Department of Pulmonary Disease, University of Groningen and University Medical Center Groningen, Hanzeplein 1, Box 30.001, 9700 RB, Groningen, Netherlands.
Department of Pulmonary Diseases, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, Netherlands.
Br J Cancer. 2019 Aug;121(5):372-377. doi: 10.1038/s41416-019-0533-3. Epub 2019 Jul 24.
Retrospective studies suggest that low molecular weight heparin may delay the development of metastasis in patients with resected NSCLC.
Multicentre phase 3 study with patients with completely resected NSCLC who were randomised after surgery to receive chemotherapy with or without nadroparin. The main exclusion criteria were R1/2 and wedge/segmental resection. FDG-PET was required. The primary endpoint was recurrence-free survival (RFS).
Among 235 registered patients, 202 were randomised (nadroparin: n = 100; control n = 102). Slow accrual enabled a decrease in the number of patients needed from 600 to 202, providing 80% power to compare RFS with 94 events (α = 0.05; 2-sided). There were no differences in bleeding events between the two groups. The median RFS was 65.2 months (95% CI, 36-NA) in the nadroparin arm and 37.7 months (95% CI, 22.7-NA) in the control arm (HR 0.77 (95% CI, 0.53-1.13, P = 0.19). FDG-PET SUVmax ≥10 predicted a greater likelihood of recurrence in the first year (HR 0.48, 95% CI 0.22-0.9, P = 0.05).
Adjuvant nadroparin did not improve RFS in patients with resected NSCLC. In this study, a high SUVmax predicted a greater likelihood of recurrence in the first year.
Netherlands Trial registry: NTR1250/1217.
回顾性研究表明，低分子肝素可能会延迟 NSCLC 患者转移的发展。
这是一项多中心 3 期临床试验，纳入了完全切除 NSCLC 且术后随机接受化疗加或不加那屈肝素治疗的患者。主要排除标准为 R1/2 和楔形/节段切除术。需要进行 FDG-PET 检查。主要终点是无复发生存（RFS）。
在登记的 235 例患者中，202 例患者被随机分组（那屈肝素组：n=100；对照组：n=102）。由于入组缓慢，将所需患者数量从 600 例减少至 202 例，为比较 RFS 提供了 80%的效能，共有 94 例事件（α=0.05；双侧）。两组之间的出血事件没有差异。那屈肝素组的中位 RFS 为 65.2 个月（95%CI，36-NR），对照组为 37.7 个月（95%CI，22-NR）（HR 0.77（95%CI，0.53-1.13，P=0.19）。FDG-PET SUVmax≥10 在第一年预测复发的可能性更大（HR 0.48，95%CI 0.22-0.9，P=0.05）。
辅助那屈肝素不能改善 NSCLC 患者的 RFS。在这项研究中，高 SUVmax 预测了第一年复发的可能性更大。
荷兰临床试验注册处：NTR1250/1217。
