European journal of cancer care · 2020
Oral versus intravenous palonosetron in Chinese cancer patients receiving moderately emetogenic chemotherapy: A non-inferiority phase III trial.
Клиническое исследование III фазыСравнительное исследованиеEquivalence TrialСтатьяНазвание и аннотация: Перевод в очереди
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Cui Jiuwei, Zhang Qingyuan, Zhang Hongyu, Spinelli Tulla, Nicolas Pierre, Li Wei
Аннотация
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.
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.