Senri Yamamoto1, Hirotoshi Iihara2,3, Ryuji Uozumi4, Hitoshi Kawazoe5,6, Kazuki Tanaka7, Yukiyoshi Fujita8, Masakazu Abe9,10, Hisao Imai11,12, Masato Karayama7,13, Yoh Hayasaki14, Chiemi Hirose1, Takafumi Suda7, Kazuto Nakamura15, Akio Suzuki1,16, Yasushi Ohno17, Ken-Ichirou Morishige14, Naoki Inui18,19. 1. Department of Pharmacy, Gifu University Hospital, 1-1 Yanagido, Gifu, Gifu, 501-1194, Japan. 2. Department of Pharmacy, Gifu University Hospital, 1-1 Yanagido, Gifu, Gifu, 501-1194, Japan. dai0920@gifu-u.ac.jp. 3. Laboratory of Pharmacy Practice and Social Science, Gifu Pharmaceutical University, 1-25-4 Daigakunishi, Gifu, Gifu, 501-1196, Japan. dai0920@gifu-u.ac.jp. 4. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan. 5. Division of Pharmaceutical Care Sciences, Center for Social Pharmacy and Pharmaceutical Care Sciences, Keio University Faculty of Pharmacy, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan. 6. Division of Pharmaceutical Care Sciences, Keio University Graduate School of Pharmaceutical Sciences, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan. 7. Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1, Handayama, Hamamatsu, 431-3192, Japan. 8. Division of Pharmacy, Gunma Prefectural Cancer Center, 617-1 Takahayashi-nishi, Ota, Gunma, 373-8550, Japan. 9. Division of Gynecology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan. 10. Present address: Department of Obstetrics and Gynecology, Hamamatsu University School of Medicine, 1-20-1, Handayama, Hamamatsu, 431-3192, Japan. 11. Division of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1, Takahayashi-nishi, Ota, Gunma, 373-8550, Japan. 12. Present address: Department of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1, Yamane, Hidaka, Saitama, 350-1298, Japan. 13. Department of Clinical Oncology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu, 431-3192, Japan. 14. Department of Obstetrics and Gynecology, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu, Gifu, 501-1194, Japan. 15. Department of Gynecology, Gunma Prefectural Cancer Center, 617-1, Takahayashi-nishi, Ota, Gunma, 373-8550, Japan. 16. Laboratory of Pharmacy Practice and Social Science, Gifu Pharmaceutical University, 1-25-4 Daigakunishi, Gifu, Gifu, 501-1196, Japan. 17. Department of Cardiology and Respiratory Medicine, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu, Gifu, 501-1194, Japan. 18. Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1, Handayama, Hamamatsu, 431-3192, Japan. inui@hama-med.ac.jp. 19. Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine, 1-20-1, Handayama, Hamamatsu, 431-3192, Japan. inui@hama-med.ac.jp.
Abstract
BACKGROUND: The efficacy of olanzapine as an antiemetic agent in cancer chemotherapy has been demonstrated. However, few high-quality reports are available on the evaluation of olanzapine's efficacy and safety at a low dose of 5 mg among patients treated with carboplatin regimens. Therefore, in this study, we investigated the efficacy and safety of 5 mg olanzapine for managing nausea and vomiting in cancer patients receiving carboplatin regimens and identified patient-related risk factors for carboplatin regimen-induced nausea and vomiting treated with 5 mg olanzapine. METHODS: Data were pooled for 140 patients from three multicenter, prospective, single-arm, open-label phase II studies evaluating the efficacy and safety of olanzapine for managing nausea and vomiting induced by carboplatin-based chemotherapy. Multivariable logistic regression analyses were performed to determine the patient-related risk factors. RESULTS: Regarding the endpoints of carboplatin regimen-induced nausea and vomiting control, the complete response, complete control, and total control rates during the overall study period were 87.9, 86.4, and 72.9%, respectively. No treatment-related adverse events of grade 3 or higher were observed. The multivariable logistic regression models revealed that only younger age was significantly associated with an increased risk of non-total control. Surprisingly, there was no significant difference in CINV control between the patients treated with or without neurokinin-1 receptor antagonist. CONCLUSIONS: The findings suggest that antiemetic regimens containing low-dose (5 mg) olanzapine could be effective and safe for patients receiving carboplatin-based chemotherapy.
BACKGROUND: The efficacy of olanzapine as an antiemetic agent in cancer chemotherapy has been demonstrated. However, few high-quality reports are available on the evaluation of olanzapine's efficacy and safety at a low dose of 5 mg among patients treated with carboplatin regimens. Therefore, in this study, we investigated the efficacy and safety of 5 mg olanzapine for managing nausea and vomiting in cancerpatients receiving carboplatin regimens and identified patient-related risk factors for carboplatin regimen-induced nausea and vomiting treated with 5 mg olanzapine. METHODS: Data were pooled for 140 patients from three multicenter, prospective, single-arm, open-label phase II studies evaluating the efficacy and safety of olanzapine for managing nausea and vomiting induced by carboplatin-based chemotherapy. Multivariable logistic regression analyses were performed to determine the patient-related risk factors. RESULTS: Regarding the endpoints of carboplatin regimen-induced nausea and vomiting control, the complete response, complete control, and total control rates during the overall study period were 87.9, 86.4, and 72.9%, respectively. No treatment-related adverse events of grade 3 or higher were observed. The multivariable logistic regression models revealed that only younger age was significantly associated with an increased risk of non-total control. Surprisingly, there was no significant difference in CINV control between the patients treated with or without neurokinin-1 receptor antagonist. CONCLUSIONS: The findings suggest that antiemetic regimens containing low-dose (5 mg) olanzapine could be effective and safe for patients receiving carboplatin-based chemotherapy.
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