Evidence map›Paper›PMID 29147855›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2018

Phase II study of palonosetron, aprepitant and dexamethasone to prevent nausea and vomiting induced by multiple-day emetogenic chemotherapy.

Takeshi Ioroi, Junya Furukawa, Manabu Kume, Sachi Hirata, Yuko Utsubo, Naomi Mizuta, Hideaki Miyake, Masato Fujisawa, Midori Hirai

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 30% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. 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
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Takeshi IoroiDepartment of Pharmacy, Kobe University Hospital, 7-5-2 Kusunoki-Cho, Kobe City, Hyogo, 650-0017, Japan. ioroit@med.kobe-u.ac.jp.
Junya FurukawaDivision of Urology, Graduate School of Medicine, Kobe University, Kobe, Japan.
Manabu KumeDepartment of Pharmacy, Kobe University Hospital, 7-5-2 Kusunoki-Cho, Kobe City, Hyogo, 650-0017, Japan.
Sachi HirataDepartment of Pharmacy, Kobe University Hospital, 7-5-2 Kusunoki-Cho, Kobe City, Hyogo, 650-0017, Japan.
Yuko UtsuboDepartment of Pharmacy, Kobe University Hospital, 7-5-2 Kusunoki-Cho, Kobe City, Hyogo, 650-0017, Japan.
Naomi MizutaDepartment of Pharmacy, Kobe University Hospital, 7-5-2 Kusunoki-Cho, Kobe City, Hyogo, 650-0017, Japan.
Hideaki MiyakeDepartment of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Masato FujisawaDivision of Urology, Graduate School of Medicine, Kobe University, Kobe, Japan.
Midori HiraiDepartment of Pharmacy, Kobe University Hospital, 7-5-2 Kusunoki-Cho, Kobe City, Hyogo, 650-0017, Japan.
Kobe University Hospital · JPKobe University · JPHamamatsu University School of Medicine · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study aimed to determine the antiemetic efficacy and safety of palonosetron, aprepitant and dexamethasone in patients with testicular germ cell tumours (TGCTs) receiving 5-day cisplatin-based combination chemotherapy.

methodsIn this open-label, single-arm, single-centre study, the antiemetic therapy consisted of palonosetron 0.75 mg on day 1, aprepitant 125 mg on day 1 and 80 mg on days 2-7 and dexamethasone 6.6 mg on days 1-7. The primary endpoint was complete response (CR; no vomiting/retching or rescue medication) in the overall period (0-240 h), and secondary endpoints included complete protection (CP; defined as CR and no more than mild nausea) and total control (TC; defined as CR and no nausea). The incidence and severity of nausea were assessed on the basis of the Common Terminology Criteria for Adverse Events v4.0 and a subjective rating scale completed by patients.

resultsTwenty-five patients were enrolled and evaluated for safety, and 24 patients were evaluated for efficacy. CR was achieved in 62.5% of patients (95% confidence interval [CI] = 40.6-81.2, p = 0.043) in the overall period. CP and TC were achieved in 62.5% (95% CI = 40.6-81.2) and 25.0% of patients (95% CI = 9.8-46.7), respectively, in the overall period. The primary adverse drug reaction was hiccups (48.0%). The events were expected, and none was grade 3 or 4.

conclusionsThe examined combination antiemetic therapy was effective and well-tolerated in patients with TGCTs receiving 5-day cisplatin-based combination chemotherapy.

Indexed as

AdultAntiemeticsAprepitantDexamethasoneDrug Therapy, CombinationFemaleHumansMaleMiddle AgedNauseaPalonosetronVomitingYoung AdultAntiemeticsAprepitantDexamethasonePalonosetronAntiemetic therapyChemotherapy-induced nausea and vomitingMultiple-day chemotherapyOne-arm clinical trial

Identifiers

PMID29147855
OpenAlexW2769501584

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.