Evidence map›Paper›PMID 36356410›Full record

Trial reportESMO open2022

A multicentre, randomised, double-blind, phase II study to evaluate the tolerability of an induction dose escalation of everolimus in patients with metastatic breast cancer (DESIREE).

M Schmidt, K Lübbe, T Decker, M Thill, L Bauer, V Müller, T Link, J Furlanetto, M Reinisch, C Mundhenke and 9 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02387099 (A Multicenter, Randomized, Double-blind, Phase II Study to Evaluate the Tolerability of an Induction Dose Escalation of Everolimus in Patients With Metastatic Breast Cancer), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 10% 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.

NCT02387099 phase2completednot on this map

A Multicenter, Randomized, Double-blind, Phase II Study to Evaluate the Tolerability of an Induction Dose Escalation of Everolimus in Patients With Metastatic Breast Cancer

TypeinterventionalSponsorGBG Forschungs GmbHRan2015 to 2021Enrolled156ConditionsBreast Cancer, Hormone Receptor Positive TumorArms3 weeks Dose Induction of Everolimus, 3 weeks Conventional Everolimus Dosing, Open Label Phase with conventional 10mg Everolimus Dosing week 4-24, Standard Care after 24 weeks
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Circulating Glypican 4 and mortality risk in patients with metastatic breast cancer-results from the DESIREE study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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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 12 institutions in 1 country.

M SchmidtUniversitätsmedizin Mainz, Mainz, Germany.
K LübbeDiakovere Henriettenstift Hannover, Hanover, Germany.
T DeckerOnkologie und Hämatologie Ravensburg, Ravensburg, Germany.
M ThillKlinik für Gynäkologie und Gynäkologische Onkologie, Agaplesion Markus Krankenhaus, Frankfurt, Germany.
L BauerGRN gGmbH Klinik Weinheim, Weinheim, Germany.
V MüllerUniversitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
T LinkDepartment of Gynecology and Obstetrics, Technische Universität Dresden, Dresden, Germany.
J FurlanettoGerman Breast Group, Neu-Isenburg, Germany.
M ReinischInterdisciplinary Breast Unit, Kliniken Essen-Mitte, Essen, Germany.
C MundhenkeBrustzentrum, Gynäkologisches Krebszentrum, Perinatalzentrum Level I, Klinikum Bayreuth, Bayreuth, Germany.
O HoffmannUniversitätsklinikum Essen, Essen, Germany.
M-O ZahnMVZ Onkologische Kooperation Harz Dres./Zahn Fachärzte für Innere Medizin, Goslar, Germany.
L MüllerOnkologie UnterEms, Leer, Germany.
C DenkertInstitut für Pathologie, Philipps-Universität Marburg und Universitätsklinikum Marburg (UKGM), Marburg, Germany.
M van MackelenberghUniversitätsklinikum Schleswig-Holstein, Klinik für Gynäkologie und Geburtshilfe, Schleswig-Holstein, Kiel, Germany.
P A FaschingUniversitätsklinikum Erlangen, Erlangen, Germany.
N BurchardiGerman Breast Group, Neu-Isenburg, Germany.
V NekljudovaGerman Breast Group, Neu-Isenburg, Germany.
S LoiblGerman Breast Group, Neu-Isenburg, Germany. Electronic address: sibylle.loibl@gbg.de.
German Breast group · DEAgaplesion Markus Hospital · DEBayreuth Medical Center · DEEssen University Hospital · DEJohannes Gutenberg University Mainz · DEKliniken Essen-Mitte · DEPhilipps University of Marburg · DEPraxis für Hämatologie und Onkologie · DETU Dresden · DEUniversität Hamburg · DEUniversitätsklinikum Erlangen · DEUniversity Hospital Schleswig-Holstein · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStomatitis is one of the main reasons to discontinue everolimus in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC). To decrease stomatitis and subsequently early treatment discontinuations or dose reductions, the DESIREE trial investigated the use of a stepwise dose-escalation schedule of everolimus (EVE esc). PATIENTS AND

methodsDESIREE is a phase II, multicentre, randomised, double-blind, placebo-controlled trial in patients with HR+/HER2- mBC and progression/relapse after nonsteroidal aromatase inhibitor treatment. Patients were randomised to EVE esc (2.5 mg/day, week 1; 5 mg/day, week 2; 7.5 mg/day, week 3; 10 mg/day, weeks 4-24) or everolimus 10 mg/day (EVE 10mg) for 24 weeks plus exemestane. The primary endpoint was the incidence of stomatitis episodes grade ≥2 within 12 weeks of treatment. The secondary endpoints included toxicity, relative total dose intensity (RTDI) and quality of life (QoL).

resultsA total of 160 patients were randomised and 156 started treatment (EVE esc: 80; EVE 10mg: 76). The median age of patients was 64 years (range 33-85), 56.3% patients in the EVE esc arm versus 42.1% in the EVE 10mg arm had liver metastasis (P = 0.081) and 62.5% versus 51.3% received over one metastatic therapy line (P = 0.196). Within 12 weeks, the incidence of stomatitis episodes grade ≥2 was significantly lower in the EVE esc arm compared with the EVE 10mg arm (28.8% versus 46.1%; odds ratio 0.47, 95% confidence interval 0.24-0.92; P = 0.026). Toxicity was in line with the known safety profile without new safety concerns. The median RTDI was 91.1% in the EVE esc arm versus 80.0% in the EVE 10mg arm (P = 0.329). Discontinuation rate in the first 3 weeks was 6.3% versus 15.8%, respectively (P = 0.073). QoL was comparable between the two treatment arms.

conclusionsA dose-escalation schema of everolimus over 3 weeks can be successfully used to reduce the incidence of high-grade stomatitis in the first 12 weeks of treatment in patients with HR+/HER2- mBC.

trial registrationClinicalTrials.govNCT02387099; https://clinicaltrials.gov/ct2/show/NCT02387099.

Indexed as

Breast NeoplasmsStomatitisAdultAgedAged, 80 and overErb-b2 Receptor Tyrosine KinasesEverolimusFemaleHumansMiddle AgedNeoplasm Recurrence, LocalQuality of LifeSirolimusErb-b2 Receptor Tyrosine KinasesEverolimusSirolimuseverolimusexemestanemetastatic breast cancerstomatitis

Identifiers

PMID36356410
PMCPMC9832733
OpenAlexW4308429209

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.