Chasen, M., Urban, L., Schnadig, I., Rapoport, B., Powers, D., Arora, S., . . . Gridelli, C. (2017). Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy. Supportive Care in Cancer, 25, 85–92. 

To assess the impact of adding rolapitant to standard antiemetics (5-HT₃ receptor antagonists and dexamethasone) on the daily lives of patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC)

This is a secondary analysis study of three clinical trials (phase III experimental studies). Patients were stratified by sex and randomly assigned (1:1) to either single oral dose rolapitant 180 mg or placebo 1–2 hours prior to chemotherapy. All patients received 5-HT₃ receptor antagonists and dexamethasone. Quality of life was assessed by patients by completing the 18-item Functional Living Index-Emesis (FLI-E) questionnaire on day 6 of cycle 1.

• N = 2,402 (1,070 patients in the pooled HEC studies and 1,332 patients in the MEC/AC)   
• AGE: Between 18–90 years
• MALES: 39.1% (938 patients), FEMALES: 60.9% (1,464 patients)
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Various malignancies; a Karnofsky performance score of 60 or greater; a predicted life expectancy of four months or greater; and adequate bone marrow, kidney, and liver function
• OTHER KEY SAMPLE CHARACTERISTICS: Aged older than 18 years, naïve to their scheduled HEC/MEC

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

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

Three double-blind, phase III, randomized, controlled longitudinal trials (specified analyses [MEC/AC study]), and pooled post hoc analyses (HEC studies)

Treatment comparisons were performed between the FLI-E questionnaire total score and nausea and vomiting domain scores, in addition to the end point of no impact on daily life.

Data were analyzed for all randomized patients in the modified intent-to-treat population. Patients in the rolapitant group reported a significantly higher FLI-E total score than patients in the control group in the pooled HEC studies (confidence interval [CI] [2.6, 7.9], p < 0.001) and in the MEC/AC study (CI [1.7, 6.5], p < 0.001). A significant improvement in the nausea domain score was observed with rolapitant versus control in the pooled HEC studies (CI [0.2, 3.4], p = 0.02) and the MEC/AC study (CI [0.3, 3.3], p = 0.019), as well as the vomiting domain score in the pooled HEC studies (CI [2.1, 4.7], p < 0.001) and the MEC/AC study (CI [1.1, 3.4], p < 0.001).

This secondary analysis study demonstrated the efficacy of adding rolapitant to standard antiemetics in reducing the negative delayed impact of CINV on the daily lives of patients receiving HEC or MEC.

• Baseline sample/group differences of import
• Secondary analysis data from three experimental clinical trials
• Included patient with various cancers

Nurses should be aware of the additional benefit of adding an NK₁ receptor antagonist to the treatment of patients with cancer receiving HEC and MEC.