Efficacy and activity of treatments after progression from palbociclib plus endocrine therapy in patients with HR⁺/HER2^- metastatic breast cancer: a prospective, monocentric study.

Q2 Pharmacology, Toxicology and Pharmaceutics Drugs in Context Pub Date : 2024-02-05 eCollection Date: 2024-01-01 DOI:10.7573/dic.2023-7-5

Raffaella Palumbo, Erica Quaquarini, Giuseppe Saltalamacchia, Alberto Malovini, Pietro Lapidari, Barbara Tagliaferri, Ludovica Mollica, Cristina Maria Teragni, Chiara Barletta, Laura Deborah Locati, Federico Sottotetti

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Abstract

Background: Breast cancer is the most frequent tumour worldwide, and the HR⁺/HER2^- subtype is the most common. For this tumour type, endocrine therapy (ET) is the mainstay of treatment. The association of ET and CDK4/6 inhibitors (CDK4/6i) represents the gold standard for first-line or second-line therapies. However, the optimal therapeutic strategy after CDK4/6i progression is still a matter of debate, with several randomized clinical trials still ongoing.

Patients and methods: This is an observational, prospective, real-world study including women with HR⁺/HER2^- metastatic breast cancer progressing to palbociclib plus ET. Patients received either ET or chemotherapy (CT). The primary objective was the evaluation of efficacy of the different therapeutic strategies after palbociclib in terms of median progression-free survival 2. Secondary objectives were the activity of therapeutic strategies measured with the clinical benefit rate, evaluation of the parameters used for the treatment choice, and progression-free survival 1 related to palbociclib plus ET treatment.

Results: Overall, 48 patients (median age 53, range 33-78 years) were included. The median progression-free survival 2 was of 5 months in the overall cohort (95% CI 4-48 months) with a statistically significant difference between the two therapeutic strategies adopted (ET versus CT, 10 months versus 5 months, respectively). Regarding secondary objectives, the clinical benefit rate was 55.2% in the CT cohort and 50% in ET. Moreover, women treated with CT had a greater number of visceral metastases and a shorter median progression-free survival 1 than patients who received ET.

Conclusions: ET and CT represent two possible therapeutic alternatives for patients progressing on CDK4/6i plus ET. The choice is based on clinical parameters, with a potential preference for ET.

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HR+/HER2-转移性乳腺癌患者接受帕博西尼（palbociclib）加内分泌治疗进展后的疗效和活性：一项前瞻性单中心研究。

背景：乳腺癌是全球发病率最高的肿瘤，其中 HR+/HER2- 亚型最为常见。对于这种肿瘤类型，内分泌治疗（ET）是主要的治疗手段。ET与CDK4/6抑制剂（CDK4/6i）的联合应用代表了一线或二线治疗的黄金标准。然而，CDK4/6i进展后的最佳治疗策略仍存在争议，几项随机临床试验仍在进行中：这是一项观察性、前瞻性、真实世界研究，研究对象包括HR+/HER2-转移性乳腺癌进展至palbociclib加ET的女性患者。患者接受 ET 或化疗 (CT)。首要目标是评估帕博西尼治疗后不同治疗策略在中位无进展生存期2方面的疗效。次要目标是以临床获益率衡量治疗策略的活性、评估用于治疗选择的参数以及与palbociclib加ET治疗相关的无进展生存期1：共纳入48名患者（中位年龄53岁，33-78岁）。中位无进展生存期2为5个月（95% CI为4-48个月），两种治疗策略（ET与CT，分别为10个月与5个月）之间存在显著统计学差异。在次要目标方面，CT组的临床获益率为55.2%，ET组为50%。此外，与接受ET治疗的患者相比，接受CT治疗的女性内脏转移灶更多，中位无进展生存期1更短：ET和CT是CDK4/6i加ET治疗进展期患者的两种可能的治疗选择。选择取决于临床参数，可能更倾向于 ET。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drugs in Context Medicine-Medicine (all)

CiteScore

5.90

自引率

0.00%

发文量

审稿时长

9 weeks

期刊介绍： Covers all phases of original research: laboratory, animal and human/clinical studies, health economics and outcomes research, and postmarketing studies. Original research that shows positive or negative results are welcomed. Invited review articles may cover single-drug reviews, drug class reviews, latest advances in drug therapy, therapeutic-area reviews, place-in-therapy reviews, new pathways and classes of drugs. In addition, systematic reviews and meta-analyses are welcomed and may be published as original research if performed per accepted guidelines. Editorials of key topics and issues in drugs and therapeutics are welcomed. The Editor-in-Chief will also consider manuscripts of interest in areas such as technologies that support diagnosis, assessment and treatment. EQUATOR Network reporting guidelines should be followed for each article type. GPP3 Guidelines should be followed for any industry-sponsored manuscripts. Other Editorial sections may include Editorial, Case Report, Conference Report, Letter-to-the-Editor, Educational Section.