Lungulescu Cristian Virgil, Camen Georgiana-Cristiana, Naidin Mihaela-Simona, Berisha Tradian-Ciprian, Bita Andrei, Dinescu Venera-Cristina, Buteica Sandra Alice, Dimulescu Marina-Daniela, Volovat Simona Ruxandra, Turcu-Stiolica Adina
Oncology Department, University of Medicine and Pharmacy of Craiova, 200349 Craiova, Romania.
Radiotherapy Department, University of Medicine and Pharmacy of Craiova, 200349 Craiova, Romania.
Cancers (Basel). 2024 Dec 13;16(24):4161. doi: 10.3390/cancers16244161.
BACKGROUND/OBJECTIVES: The first reimbursed prescription for palbociclib (Palbo) in breast cancer patients in Romania was issued in July 2018. The objective of this study is to assess the efficacy, safety, and adherence to Palbo in combination with aromatase inhibitor (AI) or fulvestrant in a real-world cohort of HR+/HER2- breast cancer patients from Romania.
A retrospective analysis of reimbursed Palbo prescriptions was conducted using data extracted from the electronic database of the Romanian Health Insurance House, Dolj County, for disease code 124 (breast cancer), covering the period from 2018 to 2023. The primary outcome assessed was time to treatment discontinuation (TTD), with secondary outcomes including overall survival (OS) and Palbo adherence (which was measured by medication possession ratio).
A total of 125 patients were identified, with a median age of 62 years (IQR, 53-70), and 98% were female. Two treatment combinations were observed: Palbo + Aromatase Inhibitor (AI) in 104 patients (83.2%) and Palbo + fulvestrant in 21 patients (16.8%). The median TTD for the entire cohort was 19 months (95%CI, 19.3-24.9 months). In patients treated with Palbo + AI, the median TTD was not available/reached [NA] (95%CI, 36.0-NA months). For those receiving Palbo+fulvestrant, the median TTD was 25.0 months (95%CI, 13.0-NR months). No significant differences in TTD were observed among the two treatment combinations (χ = 1.33, df = 1, log-rank = 0.249). The 12- and 36-month TTD rates were higher for Palbl combined with AI than combined with fulvestrant: 77.8% [95%CI, 69.7-86.7%] vs. 71.8% [95%CI, 53.6-96.2%], and 56.3% [95%CI, 45.9-69%] vs. 49.7% [95%CI, 29.7-83.2%], respectively. The median OS was 38 months (95%CI, 25.5-50.9). When treatment involved Palbo + AI, the median OS was NA (95%CI, 54.8-NA) months. When treatment involved Palbo + fulvestrant, the median was 50.8 (95%CI, 34.1-NA) months. Related to OS, no significant differences were found between the two types of treatments (log-rank = 0.638). The 24- and 36-month OS rates were higher for Palbo combined with AI than combined with fulvestrant: 76.9% [95%CI, 69.2-85.5%] vs. 81% [95%CI, 65.8-99.6%], and 67.9% [95%CI, 59.2-77.8%] vs. 65.3% [95%CI, 47.4-90.0%], respectively. The mean adherence in our study was 0.91 ± 0.1. We found no correlation between adherence to Palbo and OS (Spearman's rho = 0.04, = 0.593).
While both AI and fulvestrant remain viable options, the lack of significant differences in survival between these combinations suggests that treatment choice can be tailored to individual patient needs.
背景/目的：2018年7月，罗马尼亚首次为乳腺癌患者报销了哌柏西利（Palbo）的处方。本研究的目的是评估在罗马尼亚HR + / HER2-乳腺癌患者的真实队列中，Palbo联合芳香化酶抑制剂（AI）或氟维司群的疗效、安全性和依从性。
利用从罗马尼亚多尔日县健康保险机构电子数据库中提取的疾病代码124（乳腺癌）数据，对报销的Palbo处方进行回顾性分析，涵盖2018年至2023年期间。评估的主要结局是治疗中断时间（TTD），次要结局包括总生存期（OS）和Palbo依从性（通过药物持有率衡量）。
共确定了125例患者，中位年龄为62岁（四分位间距，53 - 70岁），98%为女性。观察到两种治疗组合：104例患者（83.2%）使用Palbo + 芳香化酶抑制剂（AI），21例患者（16.8%）使用Palbo + 氟维司群。整个队列的中位TTD为19个月（95%CI，19.3 - 24.9个月）。在接受Palbo + AI治疗的患者中，中位TTD不可用/未达到[NA]（95%CI，36.0 - NA个月）。对于接受Palbo + 氟维司群治疗的患者，中位TTD为25.0个月（95%CI，13.0 - NR个月）。两种治疗组合之间在TTD方面未观察到显著差异（χ = 1.33，自由度 = 1，对数秩检验 = 0.249）。Palbo联合AI的12个月和36个月TTD率高于联合氟维司群：分别为77.8% [95%CI，69.7 - 86.7%] 对71.8% [95%CI，53.6 - 96.2%]，以及56.3% [95%CI，45.9 - 69%] 对49.7% [95%CI，29.7 - 83.2%]。中位OS为38个月（95%CI，25.5 - 50.9）。当治疗为Palbo + AI时，中位OS为NA（95%CI，54.8 - NA）个月。当治疗为Palbo + 氟维司群时，中位OS为50.8（95%CI，34.1 - NA）个月。与OS相关，两种治疗类型之间未发现显著差异（对数秩检验 = 0.638）。Palbo联合AI的24个月和36个月OS率高于联合氟维司群：分别为76.9% [95%CI，69.2 - 85.5%] 对81% [95%CI，65.8 - 99.6%]，以及67.9% [95%CI，59.2 - 77.8%] 对65.3% [95%CI，47.4 - 90.0%]。本研究中的平均依从性为0.91±0.1。我们发现Palbo依从性与OS之间无相关性（Spearman秩相关系数 = 0.04，P = 0.593）。
虽然AI和氟维司群都是可行的选择，但这些组合在生存期方面缺乏显著差异，这表明治疗选择可以根据个体患者的需求进行调整。
