Microwave ablation plus recombinant human endostatin (endostar) versus microwave ablation alone in inoperable stage I non small cell lung cancer.

8551 Background: Previous studies showed that inoperable stage I non small cell lung cancer (NSCLC) benefited from microwave ablation (MWA) alone. This prospective, randomized, control, single-center clinical trial aimed to determining the survival benefit of MWA plus recombinant human endostatin (endostar) compared with MWA alone. Methods: Patients with untreated, inoperable, stage I NSCLC were recruited. They were divided into MWA/ endostar group and MWA group, the former received MWA in the primary tumor sites, followed by 2 to 4 cycles of endostar and the latter treated with MWA only. The primary endpoint was overall survival (OS), the second endpoint included disease-free survival (DFS) , and adverse events (AE). Results: A total of 183 patients were enrolled, involved 92 cases in the MWA/ endostar group and 91 cases in the MWA group. Up to the latest follow-up , there were 24 cases of disease progression and 6 deaths in the MWA/ endostar group, versus 49 cases of disease progression and 9 deaths in the MWA group. DFS in the MWA/ endostar group (30.0 months, 95% CI, 27.1-32.9) was significantly better than MWA group (21.3 months, 95% CI, 19.5-23.1, p = 0.000). But there was no significant difference (p = 0.471) in OS between the MWA/ endostar group (31.6 months ,95% CI, 28.3-35.0) and MWA group (30.0 months, 95% CI, 27.2-36.5). The 1, 2 and 3 year survival rates in the MWA/ endostar group were 94%, 82% and 82%, respectively, while those in the MWA group were 94%, 89% and 89%, respectively. There was no significant difference between the two groups (p = 0.982, p = 0.924, p = 0.924). AEs of MWA were observed in 63.7 % patients. Endostar -associated AEs were not observed in the MWA/ endostar group. Conclusions: MWA was a safe and effective alternative treatment for patients with inoperable stage I non small cell lung cancer. MWA combined with endostar significantly improved DFS compared to MWA alone, while not increased the MWA-related complications.