Evidence map›Paper›PMID 37973958›Full record

Trial reportBritish journal of cancer2024

Dexamethasone-sparing on days 2-4 with combined palonosetron, neurokinin-1 receptor antagonist, and olanzapine in cisplatin: a randomized phase III trial (SPARED Trial).

Hiroko Minatogawa, Naoki Izawa, Kazuhiro Shimomura, Hitoshi Arioka, Hirotoshi Iihara, Mitsuhiro Sugawara, Hajime Morita, Ayako Mochizuki, Shuichi Nawata, Keisuke Mishima and 20 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in British journal of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07699276 (Steroid-sparing Regimen With Olanzapine and Ondansetron to Prevent Emesis Caused by High Dose Cisplatin in Solid Cancer Patient), which is not on this map. Cited by 11 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 4 pooled it
4.1field-weighted citation impact, top 5% 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.

NCT07699276 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Steroid-sparing Regimen With Olanzapine and Ondansetron to Prevent Emesis Caused by High Dose Cisplatin in Solid Cancer Patient : A Single Arm Phase II Study

TypeinterventionalSponsorMahidol UniversityRan2026 to 2027Enrolled95ConditionsCancer (Solid Tumors), Vomiting, Cisplatin, OlanzapineArmsdexamethasone sparing
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 4 syntheses or guidelines pooled it, 13 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
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Multi-day vs single-day dexamethasone for the prophylaxis of chemotherapy-induced nausea and vomiting: systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Pooled it
  5. Trial
  6. Global inequitable distribution of seminal studies of chemotherapy-induced nausea and vomiting.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Review
  7. Article
  8. Observational
  9. Reply to L. Celio et al.British journal of cancer · 2024
    Article
  10. Article
  11. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

30 authors at 14 institutions in 1 country.

Hiroko Minatogawa *Department of Pharmacy, St. Marianna University Hospital, Kawasaki, Japan.ORCID 0000-0002-5836-8305
Naoki Izawa *Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.
Kazuhiro ShimomuraDepartment of Pharmacy, Aichi Cancer Center Hospital, Nagoya, Japan.
Hitoshi AriokaDepartment of Medical Oncology, Yokohama Rosai Hospital, Yokohama, Japan.
Hirotoshi IiharaDepartment of Pharmacy, Gifu University Hospital, Gifu, Japan.
Mitsuhiro SugawaraResearch and Education Center for Clinical Pharmacy, Kitasato University School of Pharmacy, Sagamihara, Japan.
Hajime MoritaDepartment of Pharmacy, St. Marianna University School of Medicine, Yokohama City Seibu Hospital, Yokohama, Japan.
Ayako MochizukiDepartment of gynecology, Shizuoka Cancer Center, Shizuoka, Japan.
Shuichi NawataDepartment of Pharmacy, Showa University Northern Yokohama Hospital, Yokohama, Japan.
Keisuke MishimaDepartment of Digestive surgery, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.
Ayako TsuboyaDepartment of Pharmacy, Kawasaki municipal Tama Hospital, Kawasaki, Japan.
Tempei MiyajiDepartment of Clinical Trial Data Management Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Kazunori HondaDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Ayako YokomizoDepartment of Pharmacy, St. Marianna University Hospital, Kawasaki, Japan.
Naoya HashimotoDepartment of Pharmacy, Aichi Cancer Center Hospital, Nagoya, Japan.
Takeshi YanagiharaDepartment of Medical Oncology, Yokohama Rosai Hospital, Yokohama, Japan.
Junki EndoDepartment of Cardiology and Respiratory Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.
Takashi KawaguchiDepartment of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences, Hachioji, Japan.
Naoki FuruyaDivision of Respiratory Medicine, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.
Yumiko SoneDepartment of Clinical Pharmacy, Aichi Cancer Center Hospital, Nagoya, Japan.
Yusuke InadaDepartment of Pharmacy, Yokohama Rosai Hospital, Yokohama, Japan.
Yasushi OhnoDepartment of Cardiology and Respiratory Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.
Chikatoshi KatadaDepartment of Therapeutic Oncology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Naoya HidaDepartment of Respiratory Internal Medicine, St. Marianna University Yokohama City Seibu Hospital, Yokohama, Japan.
Kana AkiyamaDepartment of pharmacy, Shizuoka Cancer Center, Nagaizumi, Japan.
Daisuke IchikuraDepartment of Pharmacy, Showa University Northern Yokohama Hospital, Yokohama, Japan.
Akiko KonomatsuDepartment of Pharmacy, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.
Takashi OguraDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.
Takuhiro YamaguchiDivision of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.
Takako Eguchi NakajimaDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan. tnakajima@kuhp.kyoto-u.ac.jp.ORCID 0000-0002-4589-2335
St. Marianna University School of Medicine · JPAichi Cancer Center · JPYokohama Rosai Hospital · JPGifu University · JPNippon Medical School · JPShizuoka Cancer Center · JPShowa University Northern Yokohama Hospital · JPGifu University Hospital · JPKitasato University · JPKyoto University · JPThe University of Tokyo · JPTohoku University · JPTokyo University of Pharmacy and Life Sciences · JPYokohama City Seibu Hospital · JP

Funding

Japan Agency for Medical Research and Development (AMED) grant number 21ck0106501h0003
6 · The paper itself

Abstract

backgroundThis study evaluated the non-inferiority of dexamethasone (DEX) on day 1, with sparing on days 2-4 in cisplatin-based chemotherapy.

methodsPatients with malignant solid tumors who were treated with cisplatin (≥50 mg/m²) were randomly assigned (1:1) to receive either DEX on days 1-4 (Arm D4) or DEX on day 1 (Arm D1) plus palonosetron, NK-1 RA, and olanzapine (5 mg). The primary endpoint was complete response (CR) during the delayed (24-120 h) phase. The non-inferiority margin was set at -15%.

resultsA total of 281 patients were enrolled, 278 of whom were randomly assigned to Arm D4 (n = 139) or Arm D1 (n = 139). In 274 patients were included in the efficacy analysis, the rates of delayed CR in Arms D4 and D1 were 79.7% and 75.0%, respectively (risk difference -4.1%; 95% CI -14.1%-6.0%, P = 0.023). However, patients in Arm D1 had significantly lower total control rates during the delayed and overall phases, and more frequent nausea and appetite loss. There were no significant between-arm differences in the quality of life.

conclusionDEX-sparing is an alternative option for patients receiving cisplatin; however, this revised administration schedule should be applied on an individual basis after a comprehensive evaluation. CLINICAL TRIALS REGISTRY NUMBER: UMIN000032269.

Indexed as

AntiemeticsAntineoplastic AgentsCisplatinDexamethasoneHumansNeurokinin-1 Receptor AntagonistsOlanzapinePalonosetronQuality of LifeQuinuclidinesVomitingAntiemeticsAntineoplastic AgentsCisplatinDexamethasoneNeurokinin-1 Receptor AntagonistsOlanzapinePalonosetronQuinuclidines

Identifiers

PMID37973958
PMCPMC10803798
OpenAlexW4388728054

What OpenQuestion holds

Textmetadata
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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.