Hospital Clínic i Provincial, Barcelona, Spain.
University of Barcelona, Barcelona, Spain.
Support Care Cancer. 2021 Aug;29(8):4799-4807. doi: 10.1007/s00520-021-06006-1. Epub 2021 Feb 3.
The main aim of the study was to assess the impact of individualized management of breakthrough cancer pain (BTcP) on quality of life (QoL) of patients with advanced cancer in clinical practice.
A prospective, observational, multicenter study was conducted in patients with advanced cancer that were assisted by palliative care units. QoL was assessed with the EORTC QLQ-C30 questionnaire at baseline (V0) and after 28 days (V28) of individualized BTcP therapy. Data on background pain, BTcP, comorbidities, and frailty were also recorded.
Ninety-three patients completed the study. Intensity, duration, and number of BTcP episodes were reduced (p < 0.001) at V28 with individualized therapy. Transmucosal fentanyl was used in 93.8% of patients, mainly by sublingual route. Fentanyl titration was initiated at low doses (78.3% of patients received doses of 67 μg, 100 μg, or 133 μg) according to physician evaluation. At V28, mean perception of global health status had increased from 31.1 to 53.1 (p < 0.001). All scales of EORTC QLQ-C30 significantly improved (p < 0.001) except physical functioning, diarrhea, and financial difficulties. Pain scale improved from 73.6 ± 22.6 to 35.7 ± 22.3 (p < 0.001). Moreover, 85.9% of patients reported pain improvement. Probability of no ≥ 25% improvement in QoL was significantly higher in patients ≥ 65 years old (OR 1.39; 95% CI 1.001-1.079) and patients hospitalized at baseline (OR 4.126; 95% CI 1.227-13.873).
Individualized BTcP therapy improved QoL of patients with advanced cancer. Transmucosal fentanyl at low doses was the most used drug.
This study was registered at ClinicalTrials.gov database (NCT02840500) on July 19, 2016.
本研究的主要目的是评估在临床实践中对突破性癌症疼痛（BTcP）进行个体化管理对晚期癌症患者生活质量（QoL）的影响。
一项前瞻性、观察性、多中心研究在接受姑息治疗单位帮助的晚期癌症患者中进行。在基线（V0）和个体化 BTcP 治疗 28 天后（V28），使用 EORTC QLQ-C30 问卷评估 QoL。还记录了背景疼痛、BTcP、合并症和虚弱的数据。
93 名患者完成了研究。个体化治疗后，疼痛强度、持续时间和 BTcP 发作次数均减少（p<0.001）。93.8%的患者使用经粘膜芬太尼，主要通过舌下途径。根据医生评估，芬太尼滴定开始于低剂量（78.3%的患者接受 67μg、100μg 或 133μg 剂量）。在 V28，总体健康状况的平均感知从 31.1 增加到 53.1（p<0.001）。除生理功能、腹泻和经济困难外，EORTC QLQ-C30 的所有量表均显著改善（p<0.001）。疼痛量表从 73.6±22.6 改善至 35.7±22.3（p<0.001）。此外，85.9%的患者报告疼痛改善。≥65 岁的患者（OR 1.39；95%CI 1.001-1.079）和基线住院的患者（OR 4.126；95%CI 1.227-13.873）的 QoL 无≥25%改善的可能性显著更高。
个体化 BTcP 治疗改善了晚期癌症患者的生活质量。低剂量经粘膜芬太尼是最常用的药物。
该研究于 2016 年 7 月 19 日在 ClinicalTrials.gov 数据库（NCT02840500）注册。
