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. Methods: 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). Results: 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 (χ2= 1.33, df = 1, log-rankp= 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-rankp= 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,p= 0.593). Conclusions: 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：罗马尼亚首张针对乳腺癌患者的哌柏西利（Palbo）报销处方于2018年7月开具。本研究旨在评估罗马尼亚HR+/HER2−乳腺癌患者真实世界队列中，哌柏西利联合芳香化酶抑制剂（AI）或氟维司群治疗的疗效、安全性及用药依从性。方法：通过提取多尔日县罗马尼亚健康保险之家电子数据库中疾病代码124（乳腺癌）的报销处方数据，对2018年至2023年期间的哌柏西利处方进行回顾性分析。主要评估结果为治疗中断时间（TTD），次要结果包括总生存期（OS）及哌柏西利依从性（通过药物持有率衡量）。结果：共纳入125例患者，中位年龄62岁（IQR，53–70），其中98%为女性。观察到两种治疗方案：哌柏西利+AI（104例，83.2%）和哌柏西利+氟维司群（21例，16.8%）。整体队列的中位TTD为19个月（95%CI，19.3–24.9个月）。哌柏西利+AI治疗组的中位TTD未达到（95%CI，36.0-未达到个月）；哌柏西利+氟维司群治疗组的中位TTD为25.0个月（95%CI，13.0-未达到个月）。两种治疗方案的TTD无显著差异（χ²=1.33，df=1，对数秩检验p=0.249）。哌柏西利联合AI的12个月和36个月TTD率均高于联合氟维司群方案：分别为77.8% [95%CI，69.7–86.7%] vs. 71.8% [95%CI，53.6–96.2%] 和56.3% [95%CI，45.9–69%] vs. 49.7% [95%CI，29.7–83.2%]。中位OS为38个月（95%CI，25.5–50.9）。哌柏西利+AI治疗组的中位OS未达到（95%CI，54.8-未达到个月）；哌柏西利+氟维司群治疗组的中位OS为50.8个月（95%CI，34.1-未达到个月）。两种治疗方案的OS无显著差异（对数秩检验p=0.638）。哌柏西利联合AI的24个月和36个月OS率分别为76.9% [95%CI，69.2–85.5%] vs. 81% [95%CI，65.8–99.6%] 和67.9% [95%CI，59.2–77.8%] vs. 65.3% [95%CI，47.4–90.0%]。本研究中平均用药依从性为0.91 ± 0.1，未发现哌柏西利依从性与OS存在相关性（斯皮尔曼rho=0.04，p=0.593）。结论：虽然AI与氟维司群均为可行选择，但两种联合方案在生存结局上无显著差异，提示治疗方案可根据患者个体化需求进行选择。
肿瘤(癌症)患者之家