Katedra Onkologii, Wydział Lekarski, Collegium Medicum, Uniwersytet Warmińsko-Mazurski w Olsztynie, Olsztyn, Poland.
BMC Cancer. 2020 Mar 18;20(1):231. doi: 10.1186/s12885-020-06721-8.
Prophylactic cranial irradiation (PCI) is a current standard of care after confirmed response to radical chemoradiotherapy for limited disease small cell lung cancer (LD-SCLC). This standard is mostly based on results of old randomized studies when brain imaging with magnetic resonance (MRI) was not available. Survival benefit of PCI in extended disease SCLC was recently challenged by the results of randomized phase III study from Japan.
Eighty patients with LD-SCLC after response to chest chemoradiotherapy will be enrolled. Patients will be followed up by brain MRI every 3 to 6 months up to 3 years. Neurocognitive function tests will be performed at baseline and after 12 and 24 months. Patients who develop brain metastases will be irradiated with stereotactic (SRT) or whole brain RT (WBRT). The primary endpoint is overall survival. The secondary endpoints are: response rate to radiotherapy of early detected brain metastases, analysis of efficacy of SRT and WBRT; assessment and analysis of neurocognitive functions and QoL in the studied cohorts: QLQ-C30 questionnaire and the California Verbal Learning Test, Color connection test, Benton visual retention test, and verbal fluency test will be carried out.
The results of this trial may contribute to changing of LD-SCLC clinical management by deescalating the treatment. There is a lack of prospective, recent studies in LD-SCLC patients with omission of PCI and modern radiation therapy technologies for developed brain metastases. The comprehensive neurocognitive function testing will help to assess the impact of modern radiotherapy (SRT) compared with WBRT and no-PCI in SCLC patients. A subgroup of long-term survivors, who will not develop brain metastases, will not be exposed to unnecessary brain irradiation with its deleterious consequences. The limitation of our study is a lack of parallel randomized control arm. This is a potential source of bias; however, randomized study will be difficult to complete for two major reasons: (1) limited population of LD-SCLC eligible for the study and (2) opinions of our patients, who after information and discussion about benefits and potential harms of PCI, often choose to omit PCI in our practice.
ClinicalTrials.gov Identifier: NCT04168281, 19 Nov. 2019.
在局限期小细胞肺癌（LD-SCLC）患者经过根治性放化疗后出现缓解时，预防性颅脑照射（PCI）是目前的治疗标准。该标准主要基于旧的随机研究结果，当时磁共振成像（MRI）尚未应用于脑成像。最近，日本开展的一项随机 III 期研究结果对扩展期 SCLC 患者接受 PCI 的生存获益提出了挑战。
将入组 80 例 LD-SCLC 患者，这些患者在胸部放化疗后出现缓解。患者将通过 MRI 每隔 3 至 6 个月进行随访，随访时间最长为 3 年。将在基线时和 12 个月、24 个月时进行神经认知功能测试。如果出现脑转移，将采用立体定向放疗（SRT）或全脑放疗（WBRT）进行照射。主要终点为总生存。次要终点包括：早期检测到脑转移时放疗的反应率、SRT 和 WBRT 的疗效分析、研究队列的神经认知功能和生活质量评估和分析：将进行 EORTC QLQ-C30 问卷和加利福尼亚词语学习测验、颜色连线测验、邦顿视觉保持测验和词语流畅性测验。
该试验的结果可能有助于通过降低治疗强度来改变 LD-SCLC 的临床管理。对于未行 PCI 且对于已发展的脑转移瘤采用现代放疗技术的 LD-SCLC 患者，目前缺乏前瞻性的近期研究。综合的神经认知功能测试将有助于评估与 WBRT 和不进行 PCI 相比，现代放疗（SRT）对 SCLC 患者的影响。不会出现脑转移的长期生存者亚组将不会受到不必要的脑照射及其有害后果的影响。我们研究的局限性在于缺乏平行的随机对照臂。这是一个潜在的偏倚源；然而，由于两个主要原因，很难完成随机研究：（1）符合研究条件的 LD-SCLC 患者人数有限，（2）我们的患者在了解和讨论 PCI 的益处和潜在危害后，通常选择在我们的治疗中不进行 PCI。
ClinicalTrials.gov 标识符：NCT04168281，2019 年 11 月 19 日。
