Hu, W., Fang, J., Nie, J., Dai, L., Chen, X., Zhang, J., . . . Han, J. (2014). Addition of aprepitant improves protection against cisplatin-induced emesis when a conventional anti-emetic regimen fails. Cancer Chemotherapy and Pharmacology, 73, 1129–1136. 

DOI Link

Study Purpose

To study the effectiveness of aprepitant as a secondary agent to prevent chemotherapy-induced nausea and vomiting (CINV) in patients with lung cancer for whom cisplatin-induced nausea and vomiting was poorly controlled by a conventional antiemetic regimen of granisetron and dexamethasone

Intervention Characteristics/Basic Study Process

Stage 1 of the study recruited patients receiving cisplatin-based chemotherapy being actively treated for lung cancer. Patients who experienced vomiting of grade 2 or higher and needed rescue antiemetics during their first cycle of chemotherapy (stage 1) were enrolled in stage 2 of the study. During stage 2, patients had oral aprepitant added on day 1 at 125 mg and on days 2 and 3 at 80 mg daily of subsequent chemotherapy cycles. Patients were asked to keep diaries during the first two chemotherapy cycles.

Sample Characteristics

  • N = 25 (stage 2)  
  • MEDIAN AGE = 61 years (range = 32–71 years)
  • MALES: 4, FEMALES: 21
  • KEY DISEASE CHARACTERISTICS: All patients were being actively treated for lung cancer.
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients were expected to receive at least two cycles of cisplatin-based chemotherapy.

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: Beijing, China

Phase of Care and Clinical Applications

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

Study Design

Two-stage, prospective observation study

Measurement Instruments/Methods

  • Demographics and patient characteristics were collected. 
  • Patients recorded the number and times they experienced vomiting or retching, the frequency and timing of rescue antiemetic use, the severity of CINV, and adverse events or additional medications taken.
  • CINV was monitored for acute (0–24 hours) and delayed (25–120 hours) episodes using the Common Terminology Criteria for Adverse Events version 3 grading scale.
  • Outcomes were classified as complete response (CR, no emetic episodes or use of rescue therapy) or complete control (CC, no nausea, emetic episodes, or rescue therapy).

Results

Patients who advanced to stage 2 of the study and who had aprepitant added to subsequent chemotherapy regimens reported significantly less acute and delayed nausea and vomiting compared to their first chemotherapy cycle. During the first cycle of chemotherapy, 18.7% of the 132 patients initially recruited required rescue antiemetics, and 52% required intravenous hydration. Of the 25 patients continuing to stage 2 of the study, none required rescue antiemetics or required intravenous hydration. 64% met the criteria for CR, and 28% met the criteria for CC after round two of chemotherapy.

Conclusions

The findings of this study show that aprepitant was effective in preventing acute and delayed nausea after high-dose, cisplatin-based chemotherapy for patients with lung cancer at a high risk of emesis, anticipatory vomiting, and poor CINV control.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Unintended interventions or applicable interventions not described that would influence results
  • Findings not generalizable
  • Other limitations/explanation: The study was not blinded, the role of anticipatory nausea and vomiting was not considered, and the effects of the addition of aprepitant was only studied in cycle 2. 

Nursing Implications

Nursing care would benefit from improved strategies to manage CINV for patients with lung cancer receiving chemotherapy. However, the authors of this study acknowledged that larger randomized, controlled studies are needed before recommendations can be made. The assessment of CINV risk during all cycles of chemotherapy is an important aspect of nursing care and patient advocacy. Outcomes for CINV improve when standardized antiemetic guidelines are followed.