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

Jain, Sandeep; Kapoor, Gauri; Koneru, Sahitya; Vishwakarma, Gayatri

doi:10.1007/s00520-018-4158-5

Cited by 14 publications

(55 citation statements)

References 24 publications

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“…Of these, 16 studies (29 single-study arms) met our inclusion criteria ( Figure 1). 7,[22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] Agreement between reviewers for inclusion of studies was almost perfect (kappa = 0.87; 95% CI: 0.75-0.98).…”

Section: Resultsmentioning

confidence: 99%

“…The evidence base that met the eligibility criteria consisted of 29 single-study arms, 25 of which were from 13 randomized trials. 7,[22][23][24][25][26][27][28][29][30][31][32][33] The other four single-study arms were from two noncomparative prospective studies 34,35 (N = 2) and one noncomparative retrospective study 36 (N = 2). Similar to how study arms from comparative studies were counted, complete acute CIV control was able to be determined for patients receiving HEC and MEC separately for the retrospective study and thus it was treated as having two study arms.…”

Section: Resultsmentioning

confidence: 99%

“…The sample sizes of the majority of included study arms were small: only six included ≥100 patients. 23,31,36 Of the 29 study arms included, 13 evaluated complete acute CIV control in patients exclusively receiving HEC, [22][23][24][25][26]35,36 eight in patients exclusively receiving MEC [25][26][27][28]30,36 and eight in patients receiving MEC or HEC that reported their findings as a single group and who for the purposes of this review were categorized as MEC. 7,29,[31][32][33][34] There was high heterogeneity in the study populations, cointerventions and outcomes between the dexamethasone dosing regimens evaluated, even when dichotomized based on the scaled recommended adult dexamethasone doses.…”

Section: Resultsmentioning

confidence: 99%

“…In addition, only 79% of study arms (23/29) measured acute CIV or CINV control using acceptable methods (i.e., clinician assessment, patient diaries, and validated nausea assessment tools where CINV was reported). 7,22,23,[25][26][27][28][29]31,[33][34][35] Consequently, meta-analysis was not possible, and the results are narratively described.…”

Section: Resultsmentioning

confidence: 99%

“…HEC : Of the 13 included study arms with patients receiving HEC, 12 evaluated a CPG-consistent antiemetic regimen. [22][23][24][25][26]35,36 The most common regimen used was dexamethasone in combination with a 5HT 3 antagonist alone (8 study arms), [22][23][24][25]35,36 followed by four study arms that evaluated dexamethasone in combination with a 5HT 3 antagonist plus aprepitant or fosaprepitant. 22,25,26 Only one study arm evaluated dexamethasone in a non-CPG-consistent regimen.…”

Section: Acute CIV Controlmentioning

confidence: 99%

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Dexamethasone dosing for prevention of acute chemotherapy‐induced vomiting in pediatric patients: A systematic review

Patel

Olteanu

Cabral

et al. 2020

Pediatric Blood & Cancer

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A systematic review was undertaken to describe dexamethasone doses studied for chemotherapy-induced vomiting (CIV) prophylaxis in pediatric patients and their effects on achieving complete acute CIV control. No dose-finding studies were identified. However, 16 studies assessing pediatric patients who received dexamethasone were included and classified according to the emetogenicity of chemotherapy administered. Eight different total daily dexamethasone doses were administered to patients on day 1 of highly emetogenic chemotherapy: three in conjunction with aprepitant/fosaprepitant plus a 5HT 3 antagonist and five in conjunction with a 5HT 3 antagonist. Five different total daily dexamethasone doses were administered in conjunction with a 5HT 3 antagonist to patients on day 1 of moderately emetogenic chemotherapy. Due to the heterogeneity of studies identified, meta-analysis was not possible. The optimal dexamethasone dose to control acute CIV and to minimize harms in pediatric patients remains uncertain. This is a key area for future research. K E Y W O R D S chemotherapy-induced nausea and vomiting, dexamethasone, pediatric oncology, supportive care 1 INTRODUCTION Chemotherapy-induced nausea and vomiting (CINV) are two of the most distressing side effects of chemotherapy. 1-3 They have a negative influence on quality of life, have been associated with decreased growth in children, and can lead to patients becoming nonadherent with oral chemotherapy and refusing to continue cancer treatment. 4-6 Dexamethasone has been included in pediatric CINV prophylaxis regimens for over three decades. 7 Current clinical practice guidelines (CPGs) for the prevention of acute CINV strongly recommend that pediatric patients receive dexamethasone in combination with Abbreviations: CINV, chemotherapy-induced nausea and vomiting; CIV, chemotherapy-induced vomiting; CPG, clinical practice guideline; HEC, highly emetogenic chemotherapy; MEC, moderately emetogenic chemotherapy aprepitant and a 5HT 3 antagonist during receipt of highly emetogenic chemotherapy (HEC) or in combination with a 5HT 3 antagonist during receipt of moderately emetogenic chemotherapy (MEC). 8-11 These CPGs acknowledge that there are circumstances when clinicians may wish to avoid the use of dexamethasone as an antiemetic and recommend alternatives. Such circumstances include brain tumors where corticosteroids may prevent chemotherapy distribution into the central nervous system 12 ; acute myelogenous leukemia where corticosteroids may further increase the already high risk of fungal infection 12 ; and use of chemotherapy where efficacy is compromised by concurrent corticosteroid use. 11 Nevertheless, inclusion of dexamethasone in pediatric CINV prophylaxis regimens and its appropriate dose are hotly debated among the pediatric oncology community. For example, two of 36 Children's Oncology Group member institutions responding to a survey in 2015 never administered dexamethasone for CIV

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