Thoracic Surgery and Endoscopy, University Medicine Essen- Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany.
Departement of Thoracic Surgery, Evangelische Lungenklinik ELK Chest Hospital, Berlin, Germany.
Lung Cancer. 2022 Oct;172:108-116. doi: 10.1016/j.lungcan.2022.08.013. Epub 2022 Aug 24.
The oncological equivalence of anatomical segmentectomy for early stage non-small cell lung cancer (NSCLC) is still controversial. Primary aim of this study was survival outcomes in combination with improved quality of life after segmentectomy compared with lobectomy in patients with pathological stage Ia NSCLC (up to 2 cm, 7th edition) MATERIALS AND METHODS: We conducted a prospective, randomized, multicenter phase III trial to confirm the non-inferiority of segmentectomy to lobectomy in regard to prognosis (trial No. DRKS00004897). Patients were randomized to undergo either segmentectomy or lobectomy and followed up for 5-years survival and tumor recurrence. The 5-year hazard ratio comparing lobectomy with segmentectomy was required to remain above 0.5.
Between October 2013 and June 2016, 108 patients with verified or suspected NSCLC up to 2 cm diameter were enrolled; 54 were assigned to lobectomy and 54 (1 drop-out) to segmentectomy. In-hospital and 90 days mortality was 0% in both groups. Overall survival at 5 years was 86.52% in the lobectomy compared to 78.21% in the segmentectomy group (HR = 0.61, (95% CI 0.23-1.66), p-value of non-inferiority test, p-ni = 0.687). Disease free survival was 77.29% for the lobectomy and 77.96% for the segmentectomy patients (HR = 1.50, (95% CI 0.60-3.76), p-ni = 0.019). At a median follow-up of 5 years, no differences were noted in either the locoregional or distant recurrent disease in both groups (9.4% vs 7.4%, p-ni = 0.506).
Overall survival, locoregional and distant recurrences was not significantly difference for patients undergoing either segmentectomy or lobectomy for stage Ia NSCLC. The targeted non-inferiority of segmentectomy to lobectomy could not be proven for primary endpoint overall survival, but was significant for the secondary endpoint of disease free survival.
解剖性节段切除术治疗早期非小细胞肺癌（NSCLC）的肿瘤学等效性仍存在争议。本研究的主要目的是比较病理分期为 Ia 期 NSCLC（最大直径 2cm，第 7 版）的患者行节段切除术与肺叶切除术的生存结局和生活质量改善。
我们开展了一项前瞻性、随机、多中心 III 期临床试验，以确认节段切除术在预后方面不劣于肺叶切除术（试验编号 DRKS00004897）。患者被随机分为行节段切除术或肺叶切除术，并随访 5 年的生存和肿瘤复发情况。需要将肺叶切除术与节段切除术比较的 5 年风险比保持在 0.5 以上。
2013 年 10 月至 2016 年 6 月，共纳入 108 例经证实或疑似最大直径为 2cm 的 NSCLC 患者；54 例患者被分配行肺叶切除术，54 例（1 例脱落）行节段切除术。两组患者的院内死亡率和 90 天死亡率均为 0%。肺叶切除术组的 5 年总生存率为 86.52%，节段切除术组为 78.21%（HR=0.61，95%CI 0.23-1.66，非劣效性检验 p 值，p-ni=0.687）。肺叶切除术组的无病生存率为 77.29%，节段切除术组为 77.96%（HR=1.50，95%CI 0.60-3.76，p-ni=0.019）。在中位随访 5 年后，两组患者在局部或远处复发方面无差异（9.4%比 7.4%，p-ni=0.506）。
对于病理分期为 Ia 期 NSCLC 的患者，行节段切除术或肺叶切除术在总生存、局部和远处复发方面无显著差异。节段切除术非劣效于肺叶切除术的主要终点总生存不能得到证实，但次要终点无病生存得到证实。
