Sepulveda-Vildosola, A.C., Betanzos-Cabrera, Y., Lastiri, G.G., Rivera-Marquez, H., Villasis-Keever, M.A., Del Angel, V.W., … Lopez-Aguilar, E. (2008). Palonosetron hydrochloride is an effective and safe option to prevent chemotherapy-induced nausea and vomiting in children. Archives of Medical Research, 39, 601–606.

To evaluate the efficacy and safety of palonosetron for management of chemotherapy-induced nausea and vomiting (CINV) in pediatric patients

Prior to every chemotherapy cycle, patients were randomized to receive either 0.25 mg palonosetron 30 minutes before chemotherapy or 8 mg/m² IV ondansetron every 8 hours. Patients or guardians used a self-administered questionnaire to record emetic events and intensity of nausea during the next seven days. They also were asked to record secondary effects of palonosetron.

• The study involved 50 cycles of chemotherapy.
• The actual number of patients was not reported.
• The study consisted of 16% patients aged 72 months or less and 84% of patients between 72 months and 16 years.
• The study group was 69% male and 31% female.
• Patients had multiple types of cancer, with the most frequent diagnosis being osteosarcoma. 
• Chemotherapy regimens included etoposide, ifosfamide, cisplatin, carboplatin, epirubicin, cyclophosphamide, adriamycin, or irinotecan.
• Study participants who had received previous chemotherapy ranged from 42%–88%. Those who had experienced CINV with previous chemotherapy ranged from 36%–80%.

The study was conducted at a single site in Mexico.

All patients were in active treatment and pediatric.

This was a randomized, single-blind comparative study.

The authors developed a questionnaire for patients to record emesis and nausea intensity. Nausea was defined as absent, mild (decrease in oral intake), or intense (no oral intake).

• Complete control of nausea and vomiting was reported in a significantly higher proportion of cycles with palonosetron during the first three days (p < 0.001); however, on day 4, a higher percentage of cycles with ondansetron reported complete control (p = 0.002).
• From days 4–7, a higher proportion of cycles with palonosetron were associated with less nausea, but these differences were not statistically significant.
• Reduction in nausea was greater in patients older than 72 months (p = 0.000).
• As used in this study, treatment with palonosetron cost $111 USD, compared to $250–$284 USD for the ondansetron regimen.
• No clinically significant adverse effects were reported.

Palonosetron appears to be safe and effective in pediatric patients. A regimen with single-dose palonosetron may be less expensive than multiple-dose ondansetron.

• No appropriate control group was included.
• The study was not designed as a true crossover trial, and analysis was done by chemotherapy cycle, rather than by patient.
• Age groupings for subgroup analysis were very broad, given the maximum age inclusion criteria.
• Actual individual patient demographics were not clear in this report.
• Nausea was defined according to oral intake, rather than the actual experience of the symptom. Although actual symptoms may be difficult to evaluate in very young children, many patients of the age groups would be expected to be able to express actual symptoms.
• Although analysis was done according to prevalence of complete control, complete control as used in this study was not defined.
• No adherence to diary documentation was reported.

Palonosetron may be effective in this population, and single-dose palonosetron regimens may be a cost-effective alternative to multiple-day treatments. Improved symptom measurement methods in pediatric patients are worth exploring.