Isseki Maeda1, Eriko Satomi2, Daisuke Kiuchi2, Kaoru Nishijima3, Yoshinobu Matsuda4, Akihiro Tokoro4, Keita Tagami5, Yoshihisa Matsumoto6, Akemi Naito7, Tatsuya Morita8, Satoru Iwase9, Hiroyuki Otani, Takuya Odagiri, Hiroaki Watanabe, Masanori Mori, Yosuke Matsuda, Hiroka Nagaoka, Meiko Mayuzumi, Yoshiaki Kanai, Nobuhiro Sakamoto, Keisuke Ariyoshi. 1. Department of Palliative Care, Senri-Chuo Hospital, Toyonaka, Osaka, Japan. isseki.maeda@gmail.com. 2. Department of Palliative Medicine, National Cancer Center Hospital, Tokyo, Japan. 3. Department of Palliative Medicine, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan. 4. Department of Psychosomatic Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Osaka, Japan. 5. Department of Palliative Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan. 6. Department of Palliative Medicine, National Cancer Center Hospital East, Kashiwa, Chiba, Japan. 7. Department of Palliative Care, Miyazaki Medical Association Hospital, Miyazaki, Japan. 8. Palliative and Supportive Care Division, Seirei Mikatahara General Hospital, Hamamatsu, Shizuoka, Japan. 9. Department of Palliative Medicine, Saitama Medical University, Irima, Saitama, Japan.
Abstract
PURPOSE: To examine the safety, effectiveness, and patient-perceived benefit of treatment with olanzapine for nausea and vomiting (N/V) in patients with advanced cancer. METHODS: We conducted a multicenter prospective observational study in a tertiary care setting (Trial registration number: UMIN000020493, date of registration: 2016/1/12). We measured the following: average nausea in the last 24 h using a Numeric Rating Scale (NRS: range 0-10) at baseline and day 2, patient-perceived treatment benefit (based on a 5-point verbal scale), and adverse events (AEs; using the Common Terminology Criteria for Adverse Events version 4). RESULTS: The 85 participants (45% men) had a mean age of 58.7±15.8 years. Major causes of N/V were opioids (44%) and chemotherapy (34%). All patients received a daily dose of olanzapine of 5 mg or less as first-line treatment (N=35) or second- or later-line treatment (N=50). Nausea NRS decreased from 6.1±2.2 to 1.8±2.0 (differences: -4.3, 95% CI -3.7 to -4.9, p<0.001). The proportion of patients who did not experience vomiting episodes in the last 24 h increased from 40-89%. Mean decrease in nausea NRS by patient-perceived treatment benefit were as follows: -0.8 for "none" (n=4, 5%); -2.8 for "slight" (n=17, 20%); -3.3 for "moderate" (n=14, 16%); -4.7 for "lots" (n=25, 29%); and -6.1 for "complete" (n=25, 29%; p-for-trend<0.001). The most prevalent AE was somnolence (n=15, 18%). CONCLUSION: Short-term and relatively low-dose olanzapine treatment was effective for multifactorial N/V. Confirmatory studies with longer observation periods are needed to clarify the duration of the effect and adverse events.
PURPOSE: To examine the safety, effectiveness, and patient-perceived benefit of treatment with olanzapine for nausea and vomiting (N/V) in patients with advanced cancer. METHODS: We conducted a multicenter prospective observational study in a tertiary care setting (Trial registration number: UMIN000020493, date of registration: 2016/1/12). We measured the following: average nausea in the last 24 h using a Numeric Rating Scale (NRS: range 0-10) at baseline and day 2, patient-perceived treatment benefit (based on a 5-point verbal scale), and adverse events (AEs; using the Common Terminology Criteria for Adverse Events version 4). RESULTS: The 85 participants (45% men) had a mean age of 58.7±15.8 years. Major causes of N/V were opioids (44%) and chemotherapy (34%). All patients received a daily dose of olanzapine of 5 mg or less as first-line treatment (N=35) or second- or later-line treatment (N=50). Nausea NRS decreased from 6.1±2.2 to 1.8±2.0 (differences: -4.3, 95% CI -3.7 to -4.9, p<0.001). The proportion of patients who did not experience vomiting episodes in the last 24 h increased from 40-89%. Mean decrease in nausea NRS by patient-perceived treatment benefit were as follows: -0.8 for "none" (n=4, 5%); -2.8 for "slight" (n=17, 20%); -3.3 for "moderate" (n=14, 16%); -4.7 for "lots" (n=25, 29%); and -6.1 for "complete" (n=25, 29%; p-for-trend<0.001). The most prevalent AE was somnolence (n=15, 18%). CONCLUSION: Short-term and relatively low-dose olanzapine treatment was effective for multifactorial N/V. Confirmatory studies with longer observation periods are needed to clarify the duration of the effect and adverse events.
Authors: Declan Walsh; Mellar Davis; Carla Ripamonti; Eduardo Bruera; Andrew Davies; Alex Molassiotis Journal: Support Care Cancer Date: 2016-08-17 Impact factor: 3.603
Authors: F P Bymaster; D O Calligaro; J F Falcone; R D Marsh; N A Moore; N C Tye; P Seeman; D T Wong Journal: Neuropsychopharmacology Date: 1996-02 Impact factor: 7.853
Authors: Paul J Hesketh; Mark G Kris; Ethan Basch; Kari Bohlke; Sally Y Barbour; Rebecca Anne Clark-Snow; Michael A Danso; Kristopher Dennis; L Lee Dupuis; Stacie B Dusetzina; Cathy Eng; Petra C Feyer; Karin Jordan; Kimberly Noonan; Dee Sparacio; Gary H Lyman Journal: J Clin Oncol Date: 2020-07-13 Impact factor: 44.544