Tian, W., Wang, Z., Zhou, J., Zhang, S., Wang, J., Chen, Q., … Lin, T. (2010). Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population. Medical Oncology, 28, 71-78.

To compare single-dose palonosetron with single-dose granisetron in the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) with cisplatin for moderately emetogenic chemotherapy

Subjects were stratified according to having chemotherapy with cisplatin and were randomly assigned to either palonosetron during cycle 1 and granisetron during cycle 2 or the opposite sequence of antiemetics. Patients receive 0.25 mg IV palonosetron or 3 mg IV granisetron 30 minutes prior to chemotherapy infusion. Other drugs with antiemetic efficacy, including dexamethasone, were not permitted; however, use of rescue medication was allowed. Use of rescue medications was standardized. Patients used diaries to record the number of emetic episodes.

• The study consisted of 122 participants.
• Patients' mean age was 52.2 years (SD = 10.67 years), with a range 17.36—74.78.
• The sample was 46.6% female and 53.4% male.
• Cancer types were lung, breast, colorectal, and gastric.
• Approximately 40% of participants had received previous chemotherapy and experienced prior CINV.
• All patients were scheduled to receive two courses of moderately emetogenic chemotherapy (MEC) or cisplatin 60–80 mg/m².
• Patients were excluded if they were scheduled to receive highly emetogenic chemotherapy or radiotherapy to the upper abdomen or cranium.
• Patients were excluded if they had grade 2 or 3 CINV within 24 hours prior to the start of the study.
• All patients had a life expectancy of three months or more.

The study was conducted at multiple sites in China.

All patients were in active treatment.

This was a randomized, double-blind, crossover comparative trial.

• Patients recorded the number of emetic episodes, maximum severity of nausea, onset of initial symptoms, and use of rescue antiemetics in diaries.
• Nausea was graded on 4-point Likert-type scale according to degree of interference with normal daily life.
• Complete protection(CP) was defined as no emetic episodes and no use of rescue medication. Major protection was defined as 1–2 emetic episodes. Treatment failure was defined as three or more episodes of vomiting.

• No significant differences were found between treatment groups during the acute, delayed, and overall phases.
• Palonosetron and granisetron were comparable in terms of complete response rates (72.16 with palonosetron and 67.74 with granisetron).
• Time to onset of the first emetic episode was similar in both groups.
• Both drugs were well tolerated, and no serious adverse events were reported.
• Constipation and dizziness were the most frequently observed adverse events in both groups.

The efficacy of single-dose, 0.25-mg palonosetron was not inferior to 3 mg granisetron for the prevention of CINV in the acute, delayed, and overall periods.

• Adherence to diary recording was not discussed.
• Use of rescue medications was not discussed.
• This study compared only two drugs with single-dose administration, which are not recommended for standard antiemetic approaches.
• Nausea was defined in terms of interference with life activities rather than the experience of the symptom.

Palonosetron appears to have similar efficacy as granisetron for prevention of CINV in patients receiving MEC.