European journal of cancer (Oxford, England : 1990) · 2021
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.
Клиническое исследование III фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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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
Аннотация
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.
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.
Предметные рубрики MeSH
AndrostadienesAntimetabolites, AntineoplasticAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsCapecitabineDisease ProgressionEstrogen Receptor AntagonistsEuropeFemaleFulvestrantHealth StatusHumansIsraelNeoplasm MetastasisPatient Reported Outcome MeasuresPiperazinesPostmenopauseProgression-Free SurvivalProtein Kinase InhibitorsPyridinesQuality of LifeTime Factors