Even after resection of early-stage non-small-cell lung cancer (NSCLC), patients have a high risk of developing recurrence and second primary lung cancer. We aimed to assess efficacy of a follow-up approach including clinic visits, chest x-rays, chest CT scans, and fibre-optic bronchoscopy versus clinical visits and chest x-rays after surgery for resectable NSCLC. In this multicentre, open-label, randomised, phase 3 trial (IFCT-0302), patients aged 18 years or older and after complete resection of pathological stage I–IIIA NSCLC according to the sixth edition of the TNM classification were enrolled within 8 weeks of resection from 122 hospitals and tertiary centres in France. Patients were randomly assigned (1:1) to CT-based follow-up (clinic visits, chest x-rays, thoraco-abdominal CT scans, and fibre-optic bronchoscopy for non-adenocarcinoma histology) or minimal follow-up (visits and chest x-rays) after surgery for NSCLC, by means of a computer-generated sequence using the minimisation method. Procedures were repeated every 6 months for the first 2 years and yearly until 5 years. The primary endpoint was overall survival analysed in the intention-to-treat population. Secondary endpoints, also analysed in the intention-to-treat population, included disease-free survival. This trial is registered with , , and is active, but not enrolling. Between Jan 3, 2005, and Nov 30, 2012, 1775 patients were enrolled and randomly assigned to a follow-up group (888 patients to the minimal follow-up group; 887 patients to the CT-based follow-up group). Median overall survival was not significantly different between follow-up groups (8·5 years [95% CI 7·4–9·6] in the minimal follow-up group 10·3 years [8·1–not reached] in the CT-based follow-up group; adjusted hazard ratio [HR] 0·95, 95% CI 0·83–1·10; log-rank p=0·49). Disease-free survival was not significantly different between follow-up groups (median not reached [95% CI not estimable–not estimable] in the minimal follow-up group 4·9 [4·3–not reached] in the CT-based follow-up group; adjusted HR 1·14, 95% CI 0·99–1·30; log-rank p=0·063). Recurrence was detected in 246 (27·7%) of 888 patients in the minimal follow-up group and in 289 (32·6%) patients of 887 in the CT-based follow-up group. Second primary lung cancer was diagnosed in 27 (3·0%) patients in the minimal follow-up group and 40 patients (4·5%) in the CT-based follow-up group. No serious adverse events related to the trial procedures were reported. The addition of thoracic CT scans during follow-up, which included clinic visits and chest x-rays after surgery, did not result in longer survival among patients with NSCLC. However, it did enable the detection of more cases of early recurrence and second primary lung cancer, which are more amenable to curative-intent treatment, supporting the use of CT-based follow-up, especially in countries where lung cancer screening is already implemented, alongside with other supportive measures. French Health Ministry, French National Cancer Institute, Weisbrem-Benenson Foundation, La Ligue Nationale Contre Le Cancer, and Lilly Oncology. For the French translation of the abstract see Supplementary Materials section.

中文翻译：

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胸部 CT 扫描加 X 射线与胸部 X 射线对完全切除的非小细胞肺癌随访的比较 (IFCT-0302)：一项多中心、开放标签、随机、3 期试验


即使早期非小细胞肺癌（NSCLC）切除后，患者出现复发和第二原发性肺癌的风险也很高。我们的目的是评估随访方法（包括就诊、胸部 X 光检查、胸部 CT 扫描和纤维支气管镜检查）与可切除 NSCLC 术后临床就诊和胸部 X 光检查的疗效。在这项多中心、开放标签、随机、3 期试验 (IFCT-0302) 中，年龄为 18 岁或以上且根据第六版 TNM 分类完全切除病理学 I-IIIA 期 NSCLC 的患者在 8 周内入组法国 122 家医院和三级中心的切除手术。患者被随机分配 (1:1) 进行基于 CT 的随访（门诊就诊、胸部 X 光检查、胸腹部 CT 扫描和针对非腺癌组织学的纤维支气管镜检查）或最低程度的随访（就诊和随访） NSCLC 手术后，通过使用最小化方法由计算机生成的序列进行胸部 X 光检查。前 2 年每 6 个月重复一次该程序，直到 5 年每年重复一次。主要终点是意向治疗人群的总体生存率分析。次要终点也在意向治疗人群中进行了分析，包括无病生存期。该试验已在 、 、 上注册，并且处于活动状态，但尚未注册。 2005年1月3日至2012年11月30日期间，1775名患者被纳入并随机分配到随访组（888名患者被分配到最低限度随访组；887名患者被分配到基于CT的随访组）。 随访组之间的中位总生存期没有显着差异（最低限度随访组为 8·5 年 [95% CI 7·4–9·6]，随访组为 10·3 年 [8·1–未达到]）基于 CT 的随访组；调整后的风险比 [HR] 0·95，95% CI 0·83–1·10；对数秩 p=0·49）。随访组之间的无病生存率没​​有显着差异（基于 CT 的最小随访组 4·9 中位数未达到 [95% CI 不可估计 - 不可估计] [4·3 - 未达到]）随访组；调整后 HR 1·14，95% CI 0·99–1·30；对数秩 p=0·063）。最低限度随访组的 888 名患者中有 246 名患者 (27·7%) 检测到复发，CT 随访组的 887 名患者中有 289 名患者 (32·6%) 检测到复发。最小化随访组中有 27 名患者（3·0%）被诊断为第二原发性肺癌，CT 随访组中有 40 名患者（4·5%）被诊断为第二原发性肺癌。没有报告与试验程序相关的严重不良事件。随访期间增加胸部 CT 扫描（包括手术后就诊和胸部 X 光检查）并没有延长 NSCLC 患者的生存期。然而，它确实能够检测到更多早期复发和第二原发性肺癌病例，这些病例更适合治愈性治疗，支持使用基于 CT 的随访，特别是在已经实施肺癌筛查的国家，以及其他支持措施。法国卫生部、法国国家癌症研究所、Weisbrem-Benenson 基金会、国家抗癌联盟和礼来肿瘤学。有关摘要的法文翻译，请参阅补充材料部分。