Hesketh, P.J., Morrow, G., Komorowski, A.W., Ahmed, R., & Cox, D. (2012). Efficacy and safety of palonosetron as salvage treatment in the prevention of chemotherapy-induced nausea and vomiting in patients receiving low emetogenic chemotherapy (LEC). Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 20, 2633–2637.

To evaluate the efficacy and safety of IV palonosetron in preventing chemotherapy-induced nausea and vomiting (CINV) in patients with cancer who had incomplete control of CINV during their previous cycle of low-emetogenic chemotherapy (LEC)

A baseline clinical assessment was performed including demographics, history, physical exam, labs, and urinalysis, within 14 days of treatment. On day 1, eligible patients received an IV bolus injection of 0.25 mg palonosetron 30 minutes before their scheduled LEC regimen. Patients were then monitored 30 minutes after administration of LEC for any adverse reactions. Outcomes were recorded in patient diaries over a 120-hour period at the end of study visits on days 6, 7, or 8 after LEC administration. Investigators assessed presence of nausea and its severity and intensity, the number of emetic episodes, complete control rate, and the complete response rate for the acute phase (0–24 hours), delayed phase (24–120 hours), and overall response (0–120 hours). 

• The study reported on 34 participants.
• The mean age of the participants was 64.7 years (SD = 13.77 years).
• The sample was 31% male and 69% female.
• Patients had histologically or cytologically confirmed cancer
• The sample was 83% Caucasian, and the mean Karnofsky Performance Status score was 82.8. 
• All patients had received prior LEC that had induced vomiting or at least moderate nausea.
• Most patients (77.8%) consumed no alcohol.

This was a mutlisite study conducted in clinical settings at 10 centers in the United States.

• Patients were in active Treatment.
• This study has application to late effects and survivorship.

This was a prospective, single-arm, descriptive study.

• Patient diaries were used to record of the number of emetic events, use of rescue antiemetics, and measure of nausea on a 4-point Likert-type scale with 0 = no nausea to 3 = severe nausea.
• Complete response was defined as no nausea, vomiting, or need for rescue antiemetics.
• An end-of-study visit was conducted on day 6, 7, or 8.

The majority of patients (94.1%) required no rescues antiemetics in the postchemotherapy phase. In the acute postchemotherapy phase, 88.2% of patients experienced complete response. In the delayed phase, 67% experienced complete response. On two treatment-emergent adverse events occurred. Complete control rate was also noted in the acute and delayed phases. Overall, 73.5% of patients did not require rescue medications.

Palonosetron was effective in preventing CINV in both the acute and delayed postchemotherapy phases and was well tolerated in this group of patients who had a history of CINV with LEC. Unfortunately, type of cancer was not reported.

• The sample was small with fewer than 100 patients.
• No control group was included.
• Patients were receiving various chemotherapy regimens.

In patients with a history of CINV while receiving LEC, palonosetron can be considered a useful antiemetic option for acute and delayed post chemotherapy phases. A randomized study should be considered with a focus on specific LEC regimens. Nurses should note that 73% of patients did not require rescue antiemetics; however, 27% patients did need them.