Health-related quality of life and clinical complexity of a real-life cohort of patients with advanced HR+/HER2- breast cancer treated with CDK4/6 inhibitors and endocrine therapy.

Q2 Pharmacology, Toxicology and Pharmaceutics Drugs in Context Pub Date : 2023-01-01 DOI:10.7573/dic.2023-1-7
Barbara Tagliaferri, Ludovica Mollica, Raffella Palumbo, Claudia Leli, Alberto Malovini, Matteo Terzaghi, Erica Quaquarini, Cristina Teragni, Stefano Maccarone, Andrea Premoli, Federico Sottotetti
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Abstract

Background: Advanced breast cancer (ABC) is characterized by multidimensional clinical complexity that is usually not considered in randomized clinical trials. In the present real-life study, we investigated the link between clinical complexity and quality of life of patients with HR+/HER2- ABC treated with CDK4/6 inhibitors.

Methods: We evaluated multimorbidity burden assessed with the Cumulative Illness Rating Scale (CIRS), polypharmacy and patient-reported outcomes (PROs). PROs were assessed at baseline (T0), after 3 months of therapy (T1), and at disease progression (T2) using EORTC QLC-C30 and QLQ-BR23 questionnaires. Baseline PROs and changes between T0 and T1 were evaluated amongst patients with different multimorbidity burden (CIRS <5 and ≥5) and polypharmacy (<2 or ≥2 drugs).

Results: From January 2018 to January 2022, we enrolled 54 patients (median age 66 years, IQR 59-74). The median CIRS score was 5 (IQR 2-7), whilst the median number of drugs taken by patients was 2 (IQR 0-4). No changes in QLQ-C30 final scoring between T0 and T1 were observed in the overall cohort (p=0.8944). At T2, QLQ-C30 global score deteriorated with respect to baseline (p=0.0089). At baseline, patients with CIRS ≥5 had worse constipation than patients without comorbidities (p<0.05) and a lower trend in the median QLQ-C30 global score. Patients on ≥2 drugs had lower QLQ-C30 final scores and worse insomnia and constipation (p<0.05). No change in QLQ-C30 final score from T0 to T1 was observed (p>0.05).

Conclusion: Multimorbidity and polypharmacy increase the clinical complexity of patients with ABC and may affect baseline PROs. The safety profile of CDK4/6 inhibitors seems to be maintained in this population. Further studies are needed to assess clinical complexity in patients with ABC.This article is part of the Tackling clinical complexity in breast cancer Special Issue: https://www.drugsincontext.com/special_issues/tackling-clinical-complexity-in-breast-cancer/.

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CDK4/6抑制剂和内分泌疗法治疗的晚期HR+/HER2-乳腺癌患者现实生活队列的健康相关生活质量和临床复杂性
背景:晚期乳腺癌(ABC)的特点是多维临床复杂性,通常不考虑随机临床试验。在目前的现实研究中,我们调查了临床复杂性与接受CDK4/6抑制剂治疗的HR+/HER2- ABC患者的生活质量之间的关系。方法:我们用累积疾病评定量表(CIRS)、多重用药和患者报告结局(PROs)评估多重疾病负担。采用EORTC QLC-C30和QLQ-BR23问卷,在基线(T0)、治疗3个月后(T1)和疾病进展(T2)时评估PROs。在不同多重疾病负担的患者中评估基线pro和T0和T1之间的变化(CIRS结果:从2018年1月到2022年1月,我们招募了54例患者(中位年龄66岁,IQR 59-74)。CIRS评分中位数为5分(IQR 2 ~ 7分),患者用药中位数为2分(IQR 0 ~ 4分)。在整个队列中,QLQ-C30最终评分在T0和T1之间没有变化(p=0.8944)。T2时,QLQ-C30总体评分相对于基线恶化(p=0.0089)。基线时,CIRS≥5的患者便秘情况比无合并症的患者更严重(ppp>0.05)。结论:多病多药增加了ABC患者的临床复杂性,并可能影响基线PROs。CDK4/6抑制剂的安全性似乎在这一人群中保持不变。需要进一步的研究来评估ABC患者的临床复杂性。本文是解决乳腺癌临床复杂性特刊的一部分:https://www.drugsincontext.com/special_issues/tackling-clinical-complexity-in-breast-cancer/。
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
Drugs in Context Medicine-Medicine (all)
CiteScore
5.90
自引率
0.00%
发文量
63
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.
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