Evidence map›Paper›PMID 32188417›Full record

Trial reportBMC cancer2020

Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study.

Roberta Caputo, Marina Elena Cazzaniga, Andrea Sbrana, Rosalba Torrisi, Ida Paris, Monica Giordano, Vincenzo Montesarchio, Valentina Guarneri, Laura Amaducci, Domenico Bilancia and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03862144 (One Day Antiemetic Prophylaxis of NEPA), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 19% 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.

NCT03862144 phase2completednot on this map

One Day Antiemetic Prophylaxis of NEPA (Netupitant Plus Palonosetron) and Dexamethasone to Prevent Chemotherapy-induced Nausea and Vomiting (CINV) in Breast Cancer Patients Receiving an AC-based Chemotherapy Regimen

TypeinterventionalSponsorConsorzio OncotechRan2016 to 2017Enrolled150ConditionsChemotherapy-induced Nausea and VomitingArmsNetupitant/Palonosetron
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Review
  6. Review
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

18 authors at 13 institutions in 1 country.

Roberta CaputoBreast Medical Oncology Division, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Naples, Italy.
Marina Elena CazzanigaMedical Oncology Unit & Phase 1 Research Unit, ASST Monza, Monza, Italy.
Andrea SbranaMedical Oncology Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Rosalba TorrisiDepartment of Medical Oncology and Hematology, Humanitas Clinical and Research Center, Rozzano, Milan, Italy.
Ida ParisDivision of Gynecologic Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Monica GiordanoMedical Oncology Division, ASST-Lariana, Como, Italy.
Vincenzo MontesarchioOncology Unit, "Monaldi" Hospital, Naples, Italy.
Valentina GuarneriDepartment of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.
Laura AmaducciOncology Department Area Vasta Romagna, Faenza Hospital, Faenza, Ravenna, Italy.
Domenico BilanciaMedical Oncology Unit, S. Carlo Hospital, Potenza, Italy.
Giuseppina CilentiMedical Oncology Division, Fondazione IRCCS Casa Sollievo Della Sofferenza, San Giovanni Rotondo, Foggia, Italy.
Alessandra FabiIRCCS Regina Elena National Cancer Institute, Rome, Italy.
Elena CollovàOncology Unit, ASST Ovest Milanese, Legnano Hospital, Legnano, Milan, Italy.
Alessio SchironeClinical Oncology Division, Azienda Ospedaliero-Universitaria, Cona, Ferrara, Italy.
Erminio BonizzoniDepartment of Clinical Science and Community. Section of Medical Statistics, Biometry and Epidemiology "G.A. Maccacaro". Faculty of Medicine and Surgery, University of Milan, Milan, Italy.
Luigi CelioMedical Oncology Unit 1, Fondazione IRCCS "Istituto Nazionale dei Tumori", Milan, Italy.
Sabino De PlacidoClinical Medicine and Surgery Department, University of Naples Federico II, Naples, Italy.
Michelino De LaurentiisBreast Medical Oncology Division, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Naples, Italy. m.delaurentiis@istitutotumori.na.it.
Istituti di Ricovero e Cura a Carattere Scientifico · ITIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITAgostino Gemelli University Polyclinic · ITAzienda Socio Sanitaria Territoriale Lariana · ITAziende Socio Sanitarie Territoriale Ovest MilaneseFondazione IRCCS Istituto Nazionale dei Tumori · ITHumanitas University · ITIstituto Oncologico Veneto · ITOspedale Monaldi · ITOspedale per gli Infermi · ITUniversity of Milan · ITUniversity of Naples Federico II · ITUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNEPA is an oral fixed-dose combination of netupitant, a new highly selective neurokinin-1 receptor antagonist, and palonosetron. This study was conducted to evaluate whether the efficacy of NEPA against chemotherapy-induced nausea and vomiting (CINV) in cycle 1 would be maintained over subsequent chemotherapy cycles in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide (AC). The study also describes the relationship between efficacy on day 1 through 5 (overall period) and control of CINV on day 6 through 21 (very late period) in each cycle.

methodsIn this multicentre, phase II study, patients received both NEPA and dexamethasone (12 mg intravenously) just before chemotherapy. The primary efficacy endpoint was overall complete response (CR; no emesis and no rescue medication use) in cycle 1. Sustained efficacy was evaluated during the subsequent cycles by calculating the rate of CR in cycles 2-4 and by assessing the probability of sustained CR over multiple cycles. The impact of both overall CR and risk factors for CINV on the control of very late events (vomiting and moderate-to-severe nausea) were also examined.

resultsOf the 149 patients enrolled in the study, 139 were evaluable for a total of 552 cycles; 97.8% completed all 4 cycles. The proportion of patients with an overall CR was 70.5% (90% CI, 64.1 to 76.9) in cycle 1, and this was maintained in subsequent cycles. The cumulative percentage of patients with a sustained CR over 4 cycles was 53%. NEPA was well tolerated across cycles. In each cycle, patients with CR experienced a significantly better control of very late CINV events than those who experienced no CR. Among the patients with CR, the only predictor for increased likelihood of developing very late CINV was pre-chemotherapy (anticipatory) nausea (adjusted odds ratio = 0.65-0.50 for no CINV events on cycles 3 and 4).

conclusionThe high anti-emetic efficacy seen with the NEPA regimen in the first cycle was maintained over multiple cycles of adjuvant AC for breast cancer. Preliminary evidence also suggests that patients achieving a CR during the overall period gain high protection even against very late CINV events in each chemotherapy cycle.

trial registrationThis trial was retrospectively registered at Clinicaltrials.gov identifier (NCT03862144) on 05/Mar/2019.

Indexed as

AdultAgedAnthracyclinesAntiemeticsAntineoplastic Agents, AlkylatingBenzeneacetamidesBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDexamethasoneDrug CombinationsFemaleHumansMiddle AgedNeurokinin-1 Receptor AntagonistsPalonosetronAnthracyclinesAntiemeticsAntineoplastic Agents, AlkylatingBenzeneacetamidesCyclophosphamideDexamethasoneDrug CombinationsnetupitantNeurokinin-1 Receptor AntagonistsPalonosetronPiperazinesPyridinesACBreast cancerCINVNauseaNEPAVomiting

Identifiers

PMID32188417
PMCPMC7081578
OpenAlexW3011672441

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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.