Evidence map›Paper›PMID 31502400›Full record

Trial reportPediatric blood & cancer2019

Cediranib phase-II study in children with metastatic alveolar soft-part sarcoma (ASPS).

Julia W Cohen, Brigitte C Widemann, Joanne Derdak, Eva Dombi, Anne Goodwin, Jessica Dompierre, Uzoma Onukwubiri, Seth M Steinberg, Geraldine O'Sullivan Coyne, Shivaani Kummar and 2 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatric blood & cancer, 2019. 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
1.4field-weighted citation impact, top 17% 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, 18 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Randomized Phase II Trial of Sunitinib or Cediranib in Alveolar Soft Part Sarcoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  6. Review
  7. Article
  8. Review
  9. Review
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 3 institutions in 2 countries.

Julia W CohenPediatric Oncology Branch, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0003-2143-2876
Brigitte C WidemannPediatric Oncology Branch, National Cancer Institute, Bethesda, Maryland.
Joanne DerdakPediatric Oncology Branch, National Cancer Institute, Bethesda, Maryland.
Eva DombiPediatric Oncology Branch, National Cancer Institute, Bethesda, Maryland.
Anne GoodwinPediatric Oncology Branch, National Cancer Institute, Bethesda, Maryland.
Jessica DompierrePediatric Oncology Branch, National Cancer Institute, Bethesda, Maryland.
Uzoma OnukwubiriPediatric Oncology Branch, National Cancer Institute, Bethesda, Maryland.
Seth M SteinbergBiostatistics and Data Management Section, Center for Cancer Research, Bethesda, Maryland.
Geraldine O'Sullivan CoyneDevelopmental Therapeutics Clinic, National Cancer Institute, Bethesda, Maryland.
Shivaani KummarPhase I Clinical Research Program, Division of Oncology, Stanford School of Medicine, Stanford, California.
Alice P ChenDevelopmental Therapeutics Clinic, National Cancer Institute, Bethesda, Maryland.
John GlodPediatric Oncology Branch, National Cancer Institute, Bethesda, Maryland.
National Cancer Institute · USCenter for Cancer Research · USStanford Medicine · US

Funding

Intramural NIH HHS Z99 CA999999NCI NIH HHS
6 · The paper itself

Abstract

backgroundAlveolar soft-part sarcoma (ASPS), a rare vascular sarcoma with a clinically indolent course, frequently presents with metastases. Vascular endothelial growth factor (VEGF) is a promising therapeutic target. In a phase-II trial of the VEGF receptor inhibitor cediranib for adults with ASPS, the partial response (PR) rate (response evaluation criteria in solid tumors [RECIST] v1.0) was 35% (15/43; 95% confidence interval: 21-51%). We evaluated cediranib in the pediatric population. PROCEDURE: Patients <16 years old with metastatic, unresectable ASPS received cediranib at the pediatric maximum tolerated dose of 12 mg/m

resultsSeven patients (four females), with a median age of 13 years, (range 9-15), were enrolled on stage 1. The most frequent grade 2 or 3 adverse events were neutropenia, diarrhea, hypertension, fatigue, and proteinuria. The best response was stable disease (SD) (median cycle number = 34). Three patients were removed from the study treatment for disease progression (cycles 4, 5, and 36). Five of seven patients had SD for ≥14 months. Two patients with SD remain on study (34-57+ cycles).

conclusionsCediranib did not reach the target response rate in this small pediatric cohort, in contrast to the adult 35% PR rate. The pediatric dosing was 30% lower compared to the adult dosing, which may have contributed to response differences. Prolonged SD was observed in five patients, but given the indolent nature of ASPS, SD cannot be clearly attributed to cediranib. Cediranib has an acceptable safety profile.

Indexed as

AdolescentAntineoplastic AgentsChildFemaleFollow-Up StudiesHumansIndolesMaleNeoplasm MetastasisPrognosisQuinazolinesSarcoma, Alveolar Soft PartSurvival RateAntineoplastic AgentscediranibIndolesQuinazolinesalveolar soft-part sarcomacediranibpediatricphase-II study

Identifiers

PMID31502400
PMCPMC6803032
OpenAlexW2973193280

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.