Antiemetic effect of granisetron NK, a generic 5-HT3 receptor antagonist in comparison with azasetron for prevention of chemotherapy-induced nausea and vomiting in cancer patient - A crossover randomized controlled clinical trial

• Published in: Annals of Cancer Research and Therapy 2012/12/28, Vol.20(2), pp.63-67
• Main Authors: Nakamura, Kumi, Onikubo, Toshihide, Nakamura, Masato, Tauchi, Katsunori
• Format: Article
• Language: English
• Subjects: 5-HT3 receptor antagonist; azasetron; emesis; generic drug; granisetron; randomized clinical trial
• ISSN: 1344-6835; 1880-5469
• DOI: 10.4993/acrt.20.63

Purpose: Five-hydroxytryptamine-3 (5-HT3) receptor antagonists (RAs) are widely used to control chemotherapy-induced nausea and vomiting in cancer chemotherapy. Several 5-HT3 RAs could be available, there are some important points to select agents, like as efficacy, adverse events and their costs. In this study, we compared an originator drug, azasetron with a generic version, granisetronNK, to evaluate their anti-emetic efficacy and quality of life in crossover randomized setting. Patients and Methods: Patients treated with a highly emetic FEC100 regimen are registered in this study. Patients randomly assigned to 2 groups, which treated with granisetron NK in first course followed second course treated with azasetron, or vice versa. Efficacy, adverse events and quality of life (QOL) were evaluated with patient self-reporting questionnaires. Results: Twenty seven patients were recruited to this study. Fourteen patients were assigned to receive azasetron in first course followed by granisetronNK in second course, and 13 patients were assigned to receive granisetronNK in first course followed by azasetron in second course. There was no significant difference in grade and frequency of nausea, vomiting, eating status and defecation between two treatment groups. In addition, analysis of QOL showed no significant difference in two groups. Conclusion: A generic 5-HT3 RA granisetronNK which reduce 31% cost showed no significant differences in terms of efficacy, adverse events and QOL in comparison with originator drug azasetron. Effective and high cost-performance supportive therapy should be chosen.