Original Research 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
Por:
Kahan, Z, Gil-Gil, M, Ruiz-Borrego, M, Carrasco, E, Ciruelos, E, Munoz, M, Bermejo, B, Margeli, M, Anton, A, Casas, M, Csoszi, T, Murillo, L, Morales, S, Calvo, L, Lang, I, Alba, E, de la Haba-Rodriguez, J, Ramos, M, Lopez, IA, Gal-Yam, E, Garcia-Palomo, A, Alvarez, E, Gonzalez-Santiago, S, Rodriguez, CA, Servitja, S, Corsaro, M, Rodrigalvarez, G, Zielinski, C and Martin, M
Publicada:
1 oct 2021
Ahead of Print:
1 ago 2021
Resumen:
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 QLQC30 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. 2021 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Filiaciones:
Kahan, Z:
Univ Szeged, Dept Oncotherapy, 12 Koranyi Fasor, H-6720 Szeged, Hungary
Gil-Gil, M:
Inst Catal Oncol ICO, Lhospitalet De Llobregat, Spain
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Ruiz-Borrego, M:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Hosp Univ Virgen del Rocio, Seville, Spain
Carrasco, E:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Ciruelos, E:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Hosp Univ 12 Octubre, Madrid, Spain
HM Hosp Madrid, Madrid, Spain
SOLTI Grp Breast Canc Res, Madrid, Spain
Munoz, M:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Hosp Univ Clin Barcelona, Inst Clin Malalties Hematooncol ICHMO, Barcelona, Spain
Bermejo, B:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Hosp Clin Univ Valencia, Inst Invest Sanitaria INCLIVA Valencia, Valencia, Spain
CIBERONC ISCIII, Ctr Invest Biomed Red Oncol, Madrid, Spain
:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Hosp Badalona Germans Trias & Pujol, Inst Catal Oncol, Badalona Appl Res Grp Oncol ARGO Grp, Badalona, Spain
Anton, A:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
CIBERONC ISCIII, Ctr Invest Biomed Red Oncol, Madrid, Spain
Hosp Univ Miguel Servet, Inst Invest Sanitaria Aragon IISA, Zaragoza, Spain
Casas, M:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Csoszi, T:
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz R, Dept Oncol, Szolnok, Hungary
Murillo, L:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Hosp Clin Zaragoza Lozano Blesa, Med Oncol, Zaragoza, Spain
Morales, S:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Hosp Arnau Vilanova, Med Oncol, Lleida, Spain
Calvo, L:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Complejo Hosp Univ A Coruna, La Coruna, Spain
Lang, I:
Istenhegyi Gendiagnoszt Private Hlth Ctr Oncol Cl, Budapest, Hungary
Alba, E:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
CIBERONC ISCIII, Ctr Invest Biomed Red Oncol, Madrid, Spain
Hosp Reg & Virgen de la Victoria, IBIMA, UGCI Med Oncol, Malaga, Spain
de la Haba-Rodriguez, J:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Univ Cordoba, Hosp Reina Sofia Hosp, Inst Maimonides Invest Biomed, Cordoba, Spain
Ramos, M:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Ctr Oncol Galicia, La Coruna, Spain
Lopez, IA:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Hosp Univ Donostia Biodonostia, San Sebastian, Spain
Gal-Yam, E:
Sheba Med Ctr, Inst Oncol, Tel Hashomer, Israel
Garcia-Palomo, A:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Hosp Leon, Med Oncol, Leon, Spain
Alvarez, E:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Hosp Univ Lucus Augusti, Lugo, Spain
Gonzalez-Santiago, S:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Hosp Univ San Pedro de Alcantara, Caceres, Spain
Rodriguez, CA:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Hosp Clin Univ Salamanca, IBSAL, Salamanca, Spain
Servitja, S:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Hosp Mar, Barcelona, Spain
Corsaro, M:
Pfizer Inc, Milan, Italy
Rodrigalvarez, G:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
Zielinski, C:
Med Univ Vienna, Vienna Canc Ctr, Vienna, Austria
Vienna Hosp Assoc, Vienna, Austria
CECOG Cent European Cooperat Oncol Grp, Vienna, Austria
Martin, M:
GEICAM Spanish Breast Canc Grp, Madrid, Spain
CIBERONC ISCIII, Ctr Invest Biomed Red Oncol, Madrid, Spain
Inst Invest Sanitaria Gregorio Maranon, Madrid, Spain
Green Accepted, Green Published, hybrid
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