Safety and efficacy of nabilone for acute chemotherapy-induced vomiting prophylaxis in pediatric patients: A multicenter, retrospective review.

OBJECTIVES: To describe the safety and efficacy of nabilone given to pediatric patients to prevent acute chemotherapy-induced nausea and vomiting (CINV). METHODS: A multicenter, retrospective review of pediatric patients who received nabilone for acute CINV prophylaxis between December 1, 2010 and August 1, 2015 was undertaken. One course of nabilone was evaluated per patient. Adverse effects associated with nabilone use were noted. The proportion of patients who experienced complete acute chemotherapy-induced vomiting (CIV) control during the acute phase was determined. The acute phase was defined as starting with the first chemotherapy dose and continuing until 24 h after administration of the last chemotherapy dose of the chemotherapy block. RESULTS: One hundred ten eligible patients (median age: 14.0 years, range: 1.1-18.0 years; 65 male) were identified. Most (109/110) received nabilone plus a 5-HT3 antagonist for CINV prophylaxis. Adverse effects associated with nabilone were experienced by 34% (37/110) of children. All were of CTCAE Version 4.03 Grade 2 or less. Sedation (20.0%), dizziness (10.0%), and euphoria (3.6%) were the most commonly reported adverse events. Nabilone was discontinued in 10 patients due to an adverse event. The proportions of patients receiving highly or moderately emetogenic chemotherapy who experienced complete acute CIV control were 50.6% (42/83) and 53.8% (14/26), respectively. CONCLUSION: Adverse events associated with nabilone were common but of minor clinical significance. Acute CIV control in children receiving nabilone as a part of their antiemetic regimen was poor. Future work should focus on implementation of guideline-consistent CINV prophylaxis and treatment.

Nausea and vomiting in children and adolescents receiving intrathecal methotrexate: A prospective, observational study.

BACKGROUND: The prevalence of nausea and vomiting after receipt of intrathecal methotrexate (IT-MTX) in pediatric oncology patients is unknown. METHODS: Patients (4-18 years) about to receive IT-MTX were eligible to participate in this prospective, observational study. Patients received antiemetics as prescribed by their clinical team. Nausea severity (patient-assessed), timing of emetic episodes, and administration of antiemetics were recorded beginning immediately prior to IT-MTX administration, for the next 24 hr (acute phase), and for a maximum of 7 additional days (delayed phase). Complete chemotherapy-induced nausea and vomiting (CINV) control was defined as no emetic episodes and no nausea. RESULTS: One hundred patients consented to participate in this study; 70 provided evaluable data (mean age: 8.3 years; range: 4.1-17.6). Most (94%) received propofol-containing anesthesia for IT-MTX administration. Most (89%) received a 5-HT3 antagonist prior to IT-MTX. During the acute phase, 36 children (51%) experienced complete CINV control, 67 (96%) complete vomiting control, and 36 (51%) complete nausea control. Severe acute phase nausea was reported by 12 children (17%). During the delayed phase, 35 patients (50%) experienced complete CINV control, 60 (86%) complete vomiting control, and 36 (51%) complete nausea control. Severe nausea was reported in the delayed phase by 27 (39%) patients. CONCLUSIONS: Most pediatric patients who received IT-MTX and prophylaxis with ondansetron or granisetron experienced complete acute and delayed vomiting control. However, nausea control was poor and severe nausea was reported by many children. Effective interventions to control nausea are needed.