Morrow, G. R., Schwartzberg, L., Barbour, S. Y., Ballinari, G., Thorn, M. D., & Cox, D. (2014). Palonosetron versus older 5-HT3 receptor antagonists for nausea prevention in patients receiving chemotherapy: A multistudy analysis. The Journal of Community and Supportive Oncology, 12, 250–258.

DOI Link

Study Purpose

To compare the efficacy and safety of palonosetron with older 5HT3 receptor antagonists (RAs) in preventing chemotherapy-induced nausea

Intervention Characteristics/Basic Study Process

Data were pooled from four similarly designed multicenter, randomized, double-blinded clinical trials that compared palonosetron 0.25 mg or 0.75 mg with ondansetron 32 mg, dolasetron 100 mg, or granisetron 40 ug/kg for moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC). Randomization occurred in all four studies for palonosetron versus older 5HT3s. 
 
Patients and investigators were blinded to the treatment arms. Decadron was allowed in the HEC arm. Each medication was given on day 1 prior to chemotherapy. Rescue medications were allowed for patients who needed them on follow-up. Measurements of nausea, vomiting, rescue medications, nausea-free rates, nausea severity, and requirements for rescue antiemetics or antinausea medication were completed over five days.

Sample Characteristics

  • N = 1,132 (MEC), 1,781 (HEC)
  • MEAN AGE = 54.9 years (study 1), 54.4 years (study 2), 55.5 years (study 3), and 56 years (study 4)
  • MALES: 22.8% (study 1); 23.1% (study 2); 44.7% (study 3); 44% (study 4), FEMALES: 77.2% (study 1); 76.9% (study 2); 55.3% (study 3), 56% (study 4)
  • KEY DISEASE CHARACTERISTICS: Breast, lung, colorectal, ovarian, and gastric cancers and Hodgkin disease; included naïve and not naïve patients 
  • OTHER KEY SAMPLE CHARACTERISTICS: Steroids were allowed. Alcohol and tobacco use were tracked.

Setting

  • SITE: Multi-site
  • SETTING TYPE: Multiple settings
  • LOCATION: Studies that occurred in Europe or North America

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care and palliative care

Study Design

Data were pooled from four studies that were multicenter, randomized, double-blinded clinical trials comparing palonosetron, ondansetron, dolasetron, or granisetron.

Measurement Instruments/Methods

  • Nausea (complete control, nausea-free rates, nausea severity, and use of rescue medication over five days following chemotherapy)
  • Nausea and vomiting assessments were done by phone or during clinic visits. Patients were to document all episodes of emesis and nausea, the severity of nausea, and the use of rescue medication in their dairies for five days following chemotherapy.
  • A nausea severity four-point categorical scale was used.

Results

The patients treated with palonosetron experienced less nausea each day then the other 5HT3 RAs, and fewer patients receiving palonosetron had moderate to severe nausea. The use of rescue medication was less frequent among patients in the palonosetron arm. The complete control rates for palonosetron versus older 5HT3 RAs were 66% versus 63% during the acute acute phase, 52% versus 42% in the delayed phase, and 46% versus 37% in the overall phase. No safety differences or concerns were noted.

Conclusions

Palonosetron was more effective in treating and preventing nausea than ondansetron, dolasetron, and granisetron. All four agents tolerated equally well.

Limitations

  • Per the authors, the analysis included summarized data but was not powered for statistical comparisons between the agents.
  • Nausea is subjective. The reliability may be influenced by the data collector.  
  • NK1, which is a standard practice medication, was not used for HEC.

Nursing Implications

Nurses are aware that palonosetron has a longer half-life and is the medication of choice for outpatient treatment. This study reinforces palonosetron use by noting that more patients receiving it had nausea-free days, lower nausea ratings, and less rescue medication use. Nausea is very subjective, but nurses are aware that it is more of a problem in the delayed phase than actual vomiting. Nausea affects quality of life, and this study can help nurses choose the correct 5HT3 RA.