Randomized Phase II Trial Evaluating Treatment with EGFR-TKI Associated with Antiestrogen in Women with Nonsquamous Advanced-Stage NSCLC: IFCT-1003 LADIE Trial.
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Authors
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Mazieres, Julien1, 2
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Barlesi, Fabrice2, 3
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Rouquette, Isabelle4
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Molinier, Olivier2, 5
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Besse, Benjamin2, 6
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Monnet, Isabelle2, 7
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Audigier-Valette, Clarisse2, 8
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Toffart, Anne-Claire2, 9
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Renault, Patrick Aldo2, 10
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Fraboulet, Séverine2, 11
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Hiret, Sandrine2, 12
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Mennecier, Bertrand2, 13
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Debieuvre, Didier2, 14
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Westeel, Virginie2, 15
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Masson, Philippe2, 16
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Madroszyk-Flandin, Anne2, 17
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Pichon, Eric2, 18
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Cortot, Alexis B2, 19
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Amour, Elodie2
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Morin, Franck2
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Zalcman, Gérard2, 20
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Moro-Sibilot, Denis2, 9
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Souquet, Pierre-Jean2, 21
And 3 more
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1
Service de Pneumologie, Hôpital Larrey, Centre Hospitalier Universitaire Toulouse, Toulouse, France. [email protected].
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(France)
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2
Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
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(France)
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3
Aix Marseille University, CNRS, INSERM, CRCM, Assistance Publique Hôpitaux de Marseille, Marseille, France.
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(France)
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4
Service d'Anatomopathologie, Centre Hospitalier Universitaire Toulouse, Toulouse, France.
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(France)
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5
Centre Hospitalier, Le Mans, France.
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(France)
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6
Cancer Medecine Department, Gustave Roussy, Villejuif, France; Paris-Sud University, Orsay, France.
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(France)
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7
CHI of Créteil, Créteil, France.
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(France)
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8
Pneumology Department, Centre Hospitalier Toulon Sainte-Musse, Toulon, France.
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(France)
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9
Thoracic Oncology Unit Teaching Hospital A Michallon, INSERM U823, Grenoble, France.
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(France)
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10
Centre Hospitalier Pau, Pau, France.
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(France)
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11
Hôpital Foch, Suresnes, France.
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(France)
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12
ICO René Gauducheau, Nantes, France.
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(France)
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13
Nouvel Hôpital Civil - Service de Pneumologie, Strasbourg, France.
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(France)
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14
GHRMSA, Mulhouse, France.
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(France)
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15
University of Franche-Comté, Besancon, France.
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(France)
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16
Centre Hospitalier De Cholet, Cholet, France.
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(France)
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17
Institut Paoli-Calmettes, Marseille, France.
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(France)
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18
Centre Hospitalier Universitaire, Tours, France.
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(France)
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19
Thoracic Oncology Department, CHU Lille, Univ. Lille, CNRS, Institut Pasteur de Lille, Lille, France.
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(France)
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20
GH Bichat Claude Bernard, AP-HP, Paris, France.
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(France)
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21
Hôpital Lyon-Sud, Pierre-Bénite, France.
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(France)
- Type
- Published Article
- Journal
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Clinical Cancer Research
- Publisher
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American Association for Cancer Research
- Publication Date
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Jun 30, 2020
- Volume
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26
- Issue
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13
- Pages
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3172–3181
- Identifiers
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DOI: 10.1158/1078-0432.CCR-19-3056
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PMID: 32144133
- Source
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Medline
- Language
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English
- License
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Unknown
Abstract
The incidence of lung cancer has dramatically increased in women. Preclinical data have suggested that combining EGFR-tyrosine kinase inhibitor (TKI) with an antiestrogen may overcome resistance to EGFR-TKI. The IFCT-1003 LADIE trial was a 2 × 2 arms parallel open-label randomized phase II trial. EGFR-TKI-naïve postmenopausal women with advanced lung cancer were treated with gefitinib (G) versus gefitinib + fulvestrant (G+F) in the EGFR-mutated group (EGFR+) or with erlotinib (E) versus erlotinib + fulvestrant (E+F) in the EGFR wild-type group (EGFR-WT). The primary objective was progression-free survival (PFS) at 3 and 9 months for EGFR-WT and EGFR+ patients. Overall, 204 patients (gefitinib 104 and G+F 100) and 175 patients (erlotinib 87 and E+F 88) were enrolled in the EGFR+ and EGFR-WT cohorts. In the EGFR+ cohort, the primary endpoint was reached, with 58% of the G+F group patients being nonprogressive at 9 months. Adding fulvestrant to gefitinib was not associated with improved PFS (9.9 vs 9.4 months) or overall survival (OS; 22.1 vs 28.6 months). In the EGFR-WT cohort, the primary endpoint was also achieved (33.7% of the patients were nonprogressive at 3 months). Adding fulvestrant to erlotinib was not associated with improved outcome (PFS 1.8 vs 2.0 and OS 10.3 vs 7.3 months). No PFS difference was observed regarding estrogen receptor alpha expression. The tolerance was as expected with no treatment-related death. Adding fulvestrant to EGFR-TKI is feasible, but not associated with prolonged PFS regardless of EGFR status. The lack of benefits while combining fulvestrant to EGFR-TKI does not support its future development in an unselected population. ©2020 American Association for Cancer Research.
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This record was last updated on 01/23/2021 and may not reflect the most current and accurate biomedical/scientific data available from NLM.
The corresponding record at NLM can be accessed at
https://www.ncbi.nlm.nih.gov/pubmed/32144133
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