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Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas.

Identifieur interne : 001875 ( PubMed/Checkpoint ); précédent : 001874; suivant : 001876

Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas.

Auteurs : R K Ramanathan [États-Unis] ; D. Goldstein [Australie] ; R L Korn ; F. Arena [États-Unis] ; M. Moore [Canada] ; S. Siena [Italie] ; L. Teixeira [France] ; J. Tabernero [Espagne] ; J-L Van Laethem [Belgique] ; H. Liu ; D. Mcgovern ; B. Lu ; D D Von Hoff [États-Unis]

Source :

RBID : pubmed:26802153

Descripteurs français

English descriptors

Abstract

In the phase III MPACT trial, nab-paclitaxel plus gemcitabine (nab-P + Gem) demonstrated superior efficacy versus Gem alone for patients with metastatic pancreatic cancer. We sought to examine the feasibility of positron emission tomography (PET) and to compare metabolic response rates and associated correlations with efficacy in the MPACT trial.

DOI: 10.1093/annonc/mdw020
PubMed: 26802153


Affiliations:


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pubmed:26802153

Le document en format XML

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<div type="abstract" xml:lang="en">In the phase III MPACT trial, nab-paclitaxel plus gemcitabine (nab-P + Gem) demonstrated superior efficacy versus Gem alone for patients with metastatic pancreatic cancer. We sought to examine the feasibility of positron emission tomography (PET) and to compare metabolic response rates and associated correlations with efficacy in the MPACT trial.</div>
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<Title>Annals of oncology : official journal of the European Society for Medical Oncology</Title>
<ISOAbbreviation>Ann. Oncol.</ISOAbbreviation>
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<ArticleTitle>Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas.</ArticleTitle>
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<MedlinePgn>648-53</MedlinePgn>
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<ELocationID EIdType="doi" ValidYN="Y">10.1093/annonc/mdw020</ELocationID>
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<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In the phase III MPACT trial, nab-paclitaxel plus gemcitabine (nab-P + Gem) demonstrated superior efficacy versus Gem alone for patients with metastatic pancreatic cancer. We sought to examine the feasibility of positron emission tomography (PET) and to compare metabolic response rates and associated correlations with efficacy in the MPACT trial.</AbstractText>
<AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">Patients with previously untreated metastatic adenocarcinoma of the pancreas were randomized 1:1 to receive nab-P + Gem or Gem alone. Treatment continued until disease progression by RECIST or unacceptable toxicity.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">PET scans were carried out on the first 257 patients enrolled at PET-equipped centers (PET cohort). Most patients (252 of 257) had ≥2 PET-avid lesions, and median maximum standardized uptake values at baseline were 4.6 and 4.5 in the nab-P + Gem and Gem-alone arms, respectively. In a pooled treatment arm analysis, a metabolic response by PET (best response at any time during study) was associated with longer overall survival (OS) (median 11.3 versus 6.9 months; HR, 0.56; P < 0.001). Efficacy results within each treatment arm appeared better for patients with a metabolic response. The metabolic response rate (best response and week 8 response) was higher for nab-P + Gem (best response: 72% versus 53%, P = 0.002; week 8: 67% versus 51%; P = 0.014). Efficacy in the PET cohort was greater for nab-P + Gem versus Gem alone, including for OS (median 10.5 versus 8.4 months; hazard ratio [HR], 0.71; P = 0.009) and ORR by RECIST (31% versus 11%; P < 0.001).</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Pancreatic lesions were PET avid at baseline, and the rate of metabolic response was significantly higher for nab-P + Gem versus Gem alone at week 8 and for best response during study. Having a metabolic response was associated with longer survival, and more patients experienced a metabolic response than a RECIST-defined response.</AbstractText>
<AbstractText Label="CLINICALTRIALSGOV" NlmCategory="UNASSIGNED">NCT00844649.</AbstractText>
<CopyrightInformation>© The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.</CopyrightInformation>
</Abstract>
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<Author ValidYN="Y">
<LastName>Ramanathan</LastName>
<ForeName>R K</ForeName>
<Initials>RK</Initials>
<AffiliationInfo>
<Affiliation>Division of Hematology/Oncology, Mayo Clinic, Scottsdale, USA ramanathan.ramesh@mayo.edu.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Goldstein</LastName>
<ForeName>D</ForeName>
<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>Department of Medical Oncology, Prince of Wales Hospital, Sydney, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Korn</LastName>
<ForeName>R L</ForeName>
<Initials>RL</Initials>
<AffiliationInfo>
<Affiliation>Diagnostic Radiology, Scottsdale Medical Imaging, Ltd, Scottsdale.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Arena</LastName>
<ForeName>F</ForeName>
<Initials>F</Initials>
<AffiliationInfo>
<Affiliation>Hematology/Oncology, NYU Langone Arena Oncology, Lake Success, USA.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Moore</LastName>
<ForeName>M</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Provencial Health Services Authority, BC Cancer Agency, Vancouver, Canada.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Siena</LastName>
<ForeName>S</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Falck Division of Oncology, Department of Oncology and Hematology, Niguarda Cancer Center, Ospedale Niguarda Ca' Granda and Università degli Studi di Millano, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Teixeira</LastName>
<ForeName>L</ForeName>
<Initials>L</Initials>
<AffiliationInfo>
<Affiliation>Department of Medical Oncology, Hôpital Saint-Antoine, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Tabernero</LastName>
<ForeName>J</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>Department of Medical Oncology, Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Van Laethem</LastName>
<ForeName>J-L</ForeName>
<Initials>JL</Initials>
<AffiliationInfo>
<Affiliation>University Clinic of Brussels, Hôpital Erasme, Brussels, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Liu</LastName>
<ForeName>H</ForeName>
<Initials>H</Initials>
<AffiliationInfo>
<Affiliation>Biostatistics and Research and Design, Celgene Corporation, Summit.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>McGovern</LastName>
<ForeName>D</ForeName>
<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>Biostatistics and Research and Design, Celgene Corporation, Summit.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Lu</LastName>
<ForeName>B</ForeName>
<Initials>B</Initials>
<AffiliationInfo>
<Affiliation>Biostatistics and Research and Design, Celgene Corporation, Summit.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Von Hoff</LastName>
<ForeName>D D</ForeName>
<Initials>DD</Initials>
<AffiliationInfo>
<Affiliation>Clinical Research, Translational Genomics Research Institute and Honor Health, Scottsdale, USA.</Affiliation>
</AffiliationInfo>
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<Language>eng</Language>
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<PublicationType UI="D016428">Journal Article</PublicationType>
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<ArticleDate DateType="Electronic">
<Year>2016</Year>
<Month>01</Month>
<Day>22</Day>
</ArticleDate>
</Article>
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<Country>England</Country>
<MedlineTA>Ann Oncol</MedlineTA>
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<ISSNLinking>0923-7534</ISSNLinking>
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<DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
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<DescriptorName UI="D017239" MajorTopicYN="N">Paclitaxel</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
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<name sortKey="Siena, S" sort="Siena, S" uniqKey="Siena S" first="S" last="Siena">S. Siena</name>
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