Song, Z., Wang, H., Zhang, H., Zhao, K., Zhang, M., & Yang, F. (2016). Efficacy and safety of triple therapy with aprepitant, ondansetron, and prednisone for preventing nausea and vomiting induced by R-CEOP or CEOP chemotherapy regimen for non-Hodgkin lymphoma: A phase 2 open-label, randomized comparative trial. Leukemia and Lymphoma, 58, 816–821. 

DOI Link

Study Purpose

To compare the use of a three-drug antiemetic regimen to a two-drug antiemetic regimen in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with non-Hodgkin lymphoma receiving R-CEOP or CEOP, highly emetogenic regimens (HECs)

Intervention Characteristics/Basic Study Process

The assignment of patients was random. The experimental group received oral aprepitant 125 mg, oral prednisone 100 mg, and IV ondansetron 24 mg on day 1 of chemotherapy and oral aprepitant 80 mg and prednisone 100 mg daily on days 2–3 and oral prednisone 100 mg daily on days 4–5. The control group received oral prednisone 100 mg and IV ondansetron 24 mg on day 1 and oral prednisone 100 mg daily on days 2–5. Rescue medications included 5-HT3 antagonists, phenothiazines, diazepam, corticosteroids, and metoclopramide. Both groups used a diary to report vomiting or retching per the Common Criteria for Adverse Events (CTCAE), version 4, during days 1–5, including use of rescue medications. Nausea was recorded daily in the morning using a 100 mm visual analog scale (VAS). On day 6, Functional Living Index-Emesis (FLI-E) questionnaires were used to evaluate how CINV affected quality of life. Patients were also assessed on days 6 and 8 for vital signs, weight, lab tests, echocardiogram, and adverse events.

Sample Characteristics

  • N = 108 enrolled, 90 completed the study.  
  • AGE = 40.4 years
  • MALES: 68.5%, FEMALES: 31.4%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Non-Hodgkin lymphoma
  • OTHER KEY SAMPLE CHARACTERISTICS: Treatment with R-CEOP or CEOP

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: China

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Prospective, open-label, randomized, comparative clinical trial

Measurement Instruments/Methods

  • Diaries–patient self-report
  • CTCAE, version 4, for vomiting and retching
  • VAS for nausea
  • FLI-E questionnaires for quality of life

Results

Complete response (CR) was defined as no emesis and no use of rescue medications. 

  • Overall study CR: Aprepitant group 77%, control group 56% (p = 0.03)
  • CR acute phase: Aprepitant group 92%, control 78% (p = 0.045)
  • CR delayed phase: Aprepitant group 82%, control 64% (p = 0.037)
  •  Secondary end point–no emesis:  
  • Acute phase: Aprepitant group 94%, control 84% (p = 0.153)
  • Delayed phase: Aprepitant group 86%, control 64% (p = 0.003)
  • Overall study: Aprepitant group 78%, control 60% (p = 0.02)
  • No differences for nausea in the acute phase and overall phase between the groups
  • In the delayed phase, 73% of the aprepitant group reported no nausea and 50% of the control group (p = 0.2).
  • FLI-E scores for CINV with minimal or no effect on quality of life: Aprepitant group 84%, control 64% (p = 0.02)

Conclusions

CR rate was achieved significantly with the addition of aprepitant to a two-drug antiemetic in both the acute and delayed phases. There were significant differences related to no emesis between the groups but no differences in nausea. For patients taking aprepitant, CINV had less affect on quality of life throughout treatment.

Limitations

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

 

Nursing Implications

For patients receiving R-CEOP or CEOP for non-Hodgkin lymphoma, a three-drug regimen was more effective in preventing CINV  than a two-drug regimen and was generally well-tolerated.