Kim, K.I., Lee, D.E., Cho, I., Yoon, J.H., Yoon, S.S., Lee, H.S., & Oh, J.M. (2012). Effectiveness of palonosetron versus other serotonin 5-HT3 receptor antagonists in triple antiemetic regimens during multiday highly emetogenic chemotherapy. The Annals of Pharmacotherapy, 46(12), 1637–1644.

To compare palonosetron-based and first generation 5-HT3 receptor antagonist-based triple drug therapies on chemotherapy-induced nausea and vomiting (CINV) in patients receiving multiday highly emetogenic chemotherapy (HEC)

The study was open to patients who received multiday HEC. Patients were divided into two groups according to the triple-drug antiemetic therapy prescribed by the treating physician. The experimental group received 0.25 mg fixed-dose palonosetron 30 minutes prior to chemotherapy. The control group received any first-generation 5-HT3 receptor antagonist including ondansetron, granisetron, dolasetron, and ramosetron. The first-generation drug was administered at the recommended dose prior to chemotherapy either via IV or orally. All patients received 125 mg oral aprepitant and 12 mg oral dexamethasone on day 1 prior to chemotherapy and received 80 mg oral aprepitant and 8 mg oral or IV dexamethasone on both days 2 and 3 prior to chemotherapy. Either 10 mg IV metoclopramide or 1 mg lorazepam was used for breakthrough CINV. Baseline data and CINV-related data were collected from electronic medical records for 120 hours after chemotherapy began.

• N = 115  
• MEAN AGE = 54.39 years
• MALES: 63.5%, FEMALES: 36.5%
• KEY DISEASE CHARACTERISTICS: 80.9% of patients had solid tumors
• OTHER KEY SAMPLE CHARACTERISTICS: 88.7% of patients received cisplatin-based therapy

• SITE: Single-site    
• SETTING TYPE: Not specified    
• LOCATION: South Korea

• PHASE OF CARE: Active antitumor treatment

Retrospective analysis

• Number of emetic episodes
• Time to first emetic episode
• Severity of nausea (categorized by patient’s physician)
• Use of rescue medication
• Number of days with rescue medications
• Time to first administration of rescue medication

There was no statistically significant difference in complete response rates between the two study groups in any phase (acute phase 0–24 hours [p = .877]; overlap phase 24–120 hours [p = .997]; overall phase 0–120 hours [p = .723]). There was no statistically significant difference in the number of patients who achieved complete control in any phase of the study (acute phase 0–24 hours [p = .862]; overlap phase 24–120 hours [p = .838]; overall phase 0–120 hours [p = .828]). Within this sample, more women than men experienced acute nausea (p = .040) and vomiting (p = .046).

There was no significant difference in the complete response between the two groups in the acute phase (0–24 hours), overlap phase (24–120 hours), or overall phase (0–120 hours).

• Risk of bias (no blinding)
• Risk of bias (no random assignment)

Palonosetron-based triple antiemetic therapy is not more effective than triple therapies that use older 5-HT3 receptor antagonists as part of the regimen. Both regimens should be considered when choosing a triple-drug therapy combination for the prevention and management of CINV.