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Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study.
Kahan, Zsuzsanna; Gil-Gil, Miguel; Ruiz-Borrego, Manuel; Carrasco, Eva; Ciruelos, Eva; Muñoz, Montserrat; Bermejo, Begoña; Margeli, Mireia; Antón, Antonio; Casas, Maribel; Csöszi, Tibor; Murillo, Laura; Morales, Serafín; Calvo, Lourdes; Lang, Istvan; Alba, Emilio; de la Haba-Rodriguez, Juan; Ramos, Manuel; López, Isabel Álvarez; Gal-Yam, Einav; Garcia-Palomo, Andrés; Alvarez, Elena; González-Santiago, Santiago; Rodríguez, César A; Servitja, Sonia; Corsaro, Massimo; Rodrigálvarez, Graciela; Zielinski, Christoph; Martín, Miguel.
Afiliación
  • Kahan Z; Department of Oncotherapy, University of Szeged, Szeged, Hungary. Electronic address: kahan.zsuzsanna@med.u-szeged.hu.
  • Gil-Gil M; Institut Catalá d'Oncologia (ICO), L'Hospitalet de Llobregat, Spain; GEICAM Spanish Breast Cancer Group, Madrid, Spain.
  • 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 E; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitario 12 de Octubre, Madrid, Spain; HM Hospitales Madrid, Spain; SOLTI Group on Breast Cancer Research, Spain.
  • Muñoz M; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitari Clinic de Barcelona, Institut Clinic de Malalties Hemato-Oncològiques-ICHMO, Barcelona, Spain.
  • Bermejo B; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Hospital Clínico Universitario de Valencia, Instituto de Investigación Sanitaria-INCLIVA Valencia, Spain; Centro de Investigacion Biomedica en Red de Oncologia, CIBERONC-ISCIII, Madrid, Spain.
  • Margeli 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.
  • Antón A; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Centro de Investigacion Biomedica en Red de Oncologia, CIBERONC-ISCIII, Madrid, Spain; Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón-IISA, Zaragoza, Spain.
  • Casas M; GEICAM Spanish Breast Cancer Group, Madrid, Spain.
  • Csöszi T; Department of Oncology, Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok, Hungary.
  • Murillo L; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Medical Oncology, Hospital Clínico de Zaragoza Lozano Blesa, Zaragoza, Spain.
  • Morales S; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Medical Oncology, Hospital Universitario Arnau de Vilanova, Lleida, Spain.
  • Calvo L; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Complejo Hospitalario Universitario A Coruña, A Coruña, Spain.
  • Lang I; Istenhegyi Géndiagnosztika Private Health Center Oncology Clinic, Hungary.
  • Alba E; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Centro de Investigacion Biomedica en Red de Oncologia, CIBERONC-ISCIII, Madrid, Spain; UGCI Medical Oncology, Hospitales Regional y Virgen de la Victoria, IBIMA, Málaga, Spain.
  • de la Haba-Rodriguez J; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Instituto Maimonides de Investigacion Biomedica, Hospital Reina Sofia Hospital, Universidad de Córdoba, Córdoba, Spain.
  • Ramos M; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Centro Oncológico de Galicia, A Coruña, Spain.
  • López IÁ; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitario Donostia-Biodonostia, San Sebastián, Spain.
  • Gal-Yam E; Institute of Oncology, Sheba Medical Center, Tel-Hashomer, Israel.
  • Garcia-Palomo A; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Medical Oncology. Hospital de León, León, Spain.
  • Alvarez E; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitario Lucus Augusti, Lugo, Spain.
  • González-Santiago S; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Hospital Universitario San Pedro de Alcantara, Cáceres, Spain.
  • Rodríguez CA; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Hospital Clínico Universitario de Salamanca-IBSAL, Spain.
  • Servitja S; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Hospital del Mar, Barcelona, Spain.
  • Corsaro M; Pfizer Inc, Milan, Italy.
  • Rodrigálvarez G; GEICAM Spanish Breast Cancer Group, Madrid, Spain.
  • Zielinski C; Vienna Cancer Center, Medical University Vienna and Vienna Hospital Association, Vienna, Austria; CECOG Central European Cooperative Oncology Group, Vienna, Austria.
  • Martín M; GEICAM Spanish Breast Cancer Group, Madrid, Spain; Centro de Investigacion Biomedica en Red de Oncologia, CIBERONC-ISCIII, Madrid, Spain; Instituto de Investigacion Sanitaria Gregorio Maranon, Madrid, Spain.
Eur J Cancer ; 156: 70-82, 2021 10.
Article en En | MEDLINE | ID: mdl-34425406
BACKGROUND: The PEARL study showed that palbociclib plus endocrine therapy (palbociclib/ET) was not superior to capecitabine in improving progression-free survival in postmenopausal patients with metastatic breast cancer resistant to aromatase inhibitors, but was better tolerated. This analysis compared patient-reported outcomes. PATIENTS AND METHODS: The PEARL quality of life (QoL) population comprised 537 patients, 268 randomised to palbociclib/ET (exemestane or fulvestrant) and 269 to capecitabine. Patients completed the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23 and EQ-5D-3L questionnaires. Changes from the baseline and time to deterioration (TTD) were analysed using linear mixed-effect and stratified Cox regression models, respectively. RESULTS: Questionnaire completion rate was high and similar between treatment arms. Significant differences were observed in the mean change in global health status (GHS)/QoL scores from the baseline to cycle 3 (2.9 for palbociclib/ET vs. -2.1 for capecitabine (95% confidence interval [CI], 1.4-8.6; P = 0.007). The median TTD in GHS/QoL was 8.3 months for palbociclib/ET versus 5.3 months for capecitabine (adjusted hazard ratio, 0.70; 95% CI, 0.55-0.89; P = 0.003). Similar improvements for palbociclib/ET were also seen for other scales as physical, role, cognitive, social functioning, fatigue, nausea/vomiting and appetite loss. No differences were observed between the treatment arms in change from the baseline in any item of the EQ-5D-L3 questionnaire as per the overall index score and visual analogue scale. CONCLUSION: Patients receiving palbociclib/ET experienced a significant delay in deterioration of GHS/QoL and several functional and symptom scales compared with capecitabine, providing additional evidence that palbociclib/ET is better tolerated. TRIAL REGISTRATION NUMBER: NCT02028507 (ClinTrials.gov). EUDRACT STUDY NUMBER: 2013-003170-27.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piperazinas / Piridinas / Calidad de Vida / Neoplasias de la Mama / Protocolos de Quimioterapia Combinada Antineoplásica / Posmenopausia / Antineoplásicos Hormonales / Inhibidores de Proteínas Quinasas / Capecitabina / Medición de Resultados Informados por el Paciente Tipo de estudio: Clinical_trials / Prognostic_studies Aspecto: Patient_preference Límite: Female / Humans País/Región como asunto: Asia / Europa Idioma: En Revista: Eur J Cancer Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piperazinas / Piridinas / Calidad de Vida / Neoplasias de la Mama / Protocolos de Quimioterapia Combinada Antineoplásica / Posmenopausia / Antineoplásicos Hormonales / Inhibidores de Proteínas Quinasas / Capecitabina / Medición de Resultados Informados por el Paciente Tipo de estudio: Clinical_trials / Prognostic_studies Aspecto: Patient_preference Límite: Female / Humans País/Región como asunto: Asia / Europa Idioma: En Revista: Eur J Cancer Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido