Evidence map›Paper›PMID 24890858›Full record

Trial reportInvestigational new drugs2014

Phase II trial of bortezomib plus doxorubicin in hepatocellular carcinoma (E6202): a trial of the Eastern Cooperative Oncology Group.

Kristen K Ciombor, Yang Feng, Al Bowen Benson, Yingjun Su, Linda Horton, Sarah P Short, John Sae Wook Kauh, Charles Staley, Mary Mulcahy, Mark Powell and 3 more

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

Trial report in Investigational new drugs, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.3field-weighted citation impact, top 21% 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

16 citing papers in PubMed, 32 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

13 authors at 9 institutions in 3 countries.

Kristen K CiomborDivision of Medical Oncology, Department of Internal Medicine, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, A445A Starling Loving Hall, 320 West 10th Avenue, Columbus, OH, 43212, USA, kristen.ciombor@osumc.edu.
Yang Feng
Al Bowen Benson
Yingjun Su
Linda Horton
Sarah P Short
John Sae Wook Kauh
Charles Staley
Mary Mulcahy
Mark Powell
Katayoun I Amiri
Ann Richmond
Jordan Berlin
Vanderbilt University · USEmory University · USNorthwestern University · USBristol-Myers Squibb (Switzerland) · CHDana-Farber Cancer Institute · USNew York Proton Center · USThe Ohio State University · USUnited States Department of Veterans Affairs · USXijing Hospital · CN

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
Translational Analysis CoreP30DK058404 · NIDDK · VANDERBILT UNIVERSITY MEDICAL CENTER · PI RICHARD M. PEEK · 2002 to 2026
$29.9M
Vanderbilt Clinical Oncology Research Career Development ProgramK12CA090625 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Debra L. Friedman, Paula Jill Hurley · 2001 to 2026
$16.9M
ECOG Specimen BankingU24CA114737 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI COMIS, ROBERT L · 2005 to 2014
$9.3M
Targeting the NF-kappaB Pathway in MelanomaR01CA116021 · NCI · VANDERBILT UNIVERSITY · PI RICHMOND, ANN, YAN, CHI · 2005 to 2024
$6.7M
ECOG Clinical TrialsU10CA017145 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI BENSON, AL B · 1985 to 2013
$6.1M
ONCOLOGYU10CA049957 · NCI · VANDERBILT UNIVERSITY · PI BERLIN, JORDAN D · 1989 to 2013
$5.4M
MELANOMA GROWTH STIMULATORY ACTIVITYR01CA034590 · NCI · VANDERBILT UNIVERSITY · PI RICHMOND, ANN · 1986 to 2017
$5.2M
BLRD VA IK6 BX005225NCI NIH HHS 5R21 CA099269-02NCI NIH HHS CA116021NCI NIH HHS CA17145NCI NIH HHS CA21115NCI NIH HHS CA23318NCI NIH HHS CA49957NCI NIH HHS CA66636NCI NIH HHS CA9060625NCI NIH HHS K12 CA090625NCI NIH HHS R01 CA034590NCI NIH HHS R01 CA116021NCI NIH HHS R21 CA099269NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA049957NCI NIH HHS U10 CA066636NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U24 CA114737NIDDK NIH HHS P30 DK058404
6 · The paper itself

Abstract

purposeTo evaluate the efficacy and tolerability of bortezomib in combination with doxorubicin in patients with advanced hepatocellular carcinoma, and to correlate pharmacodynamic markers of proteasome inhibition with response and survival. EXPERIMENTAL

designThis phase II, open-label, multicenter study examined the efficacy of bortezomib (1.3 mg/m(2) IV on d1, 4, 8, 11) and doxorubicin (15 mg/m(2) IV on d1, 8) in 21-day cycles. The primary endpoint was objective response rate.

resultsBest responses in 38 treated patients were 1 partial response (2.6 %), 10 (26.3 %) stable disease, and 17 (44.7 %) progressive disease; 10 patients were unevaluable. Median PFS was 2.2 months. Median OS was 6.1 months. The most common grade 3 to 4 toxicities were hypertension, glucose intolerance, ascites, ALT elevation, hyperglycemia and thrombosis/embolism. Worse PFS was seen in patients with elevated IL-6, IL-8, MIP-1α and EMSA for NF-κB at the start of treatment. Worse OS was seen in patients with elevated IL-8 and VEGF at the start of treatment. Patients had improved OS if a change in the natural log of serum MIP-1α/CCL3 was seen after treatment. RANTES/CCL5 levels decreased significantly with treatment.

conclusionsThe combination of doxorubicin and bortezomib was well-tolerated in patients with hepatocellular carcinoma, but the primary endpoint was not met. Exploratory analyses of markers of proteasome inhibition suggest a possible prognostic and predictive role and should be explored further in tumor types for which bortezomib is efficacious.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibCarcinoma, HepatocellularChemokine CCL5CytokinesDisease-Free SurvivalDoxorubicinFemaleHumansLiver NeoplasmsMaleMiddle AgedPyrazinesBoronic AcidsBortezomibCCL5 protein, humanChemokine CCL5CytokinesDoxorubicinPyrazinesVascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID24890858
PMCPMC4171216
OpenAlexW2052770006

What OpenQuestion holds

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Registered trials

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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.