Aapro, M., Fabi, A., Nole, F., Medici, M., Steger, G., Bachmann, C., … Roila, F. (2010). Double-blind, randomised, controlled study of the efficacy and tolerability of palonosetron plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy. Annals of Oncology, 21, 1083–1088. 

To compare two treatments (palonosetron plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3) for the management of chemotherapy-induced nausea and vomiting (CINV) in the overall study period (days 1–5) and to show comparison between the two treatments in complete response (CR) rates

• At the first cycle of chemotherapy, patients were randomly assigned to receive one of two treatment regimens. Group one received 0.25 mg palonosetron plus 8 mg IV dexamethasone on day 1 and placebo on days 2 and 3, and group two received 0.25 mg palonosetron plus 8 mg dexamethasone on day 1 and 4 mg oral dexamethasone twice a day on days 2 and 3.
• Patients recorded emetic episodes, use of rescue medication, and daily nausea ratings of nausea in diaries.
• Patients were allowed to take rescue medication, and the choice of rescue medication was at the discretion of the individual physician, except that no phenothiazines were allowed.

• The study consisted of 300 participants.
• Mean age was 51.6 years old (SD = 10.11 years).
• The sample was 100% female.
• Participants were chemotherapy-naïve patients with breast cancer receiving moderately emetogenic chemotherapy (MEC).

The study was conducted at multiple outpatient settings in Austria, Germany, Italy, and Spain.

This was a double-blind, randomized, controlled study.

• Patients used diaries to record date and time of emetic episodes, use of rescue medication, daily nausea ratings on a 0-10 visual analogue scale (VAS). 
• CR rate, defined as no emesis and no rescue medication during overall period (days 1–5), was recorded for acute phase (day 1) and delayed periods (days 2–5).
• Maximum severity of nausea (MSN) was recorded in daily and overall phases.
• Time-to-treatment failure (time to first emetic episode or time to first use of rescue medication) was recorded.
• Functional Living Index—Emesis (FLIE) was used in the screening phase and on day 6.
• Adverse events were recorded.

• More than 70% of patients had no emesis.
• CR was not significantly different in the overall, acute, and delayed phases between study groups. However on day 3, patients who received palonosetron plus dexamethasone on days 1–3 experienced less emesis (p = 0.004) and lower MSN (p = 0.028).
• Time-to-treatment failure and use of rescue medication was similar between groups.
• FLIE score and percentage of adverse events was not significantly different between groups.

• The palonosetron with single-day dexamethasone dosing regimen offered high and similar protection as palonosetron with 3-day dosing of dexamethasone in terms of CR rates and patient performance.
• In some cases, the protection was insufficient on day 3, and the benefits of dexamethasone needed to be weighed against the increased risk of potential side effects.

• The sample was only women who were chemotherapy naïve receiving MEC regimens. These findings may not be generalizable to other groups, particularly as some research has shown differences in antiemetic results between men and women.
• Patient compliance with daily diary recordings was not discussed.

• With chemotherapy-naïve patients with breast cancer receiving chemotherapy, palonosetron plus dexamethasone provides fairly good control over CINV.
• In patients whose antiemetic-related side effects have been bothersome, a palonosetron plus single-dose dexamethasone regimen could be an option.
• In both groups, more than half of patients still had nausea on day 1 and about one-third still had nausea in the delayed period, pointing to the need for individualization of ongoing management.