Brugnatelli, S., Gattoni, E., Grasso, D., Rossetti, F., Perrone, T., & Danova, M. (2011). Single-dose palonosetron and dexamethasone in preventing nausea and vomiting induced by moderately emetogenic chemotherapy in breast and colorectal cancer patients. Tumori, 97(3), 362–366.

To evaluate the efficacy and safety of palonosetron followed by dexamethasone administered as a single dose for the prevention of vomiting and nausea in patients receiving moderately emetogenic chemotherapy for breast and colorectal cancer

A bolus dose of 0.25 mg IV palonosetron was given over 30 seconds beginning 30 minutes before chemotherapy, followed by 8 mg IV dexamethasone. Patients were asked to complete diaries to assess antiemetic response during the acute, delayed, and overall phases (days 1–5).

• The study consisted of 68 patients, 40 with breast cancer and 28 with colorectal cancer.
• Mean age was 61 years.
• The sample was 21% male and 79% female.
• Patients had been diagnosed with colorectal or breast cancer and were chemotherapy-naïve.
• Race/ethnicity was not specified.
• To be included, patients had to be over age 18, have a European Cooperative Oncology Group (ECOG) performance status of 0–1, and have acceptable liver and kidney function.
• Patients were exclused if they had received radiation within 30 days of initiation of chemotherapy; had previous history of vomiting episodes, including morning sickness or motion sickness; and had any concomitant severe disease.

This study was conducted at a single outpatient site in Cinisello Balsamo, Italy.

• All patients were in active treatment.
• This study has application for late effects and survivorship.

This was a phase II, open label, nonrandomized prospective study.

• The primary endpoint was the overall complete response (no nausea or vomiting), defined as the percentage of patients with no use of rescue antiemetic.     
• Secondary endpoints were evaluated at three different stages of treatment: Acute, delayed and overall percentage of complete response.
• Self report diaries of all activities from day 1 to day 5 included the onset of emesis, nausea (measured using a Likert-type scale) and its severity, and the use of rescue medications.
• Overall satisfaction with antiemetic therapy was measured using a visual analog scale (VAS).

• Complete response was observed in 67.6% of patients. Complete response during the acute and delayed phases was 75% for both cancer groups.
• Complete control was 67% overall.  A statistically significant effect of palonosetron was observed for control of emesis and nausea.
• The percentage of patients experiencing adverse events was 36.7%.

Palonosetron followed by dexamethasone in a single administration before chemotherapy to patients with breast or colorectal cancer provides significant protection during the overall phases of chemotherapy. Patients reported high satisfaction with this regimen.

• The sample size was small with fewer than 100 patients.
• The authors stated that 20 (50%) of the women with breast cancer had radical surgery prior to initiation of chemotherapy. They do not include postoperative nausea and vomiting (PONV) specifically as exclusion criteria, but it would be interesting to know if this might influence the results because motion sickness and morning sickness were exclusion criteria.

Palonosetron followed by dexamethasone should be considered as premedication on day 1 in moderately emetogenic chemotherapy regimens in patients with breast or colorectal cancer.

Although a complete response was observed in 67% of patients, 33% did not experience complete response. Despite this, the authors stated that this medication regimen adequately controlled CINV during the entire period of emetic risk. Additionally, the 33% of nonresponders does not include high-risk patients who were excluded from this study because of a history of previous nausea and vomiting.

The key takeaway for nurses is that a significant number of patients may require both pharmacologic and nonpharmacologic strategies  to help them through this time.