Yu, Z., Liu, W., Wang, L., Liang, H., Huang, Y., Si, X., … Zhang, H. (2009). The efficacy and safety of palonosetron compared with granisetron in preventing highly emetogenic chemotherapy-induced vomiting in the Chinese cancer patients: A phase II, multicenter, randomized, double-blind, parallel, comparative clinical trial. Supportive Care in Cancer, 17, 99–102. 

To evaluate the safety and efficacy of palonosetron versus granisetron for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving emetogenic chemotherapy

Patients were randomly assigned to receive a single IV dose of either palonosetron 0.25 mg or granisetron 3 mg as a bolus dose, 30 minutes before receiving chemotherapy. Patients were evaluated daily from study days 1–7, and investigators were responsible for recording emetic episodes, rescue medication, and adverse events. Complete response was defined as no emetic episodes and no rescue medication for the first 24-hour interval after chemotherapy and during successive 24-hour time periods.

• The study consisted of 208 participants.
• Mean age was 51.5 years.
• The study group was 36.54% female and 63.46% male.
• The most common cancer types were non-small cell lung, gastric, and breast cancers. A variety of other types were included.
• The majority of the palonosetron group (92%) and the granisetron group (87%) were receiving cisplatin-containing chemotherapy; 17% in the granisetron and 19% in the palonosetron group were receiving epirubicin-containing therapy.
• Approximately half of the sample was chemotherapy naïve.

The study was conducted at multiple sites in China.

All patients were in active treatment.

This was a double-blind, randomized, parallel comparative study.

Evaluation was based on the World Health Organization's evaluation criteria of emesis. Emetic episodes and use of rescue medication were recorded.

• No significant differences were reported between groups in complete response rates.
• In the granisetron group, 72% of patients had complete response in the 0–24 hour period compared to 83% in the palonosetron group.
• Response rates declined in both groups from 24–96 hours.
• No clinically relevant differences were reported between groups in overall incidence of adverse events.
• No serious adverse events were found to be associated with the study drugs.
• The most frequent adverse events were headache and constipation.

Palonosetron and granisetron appeared to provide similar results in control of CINV in the immediate, acute phase.

• The level and distribution of emetogenicity of chemotherapeutic regimens was not described, and no subgroup analysis based on this was done.
• Nausea was not measured.
• Methods of blinding were not described.
• Reliability of recording vomiting and nausea episodes was unclear.
• The authors did not report if the study was conducted in an inpatient setting.
• The study only looked at single dose adminiatration, and the study had a short duration.

• Palonosetron and granisetron appear to have similar efficacy and tolerability for the management of CINV in the immediate acute period.
• Most patients (70%–80%) in the study population had an effective short-term response.
• Response was less in the delayed phase.