Molassiotis, A., Nguyen, A.M., Rittenberg, C.N., Makalinao, A., & Carides, A. (2013). Analysis of aprepitant for prevention of chemotherapy-induced nausea and vomiting with moderately and highly emetogenic chemotherapy. Future Oncology (London, England), 9(10), 1443–1450.  

DOI Link

Study Purpose

To determine how aprepitant affects the impact of chemotherapy-induced nausea and vomiting (CINV) on daily activities during highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC)

Intervention Characteristics/Basic Study Process

Data for this analysis were obtained from the aprepitant phase III clinical trial program and included data from two HEC trials and one MEC trial. Patients who met the entry criteria were allocated to one of two treatment groups according to a computer-generated randomization schedule and stratified by gender and use of concomitant emetogenic chemotherapy as categorized by the Hesketh classification of emetogenicity. The aprepitant group took triple-combination antiemetics (aprepitant, ondansetron, and dexamethasone), and the standard antiemetic group received ondansetron and dexamethasone. In these three trials, the primary efficacy end point was complete response, defined in the HEC trials as no vomiting and no use of rescue medications over five days (0–120 hours) and in the MEC trials as no emesis in the 120-hour period following chemotherapy during cycle one. In all three trials, the primary patient-reported outcome endpoint was no or minimal impact of CINV on daily life (NIDL), which was assessed using the modified version of the Functional Living Index–Emesis (FLIE) with five-day recall. In all three trials, FLIE questionnaires were completed by patients on day 1 (for training purposes) and on day 6 (five-day recall) during cycle one of chemotherapy. Day 6 FLIE data were used for all analyses. The proportion of patients reporting NIDL for each treatment group was calculated.

Sample Characteristics

  • N = 1,014 (HEC), 848 (MEC)
  • MEAN AGE = 58–59 years (Study 1 HEC, SD = 12 years), 53–54 years (Study 2 HEC, SD = 13–14 years). Demographic results of the HEC studies were reported. Data only about females participants were reported.  
  • MALES: Study I = 62%, Study II = 61% (both for HEC studies), FEMALES: Study 1 = 38%, Study 2 = 39%. All results are related to the HEC studies.
  • KEY DISEASE CHARACTERISTICS: Respiratory, urogenital, and others (not specified)

Setting

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

Phase of Care and Clinical Applications

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

Study Design

Phase III clinical trial program; included data from two HEC trials and one MEC trial

Measurement Instruments/Methods

  • Modified version of the Functional Living Index–Emesis (FLIE)

Results

More patients who received the aprepitant regimen in the HEC trials achieved overall complete response compared with those on standard antiemetic therapy in cycle one adjusted for gender, region, and use of concomitant chemotherapy (67.7% versus 47.8%, p < 0.01). A significantly higher number of patients who received aprepitant reported NIDL (74.4%) as compared with those on the standard antiemetic regimen (63.9%, p < 0.01). In the HEC group, when compared to standard therapy, patients who received aprepitant reported significantly lower nausea (70.2% versus 60.9%) and vomiting (84.6% versus 68.7%, p < 0.01). In the MEC trial, reports of no emesis were significantly lower in the aprepitant group (76.2%) than in the standard regimen (61.1%, p < 0.001) after the first cycle of chemotherapy. Patients receiving aprepitant in the MEC trial had a significantly higher percentage of complete response (68.7%) than the patients in the standard regimen (56.3%, p < 0.001). Aprepitant also had a significant impact on patient report of NIDL with 73.4% reporting no impact compared to 66.3% in the standard regimen group (p < 0.05).

Conclusions

Aprepitant, when given with HEC, led to higher overall complete response rates than the standard regimen. Patients who received aprepitant and MEC also reported lower levels of nausea and vomiting. For patients receiving both HEC and MEC, aprepitant improved outcomes on activities of daily living (ADL).

Limitations

  • Patients may not be able to detect the effect of chemotherapy on their daily function.
  • Recall bias could be considered as a limitation.

Nursing Implications

Aprepitant, in addition to standard CINV prophylactic medications, reduces nausea and vomiting associated with chemotherapy and decreases the impact of CINV on ADLs. This is true for patients receiving HEC and MEC. Nurses should spend time educating patients on how CINV can impact ADLs and work with patients to create patient-centered, nurse-led interventions to ease the influence of CINV on patient quality of life.