1220P - A phase III randomized trial investigating preventive effects of perioperative landiolol, a selective beta1 blocker, on the reduction of recurrence of completely resected NSCLC

Background

Recent studies have indicated that perioperative use of beta blockers may be associated with prolonged survival in patients (pts) with NSCLC. This study aims to evaluate the preventive effects of landiolol, an ultra-short-acting beta-1-selective blocker, on reducing recurrence of NSCLC after curative surgery.

Methods

This phase III, multicenter, open-label, randomized trial included two parallel groups of pts with NSCLC, comparing surgery alone (S) with surgery combined with continuous infusion of landiolol for 3 days during the perioperative period (L). The primary endpoints were two-year relapse-free survival (RFS) and overall survival (OS).

Results

A total of 404 patients (pts) were enrolled from 12 Japanese institutions, with pts randomized to L (n=197) and S (n=207). The two-year RFS for L and S were 77.2% (95%CI, 71.8 to 83.8) and 78.5% (70.5 to 82.5), respectively. The hazard ratio (HR) for RFS in L was 0.986 (0.639 to 1.522) compared to S, while the HR for OS was 1.339 (0.752 to 2.382). In the safety analysis set population of 392 pts (192 in L and 200 in S), there were no severe adverse events (SAEs) definitively attributed to the study drug. The incidence of adverse events (AEs) leading to discontinuation of the study drug without definitive causality to the study drug was 3.6% (7/192). Adverse events leading to discontinuation of the study drug included bradycardia in 4 pts, sinus bradycardia, bradyarrhythmia, laryngeal edema, recurrent nerve palsy, hypotension, delirium, and injection site extravasation in 1 pt each. AEs leading to death included one case of interstitial lung disease in the L group, which was not causally related to the study drug. Table: 1220P

Inclusion and exclusion criteria of the study

Conclusions

No significant effect of perioperative landiolol on RFS or OS was observed. Regarding safety, there were no SAEs that definitively correlated with the study drug, and no other notable AEs were observed.

Clinical trial identification

Japan Registry of Clinical Trials, jRCT2011180004, registered 17 January.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Ono Pharmaceutical Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.