Oral versus intravenous palonosetron in Chinese cancer patients receiving moderately emetogenic chemotherapy: A non‐inferiority phase III trial. (21st June 2020)

• Record Type: Journal Article
• Authors: Cui, Jiuwei; Zhang, Qingyuan; Zhang, Hongyu; Spinelli, Tulla; Nicolas, Pierre; Li, Wei
• Is Part Of: European journal of cancer care. Volume 29:Number 4(2020)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2020-06-21
• Subjects: chemotherapy‐induced nausea and vomiting -- intravenous palonosetron -- moderately emetogenic chemotherapy -- non‐inferiority -- Oral palonosetron -- phase III; Cancer -- Nursing -- Periodicals; 616.994
• DOI: 10.1111/ecc.13245
• Languages: English
• ISSNs: 0961-5423

Abstract

Abstract: Objective: The 5‐hydroxytryptamine‐3 receptor antagonist palonosetron (PALO) is approved (United States/Europe) as an oral formulation for prevention of chemotherapy‐induced nausea and vomiting in adult cancer patients undergoing moderately emetogenic chemotherapy (MEC) for the acute phase only, in the United States, or as intravenous (IV) formulation in patients undergoing MEC or highly emetogenic chemotherapy. This phase III study compares the efficacy/safety of oral versus IV PALO in Chinese patients. Methods: Chemotherapy‐naive patients with solid tumours scheduled for MEC received oral PALO 0.50 mg or IV PALO 0.25 mg. The primary objective was to demonstrate non‐inferiority in terms of patients with complete response in the acute phase (0–24 hr post‐chemotherapy). Results: Complete response rates (acute phase), evaluated in 318/320 randomised patients, were 84.6% and 85.9% for oral and IV PALO respectively. Non‐inferiority was demonstrated; the two formulations showed similar efficacy/safety. Conclusion: Non‐inferiority of oral versus IV PALO in the acute phase was demonstrated in Chinese patients. Clinical trial registration: CTR20140711.