Evidence map›Paper›PMID 20574663›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2011

Palonosetron in combination with 1-day versus 3-day dexamethasone for prevention of nausea and vomiting following moderately emetogenic chemotherapy: a randomized, multicenter, phase III trial.

Luigi Celio, Sergio Frustaci, Angela Denaro, Angela Buonadonna, Antonio Ardizzoia, Elena Piazza, Alessandra Fabi, Alba Maria Capobianco, Luciano Isa, Luigi Cavanna and 4 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 12 pooled it
8.6field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 12 syntheses or guidelines pooled it, 100 citations in OpenAlex.

  1. Pooled it
  2. 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
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  4. Palonosetron for prevention of delayed chemotherapy-induced nausea and vomiting in pediatric patients: a meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Pooled it
  5. Pooled it
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  9. 2016 Updated MASCC/ESMO Consensus Recommendations: Prevention of Nausea and Vomiting Following High Emetic Risk Chemotherapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017
    Pooled it
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  12. Antiemetics: American Society of Clinical Oncology clinical practice guideline update.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2011
    Guideline
  13. Low dose of dexamethasone combined with netupitant and palonosetron in preventing nausea and vomiting in breast cancer patients induced by anthracycline drugs.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Trial
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  15. 5HTCancer science · 2021
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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

14 authors at 7 institutions in 1 country.

Luigi CelioMedical Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy. luigi.celio@istitutotumori.mi.it
Sergio Frustaci
Angela Denaro
Angela Buonadonna
Antonio Ardizzoia
Elena Piazza
Alessandra Fabi
Alba Maria Capobianco
Luciano Isa
Luigi Cavanna
Alessandro Bertolini
Ettore Bichisao
Emilio Bajetta
Italian Trials in Medical Oncology Group
Fondazione IRCCS Istituto Nazionale dei Tumori · ITCentro di Riferimento Oncologico · ITAzienda Ospedaliera di Valtellina e Valchiavenna · ITAzienda Ospedaliera San Gerardo · ITCentro di Riferimento Oncologico della Basilicata · ITGuglielmo da Saliceto Hospital · ITLuigi Sacco Hospital · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeA phase III trial assessed the efficacy of palonosetron plus dexamethasone given once in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) following a broad range of moderately emetogenic chemotherapy (MEC) regimens.

methodsThis multicentre, randomized, open-label, non-inferiority trial evaluated two different treatment groups. One group received palonosetron (0.25 mg intravenously) and dexamethasone (8 mg intravenously) before chemotherapy, while the other was administered the same regimen on day 1 followed by dexamethasone 8 mg orally on days 2 and 3. The primary endpoint was complete response (CR; defined as no emetic episodes and no rescue medication) during the overall phase (days 1-5 after chemotherapy initiation). The non-inferiority margin was predefined as a 15% difference between groups in the primary endpoint.

resultsOf 332 chemotherapy-naïve patients included in the intention-to-treat analysis, 65.1% were female, and 35.2% received anthracycline plus cyclophosphamide (AC)-based regimens. Overall CR rates were 67.5% for those administered dexamethasone only on day 1 (n = 166), and 71.1% for those also administered dexamethasone on days 2 and 3 (n = 166; difference -3.6% (95% confidence interval, -13.5 to 6.3)). CR rates were not significantly different between groups during the acute (0-24 h post-chemotherapy; 88.6% versus 84.3%; P = 0.262) and delayed phases (days 2-5; 68.7% versus 77.7%; P = 0.116).

conclusionsPalonosetron plus single-dose dexamethasone administered before common MEC regimens provide protection against acute and delayed CINV which is non-inferior to that of palonosetron plus dexamethasone for 3 days. However, the major benefit of the single-day regimen occurs in patients receiving non-AC MEC regimens.

Indexed as

AgedAnthracyclinesAntineoplastic Agents, HormonalChi-Square DistributionConfidence IntervalsDexamethasoneDrug-Related Side Effects and Adverse ReactionsDrug Therapy, CombinationFemaleHealth Status IndicatorsHumansIsoquinolinesMaleMiddle AgedMultivariate AnalysisNauseaAnthracyclinesAntineoplastic Agents, HormonalDexamethasoneIsoquinolinesPalonosetronQuinuclidinesSerotonin Antagonists

Identifiers

PMID20574663
PMCPMC3128271
OpenAlexW2020695269

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.