Timmins, P., III, Kredentser, D., Hancock, K., Messing, M., Boehm, K.A., Mull, S., & Asmar, L. (2008). Results of an open-label study to evaluate the efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with carboplatin-containing chemotherapy in patients with ovarian cancer, primary peritoneal, or fallopian tube carcinoma (stage I–IV) or papillary serous cancer of the uterus. Clinical Ovarian Cancer, 1, 60–65. 

DOI Link

Study Purpose

To evaluate the effectiveness of the combination of palonosetron, aprepitant, and dexamethasone for prevention of chemotherapy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

In cycle 1 of chemotherapy, safety and efficacy was assessed. In subsequent cycles, assessment of nausea was emphasized. Actual dosage and schedule of medications was not described. Patients completed Functional Living Index-Emesis (FLIE) scores at various time points in the study; however, these specific time points were not stated.

Sample Characteristics

  • The study consisted of 50 participants.
  • Median age was 60.6 years, with a range of 31–68.9 years
  • All patients were female.
  • Diagnoses were ovarian, peritoneal, uterine, or fallopian tube cancer.
  • The majority of patients (96%) had undergone previous surgery, but only one patient had received prior chemotherapy.
  • All patients were scheduled to receive paclitaxel and carboplatin for several cycles.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a prospective, open-label trial.

Measurement Instruments/Methods

  • Complete response (CR) was defined as no emesis and no need for rescue medications.
  • The FLIE questionnaire was used.

Results

  • Four patients dropped out after experiencing uncontrolled nausea and vomiting.
  • FLIE scores were reported for nausea and vomiting per cycles and days.
  • The percent of patients experiencing CR was not reported.
  • Treatment-related adverse events were few and of low grades.

Conclusions

The combination of drugs used appeared to be well tolerated. Firm conclusions regarding efficacy cannot be drawn.

Limitations

  • The study had a small sample.
  • The study report did not provide much actual information or report overall results.
  • Only cumulative drug dosages were reported; no information was provided about dosages and schedules.
  • No control or comparison group was included.

Nursing Implications

This study provides some evidence that combinations of palonosetron, aprepitant, and dexamethasone can be well tolerated.