Evidence map›Paper›PMID 31513481›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Randomized Phase II Trial of Bevacizumab or Temsirolimus in Combination With Chemotherapy for First Relapse Rhabdomyosarcoma: A Report From the Children's Oncology Group.

Leo Mascarenhas, Yueh-Yun Chi, Pooja Hingorani, James R Anderson, Elizabeth R Lyden, David A Rodeberg, Daniel J Indelicato, Simon C Kao, Roshni Dasgupta, Sheri L Spunt and 2 more

Open access · greenAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 78 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 2 pooled it
8.2field-weighted citation impact, top 2% 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

78 citing papers in PubMed, 2 syntheses or guidelines pooled it, 110 citations in OpenAlex.

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  8. Reduced-Intensity Haploidentical Bone Marrow Transplantation with Post-Transplant Cyclophosphamide for Solid Tumors in Pediatric and Young Adult Patients.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2017
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  20. Case Report: Management of aFrontiers in medicine · 2025
    Article

18 more citing papers are in PubMed but not listed here.

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 11 institutions in 1 country.

Leo MascarenhasChildren's Hospital Los Angeles and University of Southern California Keck School of Medicine, Los Angeles, CA.
Yueh-Yun ChiUniversity of Florida, Gainesville, FL.
Pooja HingoraniPhoenix Children's Hospital, Phoenix, AZ.
James R AndersonMerck Research Laboratories: Oncology, North Wales, PA.
Elizabeth R LydenUniversity of Nebraska College of Medicine, Omaha, NE.
David A RodebergEast Carolina University, Greenville, NC.
Daniel J IndelicatoUniversity of Florida, Jacksonville, FL.
Simon C KaoUniversity of Iowa Carver College of Medicine, Iowa City, IA.
Roshni DasguptaCincinnati Children's Hospital Medical Center, Cincinnati, OH.
Sheri L SpuntStanford University School of Medicine, Stanford, CA.
William H MeyerUniversity of Oklahoma Health Sciences Center, Oklahoma City, OK.
Douglas S HawkinsUniversity of Washington, Seattle, WA.
University of Florida · USCincinnati Children's Hospital Medical Center · USEast Carolina University · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USPhoenix Children's Hospital · USStanford University · USUniversity of Iowa · USUniversity of Nebraska at Omaha · USUniversity of Oklahoma Health Sciences Center · USUniversity of Southern California · USUniversity of Washington · US

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899
6 · The paper itself

Abstract

purposeThe primary aim of this clinical trial was to prioritize bevacizumab or temsirolimus for additional investigation in rhabdomyosarcoma (RMS) when administered in combination with cytotoxic chemotherapy to patients with RMS in first relapse with unfavorable prognosis. PATIENTS AND

methodsPatients were randomly assigned to receive bevacizumab on day 1 or temsirolimus on days 1, 8, and 15 of each 21-day treatment cycle, together with vinorelbine on days 1 and 8, and cyclophosphamide on day 1 for a maximum of 12 cycles. Local tumor control with surgery and/or radiation therapy was permitted after 6 weeks of treatment. The primary end point was event-free survival (EFS). Radiographic response was assessed at 6 weeks. The study had a phase II selection that was design to detect a 15% difference between the two regimens (α = .2; 1-β = 0.8; two sided test).

resultsEighty-seven of 100 planned patients were enrolled when the trial was closed after the second interim analysis after 46 events occurred in 68 patients with sufficient follow-up. The O'Brien Fleming boundary at this analysis corresponded to a two-sided

conclusionPatients who received temsirolimus had a superior EFS compared with bevacizumab. Temsirolimus has been selected for additional investigation in newly diagnosed patients with intermediate-risk RMS.

Indexed as

Neoplasm Recurrence, LocalAdolescentAdultAge FactorsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabChildCyclophosphamideDisease ProgressionFeasibility StudiesFemaleHumansMaleProgression-Free SurvivalRhabdomyosarcomaSirolimusBevacizumabCyclophosphamideSirolimustemsirolimusVinorelbine

Identifiers

PMID31513481
PMCPMC6823886
OpenAlexW2972537131

What OpenQuestion holds

Textmetadata
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.