Evidence map›Paper›PMID 30069696›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2019

The feasibility of dexamethasone omission in weekly paclitaxel treatment for breast cancer patients.

Ana Luísa de Castro Baccarin, Macilon Nonato Irene, Daniel de Iracema Gomes Cubero, Ariana Sales Luz, Suelen Nastri Castro, Renan Sordi, Luis Eduardo Silva Móz, Auro Del Giglio

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04669132 (Efficacy of Olanzapine, Netupitant and Palonosetron in Controlling Nausea and Vomiting Associated With Highly Emetogenic Chemotherapy in Patients With Breast Cancer), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT04669132 phase2completednot on this mapstarted 2020, after this paper: background citation

Efficacy of Olanzapine, Netupitant and Palonosetron in Controlling Nausea and Vomiting Associated With Highly Emetogenic Chemotherapy in Patients With Breast Cancer

TypeinterventionalSponsorInstituto Brasileiro de Controle do CancerRan2020 to 2022Enrolled50ConditionsNausea Post ChemotherapyArmsOlanzapine, Netupitant, Palonesetron
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pre-medication protocols for the prevention of paclitaxel-induced infusion related reactions: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Pooled it
  2. Trial
  3. Review
  4. Article
  5. Premedications for Cancer Therapies: A Primer for the Hematology/Oncology Provider.Journal of the advanced practitioner in oncology · 2021
    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

8 authors.

Ana Luísa de Castro BaccarinInstituto Brasileiro de Controle do Câncer, São Paulo, Brazil. larciprete@gmail.com.
Macilon Nonato IreneInstituto Brasileiro de Controle do Câncer, São Paulo, Brazil.
Daniel de Iracema Gomes CuberoFaculdade de Medicina do ABC, Santo André, Brazil.
Ariana Sales LuzInstituto Brasileiro de Controle do Câncer, São Paulo, Brazil.
Suelen Nastri CastroInstituto Brasileiro de Controle do Câncer, São Paulo, Brazil.
Renan SordiInstituto Brasileiro de Controle do Câncer, São Paulo, Brazil.
Luis Eduardo Silva MózInstituto Brasileiro de Controle do Câncer, São Paulo, Brazil.
Auro Del GiglioFaculdade de Medicina do ABC (Chief), São Paulo, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesPatients with breast cancer who receive weekly paclitaxel therapy may experience deleterious effects associated with prophylactic dexamethasone use for 12 consecutive weeks. Approximately 90% of paclitaxel hypersensitivity reactions (HSRs) occur within the first 10 to 15 min of the first two infusions. We investigated the feasibility of dexamethasone withdrawal between weeks 3 and 12 (W3 and W12) in early stage breast cancer patients treated with weekly paclitaxel at the standard dose (80 mg/m

methodsAll patients received intravenous prophylaxis of dexamethasone 20 mg, ranitidine 50 mg, and diphenhydramine 50 mg in the first 2 weeks (W1 and W2) of treatment. Provided that no serious (G3/G4) HSRs events occurred, dexamethasone was omitted between W3 and W12, while ranitidine and diphenhydramine were continued. The primary end point was the incidence of any grade HSRs during the treatment period, and the secondary end points were quality of life and weight changes.

resultsTwenty-five patients were included in the study, and 300 infusion cycles of paclitaxel were evaluated for HSRs. The overall incidence of HSRs was 0.6% (2 events), and both of these events occurred in the first week. There were no incidents of serious HSRs or anaphylaxis and no G3 or G4 toxicities. Scores from the EORTC QLQ-C30 questionnaire did not change significantly for the global health status/quality of life scale or for the symptoms scales, although changes in scores differed significantly for the functional scales. There were no clinically relevant weight changes during the treatment period.

conclusionsDexamethasone withdrawal from W3 to W12 in early stage breast cancer patients treated with weekly paclitaxel is feasible. The incidence of all grades of HSRs was comparable to that reported in trials with dexamethasone for 12 consecutive weeks, and no serious events (G3/G4) occurred. Studies with larger sample sizes are needed to confirm our results which are important, especially for patients for whom corticosteroids are contraindicated.

Indexed as

AdultAgedAntineoplastic Agents, HormonalAntineoplastic Agents, PhytogenicBreast NeoplasmsDexamethasoneDiphenhydramineDrug Administration ScheduleDrug HypersensitivityDrug SubstitutionFeasibility StudiesFemaleHumansIncidenceInfusions, IntravenousMiddle AgedAntineoplastic Agents, HormonalAntineoplastic Agents, PhytogenicDexamethasoneDiphenhydraminePaclitaxelDexamethasoneHypersensitivity reactionsPaclitaxelProphylaxis

Identifiers

PMID30069696

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.