Adra, N., Albany, C., Brames, M.J., Case-Eads, S., Johnson, C.S., Liu, Z., . . . Einhorn, L.H. (2016). Phase II study of fosaprepitant 5HT3 receptor antagonist dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: A Hoosier Cancer Research Network study. Supportive Care in Cancer, 24, 2837–2842.

DOI Link

Study Purpose

To assess the efficacy and safety of fosaprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving multiday cisplatin combination chemotherapy

Intervention Characteristics/Basic Study Process

Germ cell tumor patients receiving a five-day cisplatin combination chemotherapy were enrolled. Fosaprepitant 150 mg was given intravenously on days 3 and 5. A 5HT3 receptor antagonist was administered on days 1–2 (on days 1, 3, and 5, if palonosetron), plus 20 mg dexamethasone on days 1–2 and 4 mg twice a day on days 6–8. Patients were asked to keep a diary of the chemotherapy cycle on days 1–8.

Sample Characteristics

  • N = 54   
  • MEDIAN AGE = 33 years
  • MALES: 100%  
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Germ cell tumors
  • OTHER KEY SAMPLE CHARACTERISTICS: Caucasian, mostly chemotherapy naïve, stage I–II

Setting

  • SITE: Not stated/unknown   
  • SETTING TYPE: Not specified    
  • LOCATION: Not stated

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

  • Single-arm, phase-II trial

Measurement Instruments/Methods

  • 100 mm visual analog scale (VAS)
  • Acute phase CINV defined as days 1–5 and delayed phase defined as days 6–8

Results

The primary objective was to determine the complete response (CR) rate as no emetic episodes or use of antiemetic medications. The CR was observed in 12 (24.1%) patients.

Conclusions

The reported CR rate was much lower than that generally reported, suggesting a much lower efficacy for CINV with a five-day cisplatin regimen.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no appropriate attentional control condition)
  • Key sample group differences that could influence results
  • Measurement validity/reliability questionable

 

Nursing Implications

Whether substituting fosaprepitant for aprepitant provides the same benefit in a multiday cisplatin regimen is unknown.