Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials

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,...

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Published in:BMC Cancer
Main Authors: Senri Yamamoto, Hirotoshi Iihara, Ryuji Uozumi, Hitoshi Kawazoe, Kazuki Tanaka, Yukiyoshi Fujita, Masakazu Abe, Hisao Imai, Masato Karayama, Yoh Hayasaki, Chiemi Hirose, Takafumi Suda, Kazuto Nakamura, Akio Suzuki, Yasushi Ohno, Ken-ichirou Morishige, Naoki Inui
Format: Article
Language:English
Published: BMC 2021-07-01
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Online Access:https://doi.org/10.1186/s12885-021-08572-3
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author Senri Yamamoto
Hirotoshi Iihara
Ryuji Uozumi
Hitoshi Kawazoe
Kazuki Tanaka
Yukiyoshi Fujita
Masakazu Abe
Hisao Imai
Masato Karayama
Yoh Hayasaki
Chiemi Hirose
Takafumi Suda
Kazuto Nakamura
Akio Suzuki
Yasushi Ohno
Ken-ichirou Morishige
Naoki Inui
author_facet Senri Yamamoto
Hirotoshi Iihara
Ryuji Uozumi
Hitoshi Kawazoe
Kazuki Tanaka
Yukiyoshi Fujita
Masakazu Abe
Hisao Imai
Masato Karayama
Yoh Hayasaki
Chiemi Hirose
Takafumi Suda
Kazuto Nakamura
Akio Suzuki
Yasushi Ohno
Ken-ichirou Morishige
Naoki Inui
author_sort Senri Yamamoto
collection DOAJ
container_title BMC Cancer
description 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.
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spelling doaj-art-79cd99ffcbf44d7699d8a53b2348bb062025-08-19T20:46:54ZengBMCBMC Cancer1471-24072021-07-0121111010.1186/s12885-021-08572-3Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trialsSenri Yamamoto0Hirotoshi Iihara1Ryuji Uozumi2Hitoshi Kawazoe3Kazuki Tanaka4Yukiyoshi Fujita5Masakazu Abe6Hisao Imai7Masato Karayama8Yoh Hayasaki9Chiemi Hirose10Takafumi Suda11Kazuto Nakamura12Akio Suzuki13Yasushi Ohno14Ken-ichirou Morishige15Naoki Inui16Department of Pharmacy, Gifu University HospitalDepartment of Pharmacy, Gifu University HospitalDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of MedicineDivision of Pharmaceutical Care Sciences, Center for Social Pharmacy and Pharmaceutical Care Sciences, Keio University Faculty of PharmacySecond Division, Department of Internal Medicine, Hamamatsu University School of MedicineDivision of Pharmacy, Gunma Prefectural Cancer CenterDivision of Gynecology, Shizuoka Cancer CenterDivision of Respiratory Medicine, Gunma Prefectural Cancer CenterSecond Division, Department of Internal Medicine, Hamamatsu University School of MedicineDepartment of Obstetrics and Gynecology, Gifu University Graduate School of MedicineDepartment of Pharmacy, Gifu University HospitalSecond Division, Department of Internal Medicine, Hamamatsu University School of MedicineDepartment of Gynecology, Gunma Prefectural Cancer CenterDepartment of Pharmacy, Gifu University HospitalDepartment of Cardiology and Respiratory Medicine, Gifu University Graduate School of MedicineDepartment of Obstetrics and Gynecology, Gifu University Graduate School of MedicineSecond Division, Department of Internal Medicine, Hamamatsu University School of MedicineAbstract 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.https://doi.org/10.1186/s12885-021-08572-3AntiemeticsCarboplatinNauseaOlanzapineVomiting
spellingShingle Senri Yamamoto
Hirotoshi Iihara
Ryuji Uozumi
Hitoshi Kawazoe
Kazuki Tanaka
Yukiyoshi Fujita
Masakazu Abe
Hisao Imai
Masato Karayama
Yoh Hayasaki
Chiemi Hirose
Takafumi Suda
Kazuto Nakamura
Akio Suzuki
Yasushi Ohno
Ken-ichirou Morishige
Naoki Inui
Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials
Antiemetics
Carboplatin
Nausea
Olanzapine
Vomiting
title Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials
title_full Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials
title_fullStr Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials
title_full_unstemmed Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials
title_short Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials
title_sort efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin integrated study of three prospective multicenter phase ii trials
topic Antiemetics
Carboplatin
Nausea
Olanzapine
Vomiting
url https://doi.org/10.1186/s12885-021-08572-3
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