Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial.
Identifieur interne : 002069 ( Main/Exploration ); précédent : 002068; suivant : 002070Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial.
Auteurs : Werner Scheithauer [États-Unis] ; Ramesh K. Ramanathan [États-Unis] ; Malcolm Moore [États-Unis] ; Teresa Macarulla [États-Unis] ; David Goldstein [États-Unis] ; Pascal Hammel [États-Unis] ; Volker Kunzmann [États-Unis] ; Helen Liu [États-Unis] ; Desmond Mcgovern [États-Unis] ; Alfredo Romano [États-Unis] ; Daniel D. Von Hoff [États-Unis]Source :
- Journal of gastrointestinal oncology [ 2078-6891 ] ; 2016.
Abstract
Dose modifications following adverse events (AEs) are an important part of the management of patients with pancreatic cancer treated with chemotherapy. While dose modifications are utilized to ensure patient safety, the subsequent influence of dose adjustments on treatment exposure and efficacy have not been reported in detail. This exploratory analysis examined the influence of dose modifications on treatment exposure and efficacy in the phase III MPACT trial, which demonstrated superior efficacy of nab-paclitaxel (nab-P) plus gemcitabine (Gem) to Gem alone for the treatment of metastatic pancreatic cancer.
DOI: 10.21037/jgo.2016.01.03
PubMed: 27284481
Affiliations:
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<affiliation wicri:level="2"><nlm:affiliation>1 Medizinische Universität Wien, Wien, Austria ; 2 Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona, USA ; 3 BC Cancer Agency, Vancouver, British Columbia, Canada ; 4 Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain ; 5 Prince of Wales Hospital, Sydney, NSW, Australia ; 6 Hôpital Beaujon, Clichy, France ; 7 Universitätsklinikum Würzburg, Würzburg, Germany ; 8 Celgene Corporation, Summit, New Jersey, USA ; 9 Celgene Corporation, Boudry, Switzerland ; 10 Translational Genomics Research Institute and Honor Health, Scottsdale, Arizona, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>1 Medizinische Universität Wien, Wien, Austria ; 2 Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona, USA ; 3 BC Cancer Agency, Vancouver, British Columbia, Canada ; 4 Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain ; 5 Prince of Wales Hospital, Sydney, NSW, Australia ; 6 Hôpital Beaujon, Clichy, France ; 7 Universitätsklinikum Würzburg, Würzburg, Germany ; 8 Celgene Corporation, Summit, New Jersey, USA ; 9 Celgene Corporation, Boudry, Switzerland ; 10 Translational Genomics Research Institute and Honor Health, Scottsdale, Arizona</wicri:regionArea>
<placeName><region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Hammel, Pascal" sort="Hammel, Pascal" uniqKey="Hammel P" first="Pascal" last="Hammel">Pascal Hammel</name>
<affiliation wicri:level="2"><nlm:affiliation>1 Medizinische Universität Wien, Wien, Austria ; 2 Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona, USA ; 3 BC Cancer Agency, Vancouver, British Columbia, Canada ; 4 Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain ; 5 Prince of Wales Hospital, Sydney, NSW, Australia ; 6 Hôpital Beaujon, Clichy, France ; 7 Universitätsklinikum Würzburg, Würzburg, Germany ; 8 Celgene Corporation, Summit, New Jersey, USA ; 9 Celgene Corporation, Boudry, Switzerland ; 10 Translational Genomics Research Institute and Honor Health, Scottsdale, Arizona, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>1 Medizinische Universität Wien, Wien, Austria ; 2 Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona, USA ; 3 BC Cancer Agency, Vancouver, British Columbia, Canada ; 4 Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain ; 5 Prince of Wales Hospital, Sydney, NSW, Australia ; 6 Hôpital Beaujon, Clichy, France ; 7 Universitätsklinikum Würzburg, Würzburg, Germany ; 8 Celgene Corporation, Summit, New Jersey, USA ; 9 Celgene Corporation, Boudry, Switzerland ; 10 Translational Genomics Research Institute and Honor Health, Scottsdale, Arizona</wicri:regionArea>
<placeName><region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kunzmann, Volker" sort="Kunzmann, Volker" uniqKey="Kunzmann V" first="Volker" last="Kunzmann">Volker Kunzmann</name>
<affiliation wicri:level="2"><nlm:affiliation>1 Medizinische Universität Wien, Wien, Austria ; 2 Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona, USA ; 3 BC Cancer Agency, Vancouver, British Columbia, Canada ; 4 Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain ; 5 Prince of Wales Hospital, Sydney, NSW, Australia ; 6 Hôpital Beaujon, Clichy, France ; 7 Universitätsklinikum Würzburg, Würzburg, Germany ; 8 Celgene Corporation, Summit, New Jersey, USA ; 9 Celgene Corporation, Boudry, Switzerland ; 10 Translational Genomics Research Institute and Honor Health, Scottsdale, Arizona, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>1 Medizinische Universität Wien, Wien, Austria ; 2 Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona, USA ; 3 BC Cancer Agency, Vancouver, British Columbia, Canada ; 4 Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain ; 5 Prince of Wales Hospital, Sydney, NSW, Australia ; 6 Hôpital Beaujon, Clichy, France ; 7 Universitätsklinikum Würzburg, Würzburg, Germany ; 8 Celgene Corporation, Summit, New Jersey, USA ; 9 Celgene Corporation, Boudry, Switzerland ; 10 Translational Genomics Research Institute and Honor Health, Scottsdale, Arizona</wicri:regionArea>
<placeName><region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Liu, Helen" sort="Liu, Helen" uniqKey="Liu H" first="Helen" last="Liu">Helen Liu</name>
<affiliation wicri:level="2"><nlm:affiliation>1 Medizinische Universität Wien, Wien, Austria ; 2 Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona, USA ; 3 BC Cancer Agency, Vancouver, British Columbia, Canada ; 4 Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain ; 5 Prince of Wales Hospital, Sydney, NSW, Australia ; 6 Hôpital Beaujon, Clichy, France ; 7 Universitätsklinikum Würzburg, Würzburg, Germany ; 8 Celgene Corporation, Summit, New Jersey, USA ; 9 Celgene Corporation, Boudry, Switzerland ; 10 Translational Genomics Research Institute and Honor Health, Scottsdale, Arizona, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>1 Medizinische Universität Wien, Wien, Austria ; 2 Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona, USA ; 3 BC Cancer Agency, Vancouver, British Columbia, Canada ; 4 Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain ; 5 Prince of Wales Hospital, Sydney, NSW, Australia ; 6 Hôpital Beaujon, Clichy, France ; 7 Universitätsklinikum Würzburg, Würzburg, Germany ; 8 Celgene Corporation, Summit, New Jersey, USA ; 9 Celgene Corporation, Boudry, Switzerland ; 10 Translational Genomics Research Institute and Honor Health, Scottsdale, Arizona</wicri:regionArea>
<placeName><region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mcgovern, Desmond" sort="Mcgovern, Desmond" uniqKey="Mcgovern D" first="Desmond" last="Mcgovern">Desmond Mcgovern</name>
<affiliation wicri:level="2"><nlm:affiliation>1 Medizinische Universität Wien, Wien, Austria ; 2 Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona, USA ; 3 BC Cancer Agency, Vancouver, British Columbia, Canada ; 4 Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain ; 5 Prince of Wales Hospital, Sydney, NSW, Australia ; 6 Hôpital Beaujon, Clichy, France ; 7 Universitätsklinikum Würzburg, Würzburg, Germany ; 8 Celgene Corporation, Summit, New Jersey, USA ; 9 Celgene Corporation, Boudry, Switzerland ; 10 Translational Genomics Research Institute and Honor Health, Scottsdale, Arizona, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>1 Medizinische Universität Wien, Wien, Austria ; 2 Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona, USA ; 3 BC Cancer Agency, Vancouver, British Columbia, Canada ; 4 Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain ; 5 Prince of Wales Hospital, Sydney, NSW, Australia ; 6 Hôpital Beaujon, Clichy, France ; 7 Universitätsklinikum Würzburg, Würzburg, Germany ; 8 Celgene Corporation, Summit, New Jersey, USA ; 9 Celgene Corporation, Boudry, Switzerland ; 10 Translational Genomics Research Institute and Honor Health, Scottsdale, Arizona</wicri:regionArea>
<placeName><region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Romano, Alfredo" sort="Romano, Alfredo" uniqKey="Romano A" first="Alfredo" last="Romano">Alfredo Romano</name>
<affiliation wicri:level="2"><nlm:affiliation>1 Medizinische Universität Wien, Wien, Austria ; 2 Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona, USA ; 3 BC Cancer Agency, Vancouver, British Columbia, Canada ; 4 Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain ; 5 Prince of Wales Hospital, Sydney, NSW, Australia ; 6 Hôpital Beaujon, Clichy, France ; 7 Universitätsklinikum Würzburg, Würzburg, Germany ; 8 Celgene Corporation, Summit, New Jersey, USA ; 9 Celgene Corporation, Boudry, Switzerland ; 10 Translational Genomics Research Institute and Honor Health, Scottsdale, Arizona, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>1 Medizinische Universität Wien, Wien, Austria ; 2 Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona, USA ; 3 BC Cancer Agency, Vancouver, British Columbia, Canada ; 4 Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain ; 5 Prince of Wales Hospital, Sydney, NSW, Australia ; 6 Hôpital Beaujon, Clichy, France ; 7 Universitätsklinikum Würzburg, Würzburg, Germany ; 8 Celgene Corporation, Summit, New Jersey, USA ; 9 Celgene Corporation, Boudry, Switzerland ; 10 Translational Genomics Research Institute and Honor Health, Scottsdale, Arizona</wicri:regionArea>
<placeName><region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Von Hoff, Daniel D" sort="Von Hoff, Daniel D" uniqKey="Von Hoff D" first="Daniel D" last="Von Hoff">Daniel D. Von Hoff</name>
<affiliation wicri:level="2"><nlm:affiliation>1 Medizinische Universität Wien, Wien, Austria ; 2 Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona, USA ; 3 BC Cancer Agency, Vancouver, British Columbia, Canada ; 4 Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain ; 5 Prince of Wales Hospital, Sydney, NSW, Australia ; 6 Hôpital Beaujon, Clichy, France ; 7 Universitätsklinikum Würzburg, Würzburg, Germany ; 8 Celgene Corporation, Summit, New Jersey, USA ; 9 Celgene Corporation, Boudry, Switzerland ; 10 Translational Genomics Research Institute and Honor Health, Scottsdale, Arizona, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>1 Medizinische Universität Wien, Wien, Austria ; 2 Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona, USA ; 3 BC Cancer Agency, Vancouver, British Columbia, Canada ; 4 Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain ; 5 Prince of Wales Hospital, Sydney, NSW, Australia ; 6 Hôpital Beaujon, Clichy, France ; 7 Universitätsklinikum Würzburg, Würzburg, Germany ; 8 Celgene Corporation, Summit, New Jersey, USA ; 9 Celgene Corporation, Boudry, Switzerland ; 10 Translational Genomics Research Institute and Honor Health, Scottsdale, Arizona</wicri:regionArea>
<placeName><region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">Journal of gastrointestinal oncology</title>
<idno type="ISSN">2078-6891</idno>
<imprint><date when="2016" type="published">2016</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Dose modifications following adverse events (AEs) are an important part of the management of patients with pancreatic cancer treated with chemotherapy. While dose modifications are utilized to ensure patient safety, the subsequent influence of dose adjustments on treatment exposure and efficacy have not been reported in detail. This exploratory analysis examined the influence of dose modifications on treatment exposure and efficacy in the phase III MPACT trial, which demonstrated superior efficacy of nab-paclitaxel (nab-P) plus gemcitabine (Gem) to Gem alone for the treatment of metastatic pancreatic cancer.</div>
</front>
</TEI>
<affiliations><list><country><li>États-Unis</li>
</country>
<region><li>Arizona</li>
</region>
</list>
<tree><country name="États-Unis"><region name="Arizona"><name sortKey="Scheithauer, Werner" sort="Scheithauer, Werner" uniqKey="Scheithauer W" first="Werner" last="Scheithauer">Werner Scheithauer</name>
</region>
<name sortKey="Goldstein, David" sort="Goldstein, David" uniqKey="Goldstein D" first="David" last="Goldstein">David Goldstein</name>
<name sortKey="Hammel, Pascal" sort="Hammel, Pascal" uniqKey="Hammel P" first="Pascal" last="Hammel">Pascal Hammel</name>
<name sortKey="Kunzmann, Volker" sort="Kunzmann, Volker" uniqKey="Kunzmann V" first="Volker" last="Kunzmann">Volker Kunzmann</name>
<name sortKey="Liu, Helen" sort="Liu, Helen" uniqKey="Liu H" first="Helen" last="Liu">Helen Liu</name>
<name sortKey="Macarulla, Teresa" sort="Macarulla, Teresa" uniqKey="Macarulla T" first="Teresa" last="Macarulla">Teresa Macarulla</name>
<name sortKey="Mcgovern, Desmond" sort="Mcgovern, Desmond" uniqKey="Mcgovern D" first="Desmond" last="Mcgovern">Desmond Mcgovern</name>
<name sortKey="Moore, Malcolm" sort="Moore, Malcolm" uniqKey="Moore M" first="Malcolm" last="Moore">Malcolm Moore</name>
<name sortKey="Ramanathan, Ramesh K" sort="Ramanathan, Ramesh K" uniqKey="Ramanathan R" first="Ramesh K" last="Ramanathan">Ramesh K. Ramanathan</name>
<name sortKey="Romano, Alfredo" sort="Romano, Alfredo" uniqKey="Romano A" first="Alfredo" last="Romano">Alfredo Romano</name>
<name sortKey="Von Hoff, Daniel D" sort="Von Hoff, Daniel D" uniqKey="Von Hoff D" first="Daniel D" last="Von Hoff">Daniel D. Von Hoff</name>
</country>
</tree>
</affiliations>
</record>
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