Tagliaferri Barbara, Mollica Ludovica, Palumbo Raffella, Leli Claudia, Malovini Alberto, Terzaghi Matteo, Quaquarini Erica, Teragni Cristina, Maccarone Stefano, Premoli Andrea, Sottotetti Federico
Medical Oncology Unit, ICS Maugeri IRCCS, Pavia, Italy.
University of Pavia, Pavia, Italy.
Drugs Context. 2023 Jun 20;12. doi: 10.7573/dic.2023-1-7. eCollection 2023.
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.
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).
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 (=0.8944). At T2, QLQ-C30 global score deteriorated with respect to baseline (=0.0089). At baseline, patients with CIRS ≥5 had worse constipation than patients without comorbidities (<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 (<0.05). No change in QLQ-C30 final score from T0 to T1 was observed (>0.05).
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 Special Issue: https://www.drugsincontext.com/special_issues/tackling-clinical-complexity-in-breast-cancer/.
晚期乳腺癌（ABC）具有多维度的临床复杂性，而随机临床试验通常未考虑这一点。在本项真实世界研究中，我们调查了接受CDK4/6抑制剂治疗的激素受体/人表皮生长因子受体2（HR/HER2）阳性晚期乳腺癌患者的临床复杂性与生活质量之间的联系。
我们使用累积疾病评定量表（CIRS）评估了共病负担、用药种类及患者报告结局（PROs）。使用欧洲癌症研究与治疗组织（EORTC）QLC-C30和QLQ-BR23问卷在基线（T0）、治疗3个月后（T1）以及疾病进展时（T2）评估PROs。在具有不同共病负担（CIRS<5和≥5）和用药种类（<2种或≥2种药物）的患者中评估基线PROs以及T0和T1之间的变化。
2018年1月至2022年1月，我们纳入了54例患者（中位年龄66岁，四分位间距59 - 74岁）。CIRS评分中位数为5（四分位间距2 - 7），而患者服用药物的中位数为2种（四分位间距0 - 4）。在整个队列中，未观察到T0和T1之间QLQ-C30最终评分的变化（P = 0.8944）。在T2时，QLQ-C30总体评分相对于基线恶化（P = 0.0089）。在基线时，CIRS≥5的患者便秘情况比无合并症的患者更严重（P<0.05），且QLQ-C30总体评分中位数呈较低趋势。服用≥2种药物的患者QLQ-C30最终评分较低，失眠和便秘情况更严重（P<0.05）。未观察到从T0到T1的QLQ-C30最终评分有变化（P>0.05）。
共病和用药种类增加了晚期乳腺癌患者的临床复杂性，并可能影响基线PROs。在该人群中，CDK4/6抑制剂的安全性似乎得以维持。需要进一步研究以评估晚期乳腺癌患者的临床复杂性。本文是特刊的一部分：https://www.drugsincontext.com/special_issues/tackling-clinical-complexity-in-breast-cancer/ 。
