Evidence map›Paper›PMID 32252684›Full record

Trial reportBMC cancer2020

Final results from IMPROVE: a randomized, controlled, open-label, two-arm, cross-over phase IV study to determine patients' preference for everolimus in combination with exemestane or capecitabine in combination with bevacizumab in advanced HR-positive, HER2-negative breast cancer.

Thomas Decker, Ulrike Söling, Antje Hahn, Christoph Maintz, Christian Martin Kurbacher, Ursula Vehling-Kaiser, Dagmar Sent, Peter Klare, Volker Hagen, Marco Chiabudini and 4 more

Open access · goldAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
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. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.2field-weighted citation impact, top 49% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
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

14 authors at 5 institutions in 1 country.

Thomas DeckerGemeinschaftspraxis für Hämatologie und Onkologie GbR, Elisabethenstrasse 19, 88212, Ravensburg, Germany.
Ulrike SölingOnkologische Gemeinschaftspraxis, Goethestrasse 47, 34119, Kassel, Germany.
Antje HahnKlinikum Mittelbaden Baden-Baden Bühl, Balger Strasse 50, 76532, Baden-Baden Weststadt, Germany.
Christoph MaintzHämatologisch-Onkologische Praxis, Mauerfeldchen 72, 52146, Würselen, Germany.
Christian Martin KurbacherGynäkologisches Zentrum Bonn, Friedenplatz 16, 53111, Bonn, Germany.
Ursula Vehling-KaiserHämatologisch-onkologische Tagesklinik, Achdorfer Weg 5, 84036, Landshut, Germany.
Dagmar SentKlinikum Leverkusen gGmbH, Am Gesundheitspark 11, 51375, Leverkusen, Germany.
Peter KlareMediOnko-Institut GbR, Möllendorffstr. 52, 10367, Berlin, Germany.
Volker HagenSt.-Johannes-Hospital, Johannesstr. 9-17, 44137, Dortmund, Germany.
Marco ChiabudiniiOMEDICO AG, Ellen-Gottlieb-Straße 19, 79106, Freiburg im Breisgau, Germany.
Julia FalkensteiniOMEDICO AG, Ellen-Gottlieb-Straße 19, 79106, Freiburg im Breisgau, Germany.
Martin IndorfiOMEDICO AG, Ellen-Gottlieb-Straße 19, 79106, Freiburg im Breisgau, Germany.
Eva RunkeliOMEDICO AG, Ellen-Gottlieb-Straße 19, 79106, Freiburg im Breisgau, Germany.
Karin PotthoffiOMEDICO AG, Ellen-Gottlieb-Straße 19, 79106, Freiburg im Breisgau, Germany. manuscript@iomedico.com.
Iomedico (Germany) · DEPraxis für Hämatologie und Onkologie · DEKlinikum Leverkusen · DEKlinikum Mittelbaden · DESt.-Johannes-Hospital Dortmund · DE

Funding

Novartis Pharma NA
6 · The paper itself

Abstract

backgroundThe objective of the IMPROVE study was patients' preference for either endocrine-based therapy or combined chemo- and anti-angiogenic therapy in advanced HR-positive/HER2-negative breast cancer.

methodsIn this randomized, cross-over phase IV study, 77 patients were recruited in 26 sites in Germany. Patients were randomized 1:1 to receive either capecitabine plus bevacizumab (Cap+Bev) as first-line therapy followed by cross-over to everolimus plus exemestane (Eve+Exe) as second-line therapy (Arm A) or the reverse sequence (Arm B). The primary endpoint was patients' preference for either regimen, assessed by the Patient Preference Questionnaire 12 weeks after cross-over. Key secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and quality of life (QoL).

results61.5% of patients preferred Cap+Bev (p = 0.1653), whereas 15.4% preferred Eve+Exe and 23.1% were indecisive. Physicians showed a similar tendency towards Cap+Bev (58.1%) as the preferred regimen versus Eve+Exe (32.3%). Median first-line PFS was longer for Cap+Bev than for Eve+Exe (11.1 months versus 3.5 months). Median second-line PFS was similar between Cap+Bev and Eve+Exe (3.6 months versus 3.7 months). Median OS was comparable between Arm A (28.8 months) and Arm B (24.7 months). 73.0% and 52.6% (first-/second-line, Cap+Bev) and 54.1% and 52.9% (first-/second-line, Eve+Exe) of patients experienced grade 3/4 TEAEs. No treatment-related deaths occurred. QoL and treatment satisfaction were not significantly different between arms or treatment lines.

conclusionsPatients tended to favor Cap+Bev over Eve+Exe, which was in line with physicians' preference. Cap+Bev showed superior first-line PFS, while QoL was similar in both arms. No new safety signals were reported.

trial registrationEudraCT No: 2013-005329-22. Registered on 19 August 20.

Indexed as

Quality of LifeAgedAged, 80 and overAndrostadienesAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsCapecitabineCross-Over StudiesErb-b2 Receptor Tyrosine KinasesEstrogen Receptor alphaEverolimusFemaleHumansMiddle AgedPatient PreferenceAndrostadienesBevacizumabCapecitabineERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesESR1 protein, humanEstrogen Receptor alphaEverolimusexemestaneReceptors, ProgesteroneAdvanced breast CancerCombined chemo- and anti-Angiogenic therapyEndocrine therapyPatient preferenceRandomized, cross-over phase IV study

Identifiers

PMID32252684
PMCPMC7137210
OpenAlexW3014732318

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.