Nuclear Medicine Department, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
Eur J Nucl Med Mol Imaging. 2019 Oct;46(11):2235-2243. doi: 10.1007/s00259-019-04421-5. Epub 2019 Jul 31.
Patients with stage III non-small-cell lung cancer (NSCLC) treated with chemoradiotherapy (CRT) in low- and middle-income countries (LMIC) continue to have a poor prognosis. It is known that FDG PET/CT improves staging, treatment selection and target volume delineation (TVD), and although its use has grown rapidly, it is still not widely available in LMIC. CRT is often used as sequential treatment, but is known to be more effective when given concurrently. The aim of the PERTAIN study was to assess the impact of introducing FDG PET/CT-guided concurrent CRT, supported by training and quality control (QC), on the overall survival (OS) and progression-free survival (PFS) of patients with stage III NSCLC.
The study included patients with stage III NSCLC from nine medical centres in seven countries. A retrospective cohort was managed according to local practices between January 2010 and July 2014, which involved only optional diagnostic FDG PET/CT for staging (not for TVD), followed by sequential or concurrent CRT. A prospective cohort between August 2015 and October 2018 was treated according to the study protocol including FDG PET/CT in treatment position for staging and multimodal TVD followed by concurrent CRT by specialists trained in protocol-specific TVD and with TVD QC. Kaplan-Meier analysis was used to assess OS and PFS in the retrospective and prospective cohorts.
Guidelines for FDG PET/CT image acquisition and TVD were developed and published. All specialists involved in the PERTAIN study received training between June 2014 and May 2016. The PET/CT scanners used received EARL accreditation. In November 2018 a planned interim analysis was performed including 230 patients in the retrospective cohort with a median follow-up of 14 months and 128 patients in the prospective cohort, of whom 69 had a follow-up of at least 1 year. Using the Kaplan-Meier method, OS was significantly longer in the prospective cohort than in the retrospective cohort (23 vs. 14 months, p = 0.012). In addition, median PFS was significantly longer in the prospective cohort than in the retrospective cohort (17 vs. 11 months, p = 0.012).
In the PERTAIN study, the preliminary results indicate that introducing FDG PET/CT-guided concurrent CRT for patients with stage III NSCLC in LMIC resulted in a significant improvement in OS and PFS. The final study results based on complete data are expected in 2020.
在中低收入国家(LMIC),接受放化疗(CRT)治疗的 III 期非小细胞肺癌(NSCLC)患者预后仍然较差。FDG PET/CT 有助于分期、治疗选择和靶区勾画(TVD),其应用虽不断增加,但在 LMIC 仍未广泛应用。CRT 通常作为序贯治疗,但同步放化疗效果更好。PERTAIN 研究旨在评估在 CRT 中引入 FDG PET/CT 引导的同步治疗,同时提供培训和质量控制(QC),对 III 期 NSCLC 患者总生存(OS)和无进展生存(PFS)的影响。
该研究纳入了来自七个国家九个医疗中心的 III 期 NSCLC 患者。回顾性队列于 2010 年 1 月至 2014 年 7 月根据当地实践进行管理,仅为分期进行选择性诊断 FDG PET/CT(不用于 TVD),随后进行序贯或同步 CRT。2015 年 8 月至 2018 年 10 月的前瞻性队列按照研究方案进行治疗,包括治疗位置的 FDG PET/CT 分期和多模态 TVD,然后由专门接受过方案特异性 TVD 培训的专家进行同步 CRT,并进行 TVD QC。Kaplan-Meier 分析用于评估回顾性和前瞻性队列的 OS 和 PFS。
制定并发表了 FDG PET/CT 图像采集和 TVD 指南。所有参与 PERTAIN 研究的专家均于 2014 年 6 月至 2016 年 5 月接受培训。使用的 PET/CT 扫描仪获得了 EARL 认证。2018 年 11 月,对包括回顾性队列中 230 例患者(中位随访 14 个月)和前瞻性队列中 128 例患者(其中 69 例随访至少 1 年)的计划中期分析进行了分析。Kaplan-Meier 方法显示,前瞻性队列的 OS 明显长于回顾性队列(23 个月 vs. 14 个月,p=0.012)。此外,前瞻性队列的中位 PFS 明显长于回顾性队列(17 个月 vs. 11 个月,p=0.012)。
在 PERTAIN 研究中,初步结果表明,在 LMIC 中为 III 期 NSCLC 患者引入 FDG PET/CT 引导的同步 CRT 可显著改善 OS 和 PFS。预计 2020 年将基于完整数据得出最终研究结果。