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Enrollment of older metastatic breast cancer patients in first-line clinical trials: 9-year experience of the large-scale real-life multicenter French ESME cohort.
Bringuier, M; Carton, M; Levy, C; Patsouris, A; Pasquier, D; Debled, M; Rigal, O; Jacot, W; Gonçalves, A; Desmoulins, I; De La Motte Rouge, T; Bachelot, T; Ferrero, J-M; Eymard, J-C; Ung, M; Mouret-Reynier, M-A; Petit, T; Chevrot, M; Uwer, L; Courtinard, C; Frenel, J-S; Vianzone, A; Baldini, C.
Afiliación
  • Bringuier M; Department of Medical Oncoly and Department of Supportive Care, Institut Curie, PSL Research University, Saint-Cloud, France. michael.bringuier@curie.fr.
  • Carton M; Department of Biostatistics, Institut Curie, PSL Research University, Saint-Cloud, France.
  • Levy C; Department of Medical Oncology, Centre François Baclesse, Caen, France.
  • Patsouris A; Department of Medical Oncology, Institut de Cancérologie de l'Ouest - Paul Papin, Angers, France.
  • Pasquier D; Academic Department of Radiation Oncology Centre O. Lambret, CRIStAL, Lille University, Lille, France.
  • Debled M; Department of Medical Oncology, Institut Bergonie, Bordeaux, France.
  • Rigal O; Department of Medical Oncology, Centre Henri Becquerel, Rouen, France.
  • Jacot W; Department of Medical Oncology, Institut du Cancer de Montpellier, Montpellier, France.
  • Gonçalves A; Department of Medical Oncology, Institut Paoli-Calmettes, Marseille, France.
  • Desmoulins I; Department of Medical Oncology, Centre Georges François Leclerc, Dijon, France.
  • De La Motte Rouge T; Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.
  • Bachelot T; Department of Medical Oncology, Centre Léon Bérard, Lyon, France.
  • Ferrero JM; Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France.
  • Eymard JC; Department of Medical Oncology, Institut de Cancérologie Jean-Godinot, Reims, France.
  • Ung M; Department of Medical Oncology, Institut Claudius Regaud - IUCT Oncopole, Toulouse, France.
  • Mouret-Reynier MA; Department of Medical Oncology, Centre Jean Perrin, Clermont Ferrand, France.
  • Petit T; Department of Medical Oncology, Centre Paul Strauss, Strasbourg, France.
  • Chevrot M; Department of Research and Development, R&D Unicancer, Paris, France.
  • Uwer L; Department of Medical Oncology, Institut de Cancérologie de Lorraine, Nancy, France.
  • Courtinard C; Department of Research and Development, R&D Unicancer, Paris, France.
  • Frenel JS; Department of Medical Oncology, Institut de Cancérologie de l'Ouest - René Gauducheau, Nantes, France.
  • Vianzone A; Drug Development Department, Gustave Roussy Cancer Campus, Villejuif, France.
  • Baldini C; Drug Development Department, Gustave Roussy Cancer Campus, Villejuif, France.
Breast Cancer Res Treat ; 191(3): 577-587, 2022 Feb.
Article en En | MEDLINE | ID: mdl-34984582
PURPOSE: Older cancer patients are underrepresented in clinical trials. We aimed to evaluate the enrollment of older women aged 70 years old (yo) or over with metastatic breast cancer (MBC) in clinical trials. METHODS: We used the national Epidemio-Strategy and Medical Economics MBC Data Platform, a French multi-center real-life database. We selected MBC women over 70yo, without central nervous system metastases, with at least one line of systemic treatment, between January 1st, 2008 and December 31st, 2016, and had no other cancer in the 5 years before MBC. The primary objective was to evaluate the proportion of patients enrolled in clinical trials according to their age. Secondary objective was to identify variables associated with enrollment in older ones. RESULTS: 5552 women were aged ≥ 70 (median 74yo; IQR 72-77). 14,611 were less than 70. Of the older ones, 239 (4%) were enrolled in a clinical trial during first line of treatment, compared with 1529 (10.5%) for younger ones. Multivariable analysis of variables predicting for enrollment during first line of treatment in older patients were younger age (OR 0.50 [95%CI 0.33-0.76] for the 80-85yo class; OR 0.17 [95%CI 0.06-0.39] for the 85yo and more class), good ECOG Performance Status (PS 0-1) (OR 0.15 [95%CI 0.08-0.27] for the PS 2-4 class), HER2 + disease (OR 1.78 [95%CI 1.27-2.48]), type of treatment (chemotherapy/targeted therapy/immunotherapy OR 5.01 [95%CI 3.13-8.18]), and period (OR 1.65 [95%CI 1.22-2.26] for 2012-2016, compared to 2008-2011). CONCLUSION: In this large database, few older MBC patients were enrolled in a trial compared with younger ones.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Neoplasias Primarias Secundarias Tipo de estudio: Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Aged / Female / Humans Idioma: En Revista: Breast Cancer Res Treat Año: 2022 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Países Bajos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Neoplasias Primarias Secundarias Tipo de estudio: Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Aged / Female / Humans Idioma: En Revista: Breast Cancer Res Treat Año: 2022 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Países Bajos