Huang, J., Wang, X.J., Yu, D., Jin, Y.N., Zhen, L.Z., Xu, N., ... He, J. (2013). The effect of palonosetron hydrochloride in the prevention of chemotherapy-induced moderate and severe nausea and vomiting. Experimental and Therapeutic Medicine, 5, 1418–1426. 

DOI Link

Study Purpose

To determine the effectiveness of palonosetron hydrochloride in preventing nausea and vomiting in patients receiving chemotherapy agents known to cause moderate to severe nausea and vomiting

Intervention Characteristics/Basic Study Process

The study involved administering 0.25 mg palonosetron and a placebo to the experimental group and 3 mg granisetron and a placebo to the control group 30 minutes prior to the administration of moderate to severe emetogenic chemotherapy.

Sample Characteristics

  • N = 240
  • MEAN AGE = 52.15 years (range = 31–73 years)
  • MALES: 26.7%, FEMALES: 73.3%
  • KEY DISEASE CHARACTERISTICS: Both the control group and the experimental group had similar percentages of diseases represented: 61% were patients with breast cancer; 21% were patients with non-small cell lung cancer; and the remaining 18% were patients with colorectal, gastric, esophageal, head and neck, and ovarian cancer.    
  • OTHER KEY SAMPLE CHARACTERISTICS: About 18% of patients in both groups received moderate emetogenic chemotherapy while about 82% received severely emetogenic chemotherapy. Karnofsky Performance Status scores were ≥ 60; life expectancy was > 3 months; bone marrow function was satisfactory; liver and renal function were normal; ECGs were normal; patients had no side effects from previous treatment except alopecia and nail changes at least three weeks before the last treatment of radiotherapy and chemotherapy; and informed consent was obtained.

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Not specified 
  • LOCATION: Eight trial centers in China

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, multi-centered, double-blind, double-dummy, parallel-group, positive-controlled clinical trial

Measurement Instruments/Methods

There were observational intervals of acute (0–24 hours), delayed (24–120 hours), and full-course (0–120 hours) vomiting. Criteria used to evaluate the effect of palonosetron on vomiting were complete remission (CR) = 0 times/24 hour; partial remission (PR) = 1 time/24 hour; mild remission (MR) = 2–5 times/24 hour; and failure (F) = > 5 times/24 hours. Remission rates were calculated as CR rate = number of vomiting-free cases/total number of cases; PR rate = number of PR cases/total number of cases; and effective rate = number of CR+PR+MR cases/total number of cases.  
 
Criteria used to evaluate the effect of palonosetron on nausea were complete control (CC) = normal and nausea-free and partial control (PC) = poor appetite with no changes in food habits or decreased food intake, no marked weight loss, dehydration, or malnutrition and an infusion time of ≤ 24 hours (moderate nausea). Control rates were calculated as CC rate = number of CC cases/total number of cases and PC rate = number of CC + PC cases.

Results

The acute vomiting CR rates of both the experimental and control groups showed no significant difference—the experimental group was 49% while the control group was 42%.
 
The delayed vomiting CR rates were significantly different between both groups—the experimental group was 51.75% versus 31.03% (p = .002, 95% CL). There were no significant differences between the vomiting control times, treatment failure times, or acute vomiting.

Conclusions

Palonosetron hydrochloride demonstrated better control of delayed vomiting and has a positive preventative effect on delayed nausea and vomiting. There was no difference between granisetron and palonosetron in preventing acute vomiting CR rates, full-course vomiting CR rates, vomiting control time, treatment failure, acute nausea CR rate, or adverse effects.

Limitations

  • Measurement/methods not well described

Nursing Implications

Palonosetron hydrochloride is an effective 5-HT3 antagonist in preventing delayed nausea and vomiting related to high to moderate emetogenic chemotherapy as compared to another 5-HT3 antagonist, granisetron.