Aprepitant as an add-on therapy in children receiving highly emetogenic chemotherapy: a randomized, double-blind, placebo-controlled trial

Bakhshi, Sameer; Batra, Atul; Biswas, Bivas; Dhawan, Deepa; Paul, Reeja; Sreenivas, Vishnubhatla

doi:10.1007/s00520-015-2714-9

Cited by 50 publications

(115 citation statements)

References 21 publications

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“…An increase in the incidence of febrile neutropenia was observed in adult cancer patients who received aprepitant [36]. However, this has not been observed in pediatric population [33,34]. Few drug interactions merit discussion.…”

Section: Safety and Tolerabilitymentioning

confidence: 89%

“…Common adverse effects observed in pediatric cancer patients include hiccups, headache, and anorexia [33,34]. An increase in the incidence of febrile neutropenia was observed in adult cancer patients who received aprepitant [36].…”

Section: Safety and Tolerabilitymentioning

confidence: 98%

“…CR rates during acute phase were significantly higher in aprepitant arm (48% vs. 12%, p < 0.001). No major adverse effects were reported by patients or guardians [34].…”

Section: Two Phase 3 Trials Have Been Reported Till Datementioning

confidence: 99%

“…The second trial was conducted in a homogenous population of chemotherapy-naïve patients and all patients received dexamethasone as a part of antiemetic prophylactic regimen in aprepitant arm, whereas the first trial included patients who could have received prior chemotherapy and patients planned to receive moderately and highly emetogenic chemotherapy. Administration of dexamethasone was left to physician's discretion [33,34]. Also due to absence of data on dosage of aprepitant in pediatric population, both trials used different doses of aprepitant.…”

Section: Two Phase 3 Trials Have Been Reported Till Datementioning

confidence: 99%

“…However, some practical issues remain due to limited availability of suspension form of aprepitant. Some guidance has been provided by one of the phase 3 studies that used aprepitant in tablet form in the fixed doses as per weight groups [34]. In countries where suspension form is not available and until further data are available for fosaprepitant, fixed dose of aprepitant may be used, that is 125 mg on day 1 followed by 80 mg on days 2 and 3 in pediatric patients more than 40-kg body weight and 80 mg on days 1-3 in those weighing 15-40 kg.…”

Section: Expert Commentarymentioning

confidence: 99%

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The safety and efficacy of aprepitant in combination with other antiemetic agents for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in pediatric patients

Batra

Bakhshi

2016

Expert Review of Quality of Life in Cancer Care

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Chemotherapy induced nausea and vomiting is the one of the most dreaded complication of chemotherapy in pediatric and adult cancers. Aprepitant is a neurokinin-1 antagonist that has shown significant efficacy in controlling acute and delayed chemotherapy induced nausea and vomiting when added to the backbone of type 3 serotonin 5-hydroxytryptamine receptor antagonist and corticosteroid in patients receiving moderately and highly emetogenic chemotherapy. There is abundant data in adults regarding the use aprepitant as an anti-emetic prophylactic agent; the data in pediatric patients are limited. However, increasing number of studies is being reported in pediatric cancer patients. Two phase 3 trials have been reported in last year that showed significant efficacy of aprepitant in pediatric population in decreasing the incidence and severity of chemotherapy induced nausea and vomiting. We hereby present the consolidated existing data regarding the safety and efficacy of aprepitant in pediatric cancer patients. ARTICLE HISTORY

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Section: Safety and Tolerabilitymentioning

confidence: 89%

Section: Safety and Tolerabilitymentioning

confidence: 98%

“…CR rates during acute phase were significantly higher in aprepitant arm (48% vs. 12%, p < 0.001). No major adverse effects were reported by patients or guardians [34].…”

Section: Two Phase 3 Trials Have Been Reported Till Datementioning

confidence: 99%

Section: Two Phase 3 Trials Have Been Reported Till Datementioning

confidence: 99%

Section: Expert Commentarymentioning

confidence: 99%

See 3 more Smart Citations

The safety and efficacy of aprepitant in combination with other antiemetic agents for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in pediatric patients

Batra

Bakhshi

2016

Expert Review of Quality of Life in Cancer Care

Self Cite

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Current variations in childhood cancer supportive care in the Netherlands

Loeffen

Mulder

Wetering

et al. 2015

Cancer

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BACKGROUND: Current treatment strategies in pediatric oncology are intensive and lead to high survival rates but also to treatmentrelated complications. Therefore, supportive care plays an increasingly important role. This study was designed to evaluate variations in supportive care practice in children with cancer in the Netherlands and adherence to selected existing international guidelines through an in-depth review of local guidelines and protocols at all 6 Dutch pediatric cancer centers. METHODS: Based on shared expert opinion, a questionnaire regarding current supportive care practice was compiled. For each center, the required information was extracted from local supportive care guidelines, and the list was sent to a pediatric oncologist of that center to verify its correspondence with local daily practice. Subsequently, it was determined whether clinical practice was concordant (same in 5 of 6 centers), partly concordant (highly overlapping in 5 of 6 centers), or discordant (same in < 5 of 6 centers). Local practices were compared with strong recommendations from high-quality, evidence-based guidelines. RESULTS: The questionnaire comprised 67 questions regarding supportive care practice. Concordance was observed for 11 of 67 practice items (16%), partial concordance was observed for 6 of 67 practice items (9%), and discordance was observed for 50 of 67 practice items (75%). Adherence to strong recommendations of 4 high-quality, evidence-based guidelines varied but was generally low. CONCLUSIONS: Large variations exist in pediatric oncology supportive care practice, and this could negatively influence care. Adherence to existing evidence-based guidelines and the development and implementation of new clinical practice guidelines have the potential of standardizing supportive care practice and thereby improving outcomes for children with cancer. Cancer 2016;122:642

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Guideline for the prevention of acute chemotherapy‐induced nausea and vomiting in pediatric cancer patients: A focused update

Patel

Robinson

Thackray

et al. 2017

Pediatric Blood & Cancer

101

165

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This update of the 2013 clinical practice guideline provides clinicians with guidance regarding the use of aprepitant and palonosetron for the prevention of acute chemotherapy-induced nausea and vomiting (CINV) in children. The recommendations were based on three systematic reviews. Substantive changes were made to the guideline recommendations including the inclusion of palonosetron to the 5-HT antagonists recommended for children receiving highly emetogenic chemotherapy (HEC) and the recommendation of aprepitant for children 6 months of age or older receiving HEC. To optimize CINV control in children, future work must focus on closing critical research gaps.

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Aprepitant as an add-on therapy in children receiving highly emetogenic chemotherapy: a randomized, double-blind, placebo-controlled trial

Abstract: This double-blind, randomized, placebo-controlled trial shows that aprepitant significantly decreases the incidence of CIV during acute phase when used as an add-on drug with ondansetron and dexamethasone in children receiving highly emetogenic chemotherapy.

Cited by 50 publications

References 21 publications

The safety and efficacy of aprepitant in combination with other antiemetic agents for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in pediatric patients

The safety and efficacy of aprepitant in combination with other antiemetic agents for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in pediatric patients

Current variations in childhood cancer supportive care in the Netherlands

Guideline for the prevention of acute chemotherapy‐induced nausea and vomiting in pediatric cancer patients: A focused update

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