Abstract 1220P
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
Inclusion criteria | Patients may enter the trial if all of the followings apply |
Invasive NSCLC is suspected | |
Complete lobectomy and complete resection including mediastinal lymph node dissection is planned | |
No synchronous or metachronous (within five years) malignancies, except for carcinoma in situ or mucosal tumors curatively treated with local therapy | |
Age ≥ 20 years | |
ECOG PS 0–1 | |
Exclusion criteria | Active concurrent malignant diseases |
Beta blocker or beta-2 stimulator medication necessary | |
Preoperative chemotherapy and/or radiotherapy to the target lesion | |
Contraindicated for the test drug, Landiolol |
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.
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