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Patient-perceived symptomatic benefits of olanzapine treatment for nausea and vomiting in patients with advanced cancer who received palliative care through consultation teams: a multicenter prospective observational study

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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.

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Data availability

Data are available from the corresponding author upon reasonable request.

Code availability

Code is available from the corresponding author upon reasonable request

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Acknowledgements

The authors thank the following investigators for their contributions as collaborators: Hiroyuki Otani (National Hospital Organization Kyushu Cancer Center), Takuya Odagiri (Komaki City Hospital)

Hiroaki Watanabe (Komaki City Hospital), Masanori Mori (Seirei Hamamatsu General Hospital), Yosuke Matsuda (St. Luke's International Hospital), Hiroka Nagaoka (Tsukuba University), Meiko Mayuzumi (Teikyo University), Yoshiaki Kanai (The University of Tokyo), Nobuhiro Sakamoto (Nagoya City University), and Keisuke Ariyoshi (JORTC Data Center).

Funding

This work was supported by Grant-in-Aid for Scientific Research from the Practical Research for Innovative Cancer Control from the Japan Agency for Medical Research and Development (Grant Numbers 15ck0106059h0002) and Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology (Grant Numbers JP16H06239).

Author information

Authors and Affiliations

  1. Department of Palliative Care, Senri-Chuo Hospital, Toyonaka, Osaka, Japan

    Isseki Maeda

  2. Department of Palliative Medicine, National Cancer Center Hospital, Tokyo, Japan

    Eriko Satomi & Daisuke Kiuchi

  3. Department of Palliative Medicine, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan

    Kaoru Nishijima

  4. Department of Psychosomatic Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Osaka, Japan

    Yoshinobu Matsuda & Akihiro Tokoro

  5. Department of Palliative Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan

    Keita Tagami

  6. Department of Palliative Medicine, National Cancer Center Hospital East, Kashiwa, Chiba, Japan

    Yoshihisa Matsumoto

  7. Department of Palliative Care, Miyazaki Medical Association Hospital, Miyazaki, Japan

    Akemi Naito

  8. Palliative and Supportive Care Division, Seirei Mikatahara General Hospital, Hamamatsu, Shizuoka, Japan

    Tatsuya Morita

  9. Department of Palliative Medicine, Saitama Medical University, Irima, Saitama, Japan

    Satoru Iwase

Authors
  1. Isseki Maeda
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Consortia

On behalf of the Phase-R N/V Study Group

Contributions

Isseki Maeda: conceptualization, formal analysis, and writing—original draft. Eriko Satomi: conceptualization and writing—original draft. Daisuke Kiuchi: resources and writing—review and editing. Kaoru Nishijima: resources and writing—review and editing. Yoshinobu Matsuda: resources and writing—review and editing. Akihiro Tokoro: resources and writing—review and editing. Keita Tagami: resources and writing—review and editing. Yoshihisa Matsumoto: resources and writing—review and editing. Akemi Naito: resources and writing—review and editing. Tatsuya Morita: conceptualization and writing—review and editing, supervision. Satoru Iwase: conceptualization, supervision, and funding acquisition.

Corresponding author

Correspondence to Isseki Maeda.

Ethics declarations

Ethics approval and consent to participate

This study was conducted in accordance with the Declaration of Helsinki and the requirements set forth by the Japanese Ethical Guidelines for Epidemiology Research. Study protocol was reviewed and approved by institutional review boards of all participating sites. Opt-out methods were employed and written informed consent was waived according to the Japanese Ethical Guidelines for Epidemiology Research and the guidance of institutional review boards.

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Not applicable.

Competing interests

The authors declare no competing interests.

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Supplementary information

Subjective symptomatic benefit and nausea NRS reduction. Bar plots represent mean changes in nausea NRS and 95% confidence intervals (error bars) at Day 2. p-for-trend < 0.001

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Maeda, I., Satomi, E., Kiuchi, D. et al. Patient-perceived symptomatic benefits of olanzapine treatment for nausea and vomiting in patients with advanced cancer who received palliative care through consultation teams: a multicenter prospective observational study. Support Care Cancer 29, 5831–5838 (2021). https://doi.org/10.1007/s00520-021-06067-2

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