Nasu, R., Nannya, Y., & Kurokawa, M. (2015). A randomized controlled study evaluating the efficacy of aprepitant for highly/moderately emetogenic chemotherapies in hematological malignancies. International Journal of Hematology, 101, 376–385. 

DOI Link

Study Purpose

To assess the additional effects of aprepitant in combination with conventional 5HT3 blocker-based prophylaxis for chemotherapy-induced nausea and vomiting (CINV) during highly or moderately emetic chemotherapy for hematologic malignancies

Intervention Characteristics/Basic Study Process

Patients were divided into two arms. Patients in the conventional antiemetic therapy arm received 5HT3 receptor antagonists (RAs) alone (19 patients, control arm), and patients in the treatment group received 5HT3 RAs plus aprepitant (22 patients, aprepitant arm). The incidence of CINV and the use of rescue medications were analyzed and compared between the two groups over the total period of 10 days from the start of chemotherapy. Oral food intake also was appraised by patients and sorted into four levels: (1) not impaired, (2) slightly impaired, (3) moderately impaired to about half of the usual amount, or (4) severely impaired.

Sample Characteristics

  • N = 41  
  • AGE = ≥ 20
  • MALES: 65.85%, FEMALES: 34.14%
  • KEY DISEASE CHARACTERISTICS: Hematologic malignancies 
  • OTHER KEY SAMPLE CHARACTERISTICS: The eligible chemotherapies were limited to the following: (a) preparative regimens for autologous hematopoietic stem cell transplantation for multiple myeloma or malignant lymphoma, (b) platinum-containing regimens for resistant or refractory malignant lymphoma mainly consisting of etoposide, methylprednisolone, cytarabine, and cisplatin or its modified variant, which substitutes carboplatin for cisplatin, or (c) induction or consolidation therapies for acute leukemia, which contain either anthracyclines, high-dose methotrexate, or high-dose cytarabine. Patients with poor performance statuses or with an estimated life expectancy of less than three months were disqualified. Patients had to have sufficient cognitive capacity, adequate blood counts, no significant hepatic or renal dysfunctions at the start of chemotherapy. Patients who had had a previous history of aprepitant administration also were excluded.

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: The University of Tokyo Hospital

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Palliative care 

Study Design

Randomized, controlled study

Measurement Instruments/Methods

  • Vomiting was measured daily by the number of vomiting episode the patient reported.
  • Nausea was measured by Visual Analog Scale (VAS).
  • The amount of oral food intake was recorded daily on days 1–10 of chemotherapy administration. 
  • Rescue medication use was recorded by the physicians.

Results

Overall complete response, which was the primary endpoint of this study, was considerably superior in the aprepitant arm. Emetic episodes during the overall observation period were seen at a higher rate in the control arm. Although it was not significant, the control arm had more emetic episodes than the aprepitant arm in the acute and delayed phases. VAS scores followed almost the same trend during the first five days whereas the control arm tended to show higher VAS values at days 6 and 10. However, there were no statistically significant differences. About 50% of the patients in the aprepitant arm maintained usual amounts of oral feeding throughout the observation period whereas this rate dropped significantly in the control arm, and only 21% of participants had normal food intake on day 6.

Conclusions

This study revealed the benefit of adding aprepitant to highly emetic chemotherapy regimens for various hematologic malignancies. Sufficient antiemetic effects were achieved without obvious adverse events, and additional aprepitant use is recommended for patients who received chemotherapy for a hematologic malignancy. The additional research of individual chemotherapies that specifically prefer antiemetic intensification with aprepitant is warranted.

Limitations

  • Small sample (< 100)
  • Measurement/methods not well described

 

Nursing Implications

Aprepitant is a good option for nurses to recommend for patients receiving chemotherapy for hematologic malignancies. NK1s such as aprepitant are recommended in relevant guidelines.