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Supportive Care in Cancer

, Volume 26, Issue 9, pp 3091–3097 | Cite as

A randomized, open-label non-inferiority study to compare palonosetron and ondansetron for prevention of acute chemotherapy-induced vomiting in children with cancer receiving moderate or high emetogenic chemotherapy

  • Sandeep Jain
  • Gauri Kapoor
  • Sahitya Koneru
  • Gayatri Vishwakarma
Original Article

Abstract

Background

Chemotherapy-induced vomiting is a common adverse effect of cancer treatment. We assessed the non-inferiority of palonosetron versus ondansetron in prevention of acute chemotherapy-induced vomiting in children with cancer in 2–18 years of age.

Methods

In this single-center, open-label, randomized study, children receiving moderate and high emetogenic chemotherapy were assigned to get either ondansetron or palonosetron in addition to other antiemetic prophylaxis. The primary efficacy endpoint was the proportion of children with complete response during the acute phase of the first on-study chemotherapy cycle. Non-inferiority was assessed by demonstration of lower limit of the 97.5% confidence interval for differences in complete response rates in palonosetron arm to be superior by − 15%. Risk factors for suboptimal response and the cost of administration of two drugs were also analyzed.

Results

A total of 108 children were analyzed and various factors likely to influence response were equally distributed in two arms. These 108 patients received 412 blocks of chemotherapy. During the acute phase, complete responses were recorded in 72.2% (39/54) and 83.3% (45/54) receiving ondansetron and palonosetron, respectively (ΔCR + 11.1%). The lower limit of 97.5% confidence interval (− 6.95–28.39) for this difference was greater than − 15% in palonosetron arm. Only statistically significant risk factor that predisposed response was use of dexamethasone (p value < 0.01). The cost associated with ondansetron administration was significantly higher compared to palonosetron.

Conclusion

Palonosetron is non-inferior and cost-effective compared to ondansetron for prevention of acute chemotherapy-induced vomiting (CIV) in children receiving moderate and high emetogenic chemotherapy.

Keywords

CINV Ondansetron Palonosetron Children Chemotherapy 

Notes

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Supplementary material

520_2018_4158_MOESM1_ESM.docx (18 kb)
Online Resource 1 (DOCX 17 kb)
520_2018_4158_MOESM2_ESM.docx (19 kb)
Online Resource 2 (DOCX 18 kb)
520_2018_4158_MOESM3_ESM.docx (16 kb)
Online Resource 3 (DOCX 15 kb)

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Department of Pediatric Hematology and OncologyRajiv Gandhi Cancer Institute and Research CentreNew DelhiIndia
  2. 2.Research DepartmentRajiv Gandhi Cancer Institute and Research CentreNew DelhiIndia

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