Evidence map›Paper›PMID 31537908›Full record

Trial reportBritish journal of cancer2019

Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer.

Nicoletta Colombo, Eleonora Zaccarelli, Alessandra Baldoni, Simona Frezzini, Giovanni Scambia, Eleonora Palluzzi, Germana Tognon, Andrea A Lissoni, Daniela Rubino, Annamaria Ferrero and 11 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of 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 NCT01735071 (Multicenter, Randomized, Non-comparative, Phase II Trial on the Efficacy and Safety of the Combination of Bevacizumab and Trabectedin With or Without Carboplatin in Adult Women With Platinum Partially Sensitive Recurring Ovarian Cancer.), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.4field-weighted citation impact, top 18% 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.

NCT01735071 phase2completednot on this map

Multicenter, Randomized, Non-comparative, Phase II Trial on the Efficacy and Safety of the Combination of Bevacizumab and Trabectedin With or Without Carboplatin in Adult Women With Platinum Partially Sensitive Recurring Ovarian Cancer.

TypeinterventionalSponsorMario Negri Institute for Pharmacological ResearchRan2013 to 2018Enrolled71ConditionsOvarian Epithelial Cancer RecurrentArmsbevacizumab and trabectedin, bevacizumab, trabectedin and carboplatin
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 13 citations in OpenAlex.

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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

21 authors at 10 institutions in 1 country.

Nicoletta ColomboIstituto Europeo di Oncologia, Milano, Italy.
Eleonora ZaccarelliIstituto Europeo di Oncologia, Milano, Italy.
Alessandra BaldoniIstituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.
Simona FrezziniIstituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.
Giovanni ScambiaFondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Roma, Italy.
Eleonora PalluzziFondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Roma, Italy.
Germana TognonUO Ostetricia e Ginecologia - ASST degli Spedali Civili di Brescia, Università degli Studi, Brescia, Italy.
Andrea A LissoniUniversità di Milano-Bicocca, Clinica Ostetrica e Ginecologica, Milano, Italy.
Daniela RubinoPoliclinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii, Bologna, Italy.
Annamaria FerreroAO Ordine Mauriziano, SCDU Ginecologia ed Ostetricia, Torino, Italy.
Gabriella FarinaASST Fatebenefratelli Sacco, UOC di Oncologia, Milano, Italy.
Emanuele NegriIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Angela Pesenti GrittiIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Francesca GalliIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Elena BiagioliIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Eliana RulliIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Davide PoliIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Chiara GerardiIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Valter TorriIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Roldano FossatiIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy. roldano.fossati@marionegri.it.
Maurizio D'IncalciIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Istituti di Ricovero e Cura a Carattere Scientifico · ITMario Negri Institute for Pharmacological Research · ITAgostino Gemelli University Polyclinic · ITUniversity of Milano-Bicocca · ITA. O. Ordine Mauriziano di Torino · ITASST Fatebenefratelli Sacco · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITEuropean Institute of Oncology · ITIstituto Oncologico Veneto · ITMedica (Italy) · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTrabectedin, in addition to its antiproliferative effect, can modify the tumour microenvironment and this could be synergistic with bevacizumab. The efficacy and safety of trabectedin and bevacizumab ± carboplatin have never been investigated.

methodsIn this phase 2 study, women progressing between 6 and 12 months since their last platinum-based therapy were randomised to Arm BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin every 28 days, from cycles 1 to 6, then trabectedin and bevacizumab as in Arm BT. Primary endpoints were progression-free survival rate (PFS-6) and severe toxicity rate (ST-6) at 6 months, assuming a PFS-6 ≤35% for BT and ≤40% for BT+C as not of therapeutic interest and, for both arms, a ST-6  ≥ 30% as unacceptable.

resultsBT+C (21 patients) did not meet the safety criteria for the second stage (ST-6 45%; 95%CI: 23%-69%) but PFS-6 was 85% (95%CI: 62%-97%). BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).

conclusionsBT compared favourably with other platinum- and non-platinum-based regimens. The combination with carboplatin needs to be assessed further in a re-modulated safer schedule to confirm its apparent strong activity. CLINICAL

trial registrationNCT01735071 (Clinicaltrials.gov).

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCarcinoma, Ovarian EpithelialFemaleHumansKaplan-Meier EstimateMiddle AgedOvarian NeoplasmsProgression-Free SurvivalSurvival RateTrabectedinBevacizumabCarboplatinTrabectedin

Identifiers

PMID31537908
PMCPMC6888836
OpenAlexW2973234888

What OpenQuestion holds

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LicenceCC BY
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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.