Evidence map›Paper›PMID 27403082›Full record

ArticleSarcoma2016

A Phase I/II Clinical Trial of Belinostat (PXD101) in Combination with Doxorubicin in Patients with Soft Tissue Sarcomas.

Joanna Vitfell-Rasmussen, Ian Judson, Akmal Safwat, Robin L Jones, Philip Blach Rossen, Maja Lind-Hansen, Poul Knoblauch, Anders Krarup-Hansen

Open access · hybridAbstract read
In one paragraph

Article in Sarcoma, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.1field-weighted citation impact, top 13% 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

17 citing papers in PubMed, 31 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

8 authors at 4 institutions in 2 countries.

Joanna Vitfell-RasmussenHerlev University Hospital, Herlev Ringvej 75, 2730 Herlev, Denmark.ORCID 0000-0003-0983-0732
Ian JudsonThe Institute of Cancer Research: Royal Cancer Hospital, 123 Old Brompton Road, London SW7 3RP, UK.ORCID 0000-0002-4766-5304
Akmal SafwatAarhus University Hospital, Nørrebrogade 44, 8000 Aarhus, Denmark.ORCID 0000-0002-6020-2320
Robin L JonesThe Institute of Cancer Research: Royal Cancer Hospital, 123 Old Brompton Road, London SW7 3RP, UK.
Philip Blach RossenAarhus University Hospital, Nørrebrogade 44, 8000 Aarhus, Denmark.
Maja Lind-HansenHerlev University Hospital, Herlev Ringvej 75, 2730 Herlev, Denmark.
Poul KnoblauchOnxeo, c/o Symbion, Fruebjergvej 3, 2100 København, Denmark.
Anders Krarup-HansenHerlev University Hospital, Herlev Ringvej 75, 2730 Herlev, Denmark.ORCID 0000-0002-0200-4086
Herlev Hospital · DKAarhus University Hospital · DKInstitute of Cancer Research · GBOnxeo (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background. Belinostat is a novel histone deacetylase inhibitor. Primary Objectives. Maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of belinostat (Bel) in combination with doxorubicin (Dox) in solid tumours (phase I) and response rate (RR) in soft tissue sarcomas (phase II). Methods. Bel was administered as a 30-minute IV infusion on days 1-5 and on day 5 with Dox. The dose escalation schedule was as follows: cohort 1: Bel 600 mg/m(2) and 50 mg/m(2) Dox, cohort 2: Bel 600 mg/m(2) and 75 mg/m(2) Dox, cohort 3: Bel 800 mg/m(2) and 75 mg/m(2) Dox, and cohort 4: Bel 1000 mg/m(2) and 75 mg/m(2) Dox. Results. 41 patients were included (25 in phase I, 16 in phase II). Adverse events were fatigue (95%), nausea (76%), and alopecia (63%). There was one DLT, grade 3 rash/hand and foot syndrome. MTD was Bel 1000 mg/m(2)/d and Dox 75 mg/m(2). Four responses were seen: 2 PR in phase I, RR of 8%; in phase II, 1 PR/1 CR, RR of 13%, and 9 patients (56%) with SD. Conclusion. The combination was well tolerated. Response rate was moderate but median time to progression was 6.0 months (95% CI, 1.6-9.7 months) which is superior to some reports of single-agent Dox.

Identifiers

PMID27403082
PMCPMC4923583
OpenAlexW2421095347

What OpenQuestion holds

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LicenceCC BY
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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.