Wu Haoxuan, Fu Fangqiu, Ye Ting, Hu Hong, Yu Qiufeng, Zhang Huawei, Jiang Feng, Song Qingping, Ma Junjie, Hei Tao, Cheng Yiyun, Gong Minqiang, Wang Shengping, Gu Yajia, Li Yuan, Wu Wenli, Zhang Yang, Chen Haiquan
Department of Thoracic Surgery and State Key Laboratory of Genetics and Development of Complex Phenotypes, Fudan University Shanghai Cancer Center, Shanghai, 200032, China; Institute of Thoracic Oncology, Fudan University, Shanghai, 200032, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China.
Medical Imaging Center, Liaocheng Tumor Hospital, Liaocheng, 252000, Shandong, China.
J Thorac Oncol. 2025 Sep 20. doi: 10.1016/j.jtho.2025.09.011.
This study aimed to evaluate the safety of active surveillance and establish an individualized management approach for multifocal ground-glass opacities (GGOs).
This prospective multicenter trial (ECTOP1021, NCT06097910) enrolled patients with ≥3 GGOs (tumor diameter ≤2 cm, consolidation-to-tumor ratio [CTR] ≤0.25). The primary endpoint was 5-year overall survival; secondary endpoints included lesion progression. The surgical curative time window was defined as tumor diameter ≤2.0 cm and CTR ≤0.25, a safe radiologic profile during which patients could achieve definite cure after resection.
A total of 406 patients were recruited from five centers. The cohort consisted predominantly of females (75.6%) and never smokers (87.2%), with a median age of 53 years. In total, 1,496 lesions were under surveillance, with a median of three GGOs per patient. The median diameter of the dominant lesion was 0.8 cm. At a median follow-up of 35.4 months, the 5-year overall survival was 100%. Progression occurred in 8.1% of patients, while 1.5% developed new lesions. The median increase in tumor diameter was 0.3 cm. Eight patients underwent surgery after enrollment, all pathologic stage IA1; four had invasive adenocarcinoma and four had minimally invasive adenocarcinoma. Patients were categorized into three groups based on estimated lung function loss if complete resection, with tailored strategies accordingly.
Active surveillance within the surgical curative time window appears to be safe and feasible for patients with multifocal GGOs in the short term. It offers an alternative to immediate surgery and rationalized individualized, scenario-based management strategies.
本研究旨在评估主动监测的安全性，并建立针对多灶性磨玻璃影（GGO）的个体化管理方法。
这项前瞻性多中心试验（ECTOP1021，NCT06097910）纳入了具有≥3个GGO（肿瘤直径≤2 cm，实变与肿瘤比率[CTR]≤0.25）的患者。主要终点是5年总生存率；次要终点包括病变进展。手术治愈时间窗定义为肿瘤直径≤2.0 cm且CTR≤0.25，这是一种安全的影像学特征，在此期间患者切除术后可实现明确治愈。
共从五个中心招募了406例患者。该队列主要由女性（75.6%）和从不吸烟者（87.2%）组成，中位年龄为53岁。总共监测了1496个病变，每位患者平均有3个GGO。主要病变的中位直径为0.8 cm。在中位随访35.4个月时，5年总生存率为100%。8.1%的患者出现进展，1.5%的患者出现新病变。肿瘤直径的中位增加为0.3 cm。8例患者入组后接受了手术，均为病理IA1期；4例为浸润性腺癌，4例为微浸润性腺癌。根据完全切除时估计的肺功能损失将患者分为三组，并相应制定了个性化策略。
在手术治愈时间窗内进行主动监测对于多灶性GGO患者在短期内似乎是安全可行的。它为立即手术提供了一种替代方案，并为基于个体化、情景化的管理策略提供了合理依据。
