Video-assisted thoracoscopic versus open lobectomy in patients with early-stage lung cancer: One-year results from a randomized controlled trial (VIOLET).

Abstract

8504 Background: Video assisted thoracoscopic surgery (VATS) is a popular access for lung cancer resection. However, there is limited information from RCTs from in-hospital to one-year clinical efficacy, safety and oncologic outcomes of a minimal access approach. Methods: VIOLET is a parallel group multi-center RCT conducted in 9 centers in the United Kingdom that recruited participants with known or suspected (cT1-3, N0-1 and M0) lung cancer (ISRCTN13472721). Trial protocol: https://bmjopen.bmj.com/content/9/10/e029507.info. Results: From July 2015 to February 2019, 503 participants were randomized to VATS (n=247) or open (n=256) lobectomy. Patients allocated to VATS had less pain with a mean difference (MD) in visual analogue score of -0.54 (95%CI -0.99 to -0.10) despite less analgesic consumption (mean ratio 0.90, 95%CI 0.80 to 1.01). After discharge pain was consistent on multiple sub-scales including overall pain (MD -7.19, -10.59 to -3.80), chest pain (MD -4.66, -7.96 to -1.36) and an 18% relative risk (RR) reduction in incision pain (RR 0.82; 0.72 to 0.94) up to one-year. Better functional recovery continued in VATS arm after discharge with better physical function (primary outcome) with MD of 4.65 (1.69 to 7.61; P=0.002) at 5 weeks and overall improvement in global health status with a MD of 4.21 (1.62 to 6.79; P=0.001). In hospital, VATS arm had fewer complications (RR 0.74, 0.66 to 0.84; P<0.001) with no difference in serious adverse events (RR 0.98, 0.59 to 1.63; P=0.948). Median hospital stay was one day shorter in the VATS arm (4 vs 5 days) corresponding to hazard ratio (HR) for discharge of 1.34, 95%CI 1.09 to 1.65; P=0.006). After discharge VATS arm had 19% less serious adverse events (RR 0.81, 0.66 to 1.00; p=0.053) and lower readmission rates (29.0% vs. 35.9% respectively) to one-year. Of those with lymph node disease, 50.9% in the VATS and 45.9% in open arms received adjuvant treatment. There was no difference in the time to uptake of adjuvant chemotherapy (HR 1.12, 0.62 to 2.02; p=0.716). Recurrence with clinical follow up and CT at one-year was similar with 7.7% versus 8.1% in the VATS and open groups respectively. Progression-free survival (HR 0.74, 0.43 to 1.27; p=0.27) and overall survival HR 0.67, 0.32 to 1.40; p=0.282) was not significantly different. Conclusions: VATS lobectomy for lung cancer is associated with less pain, fewer in-hospital complications and shorter hospital stay, achieved without any compromise to early oncologic outcomes nor serious adverse events. Superior functional recovery continues in the post-operative period with improved physical function, lower re-admission rates and no difference in disease-free and overall survival up to one-year. Clinical trial information: ISRCTN13472721.