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 : 000859MONARCH 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 :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology [ 1527-7755 ] ; 2017.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Aminopyridines (administration et posologie), Benzimidazoles (administration et posologie), Femelle, Humains, Kinase-4 cycline-dépendante (antagonistes et inhibiteurs), Kinase-6 cycline-dépendante (antagonistes et inhibiteurs), Méthode en double aveugle, Oestradiol (administration et posologie), Oestradiol (analogues et dérivés), Oestradiol (usage thérapeutique), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Récepteur ErbB-2 (biosynthèse), Récepteurs des oestrogènes (biosynthèse), Récepteurs à la progestérone (biosynthèse), Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Tumeurs du sein (enzymologie), Tumeurs du sein (métabolisme), Tumeurs du sein (traitement médicamenteux).
- MESH :
- administration et posologie : Aminopyridines, Benzimidazoles, Oestradiol.
- analogues et dérivés : Oestradiol.
- antagonistes et inhibiteurs : Kinase-4 cycline-dépendante, Kinase-6 cycline-dépendante.
- biosynthèse : Récepteur ErbB-2, Récepteurs des oestrogènes, Récepteurs à la progestérone.
- enzymologie : Tumeurs du sein.
- métabolisme : Tumeurs du sein.
- traitement médicamenteux : Tumeurs du sein.
- usage thérapeutique : Oestradiol, Protocoles de polychimiothérapie antinéoplasique.
- Adulte, Adulte d'âge moyen, Femelle, Humains, Méthode en double aveugle, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Aminopyridines (administration & dosage), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Benzimidazoles (administration & dosage), Breast Neoplasms (drug therapy), Breast Neoplasms (enzymology), Breast Neoplasms (metabolism), Cyclin-Dependent Kinase 4 (antagonists & inhibitors), Cyclin-Dependent Kinase 6 (antagonists & inhibitors), Disease-Free Survival, Double-Blind Method, Estradiol (administration & dosage), Estradiol (analogs & derivatives), Estradiol (therapeutic use), Female, Humans, Middle Aged, Receptor, ErbB-2 (biosynthesis), Receptors, Estrogen (biosynthesis), Receptors, Progesterone (biosynthesis).
- MESH :
- chemical , administration & dosage : Aminopyridines, Benzimidazoles, Estradiol.
- chemical , analogs & derivatives : Estradiol.
- chemical , antagonists & inhibitors : Cyclin-Dependent Kinase 4, Cyclin-Dependent Kinase 6.
- chemical , biosynthesis : Receptor, ErbB-2, Receptors, Estrogen, Receptors, Progesterone.
- drug therapy : Breast Neoplasms.
- enzymology : Breast Neoplasms.
- metabolism : Breast Neoplasms.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols, Estradiol.
- Adult, Aged, Aged, 80 and over, Disease-Free Survival, Double-Blind Method, Female, Humans, Middle Aged.
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
Affiliations:
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Le document en format XML
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<author><name sortKey="Inoue, Kenichi" sort="Inoue, Kenichi" uniqKey="Inoue K" first="Kenichi" last="Inoue">Kenichi Inoue</name>
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<author><name sortKey="Pivot, Xavier" sort="Pivot, Xavier" uniqKey="Pivot X" first="Xavier" last="Pivot">Xavier Pivot</name>
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<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>
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<author><name sortKey="Okera, Meena" sort="Okera, Meena" uniqKey="Okera M" first="Meena" last="Okera">Meena Okera</name>
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<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>
<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="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>
<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="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>
<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="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>
</author>
<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>
</affiliation>
</author>
<author><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>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PubMed</idno>
<date when="2017">2017</date>
<idno type="RBID">pubmed:28580882</idno>
<idno type="pmid">28580882</idno>
<idno type="doi">10.1200/JCO.2017.73.7585</idno>
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<sourceDesc><biblStruct><analytic><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>
<author><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>
<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="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>
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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>
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<author><name sortKey="Lin, Yong" sort="Lin, Yong" uniqKey="Lin Y" first="Yong" last="Lin">Yong Lin</name>
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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>
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<wicri:noRegion>Valencia</wicri:noRegion>
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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>
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<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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</affiliation>
</author>
<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>
</affiliation>
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<author><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>
<wicri:noRegion>Valencia</wicri:noRegion>
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<series><title level="j">Journal of clinical oncology : official journal of the American Society of Clinical Oncology</title>
<idno type="eISSN">1527-7755</idno>
<imprint><date when="2017" type="published">2017</date>
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<front><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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<affiliations><list><country><li>Espagne</li>
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<tree><country name="Espagne"><noRegion><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>
</country>
</tree>
</affiliations>
</record>
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