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Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.
Martín, Miguel; Zielinski, Christoph; Ruiz-Borrego, Manuel; Carrasco, Eva; Ciruelos, Eva M; Muñoz, Montserrat; Bermejo, Begoña; Margelí, Mireia; Csöszi, Tibor; Antón, Antonio; Turner, Nicholas; Casas, María I; Morales, Serafín; Alba, Emilio; Calvo, Lourdes; de la Haba-Rodríguez, Juan; Ramos, Manuel; Murillo, Laura; Santaballa, Ana; Alonso-Romero, José L; Sánchez-Rovira, Pedro; Corsaro, Massimo; Huang, Xin; Thallinger, Christiane; Kahan, Zsuzsanna; Gil-Gil, Miguel.
Afiliación
  • Martín M; Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, Madrid, Spain. Electronic address: mmartin@geicam.org.
  • Zielinski C; Vienna Cancer Center, Medical University Vienna and Vienna Hospital Association, Vienna, Austria; CECOG, Central European Cooperative Oncology Group, Vienna, Austria.
  • Ruiz-Borrego M; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitario Virgen Del Rocío, Sevilla, Spain.
  • Carrasco E; GEICAM, Spanish Breast Cancer Group, Madrid, Spain.
  • Ciruelos EM; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitario 12 de Octubre, Madrid, Spain; HM Hospitales Madrid, Spain; SOLTI Group on Breast Cancer Research.
  • Muñoz M; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Translational Genomics and Targeted Therapies in Solid Tumours, August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; Department of Medical Oncology, Hospital Clinic of Barcelona, Spain.
  • Bermejo B; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, Madrid, Spain; Hospital Clínico Universitario de Valencia, Instituto de Investigación Sanitaria-INCLIVA Valencia, Spain.
  • Margelí M; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Badalona Applied Research Group in Oncology (ARGO Group), Institut Catalá D'Oncologia, Hospital Universitari Germans Trias I Pujol, Badalona, Spain.
  • Csöszi T; CECOG, Central European Cooperative Oncology Group, Vienna, Austria; Department of Oncology, Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok, Hungary.
  • Antón A; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón-IISA, Zaragoza, Spain.
  • Turner N; Institute of Cancer Research and Royal Marsden, London, UK.
  • Casas MI; GEICAM, Spanish Breast Cancer Group, Madrid, Spain.
  • Morales S; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Medical Oncology. Hospital Universitario Arnau de Vilanova, Lleida, Spain.
  • Alba E; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, Madrid, Spain; UGCI Medical Oncology, Hospitales Regional y Virgen de La Victoria. IBIMA. Málaga, Spain.
  • Calvo L; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Complejo Hospitalario Universitario A Coruña, A Coruña, Spain.
  • de la Haba-Rodríguez J; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, Madrid, Spain; Instituto Maimonides de Investigación Biomédica, Hospital Reina Sofía Hospital, Universidad de Córdoba, Córdoba, Spain.
  • Ramos M; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Centro Oncológico de Galicia, A Coruña, Spain.
  • Murillo L; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Hospital Clínico de Zaragoza Lozano Blesa, Zaragoza, Spain.
  • Santaballa A; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitario y Politécnico La Fe, Valencia, Spain.
  • Alonso-Romero JL; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitario Virgen de La Arrixaca-IMIB, Murcia, Spain.
  • Sánchez-Rovira P; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Oncology Unit, Universitary Hospital Jaén, Spain.
  • Corsaro M; Pfizer Inc., Milan, Italy.
  • Huang X; Pfizer Inc., San Diego, USA.
  • Thallinger C; CECOG, Central European Cooperative Oncology Group, Vienna, Austria; Department of Oncology, Medical University of Vienna, Austria.
  • Kahan Z; CECOG, Central European Cooperative Oncology Group, Vienna, Austria; Department of Oncotherapy, University of Szeged, Szeged, Hungary.
  • Gil-Gil M; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Institut Català D'Oncologia (ICO) & IDIBELL, L'Hospitalet, Barcelona, Spain.
Eur J Cancer ; 168: 12-24, 2022 06.
Article en En | MEDLINE | ID: mdl-35429901
BACKGROUND: An earlier analysis of the PEARL phase III study showed that palbociclib plus endocrine therapy (ET) does not improve progression-free survival (PFS) over capecitabine in aromatase inhibitor-resistant, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (MBC) patients. Here, we report the final overall survival (OS) analysis. METHODS: Postmenopausal patients (N = 601) were randomized 1:1 to capecitabine or palbociclib plus ET (exemestane, Cohort 1; fulvestrant, Cohort 2). OS was analysed in Cohort 2, the wild-type ESR1 population and the overall population. Additionally, we analysed subsequent systemic therapies and explored PFS2 (time from randomization to the end of the first subsequent therapy/death). RESULTS: OS was 31.1 months for palbociclib plus fulvestrant and 32.8 months for capecitabine (adjusted hazard ratio [aHR] 1.10, 95% confidence interval [CI] 0.81-1.50, P = 0.550). In the wild-type ESR1 population, OS was 37.2 months for palbociclib plus ET and 34.8 months for capecitabine (aHR 1.06, 95% CI 0.81-1.37, P = 0.683). In OS analyses, no subgroup showed superiority for palbociclib plus ET over capecitabine. OS in the overall population was 32.6 months for palbociclib plus ET and 30.9 months for capecitabine (P = 0.995). Subsequent systemic therapy was given to 79.8% and 82.9% of patients with palbociclib plus ET and capecitabine, respectively. Median PFS2 was similar between study arms (Cohort 2, P = 0.941; wild-type ESR1 population, P = 0.827). No new safety findings were observed. CONCLUSIONS: Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors. TRIAL REGISTRATION: NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama Tipo de estudio: Clinical_trials Límite: Female / Humans Idioma: En Revista: Eur J Cancer Año: 2022 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama Tipo de estudio: Clinical_trials Límite: Female / Humans Idioma: En Revista: Eur J Cancer Año: 2022 Tipo del documento: Article Pais de publicación: Reino Unido