Kitayama, H., Tsuji, Y., Sugiyama, J., Doi, A., Kondo, T., & Hirayama, M. (2015). Efficacy of palonosetron and 1-day dexamethasone in moderately emetogenic chemotherapy compared with fosaprepitant, granisetron, and dexamethasone: A prospective randomized crossover study. International Journal of Clinical Oncology, 20, 1051–1056.

DOI Link

Study Purpose

To determine the best antiemetic drug combinations for patients receiving moderately emetogenic chemotherapy (MEC)

Intervention Characteristics/Basic Study Process

Chemotherapy-naïve patients with a mix of malignancies receiving MEC were randomized to two treatment groups. Group A received palonosetron plus one day of dexamethasone and group B received fosaprepitant, granisetron, and dexamethasone on day 1. The primary endpoint was complete response (CR, no emesis and no rescue drugs). The secondary endpoints were complete control (CC, no vomiting, no use of rescue drugs, and no more than mild nausea), total control (TC, no nausea), and therapy chosen by patients. CR, CC, and TC were measured in the acute, delayed, and overall phases for five days. Data on chemotherapy-induced nausea and vomiting (CINV) were collected on days 2 and 5 following chemotherapy.

Sample Characteristics

  • N = 35
  • AGE RANGE = 60 ± 14 years
  • MALES: 37%, FEMALES: 63%
  • KEY DISEASE CHARACTERISTICS: Solid malignant tumors (majority breast and colon)
  • OTHER KEY SAMPLE CHARACTERISTICS: Eastern Cooperative Oncology Group performance statuses of 0, 1, and 2

Setting

  • SITE: Single site
  • SETTING TYPE: Outpatient
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Prospective, single-blinded, randomized crossover study

Measurement Instruments/Methods

  • Japanese version of the ​Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT)
  • Patients recorded the incidence and severity of CINV on days 2 and 5. The severity of nausea was recorded using a Numeric Rating Scale (NRS).

Results

There were no significant differences in the efficacy of the two protocols, and no significant difference in CC or TC during the acute, delayed, or overall period was found. Nausea scores were not reported although their collection was reported. These results suggest that palonosetron and dexamethasone have the same efficacy as fosaprepitant, granisetron, and dexamethasone.

Conclusions

The combination of palonosetron and dexamethasone was as effective as triple-drug antiemetic regimens for patients receiving MEC.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Key sample group differences that could influence results
  • Other limitations/explanation: CINV data were only collected on days 2 and 5.

Nursing Implications

The data from this study were not strong enough to affect nursing care; however, because of the similar efficacy of the study drugs, additional studies should be investigated.