Mirabile, A., Celio, L., Magni, M., Bonizzoni, E., Gianni, A.M., & Di Nicola, M. (2014). Evaluation of an every-other-day palonosetron schedule to control emesis in multiple-day high-dose chemotherapy. Future Oncology, 10, 2569–2578.

To determine the proportion of patients achieving complete control during the overall study period and continued for 24 hours after the last dose of chemotherapy, and to determine the proportion of patients achieving complete control within each 24-hour interval of observation

The first 50 patients received ondansetron plus dexamethasone. The experimental group received 0.25 mg IV palonosetron 30 minutes prior to chemotherapy on day 1, then every other day for the duration of the high-dose chemotherapy. Patients also received daily dexamethasone and omeprazole. The rescue medication was metoclopramide for any emesis or if the patient requested the medication. Nurses obtained data from the patients, including subjective nausea assessment every 24 hours and any episodes of emesis or use of rescue medication. Chemotherapy regimens included several myeloablative and non-myeloablative regimens.

• N = 108   
• AGE = 20–76
• MALES: 67%, FEMALES: 33% 
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Non-Hodgkin lymphoma, Hodgkin disease, breast cancer, testicular cancer, sarcoma
• OTHER KEY SAMPLE CHARACTERISTICS: Alcohol consumption, chemotherapy type (melphalan versus cytarabine versus other regimens)

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Milan, Italy

PHASE OF CARE: Active antitumor treatment

Exact single-stage design using a historical cohort

Nausea in the past 24 hours was measured using a subjective Likert-type scale ranging from 1–4. Emesis was measured by nurses. Use of rescue medication was measured from nurse reports. Patients who withdrew from the study were considered nonresponders. Patient age, gender, alcohol consumption, emetic regimen, and duration of chemotherapy were evaluated as predictive of chemotherapy-induced nausea and vomiting (CINV). Odds ratios, Fisher’s exact test, a chi-squared test, and the Mann-Whitney U test were used.

The average number of days of chemotherapy was 4.7 with a range of 2–6 days in the historical cohort and 4.3 days with a range of 2–6 days in the palonosetron group. Complete control was 50% for overall, 58% for early, and 82% for the historical group. In the palonosetron group, the complete control was 81%, 84.5%, and 96.5%. Overall difference for the overall study period showed a p value of 0.001. The early period showed a p value of 0.002, and the p value of the late period was 0.022. In both cohorts, patients without nausea or with mild nausea did not experience emesis. Patients with emesis were significantly more prevalent in the ondansetron arm (p < 0.005).

The change to every other day palonosetron significantly improved the management of CINV in multiday high-dose chemotherapy.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)

Evidence supports every other day palonosetron, which is safe and effective for managing CINV in high-dose chemotherapy that is given over several days.