Evidence map›Paper›PMID 31838011›Full record

Trial reportThe Lancet. Oncology2020

Olanzapine 5 mg plus standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting (J-FORCE): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

Hironobu Hashimoto, Masakazu Abe, Osamu Tokuyama, Hideaki Mizutani, Yosuke Uchitomi, Takuhiro Yamaguchi, Yukari Hoshina, Yasuhiko Sakata, Takako Yanai Takahashi, Kazuhisa Nakashima and 8 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The Lancet. Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05244577 (A Phase III Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate Olanzapine Combined With Fosaprepitant, Ondansetron, and Dexamethasone for Preventing Nausea and Vomiting in Patients With Testicular Cancer Receiving 5-day Cisplatin Combination Chemotherapy), which is not on this map. Cited by 121 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
121citing papers in PubMed, 13 pooled it
21.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05244577 phase3unknown statusnot on this mapstarted 2022, after this paper: background citation

A Phase III Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate Olanzapine Combined With Fosaprepitant, Ondansetron, and Dexamethasone for Preventing Nausea and Vomiting in Patients With Testicular Cancer Receiving 5-day Cisplatin Combination Chemotherapy

TypeinterventionalSponsorShi YanxiaRan2022 to 2024Enrolled75ConditionsOlanzapine, CINV, Testicular Cancer by AJCC V6 and V7 Stage, CisplatinArmsOlanzapine Tablets, Placebo
3 · Its place in the literature

Who cites it

121 citing papers in PubMed, 13 syntheses or guidelines pooled it, 220 citations in OpenAlex.

  1. Olanzapine (10 mg vs 5 mg vs 2.5 mg) for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV) - a systematic review and network meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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  3. Clinical benefits of adding olanzapine to 5-HTInternational journal of clinical oncology · 2025
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  11. 2023 updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following high-emetic-risk antineoplastic agents.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
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61 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 6 institutions in 1 country.

Hironobu HashimotoDepartment of Pharmacy, National Cancer Center Hospital, Tokyo, Japan.
Masakazu AbeDepartment of Gynaecologic Oncology, Shizuoka Cancer Center, Nagaizumi, Japan. Electronic address: ma.abe@scchr.jp.
Osamu TokuyamaDepartment of Gynaecology, Osaka City General Hospital, Osaka, Japan.
Hideaki MizutaniDepartment of Respiratory Medicine, Saitama Cancer Center, Ina, Japan.
Yosuke UchitomiInnovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, Tokyo, Japan.
Takuhiro YamaguchiDivision of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan; Saitama Cancer Center, Ina, Japan.
Yukari HoshinaData Management Section, National Cancer Center Hospital, Tokyo, Japan.
Yasuhiko SakataDepartment of Pharmacy, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Takako Yanai TakahashiDepartment of Pharmacy, National Cancer Center Hospital, Tokyo, Japan.
Kazuhisa NakashimaDivision of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi, Japan.
Masahiko NakaoDepartment of Pharmacy, Osaka City General Hospital, Osaka, Japan.
Daisuke TakeiDepartment of Pharmacy, Saitama Cancer Center, Ina, Japan.
Sadamoto ZendaInnovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, Tokyo, Japan.
Koki MizukamiDepartment of Pharmacy, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Satoru IwasaDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Michiru SakuraiDepartment of Pharmacy, Shizuoka Cancer Center, Nagaizumi, Japan.
Noboru YamamotoDepartment of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.
Yuichiro OheDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
National Cancer Center Hospital East · JPSaitama Cancer Center · JPShizuoka Cancer Center · JPTokyo National Hospital · JPHiroshima City Asa Citizens Hospital · JPOsaka City General Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOlanzapine 10 mg added to standard antiemetic therapy including aprepitant, palonosetron, and dexamethasone has been recommended for the prevention of chemotherapy-induced nausea and vomiting. Guidelines suggest that a dose reduction to 5 mg should be considered to prevent sedation. In several phase 2 studies, olanzapine 5 mg has shown equivalent activity to olanzapine 10 mg and a favourable safety profile in relation to somnolence. We evaluated the efficacy of olanzapine 5 mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting caused by cisplatin-based chemotherapy.

methodsThis was a randomised, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy of olanzapine 5 mg with triplet-combination antiemetic therapy done in 26 hospitals in Japan. Key inclusion criteria were patients with a malignant tumour (excluding those with a haemopoietic malignancy) who were scheduled to be treated with cisplatin (≥50 mg/m

findingsBetween Feb 9, 2017, and July 13, 2018, 710 patients were enrolled; 356 were randomly assigned to receive olanzapine and 354 were assigned to receive placebo. All eligible patients were observed 120 h after cisplatin initiation. One patient in the olanzapine group and three in the placebo group did not receive treatment and were excluded from all analyses. One patient in the olanzapine group discontinued treatment on day 1 and was excluded from the efficacy analysis. In the delayed phase, the proportion of patients who achieved a complete response was 280 (79% [95% CI 75-83] of 354 patients in the olanzapine group and 231 (66% [61-71] of 351 patients in the placebo group (p<0·0001). One patient had grade 3 constipation and one patient had grade 3 somnolence related to treatment in the olanzapine group.

interpretationOlanzapine 5 mg combined with aprepitant, palonosetron, and dexamethasone could be a new standard antiemetic therapy for patients undergoing cisplatin-based chemotherapy.

fundingJapan Agency for Medical Research and Development.

Indexed as

AdultAgedAntiemeticsAntineoplastic Combined Chemotherapy ProtocolsAprepitantCisplatinDexamethasoneDouble-Blind MethodFemaleHumansJapanMaleMiddle AgedOlanzapinePalonosetronPostoperative Nausea and VomitingAntiemeticsAprepitantCisplatinDexamethasoneOlanzapinePalonosetron

Identifiers

PMID31838011
OpenAlexW2996099006

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.