Suzuki, S., Karayama, M., Inui, N., Kuroishi, S., Fujisawa, T., Enomoto, N., . . . Suda, T. (2016). Sequential addition of aprepitant in patients receiving carboplatin-based chemotherapy. Medical Oncology, 33, 65-016-0780-6. 

DOI Link

Study Purpose

To evaluate the safety and efficacy of the addition of aprepitant in patients receiving carboplatin-based chemotherapy after initial doublet-based antiemetics in the first chemotherapy cycle

Intervention Characteristics/Basic Study Process

In the first cycle of chemotherapy, patients were receiving doublet therapy, consisting of a 5-HT3 and dexamethasone. In the second cycle, patients received aprepitant and reduced dexamethasone, as in standard triplet regimens. Patients completed daily questionnaires regarding vomiting frequency, nausea scoring, and food intake for five days of each cycle.

Sample Characteristics

  • N = 63   
  • MEAN AGE = 66 years
  • AGE RANGE = 44–81 years
  • MALES: 79.4%, FEMALES: 20.6%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Tumor types were not stated, but 11.1% had brain metastases and 71.4% had a stage IV disease.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Observational

Measurement Instruments/Methods

  • Evaluation of complete response (CR) rates (no vomiting and no rescue antiemetics)
  • Common Terminology Criteria for Adverse Events (CTCAE), version 3.0

Results

The overall (p < 0.001) and delayed phase (p < 0.001) CR rates were better in the second cycle with the addition of aprepitant. No difference existed in the CR rates in the acute phase. Fewer patients in the second cycle required rescue antiemetics (p = 0.006). The proportion of patients who had grade 2 or higher nausea was less in the cycle with aprepitant (p = 0.013).

Conclusions

The addition of aprepitant significantly improved CINV control.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Experience of CINV in the first cycle could have influenced experiences in cycle 2 and beyond.

Nursing Implications

This study showed that the addition of an NK1 as salvage for patients on MEC who did not have complete control in initial chemotherapy cycles was associated with improved CINV control, particularly in the delayed phase.