Evidence map›Paper›PMID 30547207›Full record

Trial reportEuropean journal of nuclear medicine and molecular imaging2019

Radium-223 in combination with paclitaxel in cancer patients with bone metastases: safety results from an open-label, multicenter phase Ib study.

Ravit Geva, Juanita Lopez, Sarah Danson, Heikki Joensuu, Avivit Peer, Samuel J Harris, Fabricio Souza, Kaline M C Pereira, Ruth Perets

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

Trial report in European journal of nuclear medicine and molecular imaging, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 24% 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

7 citing papers in PubMed, 17 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

9 authors at 7 institutions in 4 countries.

Ravit GevaDivision of Oncology, Tel Aviv Sourasky Medical Center, Tel-Aviv University, 6 Weizmann Street, 64239, Tel Aviv, Israel. ravitg@tlvmc.gov.il.
Juanita LopezDrug Development Unit, The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, 15 Cotswold Road, Sutton, London, SM2 5NG, UK.
Sarah DansonDepartment of Oncology and Metabolism, Sheffield Experimental Cancer Medicine Centre, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Whitham Road, Sheffield, S10 2SJ, UK.
Heikki JoensuuDepartment of Oncology, Helsinki University Hospital and University of Helsinki, Haartmaninkatu 4, 00029, Helsinki, Finland.
Avivit PeerOncology Division, Rambam Health Care Campus, 8 Haaliya Street, Haifa, Israel.
Samuel J HarrisDepartment of Medical Oncology, The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, 15 Cotswold Road, Sutton, London, SM2 5NG, UK.
Fabricio SouzaClinical Pharmacology Leader Oncology, Bayer HealthCare Pharmaceuticals, 100 Bayer Boulevard, Whippany, NJ, USA.
Kaline M C PereiraMedical and Data Management, Bayer HealthCare Pharmaceuticals, 100 Bayer Boulevard, Whippany, NJ, USA.
Ruth PeretsOncology Division, Rambam Health Care Campus, 8 Ha'Aliya Hashniya, and Technion - Israel Institute of Technology, 1 Efron Street, Haifa, Israel.
Bayer (United States) · USInstitute of Cancer Research · GBRambam Health Care Campus · ILTechnion – Israel Institute of Technology · ILTel Aviv University · ILUniversity of Helsinki · FIUniversity of Sheffield · GB

Funding

Bayer HealthCare Pharmaceuticals Not applicable
6 · The paper itself

Abstract

purposeConcomitant treatment with radium-223 and paclitaxel is a potential option for cancer patients with bone metastases; however, myelosuppression risk during coadministration is unknown. This phase Ib study in cancer patients with bone metastases evaluated the safety of radium-223 and paclitaxel.

methodsEligible patients had solid tumor malignancies with ≥2 bone metastases and were candidates for paclitaxel. Treatment included seven paclitaxel cycles (90 mg/m

resultsOf 22 enrolled patients, 15 were treated (safety population), with 7 completing all six radium-223 cycles. Treated patients had primary cancers of breast (n = 7), prostate (n = 4), bladder (n = 1), non-small cell lung (n = 1), myxofibrosarcoma (n = 1), and neuroendocrine (n = 1). No patients discontinued treatment from toxicity of the combination. In the 13 patients who completed cycle 3, the rates of grade 3 neutropenia in cycles 2 and 3 were 31% and 8%, respectively, versus 23% in cycle 1; there were no cases of grade 4 neutropenia or grade 3/4 thrombocytopenia. Breast cancer subgroup safety results were similar to the overall safety population.

conclusionRadium-223 was tolerated when combined with weekly paclitaxel, with no clinically relevant additive toxicities. This combination should be explored further in patients with bone metastases.

Indexed as

SafetyAgedBone NeoplasmsCombined Modality TherapyFemaleHumansMaleMiddle AgedPaclitaxelRadiumPaclitaxelRadiumRadium-223Bone metastasesCancerPaclitaxelRadium-223 dichlorideSafety

Identifiers

PMID30547207
PMCPMC6451720
OpenAlexW2903751233

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.