Bílek O, Selingerová I, Kysela M, Jedlička V, Kazda T, Berkovcová J, Turčáni P, Poprach A, Kiss I, Svoboda M, Zdražilová-Dubská L
Klin Onkol. 2024;37(6):433-444. doi: 10.48095/ccko2024433.
BACKGROUND: Lung cancer (LC) represents the leading cause of cancer-related deaths in the Czech Republic. Over the past decade, there have been notable advancements in LC treatment based on findings from controlled clinical trials (CTs). However, patients enrolled in CTs may not fully represent the diversity of real-world patient populations from routine clinical practice. To address this gap, we designed an observational retrospective study to describe the real-world evidence of LC treatment from a single-center registry. PATIENTS AND METHODS: We present data from an observational, retrospective study based on electronic medical records of adults with LC registered at Masaryk Memorial Cancer Institute between 2018 and 2022. The primary objective was to set up a registry including patient attributes, clinical characteristics, pathological data, treatments, survival outcomes, and adverse events. The patients were identified based on ICD-10 code C34. The study population was further limited to those with verified histological subtypes - non-small cell LC (NSCLC) and small cell LC (SCLC). The primary treatment cohort included patients diagnosed or initiated on primary treatment during the study period. The non-curative systemic therapy cohort consisted of patients who received any systemic anti-cancer therapy with non-curative intent even if being diagnosed before 2018. RESULTS: A total of 1,382 patients were identified with the ICD-10 code C34. The eligible cohort included 1,172 LC patients, of whom 877 (75%) were diagnosed during the study period. Out of 827 LC patients included in the primary treatment cohort, 723 (87%) were diagnosed with NSCLC. At LC diagnosis, 56% of patients had stage IV disease. The median follow-up of the primary treatment cohort was 40.4 months, and the five-year overall survival rate was 20% for NSCLC patients and 8.2% for SCLC patients. A total of 495 NSCLC and 79 SCLC patients received systemic anti-cancer therapy at any line of treatment. In NSCLC patients, 61 (12%) received next generation sequencing mutation testing, 106 (30%) were identified with PD-L1 ≥ 50%, and 170 patients had evidence of particular driver oncogene mutation. Based on the testing, a total of 154 NSCLC patients received target therapy, and 86 NSCLC patients received immunotherapy as monotherapy or in combination with chemotherapy in the first line. CONCLUSION: The presented descriptive study of a consecutive cohort of LC patients from one cancer center over a five-year period (2018-2022) indicates the potential of LC patient registry. The LC registry, with its prospective development including an entire-country extension, provides a tool for real-world evidence that complements data from the registration and post-registration CTs, offering invaluable insights derived from clinical practice.
背景：在捷克共和国，肺癌（LC）是癌症相关死亡的主要原因。在过去十年中，基于对照临床试验（CT）的结果，LC治疗取得了显著进展。然而，参加CT的患者可能无法完全代表常规临床实践中真实世界患者群体的多样性。为了弥补这一差距，我们设计了一项观察性回顾性研究，以描述来自单中心登记处的LC治疗的真实世界证据。 患者与方法：我们展示了一项观察性回顾性研究的数据，该研究基于2018年至2022年在马萨里克纪念癌症研究所登记的成年LC患者的电子病历。主要目标是建立一个登记处，包括患者属性、临床特征、病理数据、治疗方法、生存结果和不良事件。根据国际疾病分类第十版（ICD-10）代码C34确定患者。研究人群进一步限于组织学亚型得到验证的患者——非小细胞肺癌（NSCLC）和小细胞肺癌（SCLC）。主要治疗队列包括在研究期间被诊断或开始接受初始治疗的患者。非治愈性全身治疗队列由那些接受任何非治愈性全身抗癌治疗的患者组成，即使他们在2018年之前被诊断。 结果：共确定1382例患者的ICD-10代码为C34。符合条件的队列包括1172例LC患者，其中877例（75%）在研究期间被诊断。在纳入主要治疗队列的827例LC患者中，723例（87%）被诊断为NSCLC。在LC诊断时，56%的患者患有IV期疾病。主要治疗队列的中位随访时间为40.4个月，NSCLC患者的五年总生存率为20%，SCLC患者为8.2%。共有495例NSCLC患者和79例SCLC患者在任何治疗线接受了全身抗癌治疗。在NSCLC患者中，61例（12%）接受了下一代测序突变检测，106例（30%）的程序性死亡受体配体1（PD-L1）≥50%，170例患者有特定驱动癌基因突变的证据。基于检测结果，共有154例NSCLC患者接受了靶向治疗，86例NSCLC患者在一线接受了免疫治疗，作为单一疗法或与化疗联合使用。 结论：本研究对一个癌症中心在五年期间（2018 - 2022年）连续的LC患者队列进行了描述性研究，表明了LC患者登记处的潜力。LC登记处及其前瞻性发展，包括扩展到全国范围，提供了一个真实世界证据的工具，补充了注册和注册后CT的数据，提供了来自临床实践的宝贵见解。
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