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胸部CT联合X线vs. X线在完全切除的NSCLC患者中的价值：一项多中心、开放标签、III期临床研究
Westeel V, Foucher P, Scherpereel A, Domas J, Girard P, Trédaniel J, Wislez M, Dumont P, Quoix E, Raffy O, Braun D, Derollez M, Goupil F, Hermann J, Devin E, Barbieux H, Pichon E, Debieuvre D, Ozenne G, Muir JF, Dehette S, Virally J, Grivaux M, Lebargy F, Souquet PJ, Freijat FA, Girard N, Courau E, Azarian R, Farny M, Duhamel JP, Langlais A, Morin F, Milleron B, Zalcman G, Barlesi F. Chest CT scan plus x-ray versus chest x-ray for the follow-up of completely resected non-small-cell lung cancer (IFCT-0302): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Sep;23(9):1180-1188. doi: 10.1016/S1470-2045(22)00451-X. Epub 2022 Aug 11. PMID: 35964621.
研究方法：这是一项多中心、开放标签、III期临床研究，纳入年龄≥18周岁且接受根治性手术切除、病理分期为I-IIIa期的非小细胞肺癌患者，患者在手术后的8周内按照1:1的比例随机分为 CT为基础的随访(临床随访、胸片、胸部CT以及气管镜检查)或单纯胸片检查。前2年每6个月随访一次，随后每年进行一次随访，主要研究终点为OS，次要研究终点为DFS。
研究结果：最终X线组和CT组分别入组888例和887例患者，中位OS分别为8.5年和10.3年，HR=0.95，P=0.49；中位DFS分别为未达到和4.9个月，HR=1.14，P=0.063。X线和CT组分别观察到有27.7%和32.6%的患者出现疾病复发，两组分别有3%和4.5%的患者在随访过程中发现第二原发肺癌，无严重不良事件的报道。
研究结论：针对完全性手术切除的非小细胞肺癌患者，CT的加入并未显著改善患者的生存，但使得更多复发以及第二原发肺癌患者被发现，仍然支持CT作为常规的随访手段，尤其是对于尚未开展CT普查的国家。
Background: 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. Methods: 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 ClinicalTrials.gov, NCT00198341, and is active, but not enrolling. Findings: 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 vs 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 vs 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. Interpretation: 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. Funding: French Health Ministry, French National Cancer Institute, Weisbrem-Benenson Foundation, La Ligue Nationale Contre Le Cancer, and Lilly Oncology.
参考文献：
- Westeel V, Foucher P, Scherpereel A, Domas J, Girard P, Trédaniel J, Wislez M, Dumont P, Quoix E, Raffy O, Braun D, Derollez M, Goupil F, Hermann J, Devin E, Barbieux H, Pichon E, Debieuvre D, Ozenne G, Muir JF, Dehette S, Virally J, Grivaux M, Lebargy F, Souquet PJ, Freijat FA, Girard N, Courau E, Azarian R, Farny M, Duhamel JP, Langlais A, Morin F, Milleron B, Zalcman G, Barlesi F. Chest CT scan plus x-ray versus chest x-ray for the follow-up of completely resected non-small-cell lung cancer (IFCT-0302): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Sep;23(9):1180-1188. doi: 10.1016/S1470-2045(22)00451-X. Epub 2022 Aug 11. PMID: 35964621.
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