Petracci Fernando, Abuin Gonzalo Gomez, Pini Alejandra, Chacón Matías
Breast Cancer Department, Instituto Alexander Fleming and Sanatorio Las Lomas, Buenos Aires 1428, Argentina.
Oncology Service, Hospital Alemán, Buenos Aires 1428, Argentina.
Ecancermedicalscience. 2020 Jun 17;14:1058. doi: 10.3332/ecancer.2020.1058. eCollection 2020.
In hormone receptor-positive, HER-2 negative (HR+/HER2-) advanced breast cancer (ABC) endocrine therapy (ET) plus cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) in first and second line improved progression-free survival (PFS), overall response rate (ORR) and clinical benefit rate (CB) without deterioration in quality of life compared with ET alone. In addition, recent data showed improvement in overall survival (OS) for premenopausal women in first line setting and for different subgroups of patients in second line. Since 2015, in Argentina, the combination of ET with CDK4/6i is a standard of care in HR+/HER2- ABC.
We carried out a prospective analysis of real-world use of palbociclib with ET in HR+/HER2- ABC patients who received treatment between October 2015 and August 2019 in two private institutes from Buenos Aires, Argentina. The aims of the study were to determine efficacy and safety of patients treated with ET and palbociclib, describe patient profile and treatment strategy beyond progression.
One-hundred and twenty-eight patients were included in the final analysis. Main baseline characteristics include, median age 57 years, 20% were premenopausal women, 44% had visceral metastasis and 26% bone only disease. More than half of patients had two or more metastatic sites, 44.4% had performance status 1, and most of them (59.4%) were treated with palbociclib in first-line setting. Palbociclib was preferentially associated with aromatase inhibitors in 63.9% of patients, and with fulvestrant in the remaining. All premenopausal women received ovarian suppression or ovarian ablation (OS/OA). The median PFS was 36.7 months in first line and 24.2 months in second line. The ORR was 45.3% and 25.0% in first and second line, respectively. The median OS in the entire population was not reached. Half of patients did not require dose interruption and/or delay, dose reduction was required in 15% of patients and almost no patients required drug discontinuation (2.0%). With regard to safety, 55% of patients developed grade 3-4 adverse events, 20% neutropenia grade 3-4, and 7% febrile neutropenia. Infections were presented in one out of three patients, mostly uncomplicated.
This is the first prospective evidence of real-world use of palbociclib in a Latin American population. We found similar outcomes to the PALOMA-2 and PALOMA-3 randomised trials and Real-World Data already published, with lower incidence of side effects and treatment discontinuation, but with higher incidence of febrile neutropenia.
在激素受体阳性、HER-2阴性（HR+/HER2-）的晚期乳腺癌（ABC）中，一线和二线内分泌治疗（ET）联合细胞周期蛋白依赖性激酶4/6抑制剂（CDK4/6i）可改善无进展生存期（PFS）、总缓解率（ORR）和临床获益率（CB），且与单纯ET相比，生活质量并未恶化。此外，近期数据显示，一线治疗的绝经前女性以及二线治疗的不同亚组患者的总生存期（OS）有所改善。自2015年以来，在阿根廷，ET联合CDK4/6i的方案是HR+/HER2- ABC的标准治疗方案。
我们对2015年10月至2019年8月期间在阿根廷布宜诺斯艾利斯的两家私立机构接受治疗的HR+/HER2- ABC患者使用哌柏西利联合ET的真实世界情况进行了前瞻性分析。该研究的目的是确定接受ET和哌柏西利治疗的患者的疗效和安全性，描述患者特征以及疾病进展后的治疗策略。
最终分析纳入了128例患者。主要基线特征包括，中位年龄57岁，20%为绝经前女性，44%有内脏转移，26%仅有骨转移。超过一半的患者有两个或更多转移部位，44.4%的患者体力状况评分为1，其中大多数（59.4%）在一线治疗时使用哌柏西利。63.9%的患者哌柏西利优先与芳香化酶抑制剂联合使用，其余患者与氟维司群联合使用。所有绝经前女性均接受了卵巢抑制或卵巢去势（OS/OA）。一线治疗的中位PFS为36.7个月，二线治疗为24.2个月。一线和二线治疗的ORR分别为45.3%和25.0%。整个人群的中位OS未达到。一半的患者不需要中断和/或延迟剂量，15%的患者需要减量，几乎没有患者需要停药（2.0%）。在安全性方面，55%的患者发生3-4级不良事件，20%为3-4级中性粒细胞减少，7%为发热性中性粒细胞减少。三分之一的患者发生感染，大多数无并发症。
这是拉丁美洲人群中哌柏西利真实世界使用情况的首个前瞻性证据。我们发现其结果与PALOMA-2和PALOMA-3随机试验以及已发表的真实世界数据相似，副作用和停药发生率较低，但发热性中性粒细胞减少的发生率较高。
