Evidence map›Paper›PMID 31390375›Full record

Trial reportPloS one2019

Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study.

Serena Di Cosimo, Nicla La Verde, Anna Moretti, Marina Elena Cazzaniga, Daniele Generali, Giulia Valeria Bianchi, Luigi Mariani, Valter Torri, Flavio Crippa, Biagio Paolini and 9 more

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 25% 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

5 citing papers in PubMed, 11 citations in OpenAlex.

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

19 authors at 6 institutions in 1 country.

Serena Di CosimoFondazione IRCCS Istituto Nazionale dei Tumori-Milano, Italy.
Nicla La VerdeASST Fatebenefratelli-Sacco, PO Sacco, Milano, Italy.
Anna MorettiASST Fatebenefratelli-Sacco, PO Fatebenefratelli, Milano, Italy.
Marina Elena CazzanigaASST Monza, Centro di ricerca di Fase 1, Monza, Italy.
Daniele GeneraliASST di Cremona, Cremona, Italy.
Giulia Valeria BianchiFondazione IRCCS Istituto Nazionale dei Tumori-Milano, Italy.
Luigi MarianiFondazione IRCCS Istituto Nazionale dei Tumori-Milano, Italy.
Valter TorriIRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Milano, Italy.
Flavio CrippaFondazione IRCCS Istituto Nazionale dei Tumori-Milano, Italy.
Biagio PaoliniFondazione IRCCS Istituto Nazionale dei Tumori-Milano, Italy.
Gianfranco ScaperrottaFondazione IRCCS Istituto Nazionale dei Tumori-Milano, Italy.
Maria Carmen De SantisFondazione IRCCS Istituto Nazionale dei Tumori-Milano, Italy.
Massimo Di NicolaFondazione IRCCS Istituto Nazionale dei Tumori-Milano, Italy.
Giovanni ApoloneFondazione IRCCS Istituto Nazionale dei Tumori-Milano, Italy.
Alessandro GulinoUniversity of Palermo, School of Medicine, Palermo, Italy.
Claudio TripodoUniversity of Palermo, School of Medicine, Palermo, Italy.
Mario Paolo ColomboFondazione IRCCS Istituto Nazionale dei Tumori-Milano, Italy.
Secondo FolliFondazione IRCCS Istituto Nazionale dei Tumori-Milano, Italy.
Filippo de BraudFondazione IRCCS Istituto Nazionale dei Tumori-Milano, Italy.
Fondazione IRCCS Istituto Nazionale dei Tumori · ITASST Fatebenefratelli Sacco · ITUniversity of Palermo · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITIstituti Ospitalieri di Cremona · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEribulin mesylate (E) is indicated for metastatic breast cancer patients previously treated with anthracycline and taxane. We argued that E could also benefit patients eligible for neoadjuvant chemotherapy.

methodsPatients with primary triple negative breast cancer ≥2 cm received doxorubicin 60 mg/m2 and paclitaxel 200 mg/m2 x 4 cycles (AT) followed by E 1.4 mg/m2 x 4 cycles. Primary endpoint was pathological complete response (pCR) rate; secondary and explorative endpoints included clinical/metabolic response rates and safety, and biomarker analysis, respectively. Using a two-stage Simon design, 43 patients were to be included provided that 4 of 13 patients had achieved pCR in the first stage of the study.

resultsIn stage I of the study 13 women were enrolled, median age 43 years, tumor size 2-5 cm in 9/13 (69%), positive nodal status in 8/13 (61%). Main grade 3 adverse event was neutropenia (related to AT and E in 4 and 2 cases, respectively). AT followed by E induced clinical complete + partial responses in 11/13 patients (85%), pCR in 3/13 (23%). Median measurements of maximum standardized uptake value (SUVmax) resulted 13, 3, and 1.9 at baseline, after AT and E, respectively. Complete metabolic response (CMR) occurred after AT and after E in 2 and 3 cases, respectively. Notably, 2 of the 5 (40%) patients with CMR achieved pCR at surgery. Immunostaining of paired pre-/post-treatment tumor specimens showed a reduction of β-catenin, CyclinD1, Zeb-1, and c-myc expression, in the absence of N-cadherin modulation. The study was interrupted at stage I due to the lack of the required patients with pCR.

conclusionsDespite the early study closure, preoperative E following AT showed clinical and biological activity in triple negative breast cancer patients. Furthermore, the modulation of β-catenin pathway core proteins, supposedly outside the domain of epithelial-mesenchymal transition, claims for further investigation.

trial registrationEU Clinical Trial Register, EudraCT number 2012-004956-12.

Indexed as

AdultAnthracyclinesBridged-Ring CompoundsFemaleFuransHumansKetonesNeoadjuvant TherapyPolyether PolyketidesTaxoidsTreatment OutcomeTriple Negative Breast NeoplasmsAnthracyclinesBridged-Ring CompoundseribulinFuransKetonesPolyether PolyketidestaxaneTaxoids

Identifiers

PMID31390375
PMCPMC6685628
OpenAlexW2965703140

What OpenQuestion holds

Textmetadata
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.