A phase II study of the safety of olanzapine for oxaliplatin based chemotherapy in coloraectal patients

Abstract Olanzapine has exhibited efficacy as an antiemetic agent when used with 5-HT3 receptor antagonists, dexamethasone, and NK1 receptor antagonists for patients receiving highly emetogenic chemotherapy. In addition, several studies have reported the efficacy or safety of olanzapine in patients...

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Autores principales: Junichi Nishimura, Akiko Hasegawa, Toshihiro Kudo, Tomoyuki Otsuka, Masayoshi Yasui, Chu Matsuda, Naotsugu Haraguchi, Hajime Ushigome, Nozomu Nakai, Tomoki Abe, Hisashi Hara, Naoki Shinno, Kei Asukai, Shinichiro Hasegawa, Daisaku Yamada, Keijiro Sugimura, Kazuyoshi Yamamoto, Hiroshi Wada, Hidenori Takahashi, Takeshi Omori, Hiroshi Miyata, Masayuki Ohue
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Publicado: Nature Portfolio 2021
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spelling oai:doaj.org-article:a96bf649e84c4db8abb0c8667118f6232021-12-02T15:54:14ZA phase II study of the safety of olanzapine for oxaliplatin based chemotherapy in coloraectal patients10.1038/s41598-021-84225-62045-2322https://doaj.org/article/a96bf649e84c4db8abb0c8667118f6232021-02-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-84225-6https://doaj.org/toc/2045-2322Abstract Olanzapine has exhibited efficacy as an antiemetic agent when used with 5-HT3 receptor antagonists, dexamethasone, and NK1 receptor antagonists for patients receiving highly emetogenic chemotherapy. In addition, several studies have reported the efficacy or safety of olanzapine in patients receiving moderately emetogenic chemotherapy, including carboplatin, irinotecan, and oxaliplatin. However, no reports of olanzapine use have focused on patients receiving oxaliplatin-based chemotherapy. Therefore, we analyzed the safety of antiemetic therapy using olanzapine, palonosetron, aprepitant, and dexamethasone in colorectal cancer patients undergoing oxaliplatin-based chemotherapy. This study was a prospective phase II single-institution study of 40 patients (median age 60 years, 23 patients were male). The primary endpoint was the incidence of adverse events, and the exploratory endpoints were the rate of chemotherapy-induced nausea and vomiting. Almost all patients (90%) had a performance status of 0. All patients received the scheduled antiemetic therapy. The most common adverse event was somnolence (n = 7 patients, 17.5%). All adverse events were grade 1. Thirty-six patients were included in the exploratory analysis of efficacy. No patients experienced vomiting during the first 120 h after chemotherapy, and complete response and complete control were both 86.1%. The rate of total control was 55.6% during the same time period. Olanzapine use with 5-HT3 receptor antagonists, dexamethasone, and NK1 receptor antagonists was safe for colorectal cancer patients receiving oxaliplatin-based chemotherapy.Junichi NishimuraAkiko HasegawaToshihiro KudoTomoyuki OtsukaMasayoshi YasuiChu MatsudaNaotsugu HaraguchiHajime UshigomeNozomu NakaiTomoki AbeHisashi HaraNaoki ShinnoKei AsukaiShinichiro HasegawaDaisaku YamadaKeijiro SugimuraKazuyoshi YamamotoHiroshi WadaHidenori TakahashiTakeshi OmoriHiroshi MiyataMasayuki OhueNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-6 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Junichi Nishimura
Akiko Hasegawa
Toshihiro Kudo
Tomoyuki Otsuka
Masayoshi Yasui
Chu Matsuda
Naotsugu Haraguchi
Hajime Ushigome
Nozomu Nakai
Tomoki Abe
Hisashi Hara
Naoki Shinno
Kei Asukai
Shinichiro Hasegawa
Daisaku Yamada
Keijiro Sugimura
Kazuyoshi Yamamoto
Hiroshi Wada
Hidenori Takahashi
Takeshi Omori
Hiroshi Miyata
Masayuki Ohue
A phase II study of the safety of olanzapine for oxaliplatin based chemotherapy in coloraectal patients
description Abstract Olanzapine has exhibited efficacy as an antiemetic agent when used with 5-HT3 receptor antagonists, dexamethasone, and NK1 receptor antagonists for patients receiving highly emetogenic chemotherapy. In addition, several studies have reported the efficacy or safety of olanzapine in patients receiving moderately emetogenic chemotherapy, including carboplatin, irinotecan, and oxaliplatin. However, no reports of olanzapine use have focused on patients receiving oxaliplatin-based chemotherapy. Therefore, we analyzed the safety of antiemetic therapy using olanzapine, palonosetron, aprepitant, and dexamethasone in colorectal cancer patients undergoing oxaliplatin-based chemotherapy. This study was a prospective phase II single-institution study of 40 patients (median age 60 years, 23 patients were male). The primary endpoint was the incidence of adverse events, and the exploratory endpoints were the rate of chemotherapy-induced nausea and vomiting. Almost all patients (90%) had a performance status of 0. All patients received the scheduled antiemetic therapy. The most common adverse event was somnolence (n = 7 patients, 17.5%). All adverse events were grade 1. Thirty-six patients were included in the exploratory analysis of efficacy. No patients experienced vomiting during the first 120 h after chemotherapy, and complete response and complete control were both 86.1%. The rate of total control was 55.6% during the same time period. Olanzapine use with 5-HT3 receptor antagonists, dexamethasone, and NK1 receptor antagonists was safe for colorectal cancer patients receiving oxaliplatin-based chemotherapy.
format article
author Junichi Nishimura
Akiko Hasegawa
Toshihiro Kudo
Tomoyuki Otsuka
Masayoshi Yasui
Chu Matsuda
Naotsugu Haraguchi
Hajime Ushigome
Nozomu Nakai
Tomoki Abe
Hisashi Hara
Naoki Shinno
Kei Asukai
Shinichiro Hasegawa
Daisaku Yamada
Keijiro Sugimura
Kazuyoshi Yamamoto
Hiroshi Wada
Hidenori Takahashi
Takeshi Omori
Hiroshi Miyata
Masayuki Ohue
author_facet Junichi Nishimura
Akiko Hasegawa
Toshihiro Kudo
Tomoyuki Otsuka
Masayoshi Yasui
Chu Matsuda
Naotsugu Haraguchi
Hajime Ushigome
Nozomu Nakai
Tomoki Abe
Hisashi Hara
Naoki Shinno
Kei Asukai
Shinichiro Hasegawa
Daisaku Yamada
Keijiro Sugimura
Kazuyoshi Yamamoto
Hiroshi Wada
Hidenori Takahashi
Takeshi Omori
Hiroshi Miyata
Masayuki Ohue
author_sort Junichi Nishimura
title A phase II study of the safety of olanzapine for oxaliplatin based chemotherapy in coloraectal patients
title_short A phase II study of the safety of olanzapine for oxaliplatin based chemotherapy in coloraectal patients
title_full A phase II study of the safety of olanzapine for oxaliplatin based chemotherapy in coloraectal patients
title_fullStr A phase II study of the safety of olanzapine for oxaliplatin based chemotherapy in coloraectal patients
title_full_unstemmed A phase II study of the safety of olanzapine for oxaliplatin based chemotherapy in coloraectal patients
title_sort phase ii study of the safety of olanzapine for oxaliplatin based chemotherapy in coloraectal patients
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/a96bf649e84c4db8abb0c8667118f623
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