Kitamura, H., Takahashi, A., Hotta, H., Kato, R., Kunishima, Y., Takei, F., . . . Sapporo Medical University Urologic Oncology Consortium. (2015). Palonosetron with aprepitant plus dexamethasone to prevent chemotherapy-induced nausea and vomiting during gemcitabine/cisplatin in urothelial cancer patients. International Journal of Urology, 22, 911–914. 

DOI Link

Study Purpose

To evaluate the antiemetic potential of palonosetron, aprepitant, and dexamethasone in patients with urothelial cancer receiving gemcitabine and cisplatin chemotherapy

Intervention Characteristics/Basic Study Process

Patients received one of two antiemetic regimens, ondansetron or granisetron plus dexamethasone, or palonosetron, aprepitant, and dexamethasone, and over one cycle of chemotherapy were evaluated for chemotherapy-induced nausea and vomiting (CINV) events, rescue medications needed, and food intake.

Sample Characteristics

  • N = 122   
  • AGE RANGE = 36–82 years
  • MEDIAN AGE = 68–70 years
  • MALES: 86%, FEMALES: 13.9%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Urothelial cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients receiving gemcitabine and cisplatin chemotherapy

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Not specified    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Nonrandomized, nonblinded, two-group comparison

Measurement Instruments/Methods

  • CINV events and anorexia were identified through review of the medical record and rated based on criteria from the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
  • The rescue medications used were identified through the review of the medical record.

Results

Patients in the palonosetron, aprepitant, and dexamethasone group had significantly fewer episodes of CINV, anorexia, and rescue medication used compared to the ondansetron or granisetron plus dexamethasone group during the first cycle of chemotherapy (p = 0.012) and overall during chemotherapy (p = 0.0019).

Conclusions

The use of palonosetron plus aprepitant and dexamethasone results in significantly fewer episodes of CINV, anorexia, and rescue medications used in people with urothelial cancer treated with gemcitabine and cisplatin as compared to another commonly used antiemetic regimen, ondansetron or granisetron plus dexamethasone.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Key sample group differences that could influence results
  • The two groups were different sizes: ondansetron or granisetron plus dexamethasone (n = 75), and palonosetron, aprepitant, and dexamethasone (n = 47), so the intervention effect may be influenced.

Nursing Implications

Palonosetron, aprepitant, and dexamethasone may offer more relief from CINV in people being treated with gemcitabine and cisplatin chemotherapy.