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MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy.

Identifieur interne : 000858 ( Main/Exploration ); précédent : 000857; suivant : 000859

MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy.

Auteurs : George W. Sledge [Espagne] ; Masakazu Toi [Espagne] ; Patrick Neven [Espagne] ; Joohyuk Sohn [Espagne] ; Kenichi Inoue [Espagne] ; Xavier Pivot [Espagne] ; Olga Burdaeva [Espagne] ; Meena Okera [Espagne] ; Norikazu Masuda [Espagne] ; Peter A. Kaufman [Espagne] ; Han Koh [Espagne] ; Eva-Maria Grischke [Espagne] ; Martin Frenzel [Espagne] ; Yong Lin [Espagne] ; Susana Barriga [Espagne] ; Ian C. Smith [Espagne] ; Nawel Bourayou [Espagne] ; Antonio Llombart-Cussac [Espagne]

Source :

RBID : pubmed:28580882

Descripteurs français

English descriptors

Abstract

Purpose MONARCH 2 ( ClinicalTrials.gov identifier: NCT02107703) compared the efficacy and safety of abemaciclib, a selective cyclin-dependent kinase 4 and 6 inhibitor, plus fulvestrant with fulvestrant alone in patients with advanced breast cancer (ABC). Patients and Methods MONARCH 2 was a global, double-blind, phase III study of women with hormone receptor-positive and human epidermal growth factor receptor 2-negative ABC who had progressed while receiving neoadjuvant or adjuvant endocrine therapy (ET), ≤ 12 months from the end of adjuvant ET, or while receiving first-line ET for metastatic disease. Patients were randomly assigned 2:1 to receive abemaciclib or placebo (150 mg twice daily) on a continuous schedule and fulvestrant (500 mg, per label). The primary end point was investigator-assessed progression-free survival (PFS), and key secondary end points included overall survival, objective response rate (ORR), duration of response, clinical benefit rate, quality of life, and safety. Results Between August 2014 and December 2015, 669 patients were randomly assigned to receive abemaciclib plus fulvestrant (n = 446) or placebo plus fulvestrant (n = 223). Abemaciclib plus fulvestrant significantly extended PFS versus fulvestrant alone (median, 16.4 v 9.3 months; hazard ratio, 0.553; 95% CI, 0.449 to 0.681; P < .001). In patients with measurable disease, abemaciclib plus fulvestrant achieved an ORR of 48.1% (95% CI, 42.6% to 53.6%) compared with 21.3% (95% CI, 15.1% to 27.6%) in the control arm. The most common adverse events in the abemaciclib versus placebo arms were diarrhea (86.4% v 24.7%), neutropenia (46.0% v 4.0%), nausea (45.1% v 22.9%), and fatigue (39.9% v 26.9%). Conclusions Abemaciclib at 150 mg twice daily plus fulvestrant was effective, significantly improving PFS and ORR and demonstrating a tolerable safety profile in women with hormone receptor-positive and human epidermal growth factor receptor 2-negative ABC who progressed while receiving ET.

DOI: 10.1200/JCO.2017.73.7585
PubMed: 28580882


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<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
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</affiliation>
</author>
<author>
<name sortKey="Koh, Han" sort="Koh, Han" uniqKey="Koh H" first="Han" last="Koh">Han Koh</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
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<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Grischke, Eva Maria" sort="Grischke, Eva Maria" uniqKey="Grischke E" first="Eva-Maria" last="Grischke">Eva-Maria Grischke</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
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<wicri:noRegion>Valencia</wicri:noRegion>
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<author>
<name sortKey="Frenzel, Martin" sort="Frenzel, Martin" uniqKey="Frenzel M" first="Martin" last="Frenzel">Martin Frenzel</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
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<author>
<name sortKey="Lin, Yong" sort="Lin, Yong" uniqKey="Lin Y" first="Yong" last="Lin">Yong Lin</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
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<author>
<name sortKey="Barriga, Susana" sort="Barriga, Susana" uniqKey="Barriga S" first="Susana" last="Barriga">Susana Barriga</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
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<author>
<name sortKey="Smith, Ian C" sort="Smith, Ian C" uniqKey="Smith I" first="Ian C" last="Smith">Ian C. Smith</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
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<name sortKey="Bourayou, Nawel" sort="Bourayou, Nawel" uniqKey="Bourayou N" first="Nawel" last="Bourayou">Nawel Bourayou</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
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<name sortKey="Llombart Cussac, Antonio" sort="Llombart Cussac, Antonio" uniqKey="Llombart Cussac A" first="Antonio" last="Llombart-Cussac">Antonio Llombart-Cussac</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
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<title xml:lang="en">MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy.</title>
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<name sortKey="Sledge, George W" sort="Sledge, George W" uniqKey="Sledge G" first="George W" last="Sledge">George W. Sledge</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
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</affiliation>
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<name sortKey="Toi, Masakazu" sort="Toi, Masakazu" uniqKey="Toi M" first="Masakazu" last="Toi">Masakazu Toi</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Neven, Patrick" sort="Neven, Patrick" uniqKey="Neven P" first="Patrick" last="Neven">Patrick Neven</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Sohn, Joohyuk" sort="Sohn, Joohyuk" uniqKey="Sohn J" first="Joohyuk" last="Sohn">Joohyuk Sohn</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Inoue, Kenichi" sort="Inoue, Kenichi" uniqKey="Inoue K" first="Kenichi" last="Inoue">Kenichi Inoue</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Pivot, Xavier" sort="Pivot, Xavier" uniqKey="Pivot X" first="Xavier" last="Pivot">Xavier Pivot</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Burdaeva, Olga" sort="Burdaeva, Olga" uniqKey="Burdaeva O" first="Olga" last="Burdaeva">Olga Burdaeva</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Okera, Meena" sort="Okera, Meena" uniqKey="Okera M" first="Meena" last="Okera">Meena Okera</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Masuda, Norikazu" sort="Masuda, Norikazu" uniqKey="Masuda N" first="Norikazu" last="Masuda">Norikazu Masuda</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Kaufman, Peter A" sort="Kaufman, Peter A" uniqKey="Kaufman P" first="Peter A" last="Kaufman">Peter A. Kaufman</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Koh, Han" sort="Koh, Han" uniqKey="Koh H" first="Han" last="Koh">Han Koh</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Grischke, Eva Maria" sort="Grischke, Eva Maria" uniqKey="Grischke E" first="Eva-Maria" last="Grischke">Eva-Maria Grischke</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Frenzel, Martin" sort="Frenzel, Martin" uniqKey="Frenzel M" first="Martin" last="Frenzel">Martin Frenzel</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
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<wicri:noRegion>Valencia</wicri:noRegion>
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<name sortKey="Lin, Yong" sort="Lin, Yong" uniqKey="Lin Y" first="Yong" last="Lin">Yong Lin</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
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<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
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<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
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<name sortKey="Smith, Ian C" sort="Smith, Ian C" uniqKey="Smith I" first="Ian C" last="Smith">Ian C. Smith</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
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<author>
<name sortKey="Bourayou, Nawel" sort="Bourayou, Nawel" uniqKey="Bourayou N" first="Nawel" last="Bourayou">Nawel Bourayou</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
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<name sortKey="Llombart Cussac, Antonio" sort="Llombart Cussac, Antonio" uniqKey="Llombart Cussac A" first="Antonio" last="Llombart-Cussac">Antonio Llombart-Cussac</name>
<affiliation wicri:level="1">
<nlm:affiliation>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia, Spain.</nlm:affiliation>
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<wicri:regionArea>George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva, Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russian Federation; Meena Okera, Adelaide Cancer Centre, Adelaide, Australia; Peter A. Kaufman, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Eva-Maria Grischke, Universitätsklinikum Tübingen Frauenklinik, Tübingen, Germany; Martin Frenzel, Yong Lin, and Ian C. Smith, Eli Lilly, Indianapolis, IN; Susana Barriga, Eli Lilly, Madrid; and Antonio Llombart-Cussac, Hospital Arnau Vilanova, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
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</analytic>
<series>
<title level="j">Journal of clinical oncology : official journal of the American Society of Clinical Oncology</title>
<idno type="eISSN">1527-7755</idno>
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<date when="2017" type="published">2017</date>
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<term>Adult</term>
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<term>Aminopyridines (administration & dosage)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term>
<term>Benzimidazoles (administration & dosage)</term>
<term>Breast Neoplasms (drug therapy)</term>
<term>Breast Neoplasms (enzymology)</term>
<term>Breast Neoplasms (metabolism)</term>
<term>Cyclin-Dependent Kinase 4 (antagonists & inhibitors)</term>
<term>Cyclin-Dependent Kinase 6 (antagonists & inhibitors)</term>
<term>Disease-Free Survival</term>
<term>Double-Blind Method</term>
<term>Estradiol (administration & dosage)</term>
<term>Estradiol (analogs & derivatives)</term>
<term>Estradiol (therapeutic use)</term>
<term>Female</term>
<term>Humans</term>
<term>Middle Aged</term>
<term>Receptor, ErbB-2 (biosynthesis)</term>
<term>Receptors, Estrogen (biosynthesis)</term>
<term>Receptors, Progesterone (biosynthesis)</term>
</keywords>
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<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Aminopyridines (administration et posologie)</term>
<term>Benzimidazoles (administration et posologie)</term>
<term>Femelle</term>
<term>Humains</term>
<term>Kinase-4 cycline-dépendante (antagonistes et inhibiteurs)</term>
<term>Kinase-6 cycline-dépendante (antagonistes et inhibiteurs)</term>
<term>Méthode en double aveugle</term>
<term>Oestradiol (administration et posologie)</term>
<term>Oestradiol (analogues et dérivés)</term>
<term>Oestradiol (usage thérapeutique)</term>
<term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term>
<term>Récepteur ErbB-2 (biosynthèse)</term>
<term>Récepteurs des oestrogènes (biosynthèse)</term>
<term>Récepteurs à la progestérone (biosynthèse)</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Survie sans rechute</term>
<term>Tumeurs du sein (enzymologie)</term>
<term>Tumeurs du sein (métabolisme)</term>
<term>Tumeurs du sein (traitement médicamenteux)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en">
<term>Aminopyridines</term>
<term>Benzimidazoles</term>
<term>Estradiol</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en">
<term>Estradiol</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en">
<term>Cyclin-Dependent Kinase 4</term>
<term>Cyclin-Dependent Kinase 6</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="biosynthesis" xml:lang="en">
<term>Receptor, ErbB-2</term>
<term>Receptors, Estrogen</term>
<term>Receptors, Progesterone</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr">
<term>Aminopyridines</term>
<term>Benzimidazoles</term>
<term>Oestradiol</term>
</keywords>
<keywords scheme="MESH" qualifier="analogues et dérivés" xml:lang="fr">
<term>Oestradiol</term>
</keywords>
<keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr">
<term>Kinase-4 cycline-dépendante</term>
<term>Kinase-6 cycline-dépendante</term>
</keywords>
<keywords scheme="MESH" qualifier="biosynthèse" xml:lang="fr">
<term>Récepteur ErbB-2</term>
<term>Récepteurs des oestrogènes</term>
<term>Récepteurs à la progestérone</term>
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<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Breast Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="enzymologie" xml:lang="fr">
<term>Tumeurs du sein</term>
</keywords>
<keywords scheme="MESH" qualifier="enzymology" xml:lang="en">
<term>Breast Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="metabolism" xml:lang="en">
<term>Breast Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr">
<term>Tumeurs du sein</term>
</keywords>
<keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en">
<term>Antineoplastic Combined Chemotherapy Protocols</term>
<term>Estradiol</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr">
<term>Tumeurs du sein</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr">
<term>Oestradiol</term>
<term>Protocoles de polychimiothérapie antinéoplasique</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Disease-Free Survival</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Middle Aged</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Humains</term>
<term>Méthode en double aveugle</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Survie sans rechute</term>
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<div type="abstract" xml:lang="en">Purpose MONARCH 2 ( ClinicalTrials.gov identifier: NCT02107703) compared the efficacy and safety of abemaciclib, a selective cyclin-dependent kinase 4 and 6 inhibitor, plus fulvestrant with fulvestrant alone in patients with advanced breast cancer (ABC). Patients and Methods MONARCH 2 was a global, double-blind, phase III study of women with hormone receptor-positive and human epidermal growth factor receptor 2-negative ABC who had progressed while receiving neoadjuvant or adjuvant endocrine therapy (ET), ≤ 12 months from the end of adjuvant ET, or while receiving first-line ET for metastatic disease. Patients were randomly assigned 2:1 to receive abemaciclib or placebo (150 mg twice daily) on a continuous schedule and fulvestrant (500 mg, per label). The primary end point was investigator-assessed progression-free survival (PFS), and key secondary end points included overall survival, objective response rate (ORR), duration of response, clinical benefit rate, quality of life, and safety. Results Between August 2014 and December 2015, 669 patients were randomly assigned to receive abemaciclib plus fulvestrant (n = 446) or placebo plus fulvestrant (n = 223). Abemaciclib plus fulvestrant significantly extended PFS versus fulvestrant alone (median, 16.4 v 9.3 months; hazard ratio, 0.553; 95% CI, 0.449 to 0.681; P < .001). In patients with measurable disease, abemaciclib plus fulvestrant achieved an ORR of 48.1% (95% CI, 42.6% to 53.6%) compared with 21.3% (95% CI, 15.1% to 27.6%) in the control arm. The most common adverse events in the abemaciclib versus placebo arms were diarrhea (86.4% v 24.7%), neutropenia (46.0% v 4.0%), nausea (45.1% v 22.9%), and fatigue (39.9% v 26.9%). Conclusions Abemaciclib at 150 mg twice daily plus fulvestrant was effective, significantly improving PFS and ORR and demonstrating a tolerable safety profile in women with hormone receptor-positive and human epidermal growth factor receptor 2-negative ABC who progressed while receiving ET.</div>
</front>
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<name sortKey="Sledge, George W" sort="Sledge, George W" uniqKey="Sledge G" first="George W" last="Sledge">George W. Sledge</name>
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<name sortKey="Barriga, Susana" sort="Barriga, Susana" uniqKey="Barriga S" first="Susana" last="Barriga">Susana Barriga</name>
<name sortKey="Bourayou, Nawel" sort="Bourayou, Nawel" uniqKey="Bourayou N" first="Nawel" last="Bourayou">Nawel Bourayou</name>
<name sortKey="Burdaeva, Olga" sort="Burdaeva, Olga" uniqKey="Burdaeva O" first="Olga" last="Burdaeva">Olga Burdaeva</name>
<name sortKey="Frenzel, Martin" sort="Frenzel, Martin" uniqKey="Frenzel M" first="Martin" last="Frenzel">Martin Frenzel</name>
<name sortKey="Grischke, Eva Maria" sort="Grischke, Eva Maria" uniqKey="Grischke E" first="Eva-Maria" last="Grischke">Eva-Maria Grischke</name>
<name sortKey="Inoue, Kenichi" sort="Inoue, Kenichi" uniqKey="Inoue K" first="Kenichi" last="Inoue">Kenichi Inoue</name>
<name sortKey="Kaufman, Peter A" sort="Kaufman, Peter A" uniqKey="Kaufman P" first="Peter A" last="Kaufman">Peter A. Kaufman</name>
<name sortKey="Koh, Han" sort="Koh, Han" uniqKey="Koh H" first="Han" last="Koh">Han Koh</name>
<name sortKey="Lin, Yong" sort="Lin, Yong" uniqKey="Lin Y" first="Yong" last="Lin">Yong Lin</name>
<name sortKey="Llombart Cussac, Antonio" sort="Llombart Cussac, Antonio" uniqKey="Llombart Cussac A" first="Antonio" last="Llombart-Cussac">Antonio Llombart-Cussac</name>
<name sortKey="Masuda, Norikazu" sort="Masuda, Norikazu" uniqKey="Masuda N" first="Norikazu" last="Masuda">Norikazu Masuda</name>
<name sortKey="Neven, Patrick" sort="Neven, Patrick" uniqKey="Neven P" first="Patrick" last="Neven">Patrick Neven</name>
<name sortKey="Okera, Meena" sort="Okera, Meena" uniqKey="Okera M" first="Meena" last="Okera">Meena Okera</name>
<name sortKey="Pivot, Xavier" sort="Pivot, Xavier" uniqKey="Pivot X" first="Xavier" last="Pivot">Xavier Pivot</name>
<name sortKey="Smith, Ian C" sort="Smith, Ian C" uniqKey="Smith I" first="Ian C" last="Smith">Ian C. Smith</name>
<name sortKey="Sohn, Joohyuk" sort="Sohn, Joohyuk" uniqKey="Sohn J" first="Joohyuk" last="Sohn">Joohyuk Sohn</name>
<name sortKey="Toi, Masakazu" sort="Toi, Masakazu" uniqKey="Toi M" first="Masakazu" last="Toi">Masakazu Toi</name>
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</record>

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}}

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HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i   -Sk "pubmed:28580882" \
       | HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd   \
       | NlmPubMed2Wicri -a AustralieFrV1 

Wicri

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