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Final analysis of survival outcomes in the randomized phase 3 FIRST trial.

Identifieur interne : 000120 ( PubMed/Corpus ); précédent : 000119; suivant : 000121

Final analysis of survival outcomes in the randomized phase 3 FIRST trial.

Auteurs : Thierry Facon ; Meletios A. Dimopoulos ; Angela Dispenzieri ; John V. Catalano ; Andrew Belch ; Michele Cavo ; Antonello Pinto ; Katja Weisel ; Heinz Ludwig ; Nizar J. Bahlis ; Anne Banos ; Mourad Tiab ; Michel Delforge ; Jamie D. Cavenagh ; Catarina Geraldes ; Je-Jung Lee ; Christine Chen ; Albert Oriol ; Javier De La Rubia ; Darell White ; Daniel Binder ; Jin Lu ; Kenneth C. Anderson ; Philippe Moreau ; Michel Attal ; Aurore Perrot ; Bertrand Arnulf ; Lugui Qiu ; Murielle Roussel ; Eileen Boyle ; Salomon Manier ; Mohamad Mohty ; Herve Avet-Loiseau ; Xavier Leleu ; Annette Ervin-Haynes ; Guang Chen ; Vanessa Houck ; Lotfi Benboubker ; Cyrille Hulin

Source :

RBID : pubmed:29150421

Abstract

This FIRST trial final analysis examined survival outcomes in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM) treated with lenalidomide and low-dose dexamethasone until disease progression (Rd continuous), Rd for 72 weeks (18 cycles; Rd18), or melphalan, prednisone, and thalidomide (MPT; 72 weeks). The primary endpoint was progression-free survival (PFS; primary comparison: Rd continuous vs MPT). Overall survival (OS) was a key secondary endpoint (final analysis prespecified ≥ 60 months' follow-up). Patients were randomized to Rd continuous (n = 535), Rd18 (n = 541), or MPT (n = 547). At a median follow-up of 67 months, PFS was significantly longer with Rd continuous vs MPT (HR, 0.69; 96% CI, 0.59-0.79; P < .00001) and was similarly extended vs Rd18. Median OS was 10 months longer with Rd continuous vs MPT (59.1 vs 49.1 months; HR, 0.78; 95% CI, 0.63-0.95; P = .0144), and similar with Rd18 (62.3 months). In patients achieving complete or very good partial responses, Rd continuous had a ≈ 30-month-longer median time to next treatment vs Rd18 (69.5 vs 39.9 months). Over half of all patients who received second-line treatment were given a bortezomib-based therapy. Second-line outcomes were improved in patients receiving bortezomib after Rd continuous and Rd18 vs after MPT. No new safety concerns, including risk for secondary malignancies, were observed. Treatment with Rd continuous significantly improved survival outcomes vs MPT, supporting Rd continuous as a standard of care for patients with transplant-ineligible NDMM. Study registration is at Clinicaltrials.gov (NCT00689936) and EudraCT (2007-004823-39).

DOI: 10.1182/blood-2017-07-795047
PubMed: 29150421

Links to Exploration step

pubmed:29150421

Le document en format XML

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<name sortKey="Facon, Thierry" sort="Facon, Thierry" uniqKey="Facon T" first="Thierry" last="Facon">Thierry Facon</name>
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<nlm:affiliation>Service des Maladies du Sang, Hopital Claude Huriez, Lille, France; thierry.facon@chru-lille.fr.</nlm:affiliation>
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<name sortKey="Catalano, John V" sort="Catalano, John V" uniqKey="Catalano J" first="John V" last="Catalano">John V. Catalano</name>
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<name sortKey="Belch, Andrew" sort="Belch, Andrew" uniqKey="Belch A" first="Andrew" last="Belch">Andrew Belch</name>
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<nlm:affiliation>Cross Cancer Institute, Edmonton, Canada.</nlm:affiliation>
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<name sortKey="Cavo, Michele" sort="Cavo, Michele" uniqKey="Cavo M" first="Michele" last="Cavo">Michele Cavo</name>
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<name sortKey="Pinto, Antonello" sort="Pinto, Antonello" uniqKey="Pinto A" first="Antonello" last="Pinto">Antonello Pinto</name>
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<name sortKey="Weisel, Katja" sort="Weisel, Katja" uniqKey="Weisel K" first="Katja" last="Weisel">Katja Weisel</name>
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<nlm:affiliation>University of Tuebingen, Germany.</nlm:affiliation>
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<name sortKey="Ludwig, Heinz" sort="Ludwig, Heinz" uniqKey="Ludwig H" first="Heinz" last="Ludwig">Heinz Ludwig</name>
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<nlm:affiliation>Wilhelminenspital, Center for Oncology, Vienna, Austria.</nlm:affiliation>
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<name sortKey="Bahlis, Nizar J" sort="Bahlis, Nizar J" uniqKey="Bahlis N" first="Nizar J" last="Bahlis">Nizar J. Bahlis</name>
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<name sortKey="Banos, Anne" sort="Banos, Anne" uniqKey="Banos A" first="Anne" last="Banos">Anne Banos</name>
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<nlm:affiliation>Centre Hospitalier de la Cote Basque, Bayonne, France.</nlm:affiliation>
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<name sortKey="Tiab, Mourad" sort="Tiab, Mourad" uniqKey="Tiab M" first="Mourad" last="Tiab">Mourad Tiab</name>
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<nlm:affiliation>University Hospital La Roche Sur Yon, France.</nlm:affiliation>
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<name sortKey="Delforge, Michel" sort="Delforge, Michel" uniqKey="Delforge M" first="Michel" last="Delforge">Michel Delforge</name>
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<nlm:affiliation>University Hospital Leuven, Belgium.</nlm:affiliation>
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<name sortKey="Cavenagh, Jamie D" sort="Cavenagh, Jamie D" uniqKey="Cavenagh J" first="Jamie D" last="Cavenagh">Jamie D. Cavenagh</name>
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<nlm:affiliation>Barts Health NHS Trust, London, United Kingdom.</nlm:affiliation>
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<name sortKey="Geraldes, Catarina" sort="Geraldes, Catarina" uniqKey="Geraldes C" first="Catarina" last="Geraldes">Catarina Geraldes</name>
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<nlm:affiliation>Hospitais da Universidade de Coimbra, Portugal.</nlm:affiliation>
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<name sortKey="Lee, Je Jung" sort="Lee, Je Jung" uniqKey="Lee J" first="Je-Jung" last="Lee">Je-Jung Lee</name>
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<nlm:affiliation>Chonnam National University Hwasun Hospital, Jeollanamdo, Korea, Republic of.</nlm:affiliation>
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<name sortKey="Chen, Christine" sort="Chen, Christine" uniqKey="Chen C" first="Christine" last="Chen">Christine Chen</name>
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<nlm:affiliation>Princess Margaret Hospital, Toronto, Canada.</nlm:affiliation>
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<name sortKey="Oriol, Albert" sort="Oriol, Albert" uniqKey="Oriol A" first="Albert" last="Oriol">Albert Oriol</name>
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<nlm:affiliation>Institut Catala d'Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Badalona, Spain.</nlm:affiliation>
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<name sortKey="De La Rubia, Javier" sort="De La Rubia, Javier" uniqKey="De La Rubia J" first="Javier" last="De La Rubia">Javier De La Rubia</name>
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<nlm:affiliation>Hospital Dr. Peset, Valencia, Spain.</nlm:affiliation>
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<name sortKey="White, Darell" sort="White, Darell" uniqKey="White D" first="Darell" last="White">Darell White</name>
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<nlm:affiliation>Queen Elizabeth II Health Sciences Centre, Halifax, Canada.</nlm:affiliation>
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<name sortKey="Binder, Daniel" sort="Binder, Daniel" uniqKey="Binder D" first="Daniel" last="Binder">Daniel Binder</name>
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<nlm:affiliation>Kantonsspital Winterthur, Switzerland.</nlm:affiliation>
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<name sortKey="Lu, Jin" sort="Lu, Jin" uniqKey="Lu J" first="Jin" last="Lu">Jin Lu</name>
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<nlm:affiliation>Peking University People's Hospital, Beijing, China.</nlm:affiliation>
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<author>
<name sortKey="Anderson, Kenneth C" sort="Anderson, Kenneth C" uniqKey="Anderson K" first="Kenneth C" last="Anderson">Kenneth C. Anderson</name>
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<nlm:affiliation>Dana-Farber Cancer Institute, Boston, MA, United States.</nlm:affiliation>
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<name sortKey="Moreau, Philippe" sort="Moreau, Philippe" uniqKey="Moreau P" first="Philippe" last="Moreau">Philippe Moreau</name>
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<nlm:affiliation>University of Nantes, France.</nlm:affiliation>
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<name sortKey="Attal, Michel" sort="Attal, Michel" uniqKey="Attal M" first="Michel" last="Attal">Michel Attal</name>
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<nlm:affiliation>Institut Universitaire du Cancer, Toulouse-Oncopole, France.</nlm:affiliation>
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<name sortKey="Perrot, Aurore" sort="Perrot, Aurore" uniqKey="Perrot A" first="Aurore" last="Perrot">Aurore Perrot</name>
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<nlm:affiliation>CHU de Nancy, Universite de Lorraine, France.</nlm:affiliation>
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<name sortKey="Arnulf, Bertrand" sort="Arnulf, Bertrand" uniqKey="Arnulf B" first="Bertrand" last="Arnulf">Bertrand Arnulf</name>
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<nlm:affiliation>Hopital Saint Louis, Paris, France.</nlm:affiliation>
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<name sortKey="Qiu, Lugui" sort="Qiu, Lugui" uniqKey="Qiu L" first="Lugui" last="Qiu">Lugui Qiu</name>
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<nlm:affiliation>Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Tianjin, China.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Roussel, Murielle" sort="Roussel, Murielle" uniqKey="Roussel M" first="Murielle" last="Roussel">Murielle Roussel</name>
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<nlm:affiliation>CHU Purpan/IUCT Oncopole, Toulouse, France.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Boyle, Eileen" sort="Boyle, Eileen" uniqKey="Boyle E" first="Eileen" last="Boyle">Eileen Boyle</name>
<affiliation>
<nlm:affiliation>Service des Maladies du Sang, Hopital Claude Huriez, Lille, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Manier, Salomon" sort="Manier, Salomon" uniqKey="Manier S" first="Salomon" last="Manier">Salomon Manier</name>
<affiliation>
<nlm:affiliation>Service des Maladies du Sang, Hopital Claude Huriez, Lille, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Mohty, Mohamad" sort="Mohty, Mohamad" uniqKey="Mohty M" first="Mohamad" last="Mohty">Mohamad Mohty</name>
<affiliation>
<nlm:affiliation>Hopital Saint-Antoine, Paris, France.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Avet Loiseau, Herve" sort="Avet Loiseau, Herve" uniqKey="Avet Loiseau H" first="Herve" last="Avet-Loiseau">Herve Avet-Loiseau</name>
<affiliation>
<nlm:affiliation>Unite de Genomique du Myelome, CHU Rangueil, Toulouse, France.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Leleu, Xavier" sort="Leleu, Xavier" uniqKey="Leleu X" first="Xavier" last="Leleu">Xavier Leleu</name>
<affiliation>
<nlm:affiliation>Hopital de la Miletrie, CHU INSERM, Poitiers, France.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Ervin Haynes, Annette" sort="Ervin Haynes, Annette" uniqKey="Ervin Haynes A" first="Annette" last="Ervin-Haynes">Annette Ervin-Haynes</name>
<affiliation>
<nlm:affiliation>Celgene Corporation, Summit, NJ, United States.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Chen, Guang" sort="Chen, Guang" uniqKey="Chen G" first="Guang" last="Chen">Guang Chen</name>
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<nlm:affiliation>Celgene Corporation, Summit, NJ, United States.</nlm:affiliation>
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<name sortKey="Houck, Vanessa" sort="Houck, Vanessa" uniqKey="Houck V" first="Vanessa" last="Houck">Vanessa Houck</name>
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<nlm:affiliation>Celgene Corporation, Summit, NJ, United States.</nlm:affiliation>
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<author>
<name sortKey="Benboubker, Lotfi" sort="Benboubker, Lotfi" uniqKey="Benboubker L" first="Lotfi" last="Benboubker">Lotfi Benboubker</name>
<affiliation>
<nlm:affiliation>CHRU Hopital Bretonneau, Tours Cedex, France.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Hulin, Cyrille" sort="Hulin, Cyrille" uniqKey="Hulin C" first="Cyrille" last="Hulin">Cyrille Hulin</name>
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<nlm:affiliation>Bordeaux Hospital University Center (CHU), France.</nlm:affiliation>
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<title xml:lang="en">Final analysis of survival outcomes in the randomized phase 3 FIRST trial.</title>
<author>
<name sortKey="Facon, Thierry" sort="Facon, Thierry" uniqKey="Facon T" first="Thierry" last="Facon">Thierry Facon</name>
<affiliation>
<nlm:affiliation>Service des Maladies du Sang, Hopital Claude Huriez, Lille, France; thierry.facon@chru-lille.fr.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Dimopoulos, Meletios A" sort="Dimopoulos, Meletios A" uniqKey="Dimopoulos M" first="Meletios A" last="Dimopoulos">Meletios A. Dimopoulos</name>
<affiliation>
<nlm:affiliation>National and Kapodistrian University of Athens School of Medicine, Greece.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Dispenzieri, Angela" sort="Dispenzieri, Angela" uniqKey="Dispenzieri A" first="Angela" last="Dispenzieri">Angela Dispenzieri</name>
<affiliation>
<nlm:affiliation>Mayo Clinic, Rochester, MN, United States.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Catalano, John V" sort="Catalano, John V" uniqKey="Catalano J" first="John V" last="Catalano">John V. Catalano</name>
<affiliation>
<nlm:affiliation>Frankston Hospital and Monash University, Australia.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Belch, Andrew" sort="Belch, Andrew" uniqKey="Belch A" first="Andrew" last="Belch">Andrew Belch</name>
<affiliation>
<nlm:affiliation>Cross Cancer Institute, Edmonton, Canada.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Cavo, Michele" sort="Cavo, Michele" uniqKey="Cavo M" first="Michele" last="Cavo">Michele Cavo</name>
<affiliation>
<nlm:affiliation>Bologna University School of Medicine, Seragnoli Institute of Hematology, Italy.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Pinto, Antonello" sort="Pinto, Antonello" uniqKey="Pinto A" first="Antonello" last="Pinto">Antonello Pinto</name>
<affiliation>
<nlm:affiliation>Head Department of Hematology and Developmental Therapeutics, National Cancer Institute, Fondazione "Pascale", Naples, Italy.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Weisel, Katja" sort="Weisel, Katja" uniqKey="Weisel K" first="Katja" last="Weisel">Katja Weisel</name>
<affiliation>
<nlm:affiliation>University of Tuebingen, Germany.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Ludwig, Heinz" sort="Ludwig, Heinz" uniqKey="Ludwig H" first="Heinz" last="Ludwig">Heinz Ludwig</name>
<affiliation>
<nlm:affiliation>Wilhelminenspital, Center for Oncology, Vienna, Austria.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Bahlis, Nizar J" sort="Bahlis, Nizar J" uniqKey="Bahlis N" first="Nizar J" last="Bahlis">Nizar J. Bahlis</name>
<affiliation>
<nlm:affiliation>University of Calgary, Southern Alberta Cancer Research Institute, Canada.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Banos, Anne" sort="Banos, Anne" uniqKey="Banos A" first="Anne" last="Banos">Anne Banos</name>
<affiliation>
<nlm:affiliation>Centre Hospitalier de la Cote Basque, Bayonne, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Tiab, Mourad" sort="Tiab, Mourad" uniqKey="Tiab M" first="Mourad" last="Tiab">Mourad Tiab</name>
<affiliation>
<nlm:affiliation>University Hospital La Roche Sur Yon, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Delforge, Michel" sort="Delforge, Michel" uniqKey="Delforge M" first="Michel" last="Delforge">Michel Delforge</name>
<affiliation>
<nlm:affiliation>University Hospital Leuven, Belgium.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Cavenagh, Jamie D" sort="Cavenagh, Jamie D" uniqKey="Cavenagh J" first="Jamie D" last="Cavenagh">Jamie D. Cavenagh</name>
<affiliation>
<nlm:affiliation>Barts Health NHS Trust, London, United Kingdom.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Geraldes, Catarina" sort="Geraldes, Catarina" uniqKey="Geraldes C" first="Catarina" last="Geraldes">Catarina Geraldes</name>
<affiliation>
<nlm:affiliation>Hospitais da Universidade de Coimbra, Portugal.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Lee, Je Jung" sort="Lee, Je Jung" uniqKey="Lee J" first="Je-Jung" last="Lee">Je-Jung Lee</name>
<affiliation>
<nlm:affiliation>Chonnam National University Hwasun Hospital, Jeollanamdo, Korea, Republic of.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Chen, Christine" sort="Chen, Christine" uniqKey="Chen C" first="Christine" last="Chen">Christine Chen</name>
<affiliation>
<nlm:affiliation>Princess Margaret Hospital, Toronto, Canada.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Oriol, Albert" sort="Oriol, Albert" uniqKey="Oriol A" first="Albert" last="Oriol">Albert Oriol</name>
<affiliation>
<nlm:affiliation>Institut Catala d'Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Badalona, Spain.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="De La Rubia, Javier" sort="De La Rubia, Javier" uniqKey="De La Rubia J" first="Javier" last="De La Rubia">Javier De La Rubia</name>
<affiliation>
<nlm:affiliation>Hospital Dr. Peset, Valencia, Spain.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="White, Darell" sort="White, Darell" uniqKey="White D" first="Darell" last="White">Darell White</name>
<affiliation>
<nlm:affiliation>Queen Elizabeth II Health Sciences Centre, Halifax, Canada.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Binder, Daniel" sort="Binder, Daniel" uniqKey="Binder D" first="Daniel" last="Binder">Daniel Binder</name>
<affiliation>
<nlm:affiliation>Kantonsspital Winterthur, Switzerland.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Lu, Jin" sort="Lu, Jin" uniqKey="Lu J" first="Jin" last="Lu">Jin Lu</name>
<affiliation>
<nlm:affiliation>Peking University People's Hospital, Beijing, China.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Anderson, Kenneth C" sort="Anderson, Kenneth C" uniqKey="Anderson K" first="Kenneth C" last="Anderson">Kenneth C. Anderson</name>
<affiliation>
<nlm:affiliation>Dana-Farber Cancer Institute, Boston, MA, United States.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Moreau, Philippe" sort="Moreau, Philippe" uniqKey="Moreau P" first="Philippe" last="Moreau">Philippe Moreau</name>
<affiliation>
<nlm:affiliation>University of Nantes, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Attal, Michel" sort="Attal, Michel" uniqKey="Attal M" first="Michel" last="Attal">Michel Attal</name>
<affiliation>
<nlm:affiliation>Institut Universitaire du Cancer, Toulouse-Oncopole, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Perrot, Aurore" sort="Perrot, Aurore" uniqKey="Perrot A" first="Aurore" last="Perrot">Aurore Perrot</name>
<affiliation>
<nlm:affiliation>CHU de Nancy, Universite de Lorraine, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Arnulf, Bertrand" sort="Arnulf, Bertrand" uniqKey="Arnulf B" first="Bertrand" last="Arnulf">Bertrand Arnulf</name>
<affiliation>
<nlm:affiliation>Hopital Saint Louis, Paris, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Qiu, Lugui" sort="Qiu, Lugui" uniqKey="Qiu L" first="Lugui" last="Qiu">Lugui Qiu</name>
<affiliation>
<nlm:affiliation>Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Tianjin, China.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Roussel, Murielle" sort="Roussel, Murielle" uniqKey="Roussel M" first="Murielle" last="Roussel">Murielle Roussel</name>
<affiliation>
<nlm:affiliation>CHU Purpan/IUCT Oncopole, Toulouse, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Boyle, Eileen" sort="Boyle, Eileen" uniqKey="Boyle E" first="Eileen" last="Boyle">Eileen Boyle</name>
<affiliation>
<nlm:affiliation>Service des Maladies du Sang, Hopital Claude Huriez, Lille, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Manier, Salomon" sort="Manier, Salomon" uniqKey="Manier S" first="Salomon" last="Manier">Salomon Manier</name>
<affiliation>
<nlm:affiliation>Service des Maladies du Sang, Hopital Claude Huriez, Lille, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Mohty, Mohamad" sort="Mohty, Mohamad" uniqKey="Mohty M" first="Mohamad" last="Mohty">Mohamad Mohty</name>
<affiliation>
<nlm:affiliation>Hopital Saint-Antoine, Paris, France.</nlm:affiliation>
</affiliation>
</author>
<author>
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<nlm:affiliation>CHRU Hopital Bretonneau, Tours Cedex, France.</nlm:affiliation>
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<title level="j">Blood</title>
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<div type="abstract" xml:lang="en">This FIRST trial final analysis examined survival outcomes in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM) treated with lenalidomide and low-dose dexamethasone until disease progression (Rd continuous), Rd for 72 weeks (18 cycles; Rd18), or melphalan, prednisone, and thalidomide (MPT; 72 weeks). The primary endpoint was progression-free survival (PFS; primary comparison: Rd continuous vs MPT). Overall survival (OS) was a key secondary endpoint (final analysis prespecified ≥ 60 months' follow-up). Patients were randomized to Rd continuous (n = 535), Rd18 (n = 541), or MPT (n = 547). At a median follow-up of 67 months, PFS was significantly longer with Rd continuous vs MPT (HR, 0.69; 96% CI, 0.59-0.79; P < .00001) and was similarly extended vs Rd18. Median OS was 10 months longer with Rd continuous vs MPT (59.1 vs 49.1 months; HR, 0.78; 95% CI, 0.63-0.95; P = .0144), and similar with Rd18 (62.3 months). In patients achieving complete or very good partial responses, Rd continuous had a ≈ 30-month-longer median time to next treatment vs Rd18 (69.5 vs 39.9 months). Over half of all patients who received second-line treatment were given a bortezomib-based therapy. Second-line outcomes were improved in patients receiving bortezomib after Rd continuous and Rd18 vs after MPT. No new safety concerns, including risk for secondary malignancies, were observed. Treatment with Rd continuous significantly improved survival outcomes vs MPT, supporting Rd continuous as a standard of care for patients with transplant-ineligible NDMM. Study registration is at Clinicaltrials.gov (NCT00689936) and EudraCT (2007-004823-39).</div>
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<Title>Blood</Title>
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<AbstractText>This FIRST trial final analysis examined survival outcomes in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM) treated with lenalidomide and low-dose dexamethasone until disease progression (Rd continuous), Rd for 72 weeks (18 cycles; Rd18), or melphalan, prednisone, and thalidomide (MPT; 72 weeks). The primary endpoint was progression-free survival (PFS; primary comparison: Rd continuous vs MPT). Overall survival (OS) was a key secondary endpoint (final analysis prespecified ≥ 60 months' follow-up). Patients were randomized to Rd continuous (n = 535), Rd18 (n = 541), or MPT (n = 547). At a median follow-up of 67 months, PFS was significantly longer with Rd continuous vs MPT (HR, 0.69; 96% CI, 0.59-0.79; P < .00001) and was similarly extended vs Rd18. Median OS was 10 months longer with Rd continuous vs MPT (59.1 vs 49.1 months; HR, 0.78; 95% CI, 0.63-0.95; P = .0144), and similar with Rd18 (62.3 months). In patients achieving complete or very good partial responses, Rd continuous had a ≈ 30-month-longer median time to next treatment vs Rd18 (69.5 vs 39.9 months). Over half of all patients who received second-line treatment were given a bortezomib-based therapy. Second-line outcomes were improved in patients receiving bortezomib after Rd continuous and Rd18 vs after MPT. No new safety concerns, including risk for secondary malignancies, were observed. Treatment with Rd continuous significantly improved survival outcomes vs MPT, supporting Rd continuous as a standard of care for patients with transplant-ineligible NDMM. Study registration is at Clinicaltrials.gov (NCT00689936) and EudraCT (2007-004823-39).</AbstractText>
<CopyrightInformation>Copyright © 2017 American Society of Hematology.</CopyrightInformation>
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