Evidence map›Paper›PMID 30968588›Full record

Trial reportCancer medicine2019

Fixed combination of oral NEPA (netupitant-palonosetron) for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in patients receiving multiple cycles of chemotherapy: Efficacy data from 2 randomized, double-blind phase III studies.

Lee Schwartzberg, Meinolf Karthaus, Giorgia Rossi, Giada Rizzi, Maria E Borroni, Hope S Rugo, Karin Jordan, Vincent Hansen

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 11% 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.

NCT01339260 phase3completednot on this map

A Phase III Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of the Efficacy and Safety of Oral Netupitant Administered in Combination With Palonosetron and Dexamethasone Compared to Oral Palonosetron and Dexamethasone for the Prevention of Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy

TypeinterventionalSponsorHelsinn Healthcare SARan2011Enrolled1,455ConditionsChemotherapy-Induced Nausea and VomitingArmsNetupitant and Palonosetron, Palonosetron, Dexamethasone
NCT01376297 phase3completednot on this map

A Phase III, Multicenter, Randomized, Double-blind, Unbalanced (3:1) Active Control Study to Assess the Safety and Describe the Efficacy of Netupitant and Palonosetron for the Prevention of Chemotherapy-induced Nausea and Vomiting in Repeated Chemotherapy Cycles.

TypeinterventionalSponsorHelsinn Healthcare SARan2011Enrolled413ConditionsChemotherapy-Induced Nausea and VomitingArmsNetupitant and Palonosetron, Aprepitant, Palonosetron, Dexamethasone
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. MASCC antiemetics in advanced cancer updated guideline.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 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

8 authors at 6 institutions in 3 countries.

Lee SchwartzbergWest Cancer Center, Memphis, Tennessee.ORCID 0000-0002-7433-3428
Meinolf KarthausStaedt. Klinikum Neuperlach and Harlaching, Munich, Germany.
Giorgia RossiHelsinn Healthcare SA, Lugano, Switzerland.
Giada RizziHelsinn Healthcare SA, Lugano, Switzerland.
Maria E BorroniHelsinn Healthcare SA, Lugano, Switzerland.
Hope S RugoUniversity of California San Francisco Comprehensive Cancer Center, San Francisco, California.
Karin JordanDepartment of Medicine V, Hematology, Oncology and Rheumatology, University of Heidelberg, Germany.
Vincent HansenNorthern Utah Associates, Ogden, Utah.
Helsinn (Switzerland) · CHHeidelberg University · DEMünchen Klinik Harlaching · DEOgden–Weber Applied Technology College · USUniversity of California, San Francisco · USWest Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo assess the efficacy of oral NEPA (netupitant-palonosetron 300/0.50 mg) over multiple chemotherapy cycles.

methodsTwo randomized phase III studies evaluated a single dose of oral NEPA given on day 1 in chemotherapy-naive patients receiving anthracycline-cyclophosphamide (AC)-based (Study 1) or highly (HEC)/moderately (MEC) emetogenic chemotherapy (safety Study 2). Oral NEPA was compared with oral palonosetron 0.50 mg (Study 1) or oral aprepitant 125 mg day 1, 80 mg days 2-3/palonosetron 0.50 mg (Study 2; no formal statistical comparisons). Oral dexamethasone was administered in all treatment groups. Complete response (CR; no emesis/no rescue medication), no emesis, and no significant nausea (NSN) rates during acute (0-24 h) and delayed (>24-120 h) phases of chemotherapy cycles 1-4 in each study were evaluated.

resultsIn Study 1, 1450 patients received 5969 chemotherapy cycles; in Study 2, 412 patients received 1961 chemotherapy cycles. In each study, ≥75% of patients completed 4 or more cycles. In Study 1, oral NEPA was superior to palonosetron in preventing chemotherapy-induced nausea and vomiting (CINV) in the acute and delayed phases of cycle 1, with higher rates of CR (all P < 0.05), no emesis (all P < 0.05), and NSN (delayed phase P < 0.05 cycles 1, 2, and 4) reported across 4 cycles. In Study 2, oral NEPA had numerically higher CR and NSN rates in the acute and delayed phases than aprepitant-palonosetron in MEC/HEC patients.

conclusionOral NEPA was highly effective in preventing both acute and delayed CINV over multiple chemotherapy cycles of HEC, AC, and MEC regimens. CLINICAL TRIAL REGISTRATION NUMBERS: Study 1, NCT01339260; Study 2, NCT01376297.

Indexed as

Administration, OralAnthracyclinesAntiemeticsAprepitantCyclophosphamideDexamethasoneDouble-Blind MethodDrug CombinationsDrug-Related Side Effects and Adverse ReactionsFemaleHumansIsoquinolinesMaleMiddle AgedPalonosetronPyridinesAnthracyclinesAntiemeticsAprepitantCyclophosphamideDexamethasoneDrug CombinationsIsoquinolinesnetupitant, palosentron drug combinationPalonosetronPyridinesQuinuclidinesCINVdelayed phaseefficacymultiple cyclesNEPAnetupitant

Identifiers

PMID30968588
PMCPMC6536946
OpenAlexW2940201427

What OpenQuestion holds

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LicenceCC BY
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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.