Evidence map›Paper›PMID 30057406›Full record

Trial reportBritish journal of cancer2018

A phase II randomised (calibrated design) study on the activity of the single-agent trabectedin in metastatic or locally relapsed uterine leiomyosarcoma.

Angiolo Gadducci, Federica Grosso, Giovanni Scambia, Francesco Raspagliesi, Nicoletta Colombo, Giovanni Grignani, Paolo Casali, Roberta Sanfilippo, Angela Buonadonna, Armando Santoro and 10 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 14% 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
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  3. Retrospective Analysis ofJCO precision oncology · 2025
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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

20 authors at 12 institutions in 1 country.

Angiolo GadducciAzienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
Federica GrossoAzienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.
Giovanni ScambiaFondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Rome, Italy.
Francesco RaspagliesiFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Nicoletta ColomboIstituto Europeo di Oncologia, Milan, Italy.
Giovanni GrignaniCandiolo Cancer Institute FPO IRCCS, Candiolo, Turin, Italy.
Paolo CasaliFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Roberta SanfilippoFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Angela BuonadonnaCentro di Riferimento Oncologico, Pordenone, Aviano, Italy.
Armando SantoroIstituto Clinico Humanitas, Milan, Rozzano, Italy.
Milena BruzzoneOspedale Policlinico San Martino, Genova, Italy.
Grazia ArtioliAzienda Ulss 3 Serenissima, Venice, Italy.
Domenica LorussoFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Elena BiagioliIRCCS - Mario Negri Institute for Pharmacological Research, Milan, Italy.
Roldano FossatiIRCCS - Mario Negri Institute for Pharmacological Research, Milan, Italy. roldano.fossati@marionegri.it.
Francesca GalliIRCCS - Mario Negri Institute for Pharmacological Research, Milan, Italy.
Emanuele NegriIRCCS - Mario Negri Institute for Pharmacological Research, Milan, Italy.
Eliana RulliIRCCS - Mario Negri Institute for Pharmacological Research, Milan, Italy.
Valter TorriIRCCS - Mario Negri Institute for Pharmacological Research, Milan, Italy.
Maurizio D'IncalciIRCCS - Mario Negri Institute for Pharmacological Research, Milan, Italy.
Fondazione IRCCS Istituto Nazionale dei Tumori · ITMario Negri Institute for Pharmacological Research · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITAgostino Gemelli University Polyclinic · ITAzienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo · ITAzienda Ospedaliera Universitaria Pisana · ITAzienda ULSS 9 TREVISO · ITCandiolo Cancer Institute · ITCentro di Riferimento Oncologico · ITFondazione Humanitas per la Ricerca · ITOspedale Policlinico San Martino · ITUniversity of Milano-Bicocca · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with recurrent/metastatic uterine leiomyosarcoma (U-LMS) have a dismal prognosis. This phase II study aims to evaluate trabectedin efficacy and safety in advanced U-LMS.

methodsEligible patients had received ≥ one line of chemotherapy. Gemcitabine ± docetaxel naive patients were randomised to Arm A: trabectedin 1.3 mg/m

resultsOverall, 126 patients entered Arm A (45 from randomisation and 81 directly) and 42 Arm B. Arm A patients characteristics: median age = 57; ≥2 previous chemotherapy lines = 37.4%; metastatic disease = 93%. The study met the condition for trabectedin activity: PFS-6 = 35.2% (95% CI: 26.2-45). No difference in PFS by the number of previous chemotherapy lines emerged. Median OS = 20.6 months (IQR: 8-36.4). In Arm B, the PFS-6 = 51.5% (95% CI: 33.5-69.2). No toxic deaths occurred. In Arm A, only 4 patients interrupted treatment for toxicity.

conclusionsTrabectedin is active and well tolerated, retaining similar efficacy across one to three previous lines of chemotherapy.

Indexed as

AdultAgedAntineoplastic Agents, AlkylatingDeoxycytidineDisease ProgressionDocetaxelFemaleGemcitabineHumansLeiomyosarcomaMiddle AgedNeoplasm MetastasisResearch DesignSurvival AnalysisTrabectedinTreatment OutcomeAntineoplastic Agents, AlkylatingDeoxycytidineDocetaxelGemcitabineTrabectedin

Identifiers

PMID30057406
PMCPMC6162262
OpenAlexW2883910697

What OpenQuestion holds

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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.