) and delayed phase (24–120 h) to evaluate patient outcomes in both stages after each chemotherapy cycle.

Results

In (PALO) group, only 7.84% of patients showed acute vomiting, and 11.76% showed acute nausea, whereas 43.75% of patients showed acute vomiting and 89.06% showed acute nausea in (GRA) group (P < 0.0001). For delayed CINV, 23.53% of patients showed delayed vomiting, and 47.06% showed delayed nausea in the (PALO) group, while 82.81% of patients showed delayed emesis, and 92.19% showed delayed nausea in (GRA) group (P < 0.0001). The study showed that PALO is a cost-effective choice when compared to GRA in CINV prevention as 45.10% of patients in (PALO) required additional rescue medications (Domperidone 10 mg orally three times per day plus Trimebutine 200 mg orally three times per week both for 5 days), while 95.24% in the (GRA) group used the same medications. Adverse events of both antiemetic drugs (PALO and GRA) include headaches and constipation and QTc prolongation reports, mostly mild to moderate, with relatively low rates among the two groups.

Conclusion

Palonosetron, combined with dexamethasone, is more effective than granisetron and dexamethasone combination against both acute and delayed emesis induced by highly emetogenic chemotherapy (HEC) cisplatin-based protocols and the combination of cyclophosphamide and anthracyclines (AC). Medical team members should make more efforts, especially clinical pharmacy personnel, to monitor medications' effectiveness and help the medical team achieve a suitable and reliable care plan.

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Data availability

The authors confirm that the data supporting this study's findings are available within the article [and] its supplementary material.

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Acknowledgments

The authors declare that the abstract and preliminary subjective data has been presented in the ESMO breast cancer virtual meeting in MAY 2020 citation: Annals of Oncology (2020) 31 (suppl_2): S83-S87. 10.1016/annonc/annonc123.

Funding

No funding was received to assist with the preparation of this manuscript.

Author information

Authors and Affiliations

  1. Oncology Pharmacy Department, Tanta Cancer Center, Tanta, Egypt

    Mohamed A. Mahrous

  2. Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, Egypt

    Gamal A. El-Azab

  3. Medical Oncology Department, Faculty of Medicine, Tanta University, Tanta, Egypt

    Hisham A. Tawfik

  4. Oncology and Nuclear Medicine Unit, Egypt Air Hospital, 11 Abu Bakr Elsedik Street, Almaza, Heliopolis, Cairo, Egypt

    Mohamed A. Mahrous

Authors
  1. Mohamed A. Mahrous
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  2. Gamal A. El-Azab
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  3. Hisham A. Tawfik
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Contributions

MAM: checking and optimizing of the supportive care plan for all patients, also the assurance of proper patient recruitment and teaching them about study care plan according to the declaration of Helsinki and finally access different clinical response. GAAEE: supervision all the clinical pharmacy interventions and clinical outcome measures as a professor of clinical pharmacy in the faculty of pharmacy. HAT: as a professor and chairman of the medical oncology department at the Faculty of Medicine Tanta University, he played an essential role in designing study protocol and a significant percentage of the study population recruited from this Department.

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Correspondence to Mohamed A. Mahrous.

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The authors have no conflicts of interest to declare that they are relevant to this article's content.

Ethics approval

Approval was obtained from the ethics committee of Tanta university. The procedures used in this study adhere to the tenets of the Declaration of Helsinki 1964.

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

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Additional informed consent was obtained from all individual participants for identifying information in this article.

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A. Mahrous, M., A. El-Azab, G. & A. Tawfik, H. Evaluation of clinical outcomes and efficacy of palonosetron and granisetron in combination with dexamethasone in Egyptian patients receiving highly emetogenic chemotherapy. Cancer Chemother Pharmacol 88, 121–129 (2021). https://doi.org/10.1007/s00280-021-04257-7

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  • DOI: https://doi.org/10.1007/s00280-021-04257-7

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