Evidence map›Paper›PMID 32325418›Full record

ArticleEuropean journal of cancer (Oxford, England : 1990)2020

Phase I expansion cohort to evaluate the combination of bevacizumab, sorafenib and low-dose cyclophosphamide in children and young adults with refractory or recurrent solid tumours.

Sara M Federico, Kenneth J Caldwell, Mary B McCarville, Vinay M Daryani, Clinton F Stewart, Shenghua Mao, Jianrong Wu, Andrew M Davidoff, Victor M Santana, Wayne L Furman and 2 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in European journal of cancer (Oxford, England : 1990), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.1field-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

9 citing papers in PubMed, 19 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

12 authors at 4 institutions in 1 country.

Sara M FedericoDepartment of Oncology, St. Jude Children's Research Hospital, Memphis, TN 38105, USA; Department of Pediatrics, College of Medicine, University of Tennessee Health Science Center, Memphis, TN 38163, USA. Electronic address: sara.federico@stjude.org.
Kenneth J CaldwellDepartment of Oncology, St. Jude Children's Research Hospital, Memphis, TN 38105, USA.
Mary B McCarvilleDepartment of Diagnostic Imaging, St. Jude Children's Research Hospital, Memphis, TN 38105, USA.
Vinay M DaryaniDepartment of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, TN 38105, USA.
Clinton F StewartDepartment of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, TN 38105, USA.
Shenghua MaoDepartment of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN 38105, USA.
Jianrong WuDepartment of Biostatistics and Bioinformatics Shared Resource Facility, Markey Cancer Center, University of Kentucky, Lexington, KY 40504, USA.
Andrew M DavidoffDepartment of Surgery, St. Jude Children's Research Hospital, Memphis, TN 38105, USA; Department of Surgery, College of Medicine, University of Tennessee Health Science Center, Memphis, TN 38163, USA.
Victor M SantanaDepartment of Pediatrics, College of Medicine, University of Tennessee Health Science Center, Memphis, TN 38163, USA.
Wayne L FurmanDepartment of Oncology, St. Jude Children's Research Hospital, Memphis, TN 38105, USA; Department of Pediatrics, College of Medicine, University of Tennessee Health Science Center, Memphis, TN 38163, USA.
Alberto S PappoDepartment of Oncology, St. Jude Children's Research Hospital, Memphis, TN 38105, USA; Department of Pediatrics, College of Medicine, University of Tennessee Health Science Center, Memphis, TN 38163, USA.
Fariba NavidDepartment of Pediatrics, Children's Hospital Los Angeles, University of Southern California, Keck School of Medicine, Los Angeles, CA 90027, USA.
St. Jude Children's Research Hospital · USUniversity of Kentucky · USUniversity of Southern California · USUniversity of Tennessee Health Science Center · US

Funding

Viral Vector Technology (VVTSR)P30CA021765 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI CHARLES ROBERTS · 1985 to 2026
$166.9M
XENOGRAFT STUDIESP01CA023099 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI HENDERSHOT, LINDA M · 1985 to 2011
$22.4M
NCI NIH HHS P01 CA023099NCI NIH HHS P30 CA021765
6 · The paper itself

Abstract

backgroundAngiogenesis is critical for tumour growth and metastasis. Dual inhibition of vascular endothelial growth factors and platelet-derived growth factor receptors suppresses angiogenesis. This expansion cohort of a phase I study targeted angiogenesis with sorafenib, bevacizumab and low-dose cyclophosphamide in children and young adults with recurrent solid tumours.

methodsAn expansion cohort including patients with refractory or recurrent solid tumours was enrolled and received bevacizumab (15 mg/kg IV, day 1), sorafenib (90 mg/m

resultsTwenty-four patients (15 males; median age 14.5 yrs; range 1-22 yr) received a median of 6 courses (range 1-18). Twelve patients had a bone or soft tissue sarcoma. The most common grade III/IV non-haematologic toxicities were hypertension (N = 4), hand/foot rash (N = 3) and elevated lipase (N = 3). The most common grade III/IV haematologic toxicities were neutropenia (N = 7) and lymphopenia (N = 17). Three patients (2 synovial sarcoma, 1 rhabdoid tumour) achieved a partial response and 18 had stable disease. The progression-free survival at 3 and 6 months were 78.1% (95% confidence interval [CI] 60.6-95.6%) and 54% (95% CI 30.2-78.2%), respectively. Bevacizumab PKs in 15 patients was similar to published adult PK results.

conclusionsIntravenous bevacizumab combined with oral sorafenib and low-dose cyclophosphamide was tolerated and demonstrated promising activity in a subset of childhood solid tumours.

Indexed as

Salvage TherapyAdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsBevacizumabChildChild, PreschoolCyclophosphamideDrug Resistance, NeoplasmFemaleFollow-Up StudiesHumansInfantMaleMaximum Tolerated DoseNeoplasm Recurrence, LocalBevacizumabCyclophosphamideSorafenibBevacizumabCyclophosphamidePaediatricPhase ISolid tumoursSorafenib

Identifiers

PMID32325418
PMCPMC7958650
OpenAlexW3018854574

What OpenQuestion holds

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LicenceTDM
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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.