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. (October 2021)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: European journal of cancer. Volume 156(2021)
• Page Start: 70
• Page End: 82
• Publication Date: 2021-10
• Subjects: Health-related quality of life -- CDK4/6 inhibitor -- Palbociclib -- Endocrine therapy -- Hormone receptor–positive metastatic breast cancer; Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2021.07.004
• Languages: English
• ISSNs: 0959-8049

Abstract

Abstract: 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. Highlights: The PEARL study population was postmenopausal patients with metastatic breast cancer resistant to aromatase inhibitors. Palbociclib plus endocrine therapy (ET) delayed global health status/quality of life (QoL) deterioration compared with capecitabine. Palbociclib plus ET better allowed patients to maintain health-related QoL (HRQoL) than capecitabine. Palbociclib plus ET impacted more positively on the HRQoL that capecitabine.