Efficacy and safety of palonosetron for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV): a systematic review and meta-analysis of randomized controlled trials

Support Care Cancer. 2014 Jun;22(6):1685-97. doi: 10.1007/s00520-014-2175-6. Epub 2014 Mar 4.


Purpose: Palonosetron, a 5-hydroxytryptamine 3 receptor antagonist (5-HT(3)RA) with a strong binding affinity and long half-life, has been used in numerous trials for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV). We systematically reviewed the efficacy and safety of palonosetron compared to other 5-HT(3)RAs in CINV prophylaxis.

Methods: A literature search of Ovid MEDLINE, EMBASE, and CENTRAL was conducted to identify randomized controlled trials (RCTs) comparing palonosetron to other 5-HT(3)RAs in CINV prophylaxis. Primary endpoints were the percentage of patients achieving a complete response (CR), complete control (CC), no emesis, no nausea, or taking no rescue medications. Secondary endpoints were the percentage of patients suffering from 5-HT(3)RA-related adverse events.

Results: Sixteen RCTs were identified with 2,896 patients randomized to palonosetron and 3,187 patients randomized to other 5-HT(3)RAs. Palonosetron was consistently statistically superior in CR, CC, no emesis, or no nausea and was sometimes superior in no rescue medication. Subgroup analyses demonstrated similarity in efficacy between highly and moderately emetogenic chemotherapy cohorts. In the acute phase, statistical superiority of palonosetron was found for trials that did not allow dexamethasone; conversely, RCTs that administered dexamethasone to all patients were nonsignificant. Palonosetron was statistically significantly safer in dizziness and mean QTc interval change and similar in constipation, headache, and diarrhea. Clinical superiority of palonosetron was reached in 3 of 19 analyzed efficacy and safety endpoints.

Conclusions: Palonosetron is safer and more efficacious than other 5-HT(3)RAs. Future antiemetic guidelines should discuss the merits of including palonosetron as a first-line treatment.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Review
  • Systematic Review

MeSH terms

  • Antiemetics / adverse effects
  • Antiemetics / therapeutic use
  • Antineoplastic Agents / adverse effects
  • Humans
  • Isoquinolines / adverse effects*
  • Isoquinolines / therapeutic use*
  • Nausea / chemically induced
  • Nausea / prevention & control*
  • Palonosetron
  • Quinuclidines / adverse effects*
  • Quinuclidines / therapeutic use*
  • Randomized Controlled Trials as Topic
  • Serotonin Antagonists / adverse effects
  • Serotonin Antagonists / therapeutic use
  • Vomiting / chemically induced
  • Vomiting / prevention & control*


  • Antiemetics
  • Antineoplastic Agents
  • Isoquinolines
  • Quinuclidines
  • Serotonin Antagonists
  • Palonosetron