Hesketh, P.J., & Sanz-Altamira, P. (2012). Aprepitant, dexamethasone, and palonosetron in the prevention of doxorubicin/cyclophosphamide-induced nausea and vomiting. Supportive Care in Cancer, 20(3), 653-656.

DOI Link

Study Purpose

To evaluate the effectiveness of aprepitant, dexamethasone, and palonosetron in the prevention of nausea and vomiting in patients with breast cancer receiving an initial cycle of doxorubicin and cyclophosphamide (AC)

Intervention Characteristics/Basic Study Process

Patients were asked to keep a diary recording the number and timing of any episodes of vomiting or retching, frequency and timing of use of rescue antiemetics, degree of nausea using a four-point categorical scale, and notation of other medications taken. The patients were called by a study coordinator at 24, 48, 72, 96, and 120 hours after starting chemotherapy to assist the patients in the completion of the diary.

Sample Characteristics

  • The study consisted of 36 participants.
  • The median age of patients was 53 years.
  • All of the patients were female with a diagnosis of breast cancer.
  • All of the patients were chemotherapy naïve with Karnofsky performance statuses of 60 or more
  • Patients were scheduled to receive their first course of chemotherapy with cyclophosphamide (≥ 500 mg/m2) and doxorubicin (60 mg/m2) .

Setting

The study was conducted at a single outpatient setting at Lahey Clinic Medical Center in Burlington, MA.

Phase of Care and Clinical Applications

  • All patients were in active treatment.
  • The study has clinical application to elderly care.

 

Study Design

This was a prospective trial.

Measurement Instruments/Methods

Patients recorded in diaries the number and timing of any episodes of vomiting or retching, frequency and timing of rescue antiemetic use, and degree of nausea using a four-point categorical scale.

Results

  • Eighteen patients (50%) achieved a complete response during the 120-hour study period.
  • Acute (≤ 24 hours) and delayed (24–120 hours) complete response rates were 81% and 61%, respectively.
  • No emesis rates for the acute, delayed, and overall study periods were 97%, 94%, and 92%, respectively.

Conclusions

The aprepitant, dexamethasone, and palonosetron appeared to be well tolerated and effective at preventing emesis, with no emesis rates ranging from 92%–97% during the study period. However, 50% of patients still developed some degree of nausea and took antiemetic rescue medications, highlighting the need for  further improvement in chemotherapy-induced nausea and vomiting (CINV) control in patients with breast cancer receiving AC.

Limitations

  • The study had a small sample size of fewer than 100 patients.
  • Current guidelines suggest the use of a 5-HT3 receptor antagonist, dexamethasone, and aprepitant prior to treatment with an anthracycline and cyclophosphamide (AC) and then aprepitant alone on days 2 and 3. According to the large, phase-III trial that supports the use of the current suggested premedication regimen, approximately half of the patients will achieve a complete response (CR). This study yielded a 50% CR rate. The authors did try to compare the regimen in this study to the regimen used in the phase-III trial. To more fully assess the combinations, a large, randomized controlled trial would need to be done to compare the regimens.

Nursing Implications

AC is a common treatment regimen for breast cancer and is highly emetogenic. Further studies exploring ways to better control nausea in this patient population, including the use of nonpharmacologic strategies, are needed.