Evidence map›Paper›PMID 25231400›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2014

Phase II clinical trial of amatuximab, a chimeric antimesothelin antibody with pemetrexed and cisplatin in advanced unresectable pleural mesothelioma.

Raffit Hassan, Hedy L Kindler, Thierry Jahan, Lyudmila Bazhenova, Martin Reck, Anish Thomas, Ira Pastan, Jeff Parno, Daniel J O'Shannessy, Penny Fatato and 2 more

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

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 106 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
106citing papers in PubMed, 1 pooled it
15.0field-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.

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

106 citing papers in PubMed, 1 synthesis or guideline pooled it, 182 citations in OpenAlex.

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46 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 2 institutions in 1 country.

Raffit HassanThoracic and GI Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland. hassanr@mail.nih.gov.
Hedy L KindlerUniversity of Chicago, Chicago, Illinois.
Thierry JahanUniversity of California, San Francisco, California.
Lyudmila BazhenovaUniversity of California, San Diego, California.
Martin ReckDepartment of Thoracic Oncology, Lung Clinic Grosshansdorf, Member of the German Center for Lung Research (DZL), Grosshansdorf, Stormarn, Germany.
Anish ThomasThoracic and GI Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Ira PastanLaboratory of Molecular Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Jeff ParnoUnited BioSource Corp., Blue Bell, Pennsylvania.
Daniel J O'ShannessyMorphotek, Inc., Exton, Pennsylvania.
Penny FatatoMorphotek, Inc., Exton, Pennsylvania.
Julia D MaltzmanMorphotek, Inc., Exton, Pennsylvania.
Bruce A WallinMorphotek, Inc., Exton, Pennsylvania.
University of California, San Francisco · USUniversity of Chicago · US

Funding

Immunotherapy for Malignant Mesothelioma, Lung Cancer and Thymic MalignanciesZIABC010816 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI HASSAN, RAFFIT · 2009 to 2025
$25.5M
Re-Engineering Translational Research at the University of ChicagoUL1TR000430 · NCATS · UNIVERSITY OF CHICAGO · PI SOLWAY, JULIAN · 2012 to 2016
$20.2M
Thoracic and Gastrointestinal Oncology Branch Medical Clinical CoreZIDBC011540 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI HASSAN, RAFFIT · 2014 to 2025
$17.7M
Intramural NIH HHS ZIA BC010816NCATS NIH HHS UL1 TR000430
6 · The paper itself

Abstract

purposeAmatuximab is a chimeric monoclonal antibody to mesothelin, a cell surface glycoprotein highly expressed in malignant pleural mesothelioma (MPM). On the basis of its synergy with chemotherapy in preclinical studies, we evaluated the antitumor activity of amatuximab plus pemetrexed and cisplatin in patients with unresectable MPM. EXPERIMENTAL

designIn a single-arm phase II study, amatuximab (5 mg/kg) was administered on days 1 and 8 with pemetrexed (500 mg/m(2)) and cisplatin (75 mg/m(2)) on day 1 of 21-day cycles for up to six cycles. Patients with response or stable disease received amatuximab maintenance until disease progression. Primary endpoint was progression-free survival (PFS) at 6 months. Secondary endpoints were overall survival (OS), response rate, and safety.

resultsEighty-nine patients were enrolled at 26 centers. Median of five cycles (range, 1-6) of combination treatment was administered, and 56 (63%) patients received amatuximab maintenance. Combination therapy resulted in no overlapping toxicities. Eleven patients (12.4%) had amatuximab-related hypersensitivity reactions. Responses included partial responses in 33 (40%) and stable disease in 42 (51%). Six-month PFS rate was 51% [95% confidence interval (CI), 39.1-62.3)], median PFS was 6.1 months (95% CI, 5.8-6.4), and median OS was 14.8 months (95% CI, 12.4-18.5) with 29 patients alive at data cut-off.

conclusionsAmatuximab with pemetrexed and cisplatin was well tolerated with objective tumor response or stable disease rate of 90% by independent radiologic review. Although PFS was not significantly different from historical controls, the median OS was 14.8 months with a third of patients alive and 5 continuing to receive amatuximab at the time of analysis.

Indexed as

AgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkersCisplatinFemaleGlutamatesGPI-Linked ProteinsGuanineHumansLung NeoplasmsMaleMesothelinMesotheliomaMesothelioma, MalignantamatuximabAntibodies, MonoclonalBiomarkersCisplatinGlutamatesGPI-Linked ProteinsGuanineMesothelinPemetrexed

Identifiers

PMID25231400
PMCPMC4252585
OpenAlexW2150869832

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.