Evidence map›Paper›PMID 25713428›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015

Randomized phase III trial of gemcitabine plus docetaxel plus bevacizumab or placebo as first-line treatment for metastatic uterine leiomyosarcoma: an NRG Oncology/Gynecologic Oncology Group study.

Martee L Hensley, Austin Miller, David M O'Malley, Robert S Mannel, Kian Behbakht, Jamie N Bakkum-Gamez, Helen Michael

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04383119 (A Randomized Phase II Trial Comparing the Activity of trabectedIn vs Gemcitabine in Patients With Metastatic or Locally Advanced Leiomyosarcoma Pretreated With Conventional Chemotherapy), which is not on this map. Cited by 62 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 1 pooled it
12.2field-weighted citation impact, top 1% 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.

NCT04383119 phase2recruitingnot on this mapstarted 2021, after this paper: background citation

A Randomized Phase II Trial Comparing the Activity of trabectedIn vs Gemcitabine in Patients With Metastatic or Locally Advanced Leiomyosarcoma Pretreated With Conventional Chemotherapy

TypeinterventionalSponsorItalian Sarcoma GroupRan2021 to 2026Enrolled100ConditionsLeiomyosarcoma of Ovary, Soft Tissue SarcomaArmsTrabectedin, Gemcitabine, No Intervention: Observational Cohort
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 1 synthesis or guideline pooled it, 122 citations in OpenAlex.

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  16. Retrospective Analysis ofJCO precision oncology · 2025
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2 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

7 authors at 1 institution in 1 country.

Martee L HensleyMartee L. Hensley, Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York; Austin Miller, NRG Oncology, Buffalo, NY; David M. O'Malley, The Ohio State University, Columbus, OH; Robert S. Mannel, University of Oklahoma, Oklahoma City, OK; Kian Behbakht, University of Colorado Denver, Aurora, CO; Jamie N. Bakkum-Gamez, Mayo Clinic, Rochester, MN; and Helen Michael, Indiana University School of Medicine, Indianapolis, IN. gynbreast@mskcc.org.
Austin MillerMartee L. Hensley, Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York; Austin Miller, NRG Oncology, Buffalo, NY; David M. O'Malley, The Ohio State University, Columbus, OH; Robert S. Mannel, University of Oklahoma, Oklahoma City, OK; Kian Behbakht, University of Colorado Denver, Aurora, CO; Jamie N. Bakkum-Gamez, Mayo Clinic, Rochester, MN; and Helen Michael, Indiana University School of Medicine, Indianapolis, IN.
David M O'MalleyMartee L. Hensley, Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York; Austin Miller, NRG Oncology, Buffalo, NY; David M. O'Malley, The Ohio State University, Columbus, OH; Robert S. Mannel, University of Oklahoma, Oklahoma City, OK; Kian Behbakht, University of Colorado Denver, Aurora, CO; Jamie N. Bakkum-Gamez, Mayo Clinic, Rochester, MN; and Helen Michael, Indiana University School of Medicine, Indianapolis, IN.
Robert S MannelMartee L. Hensley, Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York; Austin Miller, NRG Oncology, Buffalo, NY; David M. O'Malley, The Ohio State University, Columbus, OH; Robert S. Mannel, University of Oklahoma, Oklahoma City, OK; Kian Behbakht, University of Colorado Denver, Aurora, CO; Jamie N. Bakkum-Gamez, Mayo Clinic, Rochester, MN; and Helen Michael, Indiana University School of Medicine, Indianapolis, IN.
Kian BehbakhtMartee L. Hensley, Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York; Austin Miller, NRG Oncology, Buffalo, NY; David M. O'Malley, The Ohio State University, Columbus, OH; Robert S. Mannel, University of Oklahoma, Oklahoma City, OK; Kian Behbakht, University of Colorado Denver, Aurora, CO; Jamie N. Bakkum-Gamez, Mayo Clinic, Rochester, MN; and Helen Michael, Indiana University School of Medicine, Indianapolis, IN.
Jamie N Bakkum-GamezMartee L. Hensley, Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York; Austin Miller, NRG Oncology, Buffalo, NY; David M. O'Malley, The Ohio State University, Columbus, OH; Robert S. Mannel, University of Oklahoma, Oklahoma City, OK; Kian Behbakht, University of Colorado Denver, Aurora, CO; Jamie N. Bakkum-Gamez, Mayo Clinic, Rochester, MN; and Helen Michael, Indiana University School of Medicine, Indianapolis, IN.
Helen MichaelMartee L. Hensley, Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York; Austin Miller, NRG Oncology, Buffalo, NY; David M. O'Malley, The Ohio State University, Columbus, OH; Robert S. Mannel, University of Oklahoma, Oklahoma City, OK; Kian Behbakht, University of Colorado Denver, Aurora, CO; Jamie N. Bakkum-Gamez, Mayo Clinic, Rochester, MN; and Helen Michael, Indiana University School of Medicine, Indianapolis, IN.
Memorial Sloan Kettering Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Felicity Enders · 1985 to 2026
$151.3M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
GYNECOLOGIC ONCOLOGY GROUP HEADQUARTERSU10CA027469 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 1985 to 2013
$132.6M
GYNECOLOGIC ONCOLOGY GROUP STATISTICAL OFFICEU10CA037517 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI BLESSING, JOHN A · 1985 to 2013
$67.4M
Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
OSU as Network Lead Academic Participating Site for the NCI NCTNU10CA180850 · NCI · OHIO STATE UNIVERSITY · PI BLUM, KRISTIE A, CHAKRAVARTI, ARNAB · 2014 to 2018
$6.8M
Lead Academic Participating Site for the Development and Conduct of NCTN TrialsU10CA180798 · NCI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI MANNEL, ROBERT S., MOORE, KATHLEEN N. · 2014 to 2018
$6.7M
University of Colorado NTCN Lead Academic Participating Site (LAPS) U10CA180834 · NCI · UNIVERSITY OF COLORADO DENVER · PI ELIAS, ANTHONY D · 2014 to 2018
$3.8M
NCATS NIH HHS UL1 TR000135NCI NIH HHS 1 U10 CA180822NCI NIH HHS CA27469NCI NIH HHS CA37517NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA015083NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA180798NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180834NCI NIH HHS U10 CA180850NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

purposeFixed-dose rate gemcitabine plus docetaxel achieves objective response in 35% of patients with uterine leiomyosarcoma (uLMS). This study aimed to determine whether the addition of bevacizumab to gemcitabine-docetaxel increases progression-free survival (PFS) in uLMS. PATIENTS AND

methodsIn this phase III, double-blind, placebo-controlled trial, patients with chemotherapy-naive, metastatic, unresectable uLMS were randomly assigned to gemcitabine-docetaxel plus bevacizumab or gemcitabine-docetaxel plus placebo. PFS, overall survival (OS), and objective response rates (ORRs) were compared to determine superiority. Target accrual was 130 patients to detect an increase in median PFS from 4 months (gemcitabine-docetaxel plus placebo) to 6.7 months (gemcitabine-docetaxel plus bevacizumab). Treatment effects on PFS and OS were described by hazard ratios (HRs), median times to event, and 95% CIs.

resultsIn all, 107 patients were accrued: gemcitabine-docetaxel plus placebo (n = 54) and gemcitabine-docetaxel plus bevacizumab (n = 53). Accrual was stopped early for futility. No statistically significant differences in grade 3 to 4 toxicities were observed. Median PFS was 6.2 months for gemcitabine-docetaxel plus placebo versus 4.2 months for gemcitabine-docetaxel plus bevacizumab (HR, 1.12; P = .58). Median OS was 26.9 months for gemcitabine-docetaxel plus placebo and 23.3 months for gemcitabine-docetaxel plus bevacizumab (HR, 1.07; P = .81). Objective responses were observed in 17 (31.5%) of 54 patients randomly assigned to gemcitabine-docetaxel plus placebo and 19 (35.8%) of 53 patients randomly assigned to gemcitabine-docetaxel plus bevacizumab. Mean duration of response was 8.6 months for gemcitabine-docetaxel plus placebo versus 8.8 months for gemcitabine-docetaxel plus bevacizumab.

conclusionThe addition of bevacizumab to gemcitabine-docetaxel for first-line treatment of metastatic uLMS failed to improve PFS, OS, or ORR. Gemcitabine-docetaxel remains a standard first-line treatment for uLMS.

Indexed as

AdultAgedAnemiaAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabDeoxycytidineDisease-Free SurvivalDocetaxelDouble-Blind MethodFemaleGemcitabineHumansKaplan-Meier EstimateLeiomyosarcomaMiddle AgedAntibodies, Monoclonal, HumanizedBevacizumabDeoxycytidineDocetaxelGemcitabineTaxoids

Identifiers

PMID25713428
PMCPMC4372854
OpenAlexW2167352270

What OpenQuestion holds

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Registered trials

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.