Dong, X., Huang, J., Cao, R., & Liu, L. (2010). Palonosetron for prevention of acute and delayed nausea and vomiting in non-small-cell lung carcinoma patients. Medical Oncology, 28, 1425–1429.

To verify the activity and safety of palonosetron in patients with non-small cell lung cancer treated with chemotherapy

Patients were randomized to either a single dose of 0.25 mg IV bolus palonosetron or 8 mg IV ondansetron on day one. Only dexamethasone was permitted as rescue medication. Doctors recorded daily episodes of vomiting and nausea and use of rescue medication. Patients were followed for seven days.

• The study consisted of 89 participants.
• The mean age was 53 years (range 29–76).
• The sample was 32% female and 57% male.
• Patients were diagnosed with non-small cell lung cancer, stages II–IV, and were receiving highly emetogenic chemotherapy (HEC).
• Of the palonosetron group and the ondansetron group, 68% and 64%, respectively, had previously received chemotherapy. More than 50% of these patients had experienced chemotherapy-induced nausea and vomiting (CINV).

The study was conducted at a single site in China.

All patients were in active treatment.

This was a randomized, controlled study.

The following measurement were used.

• Daily episodes of vomiting (number, duration, time)
• Nausea intensity based on a 0–3 Likert-type scale
• Use of rescue medication
• Complete response (CR): no emesis, no rescue medication
• Complete control (CC): no emesis, no rescue medication, no more than mild nausea
• Common Terminology Criteria for Adverse Events, version 3.0 (CTAE 3.0)

• The proportion of patients with CR and CC in the delayed phase was significantly higher in the palonosetron group than in the ondansetron group (p < 0.02).
• The proportion of patients with no nausea was greater in the palonosetron group (23%) than in the ondansetron group (12%) in the delayed phase (p = 0.013).
• The proportion of patients with no emesis was greater in the palonosetron group than in the ondansetron group in the delayed phase (p < 0.000).
• In the palonosetron group, the proportion of patients with no emetic episodes throughout the study was 61.4%, compared to 31.1% in the ondansetron group (p = 0.004).
• The adverse events profiles of palonosetron and ondansetron group were not statistically different. Constipation and headache were the most frequent adverse events.

Palonosetron could be an effective and safe drug for the prevention of CINV associated with HEC. Palonosetron may be particularly helpful in prevention of CINV in the delayed period.

• A small sample of fewer than 100 participants was used.
• Appropriate emetic control was not employed because the chemotherapy regimen was HEC and aprepitant and dexamethasone are recommended antiemetics for the control of CINV with HEC.

In countries where aprepitant is not widely available, palonosetron could be an option for 5-HT₃ receptor antagonists for CINV with HEC among patients with non-small cell lung cancer.