Matsuura, M., Satohisa, S., Teramoto, M., Tanaka, R., Iwasaki, M., Nishikawa, A., . . . Saito, T. (2015). Palonosetron in combination with 1-day versus 3-day dexamethasone for prevention of nausea and vomiting following paclitaxel and carboplatin in patients with gynecologic cancers: A randomized, multicenter, phase-II trial. The Journal of Obstetrics and Gynaecology Research, 41, 1607–1613. 

To examine the proportion of patients who achieve a complete response (no emetic episodes and no rescue medication during the overall phase in each arm) with the treatment

Patients were receiving chemotherapy with carboplatin and paclitaxel for a gynecologic malignancy. All patients received a single IV dose of palonosetron (0.75 mg) on day 1 as a bolus given 30 minutes prior to chemotherapy, dexamethasone at 9.9 mg if patients were on dose-dense chemotherapy, and 20 mg for traditional carboplatin paclitaxel within 45 minutes prior to chemotherapy. Patients were then randomly assigned to two groups. Dexamethasone 8 mg was given on days 2 and 3, but no additional dexamethasone. Rescue medication was allowed. Evaluation of emetic events and nausea were measured using a diary and a 4-stage Likert-type scale. Randomization was done at a registration center with a minimization method with stratification according to institution, cancer type, age, and chemotherapy regimen.

• N = 109   
• AGE = 45–68 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Ovarian, endometrial, or cervical cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Type of regimen, either conventional paclitaxel 175 mg/m²/carboplatin AUC 6 every three weeks or dose dense with carboplatin AUC 6 on day 1, taxol 80 mg/m² on days 1, 8, and 15; alcohol consumption, motion sickness, and age; patients were chemotherapy naïve or had received single-agent low emetogenic potential therapy

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: Japan

PHASE OF CARE: Active antitumor treatment

Randomized, controlled, non-placebo trial

• Used a patient diary to evaluate emetic events and nausea
• Nausea was measured using a 4-stage Likert-type scale.
• Multivariate logistic regression analysis showed relationships to other variables, such as motion sickness.
• Complete control was measured as no emetic episodes, no rescue medications, and mild nausea.
• Total control was defined as no emetic episodes, no rescue medications, and no nausea.

In the overall period, total control was 49.1% in the three-day dexamethasone group and 37.5% of the one-day dexamethasone group. In the acute phase, it was 90.6% in the three-day group and 92.9% in the one-day group. For delayed, it was 50.9% in the three-day group and 39.3% in the one-day group. Complete control in the overall period was 67.9% in the three-day group and 58.9% in the one-day group. In the acute phase, it was 98.1% in the three-day group and 96.4% of the one-day group. When looking at the responses, there were differences with motion sickness (p = 0.037), favoring the three-day dexamethasone regimen.

The authors concluded that one day of dexamethasone is as effective as three days of dexamethasone, except in special populations, such as those with motion sickness or severe hyperemesis gravidarum. Differences in efficacy were not found in patients with other risk factors, such as alcohol use and age.

Findings not generalizable

Nurses play a key role in assessing patient risk for chemotherapy-induced nausea and vomiting. Knowing past history of morning sickness or motion sickness should clue nurses into collaborating with providers to consider three days of dexamethasone as opposed to one day.