Einhorn, L.H., Brames, M.J., Dreicer, R., Nichols, C.R., Cullen, M.T., Jr., & Bubalo, J. (2007). Palonosetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy for germ cell cancer. Supportive Care in Cancer, 15(11),1293-1300.

DOI Link

Study Purpose

To evaluate the safety and efficacy of palonosetron plus dexamethasone for patients receiving multiple-day, highly emetogenic chemotherapy (HEC)

Intervention Characteristics/Basic Study Process

Patients received 0.25 mg IV palonosetron as an infusion 30 minutes before chemotherapy on days 1, 3, and 5 plus dexamethasone 20 mg IV on days 1 and 2, 8 mg orally twice daily on days 6 and 7, and 4 mg orally twice daily on day 8. Given the high receptor-binding affinity and prolonged half-life of palonosetron, this study involved alternate day dosing (days 1, 3, and 5 rather than days 1-3) combined with a standard dexamethasone regimen for multiple-day, cisplatin-based chemotherapy.

Sample Characteristics

The study consisted of 41 patients with germ cell tumors.

Study Design

This was a nonrandomized trial.

Measurement Instruments/Methods

The following data was collected.

  • Number of emetic episodes (vomiting and retching)
  • Use of rescue medication
  • Intensity and duration of nausea on a four-point Likert scale used for nausea intensity
  • Evaluation of the effect of nausea on patients’ quality of life via the Osoba nausea module, which assesses five patient-rated items using a four-point scale
  • Pharmacokinetic (PK) data

Results

  • Descriptive analysis showed complete response (CR) rates.
  • The protocol prevented vomiting for most subjects at all timepoints of the study (days 1-9). The lowest percentage came at day 4 when 68% of patients reported no vomiting.
  • Some protection against nausea was provided, with 59% or more of patients reporting no or, at maximum, mild nausea at any time on each study day.
  • No severe adverse events were noted.
  • The most common side effects were headache and constipation.
  • No evidence of cumulative toxicity PK data was reported.

Limitations

  • The sample size was small.
  • No control arm was included.
  • This was a nonrandomized trial.