Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2018
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.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.
- Palonosetron for prevention of delayed chemotherapy-induced nausea and vomiting in pediatric patients: a meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Pooled it
- Do Not Throw Away Your Patient's Shot at Complete Vomiting Control.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025Article
- Fact-finding and risk factor analysis of chemotherapy-induced nausea and vomiting in children with solid tumors: a prospective observational study.BMC pediatrics · 2025Observational
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChemotherapy-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.
methodsIn 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.
resultsA 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.
conclusionPalonosetron 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.
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