Tibau Ariadna, Martínez M Teresa, Ramos Manuel, De La Cruz-Merino Luis, Santaballa Ana, O'Connor Miriam, Martínez-Jañez Noelia, Moreno Fernando, Fernández Isaura, Virizuela Juan Antonio, Alarcón Jesús, de La Haba-Rodríguez Juan, Sánchez-Rovira Pedro, Albacar Cinta Rosa, Bueno Muiño Coralia, Kelly Catherine, Casas Maribel, Bezares Susana, Rosell Libertad, Albanell Joan
Hospital de la Santa Creu i Sant Pau, Institut d'Investigació Biomèdica Sant Pau, and Departament de Medicina de la Universitat Autònoma de Barcelona, C/ Sant Quintí, 89, Barcelona 08041, Spain.
GEICAM Spanish Breast Cancer Group, Madrid, Spain.
Ther Adv Med Oncol. 2023 Jan 19;15:17588359221148921. doi: 10.1177/17588359221148921. eCollection 2023.
In the FLIPPER trial, palbociclib/fulvestrant significantly improved progression-free survival (PFS) compared with placebo/fulvestrant in postmenopausal women with HR+/HER2- advanced breast cancer (ABC).
We assessed health-related quality of life (QoL) using patient-reported outcomes (PROs).
In this phase II double-blinded study, PROs were assessed at baseline after every three cycles and at the end of the treatment using the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23. Time to deterioration (TTD) in global health status (GHS)/QoL was defined as a decrease of ⩾10 points. Changes from baseline (CFB) and TTD were analysed using linear mixed-effect and Cox regression models, respectively.
Of the 189 randomised (1:1) patients, 178 (94%) completed ⩾1 post-baseline assessment; 50% received ⩾22 cycles of study treatment, with a questionnaire compliance >90%. Mean baseline scores were comparable between arms. GHS/QoL scores were maintained throughout the palbociclib/fulvestrant treatment. CFB showed significant differences for GHS/QoL, appetite loss, constipation and systemic therapy side effect scores favouring placebo/fulvestrant. TTD in GHS/QoL was delayed in placebo/fulvestrant palbociclib/fulvestrant [30.3 11.1 months; adjusted hazard ratio (aHR): 1.57, 95% CI: 1.03-2.39, = 0.036]; this difference was not significant in patients with progressive disease (aHR: 1.2, 95% CI: 0.6-2.2, = 0.658). No statistically significant differences in TTD were found for the other QLQ-C30 and QLQ-BR23 scales.
Although TTD in GHS/QoL was prolonged with placebo/fulvestrant, no differences were observed on other functional or symptom scales. This finding and the improvement in PFS support the combination of palbociclib/fulvestrant as a beneficial therapeutic option for HR+/HER2- ABC.
Sponsor Study Code: GEICAM/2014-12EudraCT Number: 2015-002437-21ClinTrials.gov reference: NCT02690480.
在FLIPPER试验中，与安慰剂/氟维司群相比，哌柏西利/氟维司群显著改善了激素受体阳性（HR+）/人表皮生长因子受体2阴性（HER2-）的绝经后晚期乳腺癌（ABC）患者的无进展生存期（PFS）。
我们使用患者报告结局（PRO）评估健康相关生活质量（QoL）。
在这项II期双盲研究中，使用欧洲癌症研究与治疗组织的QLQ-C30和QLQ-BR23在基线、每三个周期后以及治疗结束时评估PRO。全球健康状况（GHS）/QoL的恶化时间（TTD）定义为下降≥10分。分别使用线性混合效应模型和Cox回归模型分析基线变化（CFB）和TTD。
189例随机分组（1:1）的患者中，178例（94%）完成了≥1次基线后评估；50%接受了≥22个周期的研究治疗，问卷依从性>90%。各治疗组的平均基线评分相当。在整个哌柏西利/氟维司群治疗期间，GHS/QoL评分得以维持。CFB显示，在GHS/QoL、食欲减退、便秘和全身治疗副作用评分方面，安慰剂/氟维司群组有显著差异。安慰剂/氟维司群组的GHS/QoL TTD较哌柏西利/氟维司群组延迟[30.3对11.1个月；调整后风险比（aHR）：1.57，95%置信区间（CI）：1.03 - 2.39，P = 0.036]；在疾病进展患者中，这种差异不显著（aHR：1.2，95% CI：0.6 - 2.2，P = 0.658）。在其他QLQ-C30和QLQ-BR23量表的TTD方面未发现统计学显著差异。
尽管安慰剂/氟维司群组的GHS/QoL TTD延长，但在其他功能或症状量表上未观察到差异。这一发现以及PFS的改善支持哌柏西利/氟维司群联合用药作为HR+/HER2- ABC的一种有益治疗选择。
申办者研究代码：GEICAM/2014 - 12欧洲药品管理局临床试验编号：2015 - 002437 - 缉21美国国立医学图书馆临床试验注册中心标识符：NCT02690480。
