Evidence map›Paper›PMID 32168551›Full record

Trial reportCancer medicine2020

A double-blind, randomized, multicenter phase 3 study of palonosetron vs granisetron combined with dexamethasone and fosaprepitant to prevent chemotherapy-induced nausea and vomiting in patients with breast cancer receiving anthracycline and cyclophosphamide.

Koji Matsumoto, Masato Takahashi, Kazuhiko Sato, Akihiko Osaki, Toshimi Takano, Yoichi Naito, Kazuo Matsuura, Kenjiro Aogi, Kimiko Fujiwara, Kenji Tamura and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05841849 (Efficacy and Safety of Intravenous Versus Oral 5-HT3 Antagonists Combined With NK-1 Receptor Antagonists for the Prevention of Breast Cancer Chemotherapy-induced Nausea and Vomiting), which is not on this map. Cited by 15 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 5 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT05841849 phase4not yet recruitingnot on this mapstarted 2023, after this paper: background citation

Efficacy and Safety of Intravenous Versus Oral 5-HT3 Antagonists Combined With NK-1 Receptor Antagonists for the Prevention of Breast Cancer Chemotherapy-induced Nausea and Vomiting: a Single-center, Randomized Controlled Clinical Trial

TypeinterventionalSponsorSecond Affiliated Hospital, Zhejiang University, School of MedicineRan2023 to 2029Enrolled1,028ConditionsBreast Cancer, Chemotherapy-induced Nausea and VomitingArmsAprepitant, Palonosetron, Fosaprepitant
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 5 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. 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
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. 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
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  11. Observational
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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

19 authors at 16 institutions in 1 country.

Koji MatsumotoHyogo Cancer Center, Hyogo, Japan.ORCID 0000-0003-1907-0247
Masato TakahashiNHO Hokkaido Cancer Center, Hokkaido, Japan.
Kazuhiko SatoTokyo-West Tokushukai Hospital, Tokyo, Japan.
Akihiko OsakiSaitama Medical University, Saitama, Japan.
Toshimi TakanoToranomon Hospital, Tokyo, Japan.
Yoichi NaitoNational Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0002-8490-9064
Kazuo MatsuuraHiroshima Prefectural Hospital, Hiroshima, Japan.
Kenjiro AogiShikoku Cancer Center, Ehime, Japan.
Kimiko FujiwaraKindai University Hospital, Osaka, Japan.
Kenji TamuraNational Cancer Center Hospital, Tokyo, Japan.
Motoi BabaHokkaido University, Hokkaido, Japan.
Shinya TokunagaOsaka City General Hospital, Osaka, Japan.
Gen HiranoKyushu Hospital, Fukuoka, Japan.
Shigeru ImotoKyorin University, Tokyo, Japan.
Chieko MiyazakiJichi Medical University, Tochigi, Japan.
Kazuhiro YanagiharaKansai Electric Power Hospital, Osaka, Japan.
Chiyo K ImamuraAdvanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.
Yasutaka ChibaKindai University Hospital, Osaka, Japan.
Toshiaki SaekiSaitama Medical University, Saitama, Japan.ORCID 0000-0003-4700-4781
Kindai University Hospital · JPSaitama Medical University · JPFukuoka Tokushukai Hospital · JPHiroshima Prefectural Hospital · JPHokkaido University · JPHyogo Prefectural Cancer Center · JPJichi Medical University · JPKansai Electric Power Hospital · JPKyorin University · JPKyushu Hospital · JPNational Cancer Center Hospital East · JPOsaka City General Hospital · JPShikoku Cancer Center · JPShowa University · JPTokyo National Hospital · JPToranomon Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo investigate whether palonosetron is better than granisetron in preventing chemotherapy-induced nausea and vomiting (CINV) in a three-drug combination with dexamethasone and fosaprepitant (Fos) in patients with breast cancer who are placed on anthracycline and cyclophosphamide (AC-based regimen). PATIENTS AND

methodsChemo-naive women with primary breast cancer were randomly administered either palonosetron 0.75 mg (day 1) or granisetron 1 mg (day 1) combined with dexamethasone (12 mg at day 1, 8 mg at day 2 and day 3) and Fos 150 mg (day 1) before receiving AC-based regimen in a double-blind study. The primary endpoint was the complete response (CR) rate of emesis in cycle 1 in the delayed phase. This was defined as neither vomiting nor rescue drug usage for emesis at >24-120 hours after chemotherapy. Secondary endpoints were the CR in the acute/overall phase (0-24/0-120 hours, respectively, after chemotherapy), no nausea and vomiting, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and safety.

resultsFrom December 2012 to October 2014, 326 patients were treated and evaluated (164/162 evaluable patients in granisetron/palonosetron arm, respectively). The CR during the delayed phase was 60.4% in the granisetron regimen and 62.3% in the palonosetron regimen. The CR during acute phase (73.2% vs 75.9%, respectively) and the CR during overall phase (54.9% in both regimens) were very identical. A significantly higher number of patients in the palonosetron arm were free from nausea during the delayed phase (28% vs 40.1%; P = .029). Adverse events were also identical, although infusion site reactions (ISR) were higher (20.3%-23.3%) than preceding studies in both regimens.

conclusionIn combination with dexamethasone and Fos, this study suggests that palonosetron is not better than granisetron in chemo-naive patients with primary breast cancer receiving AC-based regimen. Administration of Fos in peripheral veins after AC-based regimen increased ISR.

Indexed as

AdultAgedAged, 80 and overAntiemeticsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclophosphamideDexamethasoneDouble-Blind MethodDoxorubicinDrug Therapy, CombinationEpirubicinFemaleFluorouracilGranisetronHumansAntiemeticsCyclophosphamideDexamethasoneDoxorubicinEpirubicinFluorouracilfosaprepitantGranisetronMorpholinesPalonosetronAC regimenCINVfosaprepitantgranisetronpalonosetron

Identifiers

PMID32168551
PMCPMC7221309
OpenAlexW3012318320

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.