Jin, Y., Sun, W., Gu, D., Yang, J., Xu, Z., & Chen, J. (2012). Comparative efficacy and safety of palonosetron with the first 5-HT3 receptor antagonists for the chemotherapy-induced nausea and vomiting: A meta-analysis. European Journal of Cancer Care, 22, 41–50.

DOI Link

Purpose

To compare the therapeutic efficacy and safety of a single-dose of 0.25 mg or 0.75 mg palonosetron with first generation 5-HT3 RAs (32 mg ondansetron, 100 mg dolasetron, or 3 mg granisetron) in preventing chemotherapy-induced nausea and vomiting (CINV) with or without IV dexamethasone before initiation of chemotherapy

Search Strategy

Databases searched were Medline (1966 to June 2011), EMBASE (1980 to June 2011), American Society of Clinical Oncology, and National Cancer Institute (403 in total).

Search keywords were palonosetron, ondansetron, granisetron, dolasetron, nausea and vomiting.

Studies were included in the review if they were

  • Incorporated a parallel-group or crossover design.
  • Reported on adult patients receiving moderately or highly emetogenic chemotherapy.
  • Provided sufficient data for evaluation of acute antiemetic efficacy.
  • Included sufficient details on the adverse effects associated with palonosetron.

Studies were excluded if they had insufficient data on polanestron safety or if the participants were applied more than once in the review.
 

Literature Evaluated

  • A total of 16 references were retrieved.
  • Homogeneity of effects across studies was assessed by using c2 statistical review.
  • Publication bias was evaluated by using a visual inspection of the funnel plot of the fixed or random effect relative risk (RR) of each study on the x-axis and the standard error of the variance of the log RR on the y-axis.
  • No evaluation was performed on the trials' quality.

Sample Characteristics

  • The final number of studies included was nine. Of these, four used 0.75 mg IV palonosetron.
  • The total sample size was 3,463, according to the author (although counting the studies listed in Table 1 yielded a total count of 3,698, and checking each study separately yielded 3,776).
  • The sample range of participants across studies was 89–1,114.
  • Key sample characteristics were adult patients receiving MEC or higher with various cancer diagnoses.

Phase of Care and Clinical Applications

  • Patients were in active treatment.
  • This study has application to palliative care and elderly care.

Results

  • Complete response (CR) was defined as no emetic episodes and no rescue medication used during the acute, delayed, and overall time intervals after initiation of qualifying chemotherapy. Complete control (CC) was defined as no emetic episodes, no need for rescue medication, and no more than mild nausea for the 0–24 hours, 24–120 hours, and 0–120 hours intervals.
  • Compared with the first-generation 5-HT3 receptor antagonists, the cumulative incidences of emesis were significantly reduced in the patients treated with palonosetron (0.25 mg IV) on the first day (RR = 1.11, 95% confidence interval (CI): 1.05–1.17), from 2 to 5 days (RR = 1.26, 95% CI: 1.16–1.36) and the overall five days (RR = 1.23, 95% CI: 1.13–1.34).
  • Regarding drug safety, no significant differences were found between the group treated with palonosetron and the group treated with first-generation 5-HT3 receptor antagonists.

Conclusions

Results from the analysis suggest that palonosetron is highly effective in preventing nausea and vomiting in the days after administration of moderately or highly emetogenic chemotherapy agents.

Legacy ID

3265