Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial.
Identifieur interne : 002237 ( PubMed/Curation ); précédent : 002236; suivant : 002238Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial.
Auteurs : Andrea Wang-Gillam [États-Unis] ; Chung-Pin Li [Taïwan] ; György Bodoky [Hongrie] ; Andrew Dean [Australie] ; Yan-Shen Shan [Taïwan] ; Gayle Jameson [États-Unis] ; Teresa Macarulla [Espagne] ; Kyung-Hun Lee [Corée du Sud] ; David Cunningham [Royaume-Uni] ; Jean F. Blanc [France] ; Richard A. Hubner [Royaume-Uni] ; Chang-Fang Chiu [Taïwan] ; Gilberto Schwartsmann [Brésil] ; Jens T. Siveke [Allemagne] ; Fadi Braiteh [États-Unis] ; Victor Moyo [États-Unis] ; Bruce Belanger [États-Unis] ; Navreet Dhindsa [États-Unis] ; Eliel Bayever [États-Unis] ; Daniel D. Von Hoff [États-Unis] ; Li-Tzong Chen [Taïwan]Source :
- Lancet (London, England) [ 1474-547X ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Camptothécine (administration et posologie), Camptothécine (analogues et dérivés), Camptothécine (effets indésirables), Carcinome du canal pancréatique (mortalité), Carcinome du canal pancréatique (traitement médicamenteux), Diarrhée (), Désoxycytidine (administration et posologie), Désoxycytidine (analogues et dérivés), Désoxycytidine (effets indésirables), Estimation de Kaplan-Meier, Fatigue (), Femelle, Fluorouracil (administration et posologie), Fluorouracil (effets indésirables), Humains, Leucovorine (administration et posologie), Leucovorine (effets indésirables), Liposomes, Mâle, Métastase tumorale, Neutropénie (), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Résultat thérapeutique, Sujet âgé, Tumeurs du pancréas (mortalité), Tumeurs du pancréas (traitement médicamenteux), Vomissement ().
- MESH :
- administration et posologie : Camptothécine, Désoxycytidine, Fluorouracil, Leucovorine.
- analogues et dérivés : Camptothécine, Désoxycytidine.
- effets indésirables : Camptothécine, Désoxycytidine, Fluorouracil, Leucovorine.
- mortalité : Carcinome du canal pancréatique, Tumeurs du pancréas.
- traitement médicamenteux : Carcinome du canal pancréatique, Tumeurs du pancréas.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
- Adulte d'âge moyen, Diarrhée, Estimation de Kaplan-Meier, Fatigue, Femelle, Humains, Liposomes, Mâle, Métastase tumorale, Neutropénie, Résultat thérapeutique, Sujet âgé, Vomissement.
English descriptors
- KwdEn :
- Aged, Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Camptothecin (administration & dosage), Camptothecin (adverse effects), Camptothecin (analogs & derivatives), Carcinoma, Pancreatic Ductal (drug therapy), Carcinoma, Pancreatic Ductal (mortality), Deoxycytidine (administration & dosage), Deoxycytidine (adverse effects), Deoxycytidine (analogs & derivatives), Diarrhea (chemically induced), Fatigue (chemically induced), Female, Fluorouracil (administration & dosage), Fluorouracil (adverse effects), Humans, Kaplan-Meier Estimate, Leucovorin (administration & dosage), Leucovorin (adverse effects), Liposomes, Male, Middle Aged, Neoplasm Metastasis, Neutropenia (chemically induced), Pancreatic Neoplasms (drug therapy), Pancreatic Neoplasms (mortality), Treatment Outcome, Vomiting (chemically induced).
- MESH :
- chemical , administration & dosage : Camptothecin, Deoxycytidine, Fluorouracil, Leucovorin.
- chemical , adverse effects : Camptothecin, Deoxycytidine, Fluorouracil, Leucovorin.
- chemical , analogs & derivatives : Camptothecin, Deoxycytidine.
- chemically induced : Diarrhea, Fatigue, Neutropenia, Vomiting.
- drug therapy : Carcinoma, Pancreatic Ductal, Pancreatic Neoplasms.
- mortality : Carcinoma, Pancreatic Ductal, Pancreatic Neoplasms.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Aged, Female, Humans, Kaplan-Meier Estimate, Liposomes, Male, Middle Aged, Neoplasm Metastasis, Treatment Outcome.
Abstract
Nanoliposomal irinotecan showed activity in a phase 2 study in patients with metastatic pancreatic ductal adenocarcinoma previously treated with gemcitabine-based therapies. We assessed the effect of nanoliposomal irinotecan alone or combined with fluorouracil and folinic acid in a phase 3 trial in this population.
DOI: 10.1016/S0140-6736(15)00986-1
PubMed: 26615328
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Blanc</name><affiliation wicri:level="1"><nlm:affiliation>Hôpital Saint-André, Bordeaux, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Saint-André, Bordeaux</wicri:regionArea></affiliation></author><author><name sortKey="Hubner, Richard A" sort="Hubner, Richard A" uniqKey="Hubner R" first="Richard A" last="Hubner">Richard A. Hubner</name><affiliation wicri:level="1"><nlm:affiliation>The Christie NHS Foundation Trust, Manchester, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>The Christie NHS Foundation Trust, Manchester</wicri:regionArea></affiliation></author><author><name sortKey="Chiu, Chang Fang" sort="Chiu, Chang Fang" uniqKey="Chiu C" first="Chang-Fang" last="Chiu">Chang-Fang Chiu</name><affiliation wicri:level="1"><nlm:affiliation>China Medical University Hospital, Taichung, Taiwan.</nlm:affiliation><country xml:lang="fr">Taïwan</country><wicri:regionArea>China Medical University Hospital, Taichung</wicri:regionArea></affiliation></author><author><name sortKey="Schwartsmann, Gilberto" sort="Schwartsmann, Gilberto" uniqKey="Schwartsmann G" first="Gilberto" last="Schwartsmann">Gilberto Schwartsmann</name><affiliation wicri:level="1"><nlm:affiliation>Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Hospital de Clínicas de Porto Alegre, Porto Alegre</wicri:regionArea></affiliation></author><author><name sortKey="Siveke, Jens T" sort="Siveke, Jens T" uniqKey="Siveke J" first="Jens T" last="Siveke">Jens T. Siveke</name><affiliation wicri:level="1"><nlm:affiliation>Klinikum rechts der Isar der T U München, Munich, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Klinikum rechts der Isar der T U München, Munich</wicri:regionArea></affiliation></author><author><name sortKey="Braiteh, Fadi" sort="Braiteh, Fadi" uniqKey="Braiteh F" first="Fadi" last="Braiteh">Fadi Braiteh</name><affiliation wicri:level="1"><nlm:affiliation>Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Comprehensive Cancer Centers of Nevada, Las Vegas, NV</wicri:regionArea></affiliation></author><author><name sortKey="Moyo, Victor" sort="Moyo, Victor" uniqKey="Moyo V" first="Victor" last="Moyo">Victor Moyo</name><affiliation wicri:level="1"><nlm:affiliation>Merrimack Pharmaceuticals, Cambridge, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merrimack Pharmaceuticals, Cambridge, MA</wicri:regionArea></affiliation></author><author><name sortKey="Belanger, Bruce" sort="Belanger, Bruce" uniqKey="Belanger B" first="Bruce" last="Belanger">Bruce Belanger</name><affiliation wicri:level="1"><nlm:affiliation>Merrimack Pharmaceuticals, Cambridge, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merrimack Pharmaceuticals, Cambridge, MA</wicri:regionArea></affiliation></author><author><name sortKey="Dhindsa, Navreet" sort="Dhindsa, Navreet" uniqKey="Dhindsa N" first="Navreet" last="Dhindsa">Navreet Dhindsa</name><affiliation wicri:level="1"><nlm:affiliation>Merrimack Pharmaceuticals, Cambridge, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merrimack Pharmaceuticals, Cambridge, MA</wicri:regionArea></affiliation></author><author><name sortKey="Bayever, Eliel" sort="Bayever, Eliel" uniqKey="Bayever E" first="Eliel" last="Bayever">Eliel Bayever</name><affiliation wicri:level="1"><nlm:affiliation>Merrimack Pharmaceuticals, Cambridge, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merrimack Pharmaceuticals, Cambridge, MA</wicri:regionArea></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="1"><nlm:affiliation>TGen, Phoenix, and HonorHealth, Scottsdale, AZ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>TGen, Phoenix, and HonorHealth, Scottsdale, AZ</wicri:regionArea></affiliation></author><author><name sortKey="Chen, Li Tzong" sort="Chen, Li Tzong" uniqKey="Chen L" first="Li-Tzong" last="Chen">Li-Tzong Chen</name><affiliation wicri:level="1"><nlm:affiliation>National Institute of Cancer Research, National Health Research Institutes, Tainan, and Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan. Electronic address: leochen@nhri.org.tw.</nlm:affiliation><country xml:lang="fr">Taïwan</country><wicri:regionArea>National Institute of Cancer Research, National Health Research Institutes, Tainan, and Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; National Cheng Kung University Hospital, National Cheng Kung University, Tainan</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:26615328</idno><idno type="pmid">26615328</idno><idno type="doi">10.1016/S0140-6736(15)00986-1</idno><idno type="wicri:Area/PubMed/Corpus">002263</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002263</idno><idno type="wicri:Area/PubMed/Curation">002237</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">002237</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial.</title><author><name sortKey="Wang Gillam, Andrea" sort="Wang Gillam, Andrea" uniqKey="Wang Gillam A" first="Andrea" last="Wang-Gillam">Andrea Wang-Gillam</name><affiliation wicri:level="1"><nlm:affiliation>Washington University School of Medicine, St Louis, MO, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Washington University School of Medicine, St Louis, MO</wicri:regionArea></affiliation></author><author><name sortKey="Li, Chung Pin" sort="Li, Chung Pin" uniqKey="Li C" first="Chung-Pin" last="Li">Chung-Pin Li</name><affiliation wicri:level="1"><nlm:affiliation>Division of Gastroenterology and Hepatology, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei, Taiwan.</nlm:affiliation><country xml:lang="fr">Taïwan</country><wicri:regionArea>Division of Gastroenterology and Hepatology, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei</wicri:regionArea></affiliation></author><author><name sortKey="Bodoky, Gyorgy" sort="Bodoky, Gyorgy" uniqKey="Bodoky G" first="György" last="Bodoky">György Bodoky</name><affiliation wicri:level="1"><nlm:affiliation>St László Teaching Hospital, Budapest, Hungary.</nlm:affiliation><country xml:lang="fr">Hongrie</country><wicri:regionArea>St László Teaching Hospital, Budapest</wicri:regionArea></affiliation></author><author><name sortKey="Dean, Andrew" sort="Dean, Andrew" uniqKey="Dean A" first="Andrew" last="Dean">Andrew Dean</name><affiliation wicri:level="1"><nlm:affiliation>St John of God Hospital, Subiaco, WA, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>St John of God Hospital, Subiaco, WA</wicri:regionArea></affiliation></author><author><name sortKey="Shan, Yan Shen" sort="Shan, Yan Shen" uniqKey="Shan Y" first="Yan-Shen" last="Shan">Yan-Shen Shan</name><affiliation wicri:level="1"><nlm:affiliation>National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan.</nlm:affiliation><country xml:lang="fr">Taïwan</country><wicri:regionArea>National Cheng Kung University Hospital, National Cheng Kung University, Tainan</wicri:regionArea></affiliation></author><author><name sortKey="Jameson, Gayle" sort="Jameson, Gayle" uniqKey="Jameson G" first="Gayle" last="Jameson">Gayle Jameson</name><affiliation wicri:level="1"><nlm:affiliation>TGen, Phoenix, and HonorHealth, Scottsdale, AZ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>TGen, Phoenix, and HonorHealth, Scottsdale, AZ</wicri:regionArea></affiliation></author><author><name sortKey="Macarulla, Teresa" sort="Macarulla, Teresa" uniqKey="Macarulla T" first="Teresa" last="Macarulla">Teresa Macarulla</name><affiliation wicri:level="1"><nlm:affiliation>Vall d'Hebron University Hospital (HUVH) and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Vall d'Hebron University Hospital (HUVH) and Vall d'Hebron Institute of Oncology (VHIO), Barcelona</wicri:regionArea></affiliation></author><author><name sortKey="Lee, Kyung Hun" sort="Lee, Kyung Hun" uniqKey="Lee K" first="Kyung-Hun" last="Lee">Kyung-Hun Lee</name><affiliation wicri:level="1"><nlm:affiliation>Seoul National University Hospital, Seoul, South Korea.</nlm:affiliation><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Seoul National University Hospital, Seoul</wicri:regionArea></affiliation></author><author><name sortKey="Cunningham, David" sort="Cunningham, David" uniqKey="Cunningham D" first="David" last="Cunningham">David Cunningham</name><affiliation wicri:level="1"><nlm:affiliation>The Royal Marsden Hospital, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>The Royal Marsden Hospital, London</wicri:regionArea></affiliation></author><author><name sortKey="Blanc, Jean F" sort="Blanc, Jean F" uniqKey="Blanc J" first="Jean F" last="Blanc">Jean F. Blanc</name><affiliation wicri:level="1"><nlm:affiliation>Hôpital Saint-André, Bordeaux, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Saint-André, Bordeaux</wicri:regionArea></affiliation></author><author><name sortKey="Hubner, Richard A" sort="Hubner, Richard A" uniqKey="Hubner R" first="Richard A" last="Hubner">Richard A. Hubner</name><affiliation wicri:level="1"><nlm:affiliation>The Christie NHS Foundation Trust, Manchester, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>The Christie NHS Foundation Trust, Manchester</wicri:regionArea></affiliation></author><author><name sortKey="Chiu, Chang Fang" sort="Chiu, Chang Fang" uniqKey="Chiu C" first="Chang-Fang" last="Chiu">Chang-Fang Chiu</name><affiliation wicri:level="1"><nlm:affiliation>China Medical University Hospital, Taichung, Taiwan.</nlm:affiliation><country xml:lang="fr">Taïwan</country><wicri:regionArea>China Medical University Hospital, Taichung</wicri:regionArea></affiliation></author><author><name sortKey="Schwartsmann, Gilberto" sort="Schwartsmann, Gilberto" uniqKey="Schwartsmann G" first="Gilberto" last="Schwartsmann">Gilberto Schwartsmann</name><affiliation wicri:level="1"><nlm:affiliation>Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Hospital de Clínicas de Porto Alegre, Porto Alegre</wicri:regionArea></affiliation></author><author><name sortKey="Siveke, Jens T" sort="Siveke, Jens T" uniqKey="Siveke J" first="Jens T" last="Siveke">Jens T. Siveke</name><affiliation wicri:level="1"><nlm:affiliation>Klinikum rechts der Isar der T U München, Munich, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Klinikum rechts der Isar der T U München, Munich</wicri:regionArea></affiliation></author><author><name sortKey="Braiteh, Fadi" sort="Braiteh, Fadi" uniqKey="Braiteh F" first="Fadi" last="Braiteh">Fadi Braiteh</name><affiliation wicri:level="1"><nlm:affiliation>Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Comprehensive Cancer Centers of Nevada, Las Vegas, NV</wicri:regionArea></affiliation></author><author><name sortKey="Moyo, Victor" sort="Moyo, Victor" uniqKey="Moyo V" first="Victor" last="Moyo">Victor Moyo</name><affiliation wicri:level="1"><nlm:affiliation>Merrimack Pharmaceuticals, Cambridge, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merrimack Pharmaceuticals, Cambridge, MA</wicri:regionArea></affiliation></author><author><name sortKey="Belanger, Bruce" sort="Belanger, Bruce" uniqKey="Belanger B" first="Bruce" last="Belanger">Bruce Belanger</name><affiliation wicri:level="1"><nlm:affiliation>Merrimack Pharmaceuticals, Cambridge, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merrimack Pharmaceuticals, Cambridge, MA</wicri:regionArea></affiliation></author><author><name sortKey="Dhindsa, Navreet" sort="Dhindsa, Navreet" uniqKey="Dhindsa N" first="Navreet" last="Dhindsa">Navreet Dhindsa</name><affiliation wicri:level="1"><nlm:affiliation>Merrimack Pharmaceuticals, Cambridge, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merrimack Pharmaceuticals, Cambridge, MA</wicri:regionArea></affiliation></author><author><name sortKey="Bayever, Eliel" sort="Bayever, Eliel" uniqKey="Bayever E" first="Eliel" last="Bayever">Eliel Bayever</name><affiliation wicri:level="1"><nlm:affiliation>Merrimack Pharmaceuticals, Cambridge, MA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merrimack Pharmaceuticals, Cambridge, MA</wicri:regionArea></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="1"><nlm:affiliation>TGen, Phoenix, and HonorHealth, Scottsdale, AZ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>TGen, Phoenix, and HonorHealth, Scottsdale, AZ</wicri:regionArea></affiliation></author><author><name sortKey="Chen, Li Tzong" sort="Chen, Li Tzong" uniqKey="Chen L" first="Li-Tzong" last="Chen">Li-Tzong Chen</name><affiliation wicri:level="1"><nlm:affiliation>National Institute of Cancer Research, National Health Research Institutes, Tainan, and Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan. Electronic address: leochen@nhri.org.tw.</nlm:affiliation><country xml:lang="fr">Taïwan</country><wicri:regionArea>National Institute of Cancer Research, National Health Research Institutes, Tainan, and Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; National Cheng Kung University Hospital, National Cheng Kung University, Tainan</wicri:regionArea></affiliation></author></analytic><series><title level="j">Lancet (London, England)</title><idno type="eISSN">1474-547X</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term><term>Camptothecin (administration & dosage)</term><term>Camptothecin (adverse effects)</term><term>Camptothecin (analogs & derivatives)</term><term>Carcinoma, Pancreatic Ductal (drug therapy)</term><term>Carcinoma, Pancreatic Ductal (mortality)</term><term>Deoxycytidine (administration & dosage)</term><term>Deoxycytidine (adverse effects)</term><term>Deoxycytidine (analogs & derivatives)</term><term>Diarrhea (chemically induced)</term><term>Fatigue (chemically induced)</term><term>Female</term><term>Fluorouracil (administration & dosage)</term><term>Fluorouracil (adverse effects)</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Leucovorin (administration & dosage)</term><term>Leucovorin (adverse effects)</term><term>Liposomes</term><term>Male</term><term>Middle Aged</term><term>Neoplasm Metastasis</term><term>Neutropenia (chemically induced)</term><term>Pancreatic Neoplasms (drug therapy)</term><term>Pancreatic Neoplasms (mortality)</term><term>Treatment Outcome</term><term>Vomiting (chemically induced)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Camptothécine (administration et posologie)</term><term>Camptothécine (analogues et dérivés)</term><term>Camptothécine (effets indésirables)</term><term>Carcinome du canal pancréatique (mortalité)</term><term>Carcinome du canal pancréatique (traitement médicamenteux)</term><term>Diarrhée ()</term><term>Désoxycytidine (administration et posologie)</term><term>Désoxycytidine (analogues et dérivés)</term><term>Désoxycytidine (effets indésirables)</term><term>Estimation de Kaplan-Meier</term><term>Fatigue ()</term><term>Femelle</term><term>Fluorouracil (administration et posologie)</term><term>Fluorouracil (effets indésirables)</term><term>Humains</term><term>Leucovorine (administration et posologie)</term><term>Leucovorine (effets indésirables)</term><term>Liposomes</term><term>Mâle</term><term>Métastase tumorale</term><term>Neutropénie ()</term><term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Tumeurs du pancréas (mortalité)</term><term>Tumeurs du pancréas (traitement médicamenteux)</term><term>Vomissement ()</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Camptothecin</term><term>Deoxycytidine</term><term>Fluorouracil</term><term>Leucovorin</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Camptothecin</term><term>Deoxycytidine</term><term>Fluorouracil</term><term>Leucovorin</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Camptothecin</term><term>Deoxycytidine</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Camptothécine</term><term>Désoxycytidine</term><term>Fluorouracil</term><term>Leucovorine</term></keywords><keywords scheme="MESH" qualifier="analogues et dérivés" xml:lang="fr"><term>Camptothécine</term><term>Désoxycytidine</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Diarrhea</term><term>Fatigue</term><term>Neutropenia</term><term>Vomiting</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Carcinoma, Pancreatic Ductal</term><term>Pancreatic Neoplasms</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Camptothécine</term><term>Désoxycytidine</term><term>Fluorouracil</term><term>Leucovorine</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Carcinoma, Pancreatic Ductal</term><term>Pancreatic Neoplasms</term></keywords><keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Carcinome du canal pancréatique</term><term>Tumeurs du pancréas</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Carcinome du canal pancréatique</term><term>Tumeurs du pancréas</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Protocoles de polychimiothérapie antinéoplasique</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Female</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Liposomes</term><term>Male</term><term>Middle Aged</term><term>Neoplasm Metastasis</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Diarrhée</term><term>Estimation de Kaplan-Meier</term><term>Fatigue</term><term>Femelle</term><term>Humains</term><term>Liposomes</term><term>Mâle</term><term>Métastase tumorale</term><term>Neutropénie</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Vomissement</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Nanoliposomal irinotecan showed activity in a phase 2 study in patients with metastatic pancreatic ductal adenocarcinoma previously treated with gemcitabine-based therapies. We assessed the effect of nanoliposomal irinotecan alone or combined with fluorouracil and folinic acid in a phase 3 trial in this population.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26615328</PMID><DateCreated><Year>2016</Year><Month>02</Month><Day>12</Day></DateCreated><DateCompleted><Year>2016</Year><Month>03</Month><Day>07</Day></DateCompleted><DateRevised><Year>2017</Year><Month>11</Month><Day>16</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-547X</ISSN><JournalIssue CitedMedium="Internet"><Volume>387</Volume><Issue>10018</Issue><PubDate><Year>2016</Year><Month>Feb</Month><Day>06</Day></PubDate></JournalIssue><Title>Lancet (London, England)</Title><ISOAbbreviation>Lancet</ISOAbbreviation></Journal><ArticleTitle>Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial.</ArticleTitle><Pagination><MedlinePgn>545-57</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/S0140-6736(15)00986-1</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0140-6736(15)00986-1</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Nanoliposomal irinotecan showed activity in a phase 2 study in patients with metastatic pancreatic ductal adenocarcinoma previously treated with gemcitabine-based therapies. We assessed the effect of nanoliposomal irinotecan alone or combined with fluorouracil and folinic acid in a phase 3 trial in this population.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">We did a global, phase 3, randomised, open-label trial at 76 sites in 14 countries. Eligible patients with metastatic pancreatic ductal adenocarcinoma previously treated with gemcitabine-based therapy were randomly assigned (1:1) using an interactive web response system at a central location to receive either nanoliposomal irinotecan monotherapy (120 mg/m(2) every 3 weeks, equivalent to 100 mg/m(2) of irinotecan base) or fluorouracil and folinic acid. A third arm consisting of nanoliposomal irinotecan (80 mg/m(2), equivalent to 70 mg/m(2) of irinotecan base) with fluorouracil and folinic acid every 2 weeks was added later (1:1:1), in a protocol amendment. Randomisation was stratified by baseline albumin, Karnofsky performance status, and ethnic origin. Treatment was continued until disease progression or intolerable toxic effects. The primary endpoint was overall survival, assessed in the intention-to-treat population. The primary analysis was planned after 305 events. Safety was assessed in all patients who had received study drug. This trial is registered at ClinicalTrials.gov, number NCT01494506.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between Jan 11, 2012, and Sept 11, 2013, 417 patients were randomly assigned either nanoliposomal irinotecan plus fluorouracil and folinic acid (n=117), nanoliposomal irinotecan monotherapy (n=151), or fluorouracil and folinic acid (n=149). After 313 events, median overall survival in patients assigned nanoliposomal irinotecan plus fluorouracil and folinic acid was 6.1 months (95% CI 4.8-8.9) vs 4.2 months (3.3-5.3) with fluorouracil and folinic acid (hazard ratio 0.67, 95% CI 0.49-0.92; p=0.012). Median overall survival did not differ between patients assigned nanoliposomal irinotecan monotherapy and those allocated fluorouracil and folinic acid (4.9 months [4.2-5.6] vs 4.2 months [3.6-4.9]; 0.99, 0.77-1.28; p=0.94). The grade 3 or 4 adverse events that occurred most frequently in the 117 patients assigned nanoliposomal irinotecan plus fluorouracil and folinic acid were neutropenia (32 [27%]), diarrhoea (15 [13%]), vomiting (13 [11%]), and fatigue (16 [14%]).</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Nanoliposomal irinotecan in combination with fluorouracil and folinic acid extends survival with a manageable safety profile in patients with metastatic pancreatic ductal adenocarcinoma who previously received gemcitabine-based therapy. This agent represents a new treatment option for this population.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Merrimack Pharmaceuticals.</AbstractText><CopyrightInformation>Copyright © 2016 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Wang-Gillam</LastName><ForeName>Andrea</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Washington University School of Medicine, St Louis, MO, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Li</LastName><ForeName>Chung-Pin</ForeName><Initials>CP</Initials><AffiliationInfo><Affiliation>Division of Gastroenterology and Hepatology, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bodoky</LastName><ForeName>György</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>St László Teaching Hospital, Budapest, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dean</LastName><ForeName>Andrew</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>St John of God Hospital, Subiaco, WA, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shan</LastName><ForeName>Yan-Shen</ForeName><Initials>YS</Initials><AffiliationInfo><Affiliation>National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jameson</LastName><ForeName>Gayle</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>TGen, Phoenix, and HonorHealth, Scottsdale, AZ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Macarulla</LastName><ForeName>Teresa</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Vall d'Hebron University Hospital (HUVH) and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lee</LastName><ForeName>Kyung-Hun</ForeName><Initials>KH</Initials><AffiliationInfo><Affiliation>Seoul National University Hospital, Seoul, South Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cunningham</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>The Royal Marsden Hospital, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Blanc</LastName><ForeName>Jean F</ForeName><Initials>JF</Initials><AffiliationInfo><Affiliation>Hôpital Saint-André, Bordeaux, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hubner</LastName><ForeName>Richard A</ForeName><Initials>RA</Initials><AffiliationInfo><Affiliation>The Christie NHS Foundation Trust, Manchester, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chiu</LastName><ForeName>Chang-Fang</ForeName><Initials>CF</Initials><AffiliationInfo><Affiliation>China Medical University Hospital, Taichung, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schwartsmann</LastName><ForeName>Gilberto</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Siveke</LastName><ForeName>Jens T</ForeName><Initials>JT</Initials><AffiliationInfo><Affiliation>Klinikum rechts der Isar der T U München, Munich, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Braiteh</LastName><ForeName>Fadi</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Moyo</LastName><ForeName>Victor</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Merrimack Pharmaceuticals, Cambridge, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Belanger</LastName><ForeName>Bruce</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Merrimack Pharmaceuticals, Cambridge, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dhindsa</LastName><ForeName>Navreet</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Merrimack Pharmaceuticals, Cambridge, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bayever</LastName><ForeName>Eliel</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Merrimack Pharmaceuticals, Cambridge, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Von Hoff</LastName><ForeName>Daniel D</ForeName><Initials>DD</Initials><AffiliationInfo><Affiliation>TGen, Phoenix, and HonorHealth, Scottsdale, AZ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Li-Tzong</ForeName><Initials>LT</Initials><AffiliationInfo><Affiliation>National Institute of Cancer Research, National Health Research Institutes, Tainan, and Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan. Electronic address: leochen@nhri.org.tw.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>NAPOLI-1 Study Group</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01494506</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>11</Month><Day>29</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet</MedlineTA><NlmUniqueID>2985213R</NlmUniqueID><ISSNLinking>0140-6736</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D008081">Liposomes</NameOfSubstance></Chemical><Chemical><RegistryNumber>0H43101T0J</RegistryNumber><NameOfSubstance UI="C051890">irinotecan</NameOfSubstance></Chemical><Chemical><RegistryNumber>0W860991D6</RegistryNumber><NameOfSubstance UI="D003841">Deoxycytidine</NameOfSubstance></Chemical><Chemical><RegistryNumber>B76N6SBZ8R</RegistryNumber><NameOfSubstance UI="C056507">gemcitabine</NameOfSubstance></Chemical><Chemical><RegistryNumber>Q573I9DVLP</RegistryNumber><NameOfSubstance UI="D002955">Leucovorin</NameOfSubstance></Chemical><Chemical><RegistryNumber>U3P01618RT</RegistryNumber><NameOfSubstance UI="D005472">Fluorouracil</NameOfSubstance></Chemical><Chemical><RegistryNumber>XT3Z54Z28A</RegistryNumber><NameOfSubstance UI="D002166">Camptothecin</NameOfSubstance></Chemical></ChemicalList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Nat Rev Clin Oncol. 2016 Apr;13(4):205-6</RefSource><PMID Version="1">26902963</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Lancet. 2016 May 14;387(10032):1997</RefSource><PMID Version="1">27203770</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Nat Rev Clin Oncol. 2016 Jan;13(1):2-3</RefSource><PMID Version="1">26667974</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Lancet. 2016 Feb 6;387(10018):507-8</RefSource><PMID Version="1">26616909</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Lancet. 2016 May 14;387(10032):1997</RefSource><PMID Version="1">27203772</PMID></CommentsCorrections><CommentsCorrections RefType="ErratumIn"><RefSource>Lancet. 2016 Feb 6;387(10018):536</RefSource><PMID Version="1">26867448</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000971" MajorTopicYN="N">Antineoplastic Combined Chemotherapy Protocols</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002166" MajorTopicYN="N">Camptothecin</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000031" MajorTopicYN="N">analogs & derivatives</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D021441" MajorTopicYN="N">Carcinoma, Pancreatic Ductal</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003841" MajorTopicYN="N">Deoxycytidine</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000031" MajorTopicYN="N">analogs & derivatives</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003967" MajorTopicYN="N">Diarrhea</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005221" MajorTopicYN="N">Fatigue</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005472" MajorTopicYN="N">Fluorouracil</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053208" MajorTopicYN="N">Kaplan-Meier Estimate</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002955" MajorTopicYN="N">Leucovorin</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008081" MajorTopicYN="N">Liposomes</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009362" MajorTopicYN="N">Neoplasm Metastasis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009503" MajorTopicYN="N">Neutropenia</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D010190" MajorTopicYN="N">Pancreatic Neoplasms</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014839" MajorTopicYN="N">Vomiting</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName></MeshHeading></MeshHeadingList><InvestigatorList><Investigator ValidYN="Y"><LastName>Adoo</LastName><ForeName>Clarence</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Anderson</LastName><ForeName>Thomas</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Asselah</LastName><ForeName>Jamil</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Azambuja</LastName><ForeName>Alan</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Bampton</LastName><ForeName>Carolyn</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Barrios</LastName><ForeName>Carlos Henrique</ForeName><Initials>CH</Initials></Investigator><Investigator ValidYN="Y"><LastName>Bekaii-Saab</LastName><ForeName>Tanios</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Bohuslav</LastName><ForeName>Melichar</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Chang</LastName><ForeName>David</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Chen</LastName><ForeName>Jen-Shi</ForeName><Initials>JS</Initials></Investigator><Investigator ValidYN="Y"><LastName>Chen</LastName><ForeName>Yeu-Chin</ForeName><Initials>YC</Initials></Investigator><Investigator ValidYN="Y"><LastName>Choi</LastName><ForeName>Hye Jin</ForeName><Initials>HJ</Initials></Investigator><Investigator ValidYN="Y"><LastName>Chung</LastName><ForeName>Ik Joo</ForeName><Initials>IJ</Initials></Investigator><Investigator ValidYN="Y"><LastName>Chung</LastName><ForeName>Vincent</ForeName><Initials>V</Initials></Investigator><Investigator ValidYN="Y"><LastName>Csoszi</LastName><ForeName>Tibor</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Cubillo</LastName><ForeName>Antonio</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>DeMarco</LastName><ForeName>Linda</ForeName><Initials>L</Initials></Investigator><Investigator ValidYN="Y"><LastName>de Wit</LastName><ForeName>Maike</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Dragovich</LastName><ForeName>Tomislav</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Edenfield</LastName><ForeName>William</ForeName><Initials>W</Initials></Investigator><Investigator ValidYN="Y"><LastName>Fein</LastName><ForeName>Luis Enrique</ForeName><Initials>LE</Initials></Investigator><Investigator ValidYN="Y"><LastName>Franke</LastName><ForeName>Fábio</ForeName><Initials>F</Initials></Investigator><Investigator ValidYN="Y"><LastName>Fuchs</LastName><ForeName>Martin</ForeName><Initials>M</Initials></Investigator><Investigator 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